pharmaceutical processing - march 2009

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NEW TECHNOLOGY FOR THE BIOPHARM/PHARMACEUTICAL PROFESSIONAL MARCH 2009

THE VIRTUES OF VALIDATIONGambling With ERP System Validation?A toolkit approach can help to eliminate risk and maintain compliance.

Following The Path To ComplianceHow to stack cGMP audit preparation chips in your favor.

Measure Twice - Fill OnceCheckweighers help AstraZeneca in a tight spot.

Ebb And FlowUnderstanding powder flow behavior.

Time Capsules The history of the hard two-piece capsule.

Using Vision To Your Advantage Vision sensors are ideal for a host of applications.

Lab Eliminates Manual Labeling Automated solution saves time, labor for testing facility.

Pharma ITImproving IT compliance return on investment.

INTERPHEX2009 FACILITY OF THE YEAR CATEGORY WINNERSAseptic TechnologiesEQUIPMENT INNOVATION

Centocor Biologics, IrelandSUSTAINABILITY

Centocor R&D, SchaffhausenFACILITY INTEGRATION

Hameln Pharma OPERATIONAL EXCELLENCE

Orchid Chemicals &PharmaceuticalsREGIONAL EXCELLENCE

Roche Pharma BiotechProduction, BaselPROJECT EXECUTION

EXHIBITOR HIGHLIGHTS

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■ IN THIS ISSUE

■ P H A R M P R O . C O M

■ 4 MARCH 2009 | PHARMACEUTICAL PROCESSING

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Volume 24, Number 00PUBLISHER, MIKE KELLY

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EDITOR-IN-CHIEF, MICHAEL AUERBACH 973-920-7055

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AUDIENCE DEVELOPMENT GAIL KIRBERGER

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EDITORIAL ADVISORY BOARDMichael J. Beier,

Senior Vice President of OperationsTITAN PHARMACEUTICALS, INC.

Dr. James V. Blackwell, PhD, ConsultantBIOPROCESS TECHNOLOGY CONSULTANTS, INC.

Ronald C. Branning, Vice President Global Quality

GENENTECH INC.Robert F. Dream, Vice President

H.D.R. COMPANY LTD.Johanna Carmel Egan,

VGP Project ManagementELI LILLY

Girish Malhotra, PresidentEPCOT INTERNATIONAL

Allan F. Pfitzenmaier, PresidentVECTECH PHARMA CONSULTANTS INC.

Susan Polizzotto, Manager, R&D QA GMP Compliance

US SANOFI PASTEURCarlos Villalobos, Sr. Dir. Global Engineering

BRISTOL-MYERS SQUIBBRichard G. Whitfield, Senior Director

PFIZERPatrick Wong, Director of Global Engineering

BRISTOL-MYERS SQUIBB (BMS)

16 Measure Twice - Fill Once Checkweighers help AstraZeneca in a tight spot.

18 Ebb And Flow Understanding powder flow behavior.

56 Time Capsules The history of the hard two-piece capsule.

58 Using Vision To Your Advantage Vision sensors are ideal for a host of applications.

60 Lab Eliminates Manual Labeling Automated solution saves time, labor for testing facility.

62 Pharma IT Improving IT compliance return on investment.

THE VIRTUES OF VALIDATION

8 Gambling With ERP System Validation?

A toolkit approach can help to eliminate risk and maintain compliance.

12 Following The Path To Compliance

How to stack cGMP audit preparation chips in your favor.

page 19

■ DEPARTMENTS

6 From The Editor

34 What’s Hot

66 INNOVATIONS:Mixing & Blending

On the Cover: Processing of

tamper-evdent caps for bulk

syringes at Centocor's

R&D facility in Schaffhausen,

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INTERPHEX 2009 FACILITY OF THE YEAR CATEGORY WINNERS22 Aseptic Technologies - EQUIPMENT INNOVATION

24 Centocor Biologics, Ireland - SUSTAINABILITY

26 Centocor R&D, Schaffhausen - FACILITY INTEGRATION

28 Hameln Pharma - OPERATIONAL EXCELLENCE

30 Orchid Chemicals & Pharmaceuticals - REGIONAL EXCELLENCE

32 Roche Pharma Biotech Production, Basel - PROJECT EXECUTION

36 EXHIBITOR HIGHLIGHTS

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TThe financial history of this great land of ours is filled with ups and downs. During this century we have seen several financial downturns - from the great depression of the 1930's through various recessions it seems as if this country's financial fortunes are forever on a roller coaster ride. Indeed - this history of financial ruin and rebound goes back even farther - my daughter was recently learning about "The Panic of 1837" so it really should surprise no one that this country is on some sort of financial boom and bust schedule. The problem as I see it is that no one seems to remember the past and works toward

not repeating it. Oh sure, measures are put into place to pre-

vent the same thing from happening again, but time and prob-ably most importantly greed, always win out and we find ourselves scratching our heads and saying - "I thought we fixed that years ago."

My fear is that a similar situation is brewing in the pharmaceuti-cal industry. Not a financial situation (although that topic could take up many pages) but one of drug safety. In the 1980's we had the Tylenol scare; earlier in this decade Vioxx and other similar drugs were grabbing headlines with their safety related problems; and now the problems and health risks of Raptiva are reaching a boiling point. Back in October the FDA added a warning to Raptiva after a 70-year old patient caught PML (progressive multifocal leukoencephalopathy) and died. The FDA is now saying there are at least three deaths asso-ciated with this drug and possibly a fourth.

To their credit, as of this writing, several regulatory agencies world-wide have already sounded the alarm. European Union regulators have recommended a ban on marketing the drug and Health Canada recommended distributor EMD Serono Canada Inc. also stop the mar-keting of Raptiva.

Let's hope the FDA steps into this situation and takes control. At this current time and place in history the industry can't afford to have history repeat itself.

■ FROM THE EDITOR


Déjà Vu - All Over Again

Have a comment or question about Pharmaceutical Processing? My E-mail is: [email protected]

My fear is that a similar situation is brewing

in the pharmaceutical industry. Not a financial

situation (although that topic could take up

many pages) but one of drug safety…

■ Michael Auerbach, Editor in Chief


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Enterprise Resource Planning (ERP) systems are increasingly deployed within life sciences companies to help improve resource management and increase operational efficiency. As these organizations

endeavor to accelerate new products to market faster, they encounter many of the requirements of other manu-

facturers but also must achieve the hurdle of software validation and verification of these complex solutions prior to deployment in a cGMP environment. For many years, ERP implementations have been plagued by poor project manage-ment and complexities which extend far beyond the boundar-ies of the I.T. organization. Significant time and money has been spent with sometimes arguably few successful implemen-tations. As life sciences companies increase their deployment of ERP solutions, they must have a clear, practical approach for software validation to ensure sustained compliance. This article will address some of the key implementation challenges unique to ERP implementations, validation implementation strategies and principles, and an efficient, cost-effective approach leveraging a validation toolkit.

THE PRINCIPLE OF INTENDED USE Software validation is a requirement of the

Quality System regulation, which was published in the Federal Register on October 7, 1996 and took ef-fect on June 1, 1997. According to U.S. FDA General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 11, 2002 “…com-puter systems used to create, modify, and maintain electronic records and to manage electronic sig-natures are also subject to the validation require-ments. (See 21 CFR §11.10(a).) Such computer systems must be validated to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records….” In general terms, ERP systems create mission-critical electronic records and are thus subjected to the valida-tion requirements. The level of validation performed on these systems should be commensurate with the level of risk imposed by the system. It is strongly recommended that a comprehensive, docu-mented risk assessment precede any vali-dation effort for ERP systems. One aspect of software validation that is sometimes overlooked in ERP implementations in

particular is the principle of “intended use”. Many companies do not take the time to define clear, reasonable requirements for the system thus making it nearly impossible to properly validate the system. According to FDA guidelines for software validation, test protocols must be developed and executed to determine if the software is suitable for its intended use. The intended use principle provides the context for the validation and is an essential element of the overall validation. Many companies focus on the development and execution of the test protocols and often overlook this fundamental requirement. ERP systems by their nature are complex systems involving comprehensive master data schemes and other relevant in-formation. Failure to clearly understand how this information is “intended” to be used across highly regulated processes can have catastrophic regulatory implications. The “intended use” of the system is typically documented in the User

Requirements Specification (URS) as part of the vali-

Gambling With ERP ■ By Valarie King-Bailey, CEO, OnShore Technology Group, Inc.

■ P H A R M P R O . C O M■ C O V E R S T O R Y

A toolkit approach can help to eliminate risk and maintain compliance


ERP environment drives cost savings from server consolidation and improved develop-ment efficiencies. The Info-Tech Research Group, in a January 2009 research paper reported that ERP virtualization may drop project Total Cost of Ownership (TCO) by as much as 30%. The reason for this impact is clear. Virtualization has been shown to significantly reduce the cost of setting up sepa-rate servers for validation, development, QA, and production machines required for an effective validation infra-structure. Setting up a multi-server environment typically in-volves buying multiple pieces of physical hardware which adds to the overall expense of the project. The obvious downside to this approach is the steep labor and equipment costs to install, maintain, and deploy physical hardware. Also, power consump-tion and energy requirements may have significant impact on the organization as a whole. Validation best practices for ERP systems require the setup of development, testing, and the production server environment so that software can be tested and implemented in a compliant, cGMP change controlled man-ner. This time-tested approach is intended to reduce risk and ensure a sustained validated state.

The question is, how does validation change when ERP systems are deployed in a virtual systems environment? What is the difference between the physical environment and the virtual environment from a validation perspec-tive? When validating a virtual infrastructure there are several key points which must be considered prior to adopting a virtualized approach. These are: 1. Physical Server Running Virtualization Software 2. System Deployment 3. Change Control

When leveraging a virtualized server environ-ment, it is understood that validation of the virtu-alization software is a key consideration. Validation protocols must be developed for each virtual machine to ensure that a repeatable process which protects the integ-rity and authenticity of the data stored. The recommended validation strategy in a virtual environment is as follows: 1. Physical Server Qualification - Develop comprehensive pro-

tocols for the Installation Qualification (IQ) of the physical server(s) in a non-virtualized physical environment.

2. Install and Qualify Virtualization Software – Upon comple-tion of the physical server IQ, an IQ for the virtualization software should be executed.

3. Virtualization Maintenance & Operation Process – After the successful IQ of the physical and virtualization soft-ware, it is important to document the process required for successful maintenance and operation of the virtual sys-

PHARMACEUTICAL PROCESSING | MARCH 2009 9 ■


■ C O V E R S T O R Y

dation artifacts. A good URS should define requirements that are easily tested through your validation initiative.

RISK: THE ELEPHANT IN THE ROOM Now more than ever, life sciences companies are increasingly

risk-averse. In these changing economic times, failure to over-look risk can have consequences that extend far beyond compli-ance boundaries. Risk-based validation is not a new concept. For many years, the FDA has advocated a risk-based approach to help minimize regulatory burdens and to help organizations answer the age-old question “how much validation is enough”. The position of the regulators has always been that the propor-tionate level of validation conducted should be based on the amount of risk attributed to the records generated by the sys-tem. Given the impact of ERP systems on financial, manufactur-ing, and business processes, risk is an important consideration for software validation of these systems. In one key aspect of regulatory requirements governing electronic records and signa-tures known as 21 CFR Part 11, the FDA recommends that soft-ware validation be focused on “a justified and documented risk assessment and a determination of the potential of the system to affect product quality and safety, and record integrity.” Many ERP systems increasingly include Part 11 features which make

them subject to these requirements and a documented risk assessment. For those organizations implement-

ing ERP systems, it should be noted that risk is highly dependent on the specific processes the system facilitates. ERP processes which

must be assessed include those within the system that create, transmit, archive, or

analyze records. A proper risk assessment must include the classification and

prioritization of each identi-fied risk. Once each risk has properly been catego-

rized and classified, the as-sessment of these risks can

then be used to help de-fine the proper extent

of validation required for the ERP system.

VIRTUALIZATION AND VALIDATION

As life sciences companies in-creasingly embrace virtualization as a

means to reduce the cost and complexity of their I.T. infrastructure, the impact on soft-

ware validation must be considered. Virtualizing the

System Validation?

tems environment including change control and disaster recovery procedures.

4. Complete IQ/OQ/PQ of ERP Software in Virtual Environment – The next logical step in the process is to execute IQ/OQ/PQ’s for all ERP software components in the virtual systems environment. The Validation Master Plan

should reflect the fact that a virtualized environment is de-ployed with the appropriate risk assessment to ensure the proper level of validation testing. It is strongly recom-mended that you initially invest time and ef-fort into designing, documenting, and testing your virtual platform up front.

It is important not to overlook the risk as-sessment aspect in a virtual environment as well as the disaster recovery plan.

ERP VALIDATION TOOLKIT – A PRACTICAL APPROACH TO VALIDATION

It has often been said that software valida-tion can cost as much as 50-100% or more of the software cost. Further, once an ERP system is implemented and validated, you must ensure that changes or enhancements to the validated configuration are properly documented. This may involve significant I.T. resources, time, and money to produce the required supporting documentation. Efficiency and cost-effectiveness are very important when validating ERP systems. However, as most organizations undertake software valida-tion initiatives, especially involving ERP, the question of how to save time and money is a key consideration.

Validation of custom software in general requires more validation due diligence than Commercially-Off-the-Shelf (COTS) software applications. Most ERP solutions are deployed as modular solutions using COTS software. For COTS software implementations, many companies are turning to the use of ‘validation toolkits’ to accelerate validation and produce the required deliverables. Validation Toolkits are defined as ‘accelerators’ which help jump start the validation document deliverables. A good validation toolkit will provide detailed document templates and protocols required for each validation effort. The most time-con-

suming document de-liverables to produce are the validation test

protocols. For an ERP sys-tem, these may be hundreds

of pages in length covering the required ‘intended use’ func-tionality of the ERP solution. The validation toolkit would not only provide the IQ/OQ/PQ test protocols but templates to

help accelerate the production of other validation deliverables.

Samples of some of toolkit deliver-ables are:

• Validation Master Plan & Risk Assessment • Validation Project Plan • User Requirements Specification (Intended

Use) • Functional Requirements Specification • 21 CFR Part 11 Assessment • Installation/Migration Plan (optional) • Installation Qualification (IQ’s) • Disaster Recovery Plan • Requirements Traceability Matrix • OQ Test Scripts - (Pre-Approved) • OQ Test Scripts - (Post-Approved) • Validation Summary Report • Final System Acceptance

The toolkit has many benefits which could save hundreds of man-hours on your next validation initiative. A summary of ben-efits includes: • Pre-Defined Validation Test Protocols – the

pre-written protocols are a huge time-saver for validation teams. These protocols can be reused or updated to meet any validation project requirements.

• Standard Methodology – Most validation tool-kits leverage standard methodology such as GAMP to ensure consistency in deliverables and implementation.

• Edit Versus Create – The toolkit allows users to edit pre-defined validation artifacts versus creating them from scratch.

• Proven Testing – The test methods have been proven over hundreds of implemen-tations thus, the user gets the benefit of knowing that the protocols are correct and the results are suitable for an FDA regulated environment.

• 21 CFR Part 11 – Compliant – The validation toolkits are often delivered with a 21 CFR Part 11 compliant assessment. This helps to ensure that the system to be validated con-

forms to the require-ments of Part 11.

• Built-in Risk Assessment – The toolkit

should include a comprehen-sive validation risk assessment based on GAMP methodology.

• Pre-defined requirements for Virtual Environment – The validation toolkit should deliver everything you need to validate your ERP system in a virtual environment. The test kit should include protocols for testing the virtualization software so that this does not have to be recreated for each validation initiative. A re there validation toolkits available for

ERP systems? The answer is yes. Fullscope has developed a validation toolkit for Microsoft Dynamics AX 2009 for process in-dustries. The toolkit is delivered on DVD and is exclusively designed to help companies overcome the challenges associated with soft-ware validation of ERP systems.

SUMMARY As life sciences companies seek to stream-

line validation efforts, the three main emerg-ing trends to watch are validation of ERP in a virtualized environment, more comprehensive risk assessment, and the use of validation toolkits to streamline the process. Lessons learned from many previous efforts clearly indicate that validation without a clear defini-tion of intended use is not acceptable. The in-tended use principle is alive and well and must be included within the User Requirements Specification (URS). To ensure that your valida-tion due diligence is commensurate with the appropriate level of risk, it is strongly recom-mended that a comprehensive risk assessment accompany any validation effort.

And finally, validation no longer has to be the burden many perceive it to be. Virtual-ization is here to stay and many companies are embracing this strategy as part of their overall implementation strategy. Virtualization requires the validation and verification of the virtualization software and its environment. Many organizations are leveraging validation toolkits to help accelerate validation initiatives. 21st century validation strategies require inno-vative techniques and methodologies to ensure success. Virtualization and the use of valida-tion toolkits help reduce the level of effort, save costs, and accelerate deployment.


■ C O V E R S T O R Y■ P H A R M P R O . C O M

Drug companies lose upwards of $600,000 - $1M of revenue for every day their drug is not avail-able in the market. Typically these figures are drawn to represent the need for speedy clinical

development; however, in this article we will talk about the enormous financial detriment of having a drug pulled from the market – even temporarily – by a regulatory agency due to a host of possible reasons.

As a consumer, if you learned that a drug was sud-denly taken off the shelves by the FDA due to incon-sistent quality control processes, for example, would you be clamoring for the product’s eventual return? Probably not. You’d likely look to alternative treat-ments if they were available and would have a negative sentiment in your mind about the drug manufacturer as well as its drug.

The point here is that the $800M+ it costs to bring a drug to market is only half the battle for drug manufac-turers. The balance of the equation is the ability to effectively and compliantly manufacture that product with unwavering consistency to ensure patient safety, mitigate risk and maintain regulatory compliance.

This article will explore the severe consequences a drug company can face if they deviate from current Good Manufacturing Practices. It will also discuss some of the so-lutions available to help these organizations streamline their quality assurance programs companywide. Moreover, with the right centralized systems in place, drug firms can better adhere to regulations, enhance operational performance, improve product quality and even derive critical intelligence from across the organization. In turn, the organization will avoid costly missteps in the manufacturing process and stave off avoidable violations and liabilities.

NON-COMPLIANCE Drug manufacturing quality is of utmost importance when

the FDA or some other regulatory body comes to conduct an impromptu or scheduled audit of a drug firm’s manufacturing operation. The pur-pose of these audits is to ensure current Good Manufacturing Practices are followed by the pharmaceutical and biotech firms to ensure that

the products produced meet specific requirements for identity, strength, quality, and purity.” (FDA guidance 21 CFR 211)

U sing the $600,000/day figure cited above for daily lost rev-enue of a pharmaceutical or biologic drug, this would equate to $18M for every month a manufacturer’s drug was not on the market. These numbers are simply too staggering for any

drug manufacturer to bear, especially given the tight patent exclusivity timelines and

heightened competition from generic drugs. By implementing the right cen-tralized systems, procedures and tech-nologies, firms can protect themselves from such product recalls and related

liabilities.

AUDIT PREPARATION AND MANAGEMENT

There are a number of issues today with how most pharmaceutical and biotechnology firms

prepare for and manage internal and external audits. First and foremost, there is almost always a lack of data central-ization to provide a companywide view of quality, risk and compliance. These large companies typically have multiple auditing groups and disparate systems spread across many geographic regions. This can make it quite difficult and inef-ficient to find and report on important information, track and trend observations and CAPA for improvement purposes and to keep tight reigns on processes that impact safety, quality and compliance.

Many drug companies today rely on Excel spreadsheets and inadequate home-grown applications to manage their product manufacturing processes. This is alarming when you consider that these are the same bellwethers whose products likely fill your home medicine cabinet. The fact of the matter is that neither ad hoc “solution” comes anywhere close to providing the necessary level of functionality and centrality to ensure cohesive global compliance and consis-

tent quality manufacturing. Fortunately there are comprehensive tools available on the market that can help these firms success-

fully navigate the turbulent waters surrounding quality drug manufacturing.

Following The Path To Compliance How to stack cGMP audit preparation chips in your favor■ By Mike Jovanis, VP Product Management, Sparta Systems

■ P H A R M P R O . C O M■ C O M P L I A N C E


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COMPREHENSIVE AUDIT MANAGEMENT SOFTWARE

Tightly integrated audit management soft-ware solutions can be installed at the company level to centralize all quality, risk and compli-ance data across the firm. An integrated closed loop tracking system, a powerful workflow engine, intelligent process auto-mation and internal control mechanisms harmonize qual-ity assurance practices, stan-dardize reporting, improve audit planning, identify root causes of inconsistencies, uncover insightful trends and afford a host of other benefits.

In turn, this helps the firm in-crease performance across the organization. Specifically, manufacturers can expect the following types of value: • Improved quality and enhanced compli-

ance across the manufacturing lifecycle by ensuring commitments are met, observa-tions and CAPAs are closed and all com-munication channels are open to share critical information

• Reduced liability by fa-cilitating visibility into significant business risks be-fore they become problematic.

• Improved operational performance by streamlining and integrating all reporting and tracking, and automating the entire audit lifecycle .

• Increased revenues and decreased expenses by improving efficiency

of auditing programs world-wide, eliminating redundant efforts, removing duplicate audit systems and driving

faster auditor response times. These enterprise software

systems can integrate with other leg-acy systems within the organization to drive process standardization, data normalization and quality manufacturing operations.

CONCLUSION As the drug industry continues to consoli-

date, development costs continue to skyrocket, patient risks continue to gain widespread atten-tion, and standards become even stricter, man-

ufacturers need to find ways to increase performance and miti-

gate risk. That is, they need to get their products to market even faster (and keep them there), while continuing to improve qual-ity, increase patient safety, and contain costs. This is definitely a very tall order. However, with the right tools and systems in place, these challenges can be met and overcome.

A company’s ability to anticipate, prepare for and successfully pass regulatory audits is paramount to its success in the tumultuous drug development and manufacturing indus-try. With drugs already being pulled off the shelves at a record pace due to poor manufac-turing quality, firms need the right audit man-agement/quality assurance program in place.

This becomes even more critical when you consider the eventual emergence of personal-ized medicine. The advent of individualized care and its foretold dramatic impact on drug manu-facturing as we know it, will raise the stakes of successful drug development to a level never seen before. When this happens, drug firms that haven’t prepared themselves adequately will find themselves in deep trouble ■

■ P H A R M P R O . C O M■ C O M P L I A N C E

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C linical drug trials provide a precisely-calibrated daily dose to partici-

pants: too little, and the trial data is useless; too much, and the patient is in danger.

The Investigational Products group, part of the Pharmaceutical and Analytical R&D function located at the AstraZeneca plant in Newark, DE, has a bottle-filling line that is utilized for the packag-ing of clinical trials. Prior to installing the Mettler-Toledo Hi-Speed checkweighers, bottle count verification was performed by 100 percent visual inspection and by manu-ally checkweighing in-process samples. This process required a high amount of resource and at times affected the efficiency of the bottle-filling operation.

In order to obtain the required accuracy, the IPS group needed to weigh the bottles they were filling twice and very pre-cisely. The first weigh would be of the empty bottle; this would establish the tare weighment of each bottle prior to filling. The bottles would be weighed a second time after filling to establish the gross weight of the bottle. The two checkweighers communi-cated with each other so each bottle’s tare weight would be de-ducted from the gross weight, thus eliminating any bottle weight variability in the final weight. This allows precise measurement of the materials packaged inside the bottle. The filling line is ca-pable of speeds of 45 to 50 bottles per minutes and the margin of error was less than a quarter of a gram per bottle.

THE SPACE RACE To make it even more challenging, space was an issue.

One scale had to be located on a right angle turn and the second one had to be mounted in a small area prior to cap-ping. Senior Delivery Technologist David Flynn turned to Mettler-Toledo Hi-Speed Checkweighing.

“Accuracy is critical in this application,” Flynn said. “We need to maintain good compliance with the clinical trial, so instead of having 50 or 100 tablets per bottle (as on a normal pharmaceutical filling line), we had just three or four – a pa-

tient’s one-day dose. The patient opens the bottle and swallows everything in-side. One more tablet or one less tablet makes a big difference in this applica-tion.” Patient safety and compliance are a major concern with these fills.

The square plastic bottles themselves added another vari-able to the problem. Variability in the weight of these bottles, not normally a significant factor in a production line, became an issue because of the precision required on this line. Two checkweighers – one for tare and one for gross – would need to be synchronized precisely and communicate with each other to ensure that a particular bottle’s tare matched with its gross.

Just to make things more interesting, this precision weigh-ing had to take place in a corner of the filling line. Here the checkweigher would have to change the direction of the bottles by 270 degrees, rather than the usual 360, and work in a tight space. The Mettler Toledo Starweigh checkweigh-ers were customized to make less than a full turn, fit into the two-foot-square opening in the line, and set over the existing conveyor belt so that no holes needed to be cut in the line.

“We looked around and found that Hi-Speed was the only company that could do this,” Flynn said. “They adapted their checkweigher to our particular application and it took consid-erable engineering to make it work. They also provided a ma-chine that didn’t require change parts when we changed bottle size. There is no need to change parts between production runs of different size bottles, this equates to less downtime, im-proved efficiencies and less frustration for the operator.” ■

Measure Twice - Fill Once Checkweighers help AstraZeneca ensure accuracy in a tight spot


■ P H A R M P R O . C O M■ F I L L I N G

Top, Astra Zeneca manages opera-tions on their bottle filling line using a Starweigh tare-gross system from Mettler-Toledo Hi-Speed. Center, Empty bottle weights are captured by the Hi-Speed Starweigh prior to filling. Bottom, The Hi-Speed Starweigh tare-gross system opera-tion and process monitoring is fast and easy with the large XS display.

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Manufacturing solid dosage forms involves several powder handling steps, including blending, transfer, storage, and feeding. This article discusses common powder handling

problems, the powder and equipment properties that can influence these problems, and some possible solutions.

FLOWABILITY The inability to achieve reliable powder flow can have an

adverse effect on the manufacture and release of a product to market. Production costs can be higher than anticipated due to excessive intervention by operators, low yield or unplanned process redesign. An understanding of key flow properties and equipment parameters can reduce these risks. Although beyond the scope of this article, there is a substantial amount of available literature regarding the mea-surement of flow properties 1-5 and addressing uniformity concerns 6, 7 that can be used to further understanding.

A powder (or bulk solid) is simply a collection of discrete solid particles. The concepts discussed in this article ap-ply to many types of solids including individual ingredients, granulations and dry blends.

Flowability describes the ability of a powder to flow through equipment reliably. There is a tendency to define flowability as a one-dimensional characteristic (e.g., a single “flow property”), usually ranking the powder on a scale from free flowing to non-flowing. A single parameter,

however, is insufficient to fully define a powder’s handling characteristics or to provide design parameters needed to address common handling concerns. Powder flow behavior is multi-dimensional, and therefore a range of flow proper-ties must be measured to characterize it 2 .

The observed flow behavior of a given powder is a function of both its flow properties and the design of the equipment used with it. A poor-flowing powder can be handled reliably in properly designed equipment, while a good-flowing powder may develop problems in improperly designed equipment. Therefore, a more accurate definition of flowability is the ability of powder to flow in the desired manner in a specific piece of equipment.

Ebb And Flow Understanding powder flow behavior ■ By Roger Barnum, Senior Consultant, Jenike & Johanson, Inc., Bulk Solids: Science/Engineering/Design


■ P H A R M P R O . C O M■POWDER HANDLING

Figure 1: The two primary flow patterns that occur in gravity discharge are funnel flow and mass flow.

Figure 2: Hoppers with asymmetric cones often provide funnel flow. Rectangular to round transitions (not pictured) can also provide funnel flow.

FLOW PATTERNS One of the first steps in assessing potential flow prob-

lems is to determine the flow pattern that will occur dur-ing gravity discharge of the powder through the handling equipment. There are two primary flow patterns that can occur: funnel flow and mass flow (Figure 1). In funnel flow, an active flow channel forms above the outlet, which is sur-rounded by stagnant material. This is a first-in, last-out flow sequence. It generally occurs in equipment with relatively shallow hoppers, often including hopper geometries such as the asymmetric cones common to tablet press feed hoppers and bins with rectangular-to-round transitions (Figure 2). In funnel flow, as the level of powder decreases, stagnant pow-der may fall into the flow channel, provided the material is sufficiently free flowing. If the powder is cohesive, a stable “rathole” may develop (Figure 3).

In mass flow, all the powder within the equipment moves when any is withdrawn. Mass flow provides a first-in, first-out flow sequence, eliminates stagnant powder, and pro-vides a steady discharge with a consistent bulk density. As a result, designing handling equipment for mass flow provides many benefits. Achieving mass flow requires an outlet large enough to prevent arching and hopper walls that are steep and smooth enough to allow the powder to flow along them. Flow properties tests and calculations are used to deter-mine these design parameters 1 .

Although mass flow designs can overcome a number of potential flow problems, it should be noted that adverse two-phase (powder and interstitial gas) flow effects can still remain. These effects can limit production rates and/or result in unacceptable variation in the product properties (weight, thickness, hardness, dissolution, etc.). This behav-ior is most common with fine powders (i.e., mean particle size of 150 microns or less) 2 .

An understanding of flow patterns is one of the steps that should be used in designing handling equipment. Each flow pattern has its own criteria, which can also be used to assess the suitability of existing equipment for a new material. These evaluations can be used for equipment ranging from storage silos to portable bins, transfer chutes and feed hoppers.

RELIABLE FUNNEL FLOW DESIGN Although mass flow has many advantages, there are in-

stances where funnel flow is appropriate. A funnel flow design can be considered if all of the following conditions are met: 1. Segregation is not a concern. Since funnel flow will result

in a first-in, last-out flow sequence, any side-to-side segre-gation that occurred when the equipment was filled will often be exacerbated 7 .

2. The powder has relatively low cohesive strength. High cohe-sive strength may result in the formation of a stable rathole.

3. Flooding is not a concern. Flooding can result in a highly aerated (low-density) powder from a feed system to a tablet press or encapsulator, which may adversely af-fect the tablet or capsule properties or become a further source of segregation 2 .

4. Bulk density variations are not a concern. Much of the machinery used to produce final dosage forms (e.g., tablets and capsules) relies on volumetric feeding. A funnel flow feed system will re-sult a more variable powder density than mass flow, since the powder will be subjected to different consolidation pressures depending on where in the equipment it was recovered from. If all four of these conditions are met, funnel flow can be

considered. The first requirement for such a design is the outlet diam-

eter, which should be greater than the critical rathole diameter (Df) calculated from cohesive strength test results, to ensure that a stable rathole will not form 1 . If ratholing is a concern,



■ POWDER HANDLING

Figure 3: Stagnant, cohesive powders can form a stable rathole in funnel flow.

Figure 4: Critical parameters to select when designing mass flow bins and hoppers

several changes can be considered to mini-mize the potential. The outlet size can be increased (within reason, of course, while still allowing an interface with downstream equip-ment), the powder fill height or equipment capacity can be reduced (thus reducing the

consolidation of the powder within, and the resulting Df), or custom equipment features such as agitation and/or mechanical assis-tance can be utilized 8 . If the option is avail-able, changing (or reformulating) the powder to reduce its cohesive strength can also reduce the likelihood of ratholing. Common methods to improve this property include increasing particle size, lowering the moisture content, and using a lubricant or glidant.

If one of the conditions for selecting funnel flow is not met (e.g., segregation is a concern), or the options available to prevent a rathole are infeasible or impractical for a given appli-

cation, mass flow should be utilized. A mass flow design cannot rathole because the pow-der moves along the hopper walls.

DESIGNING FOR MASS FLOW When designing for mass flow, these gen-

eral guidelines should be followed: 1. Size the outlet to prevent a cohesive

arch. Cohesive strength test results are used to determine the required minimum sizes. The outlet diameter should be equal to or larger than the minimum diameter (Bc, Figure 4). If a slotted outlet is used, the outlet width should be sized to be equal to or larger than the minimum slot width (Bp), provided its length is at least 3 times its width. The outlet may also need to be sized based on feed rate and two-phase flow con-siderations 2 . If the outlet cannot be sized to prevent an arch (e.g., because the tablet

press hopper outlet must mate with a fixed feed frame inlet), agitation and/or mechani-cal assistance can again be considered.

2. Once the outlet is sized, design the hopper wall slope to be equal to or steeper than the recommended hopper angle for the selected wall

surface. For a conical hopper, the walls should be equal to or steeper than the recommended mass flow angle for a conical hopper (�c), based on wall friction tests. If the hopper has a rectangular-to-round hopper, the valley angles (that form at the intersection of adjacent side walls) should be sloped to be equal to or steeper than �c. Planar walls should be equal to or steeper than the recommended mass flow angle for a planar hopper (�p) , provided the outlet length is at least 3 times its width and the feeder or valve below can provide active discharge over the entire outlet area.

3. Thoroughly specify interior wall surface fin-

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■ P H A R M P R O . C O M■ POWDER HANDLING


The observed flow behavior of a given powder is a function of both its flow properties

and the design of the equipment used with it.

ish. It is not sufficient to simply call for a type of stainless steel in a mass flow design with-out specifying the interior finish, because wall friction of the powder may vary significantly from one finish to another. It also cannot be assumed that a reduced average roughness (Ra) of the interior surface finish will allow for more shallow designs, because fine powders can become more frictional with reduced surface roughness due to increased particle/surface contact area. Therefore, measure the wall friction of the powder against the interior surface finish being considered to determine the required angles for mass flow (�c/�p).

4. Consider velocity gradients. Even when equipment is designed for mass flow, there will be a velocity gradient between mate-rial discharging at the hopper walls (mov-ing slower) compared to its center (moving faster). An increase in the velocity gradient can be used to enhance blending between vertical layers of material, while a reduction can be used to enhance side-to-side mixing (e.g., to minimize the effects of segregation). Making the hopper slope steeper with re-spect to the recommended mass flow hopper

angle (�c/�p) or changing the surface finish to reduce wall friction will reduce the veloc-ity gradient. Asymmetric hoppers, which are common to tablet presses, are especially prone to velocity gradients because powder moves faster at the steeper hopper wall.

5. Avoid upward-facing lips or ledges. These often occur where flanges mismatch or where there are level probes, view ports, gaskets, or partially opened valves protruding into the flow path. Ideally, devices that protrude into the interior are installed in non-converging (vertical walled) sections of the equipment, where they are less likely to upset the mass flow pattern.

In conclusion, costly powder flow prob-lems can be avoided with a measure of prevention: determine the flow properties of the powder for use in designing or selecting its handling equipment. ■

REFERENCES 1. Jenike, A.W., Storage and Flow of Solids

(Bulletin 123 of the Utah Engineering Experimental Station), 53 (26), (1964, re-vised 1980).

2. Prescott, J.K., and Barnum R.A., On powder flowability, Pharmaceutical Technology, October 2000, pp. 60-84 and 236.

3. Schulze, D., Measuring powder flowability: A comparison of test methods, part 1, Powder and Bulk Engineering, 10 (4), pp. 45-61 (1996).

4. Schulze, D., Measuring powder flowability: A comparison of test methods, part 2, Powder and Bulk Engineering, 10 (6), pp. 17-28 (1996).

5. Standard shear testing method for bulk solids using the Jenike shear cell, ASTM Standard D6128-97, American Society for Testing and Materials (1998).

6. Prescott, J.K. and Garcia, T. P., A solid dosage and blend content uniformity troubleshooting diagram, Pharmaceutical Technology, March 2001, pp. 68-79.

7. Prescott, J. K. and Hossfeld, R. J., Maintaining product uniformity and unin-terrupted flow to direct compression tab-let presses. Pharmaceutical Technology, 18 (6), 1994, pp. 99-114.

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■ POWDER HANDLING


Above: The filling process con-sists of a needle piercing the stopper and dispensing the liquid. After needle withdrawal, to restore closure integrity, the piercing trace is laser re-sealed.Right and Center: The closed vial technology is based on a vial provided with the stopper in place. The manufacturing process has been optimized to ensure that the vial is clean inside and sterile by use of clean room production and sterilization by gamma-irradiation. This specific manufacturing process generates ready-to-fill containers as there are no needs for washing, steril-ization and depyrogenation.Bottom: Aseptic Technologies GMP manufacturing site for aseptic filling is located in Gembloux, Belgium.


■ P H A R M P R O . C O MH I G H L I G H T S

INTERPHEX2009™

Facility of the Year Award WinnerEQUIPMENT INNOVATION

Aseptic Technologies

2009

Facility of the Year AwardCATEGORY WINNER To address the incidents that

are still recorded each year due to the injection of contaminated products, and the complexities

of vial component preparation, high-speed stoppering, and aluminum cap crimp-ing, Aseptic Technologies, a subsidiary of GlaxoSmithKline Biologicals, developed the new Crystal® Closed Vial technology for aseptic filling of injectable products.

This new technology consists of a read-to-fill vial which is supplied clean and sterile to the pharmaceutical manufacturer. To obtain a clean and sterile vial, both vial body, made of cyclo-olefin copolymer (COC), and thermo-plastic elastomer (TPE) stopper are molded in clean room Class 100 / Grade A / ISO 5 clean

room and directly assembled by robot. To ensure sterility, the container is gamma-irradi-ated prior to delivery to the pharmaceutical manufacturer.

T he filling process of this ready-to-fill container consists of a needle piercing the stop-per and dispensing the liquid.

After needle withdrawal, to restore closure integrity, the piercing trace is laser re-sealed. A cap, with the stopper surface protected until use by the doctor, is placed by snap fit. All these operations are performed inside a Closed Vial Filling System (CVFS) which ensure a permanent Class 100 / Grade A / ISO 5 envi-ronment around filling operations. All classical vial and stopper preparation steps (washing, siliconization and sterilization) have been eliminated.

As this technology was completely new, Aseptic Technologies decided to install the first Crystal Closed Vial Filling Line (CVFL) in its own Gembloux, Belgium facility and op-erate it as a contract manufacturing orga-nization to help clients obtain stability data and fill clinical batches before making large financial investments.

The major advantages of this new tech-nology are a better sterility assurance level (SAL) for the patient and a simplification of the overall process. The SAL is improved by keeping the vial permanently closed, the vial behaving as an isolator by itself. This simplifi-cation affects the entire supply chain including the manufacturing (simplified process with elimination of large quantity WFI genera-tion, sterilization, high speed stoppering and aluminum cap crimping), transportation and storage (unbreakable and secured container). Healthcare practitioners have also largely ex-pressed their preference for the closed vial in view of its ease of use (easy to open, to pierce and to collect the liquid), its resistance to shocks and the improvement of the asepsis.

The site is located in the center of Europe, 60 km away from Brussels, the cap-ital of Belgium and European Community. It is composed of two buildings: AT01 which is dedicated to offices meeting rooms and workshops and AT02 that in-cludes workshop, offices and a filling suite of 400-square-meters with all of the neces-sary equipment to perform aseptic filling in the Crystal Closed Vial technology.

™




INTERPHEX2009™

Facility of the Year Award WinnerSUSTAINABILITY

Centocor Biologics IRELAND

2009

Facility of the Year AwardCATEGORY WINNER

Centocor develops and produces biopharmaceuticals to treat autoim-mune diseases. In 2001, Centocor started looking at options to pro-

vide additional manufacturing capacity for two promising new drugs in their pipeline. However, its existing manufacturing sites were built-out, so it was necessary to con-sider a greenfield site. In June 2004, after three years of study, Centocor approved funding to establish a new cell culture and purification site in Ringaskiddy, County Cork, Ireland. The overall mission of this project, dubbed BioCork, is to have 180kg per year biologic API capacity approved for market by June of 2010 within an all inclusive budget of $650MM. All of this must be consistent with Centocor’s values. These values demand safety of personnel during construction and operation, involvement with the surrounding community, compliance with all regulatory requirements and minimizing the impact on the environment.

The BioCork team worked closely with

local residents to mitigate the impact of this large, complex project on the commu-nity. The project provided traffic mitiga-tion alternatives, utilized advanced mem-brane waste water treatment, captured rainwater for recycling, and installed a biomass (woodchip) boiler for base steam load. This project also involved extensive landscaping that included planting 70,000 trees to mitigate visual impact and air quality. BioCork is 40% more energy-ef-ficient than internal benchmark biotech facilities and there was a 90% reduction in the carbon footprint versus fossil fuel. In addition, through careful preparation, communication, and implementation of safety planning, BioCork is one of the saf-est large projects ever built in Ireland.

Through use of integrated budgeting and scheduling, coupled with full user participa-tion, this complex project was completed ahead of schedule, under budget, and ex-ceeded capability requirements in all areas, most especially in the sustainability category.

Counterclockwise from top: Biotech plants require a wide range of specialized equipment that is sourced worldwide. By prioritizing the design required for procurement and utilizing a dedicated procurement team, all equipment was ready for construction when needed.Portable processing equipment was used throughout the facility to enhance flexibility.Centocor's facility is located in Ringaskiddy, County Cork, Ireland.The bioreactors used in Cork are a new design intended to combine the best characteris-tics of the bioreactors at all existing Centocor sites.

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Counterclockwise from top left: The campus comprises a total area of 42,909 m2 and houses more than 20 closely spaced buildings. Building 63 is the location of Centocor’s F2P2. It is connected to the R&D/QC building 48 and to the commercial parenteral plants located in buildings 10 and 60. Clean room operators became subject matter experts and are responsible for operating and maintaining equipment.Processing of tamper-evident V-OVS® caps for bulk syringes.Syringes being transported to the sterilization tunnel.



H I G H L I G H T S

INTERPHEX2009™

2009


Facility of the Year Award WinnerFACILITY INTEGRATION

Centocor R&D SCHAFFHAUSEN

Several years ago, Centocor Research & Development recog-nized that it did not have the capacity or capabilities in its exist-

ing fill finish facility to meet the future needs of its expanding product pipeline. Subsequently, plans were developed to build a new 670 m2 fill finish pilot plant facil-ity (F2P2) on its Schaffhausen, Switzerland campus. Centocor's new F2P2 R&D fill finish plant replaces an older existing facility and offers a state-of-the-art technology portfolio that mirrors the set-up of commercial facili-ties to ease process comparability and scale-up. The facility produces biological drug product for early- and late-stage clinical trials and also plays a key role in the transfer of fill finish operations into a commercial plant, also located on the Schaffhausen campus.

F2P2 contributes significant advances to the pharmaceutical manufacturing industry by creating a unique solution for a multi-product, multi-format R&D clinical fill finish facility. The facility was strategically located within the Schaffhausen campus to take ad-vantage of adjacencies for central utilities, quality unit offices, and analytical group. It has been well-integrated into the existing

campus and has the possibility for expan-sion by adding floors above the existing structure. It also demonstrates the superior integration of facility and equipment de-signs that provide maximum flexibility with high levels of sterility assurance (RABS and VHP decontamination concept) and an effi-cient operation. In addition, a high level of comparability between R&D and commer-cial fill finish process, equipment, and scale have facilitated tech transfer and scalability from pilot to commercial scale The facility has allowed Centocor to expand its new product pipeline and to bring new drug candidates quickly into clinical trials.

Flexible use of equipment within a facility is an important design feature of an R&D pilot plant. This need has been addressed in a number of ways. The filling equipment has been designed to handle a number of differ-ent types of vials and syringes. For example, the vial-filling equipment can handle glass or plastic vials. The syringe line is capable of siliconization in situ or use of pre-siliconized, pre-sterilised ready-to-fill syringes and it can be modified for cartridge filling. Wherever possible, portable equipment has been incorporated to permit wheel in/out capa-bilities The facility design can also be easily modified with a containment upgrade to permit processing of high potent APIs.

The facility was designed, built, and qualified in 30 months. It produced its first batch of drug product in March 2008.

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H I G H L I G H T S

INTERPHEX2009™

2009


Facility of the Year Award WinnerOPERATIONAL EXCELLENCE

Hameln Pharma

Hameln Pharma's new, 9200-square-meter sterile production plant, located at the headquar-ters of this 50-year-old, family-

run business in Hamelin, Germany, was built to significantly increase production capacities in the area of parenteral contract manufac-turing, create expansion possibilities for the company, and ensure reliable compliance with international regulatory standards.

The plant integrates all process steps re-quired for the production and filling of paren-teral products, while the subsequent processes of visual inspection through final packaging remain in the existing building and are be-ing expanded and modernized there in the former site of the sterile operation. The new sterile production facility has new utilities and processing equipment, from weighing to filling and sterilization. Existing process equip-ment have been moved into the new build-ing, so that all products must be transferred to the new plant. With a risk based approach

to qualification and validation and the development of a “best-case strategy” for regulatory impact, the expense for the necessary activities of product-specific validations and stabil-ity studies have been

reduced to an absolute minimum by using a model substance as evidence. This reduced the cost for all qualification and validation activi-ties to a mere 6% of the total investment. This approach has been accepted by authorities and over 90% of customers

The layout of the new sterile production plant is designed to maximize efficiency and is therefore tailored to optimally support the actual production process: The arrangement of the work areas follows the flow of the individual manufacturing steps in a logical manner. Material and personnel movements within the factory are reduced to a mini-mum. Processing equipment are set up in such a way that processes run efficiently and staff are optimally supported in their activi-ties by an ergonomically designed worksta-tion. For example, all the filling lines are set up in a U-shape and can therefore be oper-ated with 33% fewer staff than the existing sterile plant. The plan was to built a fast, flexible process where the immediate impact is to reduce waste and therefore costs. To achieve this, all process steps were simu-lated in advance and defined so that each movement can be completed efficiently in a standardized manner. This ensures a smooth process and saves valuable production time. Critical processes such as the cleaning and sterilization of equipment and filters have been automated, not only to increase ef-ficiency, but also process security. For this same purpose, state-of-the-art RABS technol-ogy has also been implemented throughout the filling facilities. A sophisticated system of coordinated facility, transport and location reactivities for the cleaning and sterilization of format parts guarantees a process within the cycle that prevents waste of any type

The planning of this streamlined plant began in March 2006. Only 25 months later, Hameln was able to put a highly in-novative and flexible sterile production facility into operation.

Top: The sterile facility features 9,222 m2 gross floor area on 3 levels including the sterile production area on level 0.Vial caps are processed under class A conditions according to ANNEX 1 requirements. This area is sepa-rated by glass partitions from the stoppering and fill-ing process.View of the transfer area where semi-finished product is made ready for sterilization. Up to 5,000 liters/hour of HPW are generated, stored and distributed on level 1.Hameln Pharma specializes in anesthetics, suspensions and other aseptic or terminal sterilized liquids.

Top: To avoid operator exposure to product, many operations, such as this clean room operation, were automated.Above: To further reduce operator exposure to product, advanced powder handling systems fitted with split valves were implemented throughout the facility.Right: The Carbapenem Production Facility project is located in Aurangabad, India, 400 kilometers away from Mumbai and consists of four well-integrated production blocks (Intermediate/API/Sterile/Hydrogenation), with each block designed with dedicated service and produc-tion areas.



H I G H L I G H T S

INTERPHEX2009™

2009


Facility of the Year Award WinnerREGIONAL EXCELLENCE

Orchid Chemicals & Pharmaceuticals

To accommodate the grow-ing number of development products and promote the application of new technolo-

gies, Orchid Chemicals & Pharmaceuticals created a new facility with modern and flexible cGMP aspects to manufacture internationally acceptable products. The Carbapenem Production Facility project is located in Aurangabad, India, 400 kilo-meters away from Mumbai and consists of four well-integrated production blocks (Intermediate/API/Sterile/Hydrogenation), with each block designed with dedicated service and production areas. All critical operations are contained in clean rooms, and advanced technical systems are used in all sections of manufacturing.

Orchid took several measures to conserve energy and reduce manufacturing costs during facility design, including the imple-mentation of a horizontal scrubbing system that uses 30% less power than conventional scrubbing systems, as well as the installation of energy-efficient vacuum systems, a multi-stage evaporator, water-cooled refrigeration systems, and fluorescent lighting. In addi-tion, they implemented automated systems for nitrogen blanketing for centrifuges, flash

steam recovery, and secondary steam gen-eration from evaporators to save energy. The team also implemented equipment designs that enabled significant reduction in cycle time, such as an ultrasonic crystallizer and agitated Nutsche Filter Dryer.

In addition, there are several aspects of this project that are unique and in-novative for this geographic location. The Carbapenem Production Facility employs one of the first cGMP operational systems for bulk API handling in India. And not only was the high degree of facility auto-mation critical for providing operational ease, improved safety and process integ-rity, and consistency in production, but it is also a completely novel concept in India.

In the end, Orchid successfully com-pleted a sizable, fast-track project to meet market demand using a combination of in-novative engineering concepts and state-of art equipment to produce quality products in a safe, consistent, and environmentally sound manner. Being able to successfully accomplish these goals, while dramati-cally increasing their productivity using all in-house expertise, was one of the major reasons for their selection as a Regional Excellence Category Winner.

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Sartorius Stedim BiotechUSA +1.800.368.7178Europe +49.5661.71.3400

www.sartorius-stedim.comturning science into solutions

Single-use, reusable or hybrid The right solution for each process step

You choose: single-use, reusable or both in combination. You set thetargets; we provide the technologies to reach them. Different producttypes, scale-up levels and development stages call for different solu-tions. Together, we will simulate your processes and custom-engineerwhat best meets your needs. The result: maximum process reliability,high flexibility, optimized cost.



H I G H L I G H T S

INTERPHEX2009™

2009


Facility of the Year Award WinnerPROJECT EXECUTION

Roche Pharma Biotech Production Basel

Headquartered in Basel, Switzerland, Roche is one of the world/s leading research-focused healthcare groups in

the fields of pharmaceuticals and diagnos-tics. Their Monoclonal Anti Bodies (MAB) 95 Facility was conceived to provide addi-tional production capacity for the API of Avastin®, a successful new treatment medi-cation used in the fight against cancer.

The primary business driver of this ul-tra fast-track project was to make this in-novative product available to patients as quickly as possible. To do so, Roche expertly planned, designed, and constructed a unique vertical MAB facility on the site of a former chemical production plant in a busy residential area of Basel. By industry stan-dards, the timelines were exceptional for a project of comparable size, complexity, and environmental sensitivity. Standing 40 me-ters tall with eight floors above ground and

two floors underground, the small building footprint and absence of adjacent construc-tion lay-down areas tested the ingenuity of the project team at every turn. (For exam-ple, the construction staff occupied a proj-ect office located on an elevated platform over the main public roadway.) To reduce congestion in and around the already tight project site, cutting-edge communication technology was applied whenever possible in the day-to-day running of the project. Extensive use was made of video conferenc-ing, documentation was exchanged via the Internet prior to joint reviews, site access was restricted to key personnel, and all project participants were encouraged to conduct as much communication as possible through electronic media. As the facility had to be arranged vertically, and as all sys-tems are fully integrated, the normal option of sequential completion proved to be too slow when modeled in the schedule. This forced the project team to develop the tac-tics necessary to complete the whole facility as a single entity (i.e., work on everything in parallel). The project team competently faced this and other project challenges with a "no blame, fix the problem" mentality.

Through teamwork, innovative design, and precise construction management, this state-of-the-art project was successfully re-alized in only 35 months, six weeks ahead of an already aggressive schedule and nine percent under budget.

Counterclockwise from top:The purification area features two independent purifi-cation lines each with three chromatographic columns, ultrafiltration capabilities and cryo vessels.The fermenters feature a capacity of 14 m3 each. The suite also houses equipment for cell banking, two disc separators and two harvest tanks.The company evaluated a new kind of separator and integrated it into the process.View at night into the running facilityThe utilities supply is located in the second basement and top floor and runs supplies through a central utility shaft.

Flexible, multi-layered tablet production with optional Core-Tableting capability.• Interchangeable turret design for tablet production flexibility and reduced downtime• Modular design on all lower roll and fill cam housings for easy removal

and cleaning• Easy Clean features on press interior for faster product changeover• Tablet production of single layer, bi-layer and tri-layer tablets• Custom mechanical design for optional Core-Tableting

(Tablet-within-a-tablet)• Automated, individual layer sampling during press operation• Patented two-stage closed feeding system eliminating tote “head” pressure• Non-recirculating feeder for increased product yield• Adjustable 1st and 2nd layer upper punch penetration

Complete the equation.CCaallll TThhee EElliizzaabbeetthh CCoommppaanniieessaanndd rreeeennggiinneeeerr yyoouurr pprroodduuccttiioonn..EElliizzaabbeetthh HHaattaa 441122--882299--77770000 (US)EElliizzaabbeetthh CCaarrbbiiddee EEuurrooppee ++3322 33 883300 1100 8811 (Europe)

eelliizz..ccoomm

Tablet Presses Turrets Blister Packaging Tooling

Parts Compression Tooling Service

ELIZABETH HATA’S TRIPLE LAYER ENGINEERING


� Powder Dispense System Optimizes And Manages Resource Materials Powdernium SV (Storage Vial), is a shaker powder dispense technology ideal for novel applications such as compound management, walk-up sample prep and reference standards preparation. Powdernium SV acts as a hybrid vial hopper and storage vessel that enables low-cost storage without the requirement to sub-divide materials, helping to save and op-timally manage precious resource materials. ■ Symyx Technologies, Inc., Sunnyvale, CA 94085. www.symyx.com. or call 408-764-2000

� Digital Peristaltic Pump Designed For Lab Applications The Masterflex® P/S line of digital peristaltic pumping systems is available in a wide range of complete sys-tems, which include either a standard digital drive; a computerized drive; or a stainless steel NEMA 4X process drive. The system features a small foot-print, plus the units are stackable, making them

especially well suited for limited-space clean room and lab applications. Pumps are self-prim-

ing, able to operate dry, and contain no valves or seals to replace. ■ Thermo Fisher Scientific

Inc., Waltham, MA 02454. www.thermo.com/fluidhandling or call 800-875-1578

■ W H AT ' S H OT

WHAT’S HOT



� Vial Seals Compatible With Standard Vials And Stoppers Lyoseals are available in 13mm, 20mm and 28mm sizes. For lyophilized products, Lyo-seals help to achieve final container closure integrity inside the freeze dryer chamber, thus eliminating all potential breeches of integrity during downloading, transferring and crimp-ing the vials. In addition, Lyoseals provide for a barrier between rubber stoppers and freeze dryer shelves and prevent all sticking issues. ■ Biocorp Inc., Princeton, NJ 08540. www.biocorp.com or call 609-651-9352

Power And Process Control Panels Available With Custom Components And Communication Capabilities �

Standard, custom, and pre-engineered panels include: UL and cUL listed sub-panel; ESA electrical approval and CSA compatibility; NFPA 79 electrical standards; UL 508, NEC, and CEC standards; CE Mark and directives compliant; NEMA rated enclosures for hazardous and non-hazardous locations; and local or remote panels. A variety of capabili-ties including Z purge designs; stainless steel cabinetry; and NEMA 1, 3, 4, 4x and 12 rated enclosures are available. Some typical compo-nents include: fused and unfused disconnects, circuit breakers, power distribution blocks, terminal blocks for customer interfacing, starters, electronic controls, high limits, and panel heaters and coolers. A variety of custom components and communication capabilities are also offered. ■ Mokon, Buffalo, NY 14207. www.mokon.com or call 716-876-9951

Supply Sticks Strengthen and Simplify Process Piping � Series PCWS pressure regulating supply sticks com-bine a number of valves, connectors, and gauges into a compact, single-piece design. The unit was developed to eliminate connections and minimize space require-ments in plastic piping systems. Most significantly, the reduction in size and connections provides an overall increase in piping strength by 1400%, virtually eliminat-ing potential for breakage. The multi-function assembly, called a “stick,” incorporates the features of a pressure regulator, pressure gauge, and shut-off valve into a single unit. By eliminating the need for multiple joints and pipe sections, installation costs are reduced as well. ■ Plast-O-Matic Valves, Inc., Cedar Grove, NJ 07009. www.plastomatic.com or call 973-256-3000

Tel. 800-724-4158 • [email protected] • 163 Research Lane, Millersburg, PA 17061

www.advancedscientifics.com

Advanced Scientifics is a leader in the design and manufacture of specialized single usesystems for the pharmaceutical and biotechnology industries.

Advanced Scientifics offers Polyethylene and Ethyl Vinyl Acetate systems ranging from 50mlto 2,500 L. Incorporating C-Flex, Silicone, PVC and PharMed BPT tubing types as well asover 750 components, Advanced Scientifics can produce a sterile, specialized system for yourapplication in 3-4 weeks.

Contact us at 800-724-4158 with your specific application today!

Embrace Single Use Systems.

Visit Advanced Scientifics at Interphex Booth #636.


H I G H L I G H T S

INTERPHEX2009™

Gasket Offers Dimensional Stability For Increased Reliability The STA-PURE™ Gasket provides exceptional dimensional stability for increased sealing reliability in critical bioprocess applications. This construction helps to achieve the low particulation/spallation and leachable/extractable profiles that are necessary for aseptic processing. In addition, the durable construction enables the gasket to withstand repeated CIP/SIP cycles. Designed for the most stringent temperature and pressure requirements, the STA-PURE™ Gasket is an optimal choice for pharm/bioprocess applications, such as ultra-pure water systems, media preparation, and upstream or downstream processing. ■ Gore PharmBIO Products, Elkton, MD 21921. www.gore.com/pharmbio or call 410-506-8400 Booth No. 3101

Self-Sealing Wall Boot Forms A Flexible Seal Pipetite is a flexible, self-sealing wall boot, constructed of white silicone and 316 stainless steel. The unit fits around a tube or pipe and fastens to a wall or ceiling, forming a flexible seal that can accommo-date movement without cracking. The Pipetite product line includes: Pipetite Standard, for new instal-lations; Pipetite ReBoot, a retrofit version for existing piping; Pipetite Sleeve Boot, for tube-in-tube transitions; and Pipetite Grommet, for penetrations in cabinets, panels and enclosures. ■ CSI, Springfield, MO 65803. www.csidesigns.com or call 800-0654-5635 Booth No. 755

Tablet Press Line Offers Wide Range Of Models Company will be exhibiting the 3090i tablet press; the 2090i wash-in-place tablet press; the 1200i tablet press; die table segments; the Checkmaster tablet measuring system; and the PKB Magnesium Stearate spraying system. ■ Fette America, Rockaway, NJ 07866. www.fetteamerica.com or call 973-586-8722 Booth No. 1819

COBRA variable pitch dry screw pumps help optimize vacuum efficiency and reduce operating costs by combining high flow rates with low power consumption and reduced utilities.

Contact us today for a free cost analysis for your process or lab application.

Lower operating costs with variable pitch rotary screw vacuum pumps



H I G H L I G H T S

INTERPHEX2009™

Analyzer Features Separate Graphs For Moisture Analysis The Computrac® MAX® 4000 features a full color screen that displays separate graphs for rate of moisture evolution and total moisture evolution. The instrument facilitates faster throughput via a forced air cool-

ing system which allows the instrument to cool from test temperature to idle temperature 25% faster than previous models. It also features a Temperature Ramp Rate Control option which allows the user

to control the rate at which the instrument heats from idle to test temperature. ■ Arizona Instru-ment LLC, Chandler, AZ 85225. www.azic.com or call 800-528-7411 Booth No. 3218


XPert®

Balance EnclosuresWhen you want

perfect balance.XPert® Balance Enclosures help you achieve perfect balance conditions for critical weighing procedures that involve hazardous powders.

• Patented perforated air foil, slotted baffle and upper containment sash foil

• Naproxen sodium containment independently verified by SafeBridge Consultants, Inc.

• Flexible exhaust options allow ducting to the outside or to a FilterMate™ Portable Exhauster for filtered removal of particulates or fumes

• Available in 2 , 3 , 4 , 5 , 6 and 8 widths

For a free catalog, visit www.labconco.com or call 800-732-0031.

Kansas City, MO | 800.732.0031 www.labconco.com


H I G H L I G H T S

INTERPHEX2009™

Gravimetric Feeder Accurately Meters Powder At Rates As Low as 20 grams/hr The PureFeed® DP-4 is a highly innovative gravi-metric feeder that can accurately meter dry phar-maceutical and nutraceutical powders at feed rates as low as 20 grams/hour. A speed controlled, inert ceramic feed disc (patent pending) is at the heart of the DP-4 feeder. The disc rotates to precisely discharge tiny amounts of material, continuously and pulsation free over the entire 20 to 2,000 gram feed rate range. Also, since the feed disc separates the material supply from the discharge point, there is no compaction and no chance of flooding. Low maintenance and ease of disassembly, cleaning and containment were major design priorities for the PureFeed® DP-4 Disc Feeder. All connecting pieces are secured using sanitary quick release clamps and the inlet and discharge of the DP-4 feeder can be sealed to insure containment during transporta-tion. The feeder is ideally suited for jet milling, continuous blending, medical-grade plastics compounding, packaging, coating, and ingre-dient weighing applications. ■ Schenck AccuRate, Whitewater, WI 53190. www.accuratefeeders.com or call 888-232-4837 Booth No. 3145

Lab-Sized Grinding Equipment Improves Solubility in Pharmaceuticals MicroSeries line of agitator bead mills provides wet grinding of small batches (0.14 to 0.5 liter) with resultant particles down to 10 to 20 nanometers in size. This laboratory-sized equipment is completely scalable to full production and minimizes product loss, making it ideal for the grinding of high-quality, high-priced and scarce pharma-ceutical materials. ■ NETZSCH Incorporated, Exton, PA 19431. www.netzschusa.com or call 610-363-8010 Booth No. 3224





H I G H L I G H T S

INTERPHEX2009™

Self-Priming Pump Designed For CIP And Other Entrained Air Applications The FZX 2350 model self-priming pump for CIP and other entrained air applications handles applications with flow rates up to 330 gpm and generates up to 230 feet of head. The FZX series pumps reduce the amount of expensive high purity chemical used in CIP and ensure consistent high-quality CIP cycles by com-pletely removing all cleaning fluids from lines and vessels. Able to maintain its prime when other pumps become air-bound, it is ideal for air-entrained applications. ■ Fristam Pumps, USA, Middleton, WI 53562. www.fristam.com or call 800-841-5001 Booth No. 2073

Single-Use Systems For The Pharma And BioTech Industries With sizes ranging from 50ml to 2,500 liters, the company can produce single use containers of nearly any configura-tion as well as multiple porting options with 700+ components in-house to choose from. Company also has the capability to produce 3-D bags from 20 liters and up, specific to customer specifications. Over 60 different tubing sizes and types are available. The company offers users the ability to conform the disposable to the process - rather than conform the process to the disposable. With the capability to make purchases from all major filter and component manufacturers, exact specifications are met to ensure cus-tomer satisfaction. ■ Advanced Scientifics, Inc., Millersburg, PA 17061. www.advanced-scientifics.com or call 717-692-2104 Booth No. 636

Sieves, Separators And Screens Available FromLab To Production Sizes Stainless steel line of sanitary grade sieves, separators and screens range from lab to pilot and production sizes from 8” to 60” screen diameter. These cGMP single or multiple screen units conform to all USDA and FDA standards. Options include: CIP systems; multiple ultrasonic fine mesh deblinding kits and enclosed pressurized designs for bulk processing or special purges. ■ VORTI-SIV, Salem, OH 44460. www.vorti-siv.com or call 800-227-7487 Booth No. C319

Sanitary Gasket Eliminates Pigmentation Or Spalling The Tuf-Flex® sanitary gasket's contact surface is PTFE unitized to an EPDM rubber inner core. This totally bonded construction provides the inert, non-stick benefits of PTFE with the memory of an elastomeric gasket without fear or risk of pigmentation or spalling and is specifically designed to meet critical requirements in pharmaceutical, biotechnology, ultra-pure water, WFI (water-for-injection). ■ Rubber Fab Technologies Group, Sparta, NJ 07871. www.rubberfab.com or call 973-579-3424 Booth No. 2484


H I G H L I G H T S

INTERPHEX2009™

High Purity Stainless Steel Process Systems And Components Adhere To ASME BPE Standards Company offers state of the art custom fabrication for high purity stainless steel process systems and components. Specific examples include skid systems, utility stations and flow transfer panels for the biotechnology and pharma-ceutical industries. Process skids can include tanks, heat exchangers, valves, pumps, wiring and piping. Company adheres to ASME BPE standards for design, materials, construction, inspections, and testing. ■ CSI, Springfield, MO 65803. www.csidesigns.com or call 800-654-5635 Booth No. 755

Humidity Measurement System Offers Faster Response Times The AirChip3000 forms the core of the new HygroClip2. The AirChip3000 capabilities include the compensation of humid-ity and temperature at 30,000 reference points, the record-ing of 2000 data points, and the calculation of dew point. In addition, the AirChip3000 offers self-diagnostics. If sensor ac-curacy declines significantly, the AirChip3000 recognizes the problem and will issue an alarm. It also combines within itself an ASIC (Application Specific Integrated Circuit), a micro-con-troller and a non-volatile, electronic memory (EEPROM). Com-bined with the new technology of the AirChip3000, ROTRON-IC has further improved the humidity sensor. The HygroClip2 provides reproducibility and a guaranteed system accuracy of < 0.8 % r.h. and 0.1°C. In addition, response time has been significantly im-proved, and new filter technology provides even better protection for the sensor against environmental influences. ■ ROTRONIC Instrument Corp., Huntington, NY 11743. www.rotronic-usa.com or call 631-427-3898 Booth No. 1272

Sanitary Jet Mills Feature Quick Disconnects For Easy Cleaning Expanded production range of sanitary Micron-Master jet pulverizers now features a 15” sanitary Micron-Mas-ter jet pulverizer. The sanitary Micron-Master family of jet pulverizers are now available in 1”, 2”, 4”, 8”, 12” sizes including the new 15”. Furnished with quick disconnect assemblies for easy cleaning and fast turn around with no tools required. Mills can be combined with select process equipment to become a complete API turnkey processing system. ■ The Jet Pulverizer Co., Moorestown, NJ 08057. www.jetpulverizer.com or call 800-670-9695 Booth No. 2476

XCELODOSE® S

CFS 1200™

CapsuleCaddy™

Achieving ‘Faster Time to First in Man’

Xcelodose® S Precision Micro-Dosing System Precisely dispenses drug substances alone, as low as 100 µg, into capsules at a rate of up to 600 capsules/hour at ~2% RSD. This allows companies to eliminate timely and costly excipient compatibility, stability and preformulation studies. With 50% greater throughput than its successful predecessor, the new Xcelodose® S also offers greater robustness for longer production runs.

CFS 1200™ Liquid Filling & Sealing Machine A fully-automatic cGMP machine with a small footprint for R&D Labs, it fills and seals liquids/semi-solids into two piece hard capsules at speeds up to 1,200 capsules per hour. This helps scientists exploit the potential of lipid-based formulations for poorly soluble compounds.

CapsuleCaddy™ The perfect complement to our R&D machines, it contains 10,000 Licaps®, DBcaps® or Coni-Snap® capsules.

To order or for more information, call 888-783-6361 or visit www.capsugel.com.

www.capsugel.com

■ P H A R M P R O . C O M H I G H L I G H T S

INTERPHEX2009™

Dry Screw Vacuum Pumps Designed For Difficult Applications The COBRA NC B version dry screw vacuum pumps are designed for difficult applications in the pharmaceutical and chemical processing industries. Featuring a one piece variable pitch rotor design, these pumps provide improved efficiency and lower utility requirements that help to reduce operating costs. Available in direct or air-cooled configurations, COBRA NC B version pumps are available with pump-ing speeds to 371 ACFM and ultimate vacuum to 0.075 torr. The COBRA NC B features: 100% oil-free compression; one piece variable pitch ro-tor design; non-contacting internal components; low power consump-tion; no cooling gas required. ■ Busch LLC, Virginia Beach, VA 23452. www.buschusa.com or call 757-463-7800 Booth No. 3126


The Smartest DistanceBetween Two Points.

VAC-U-MAX is a premier manufacturer of custom pneumatic systems and supportequipment for conveying, batching, andweighing materials.

Count on us for:• Decades of engineering and conveying

expertise. • Customized solutions that meet your

specific needs. Because our systems arenot “off the shelf,” they are always onthe mark.

• Reliable equipment that’s proudly madein America.

• Our Airtight Performance Guarantee™. Westand behind every system we engineer.And we say it in writing.

For more information about our custom-engineered pneumatic systems and solutions, call:

Air-driven solutions.

Belleville, New Jersey [email protected]

1-866-239-8449or visit online at:

www.vac-u-max.com/convey

Pneumatic Conveying Systems from VAC-U-MAX.



H I G H L I G H T S

INTERPHEX2009™

Biopharm Grade Tubing Offers Fewer Extractables AdvantaFlex tubing, designed specifically for high purity fluid transfer, is manufactured from a biopharmaceutical-grade material for the pharmaceutical, biotech, medical, and critical processing industries. The combination of a tubing that is smooth, flexible, and resilient yet may be reliably welded and heat sealed is one of AdvantaFlex’s greatest advantages. It may be welded directly to biobags and components for secure connections without the entrapment issues of fittings. ■ NewAge® Industries, Inc., Southampton, PA 18966. www.advantapure.com or call 215-526-2151 Booth No. 1555

Pumping System Uses Precision Stepper Motors The PDS-100 is a programmable pumping system which uses precision step-per motors to control a variety of the company's patented valveless piston pumps. The PDS-100 has a range from 500 nanoliters per dispense to 2 liters per minute continuous flow. It will accommodate all of the company's pump sizes in both fixed and adjustable displacement configurations. The pump heads are integrally mounted to the control unit which is housed in a rugged anodized aluminum enclosure. ■ Fluid Metering, Inc., Syosset, NY 11791. www.fmipump.com or call 800-223-3388 Booth No. 3005

Hygienic Ball Valves And Other Styles On Display On display will be the company's automated stainless steel hygienic ball valves. These working samples will be able to be pneumati-cally opened and closed at the booth for your review. Also featured will be automatic weld end valves and hygienic clamp end valves with certified BPE ID contact surfaces. Also on display will be the newly designed spring check valves incorporating built in guides for assured leak proof sealing. The complete line of Maxpure® BPE products will also be on dis-play. ■ VNE Corporation, Janesville, WI 53547. www.vnestainless.com or call 800-356-1111 Booth No. 2518


High-Slip Capping And Lidding Foil For A Variety Of Bottles, Cups And Containers High-slip foil for tamper evident caps and lidding protects the contents and seal in the freshness for bottles, cups and other pharmaceutical product containers. The domestically produced rolled foil works well with a variety of container materials including PP, PS, PET, COC, HDPE and LDPE. The high-slip, low friction texture of the foil reduces the need for air pressure in the packaging ma-chinery chute, which in turn, significantly reduces dust residue and build-up. The end result is less equipment jams and less down time due to cleaning and maintenance. In addition to causing less friction, dust build-up and equipment jams, the new foil requires a lower seal temperature and less dwell time than other foils. It is available in printed and unprinted versions, as well as in retort applications. It also offers an easy peel for a consumer-friendly package, no leaks for consistent quality, and competitive pricing for potential cost savings. ■ Constantia Hueck, Wall, NJ 07719. www.constantia-hueck.com or call 803-404-6587 Booth No. 231

Partition Wall Offers Full Visibility Between Areas In addition to its “phenolic resin” mod-ular panel wall system, the company is presenting a new type partition wall which includes a range of glass walls for open spaces and for partitioning of-fering full visibility between areas. These wall types can be utilized in either aseptic rooms or for containment between packaging lines, to prevent cross contamination. ■ Nicos Group, formerly Nicomac Inc., Norwood, NJ 07648. www.nicosgroup.com or call 201-768-9501 Booth No. 518

Process/Super Skids Designed And Fabricated In-House Company designs, fabrics, automates, tests and installs high quality stainless steel process skids/super skids, tanks, auxiliary equipment and piping systems. Company offers an in-house staff of design and automation engineers, welders, fitters, QA/QC professionals and project management personnel. With over 250,000 square feet of manu-facturing capacity, the company has the internal resources to execute a project from concept to completion and can ensure success through every phase. ■ A&B Process Systems Corp., Stratford, WI 54484. www.abprocess.com or call 888-258-2789 Booth No. 1928

PHARMACEUTICAL PROCESSING | MARCH 2009

H I G H L I G H T S

INTERPHEX2009™

Innovations forformulationand synthesis

www.powdersystems.com

See us at

Interphex

New York

Booth 1330

PSL USA+1 208 376 [email protected]

• ChargePoint split valves

• Dispensaries

• Filter Dryers

• Crystallizers


H I G H L I G H T S

INTERPHEX2009™

PureFeed®

Pharmaceutical Feeders Product Line Features:• Feed rate range from .02 kg/hr to 150 kg/hr.• Easy disassembly and cleaning in minutes.• 316L stainless steel.• Ceramic feed disc delivers pulse-free metering.• Disposable, flexible hopper speeds cleaning and eliminates cross contamination.

Call us for an on-site demonstration(888) 232-4837

www.accuratefeeders.com

Schenck AccuRate is a unit of Schenck Process©2008 Schenck AccuRate

Pharmaceutical Grade

Micro-IngredientPowder Feeding

Sanitary Process Instrumentation Solve Application-Specific Problems Company offers sanitary process instrumenta-tion for the life sciences, liquid food, beverage, and cosmetic industries. Company provides users with engineered products that solve application- specific problems. Vertical integration enables the company to control all facets of design through manufacture, ensuring product reliability and performance. ■ Anderson Instrument Company, Fultonville, NY 12072. www.andinst.com or call 800-833-0081 Booth No. 3146

Global Company Provides Integrated Professional Services BE&K BioPharm and KBR BioPharm are providers of engineering, construc-tion, commissioning, and validation services. Company services the pharma/biotech and medical device industries with an integrated source of professional services. ■ BE&K Engineering Co., Birmingham, AL 35243. www.bek.com or call 302-452-9054 Booth No . 1579

Industrial Vacuum Videos Highlight Features/Benefits P roduct videos highlight the features and ben-efits of the company's most popular vacuums. The product videos, along with the company's onsite demos, are part of its “Let us Prove It” program that allow allows potential customers to see how investing in a Nilfisk CFM vac will re-sult in a more efficient, cost-effective operation. ■ Nilfisk-Advance Inc. Plymouth, MN 55447 www.stop-the-dust.com or call 800-645-3475 Booth No. 1565


Bulk Powder Enclosures Provide User Protection During Powder Transfer Operations The XPert Bulk Powder Enclosures provide user protection from hazardous airborne particulates and fumes generated dur-ing powder transfer operations. Exclusive features include an ergonomic air foil with aerodynamic Clean-Sweep airflow openings that create a constant, protective barrier from contaminants; upper dilution air sup-ply with by-pass air that bathes the back of the sash with clean air; upper containment sash foil that lowers concentrations near the user’s breathing zone and a zoned perforated rear baffle that directs inflow air in non-tur-bulent laminar streams. ■ Labconco, Kansas City, MO 64132. www.labconco.com or call 800-821-5525 Booth No. 3104

According to EUROPEAN COMMISSION ANNEX 1 (regarding the manufacture of sterilemedicinal products) any product in a partially stoppered freeze-drying vial that has beenfilled aseptically and is to be freeze-dried should be maintained within the ISO Class 5environment, from the point of stopper insertion to the freeze dryer.This requirement should be implemented in theUnited States by March 1, 2010.

EnGuard Systems Transfer CartsEnGuard Systems Transfer Carts provide the ISO Class 5environment during the transportation of products throughuncontrolled areas.

A closed, sealed environment for storage and transfersInteriors and exteriors meet cGMP cleaning requirementsFinished to pharmaceutical standardsMembrane-protected HEPA filterHEPA-filtered, unidirectional air flowManual or VHP decontaminationBattery charging via standard wall outlet

EnGuardS Y S T E M S

INTERPHEX BOOTH 2480 317.443.3723 www.enguardsys tems.com

EnGuardSystemsTransfer Cart



H I G H L I G H T S

INTERPHEX2009™

Coating Pan Maintains Content Uniformity Within 25% To 100% Of Capacity

The PERFIMA perfo-rated pan incorporates an exclusive Shark Fin baffle, enabling the pan to maintain content unifor-mity within 25% to 100% of the rated capacity. In addition position and

dimensions of the outlet air duct allow a uniform drying of the product, thus saving energy. Spray guns are mounted on a support arm and can be positioned and adjusted from the external part of the machine, by using the relevant device. The arm slides out from the coater, easing gun changing and calibration. Special seals com-pletely isolate the machine making it suitable for full containment installations and for completely automatic CIP; nozzles and spray balls covers all areas of the machine and are always in position. ■ IMA North America Inc., Bristol, PA 19007. www.imausa.net or call 215-826-8500 Booth No. 2218

In-Line Mixers Are Certified By Both EHEDG and 3A The UHS range of in-line mixers are certified by both EHEDG and 3A. With the increas-ing emphasis on sanitary construction of process equipment, the UHS mixer offers the highest standards without compromising on performance. The company will also be demonstrating a range of other high shear mixers designed for pharmaceutical appli-cations – their Ultra Sanitary Bottom Entry mixers, the new L5 Series Laboratory mixer and the Ultramix, a 3A Certified in-tank mixer with a single piece mixing head designed for Clean-In-Place (CIP) and suitable for Steril-ize-In-Place (SIP) applications. ■ Silverson Machines, Inc., East Longmeadow, MA 01028. www.silverson.com or call 413-525-4825 Booth No. 547

UNIQUE SENSING

INTELLIGENCE.

160 E. Main St • Huntington, NY 11743Tel. 631-427-3898 • Fax. 631-427-3902 • [email protected]

HygroClip2 – Innovation in Humidity and Temperature Measurement

Innovation is the key for the All-New HygroClip2 and AirChip3000 from Rotronic. The latest development from ROTRONIC raises humidity and temperature measurementto new heights of performance.

A few of the key innovations include:• Accurate to ±0.8%RH & ±0.1˚C• Sensor self-diagnostic and auto correction with alarm feature• New sensor design to speed humidity/temperature response and improve accuracy

For a complete view of all the innovative features of the HygroClip2 visit our website:www.rotronic-usa.com or call us today.



H I G H L I G H T S

INTERPHEX2009™

Replacement Diaphragms For Major Valve Lines Precision fit and de-signed for ITT, Saun-ders and Gemu valve styles, the backing on the diaphragm is made from the company's own time–tested material. Polymer rich EPDM and the TFM facing is made from time proven modified fluoropolymer, the choice of the diaphragm valve industry for pharmaceu-tical applications. Each style is mechanically tested and proven to anticipated ASME BPE standards. Also each diaphragm meets the requirements of FDA CFR title 21 177.2600 and paragraph 177.1550, and USP Class VI. Every diaphragm is fully batch traceable, with part number, manufacturer’s date and the company's own marking. ■ Newman Sanitary Gasket Co., Lebanon, OH 45036. www.newmangasket.com or call 513-932-7979 Booth No. 1381

Hygienic Rupture Disk Ideal ForCIP And SIP Applications The hygienic Opti-Gard utilizes a peripher-ally scored, reverse-acting rupture disk with a smooth media-side surface that minimizes contamination and is ideal for CIP and SIP applications. The disk provides significant financial and operational benefits for the pharmaceutical and biotechnology industries, while offering the highest performance char-acteristics available for liquid, gas and vapor. Additionally, the Hygienic Opti-Gard is avail-able with the Flo-Tel™+ sensor, a non-invasive, reusable detection system. Unlike traditional gasketed detectors, the Flo-Tel+ is reusable and only requires a one-time installation. Since it is isolated from downstream pressure fluc-tuations or aggressive media, it will not cause unnecessary downtime through false “failure” indication. ■ OSECO, Broken Arrow, OK 74013. www.oseco.com or call 800-395-3475 Booth No. 3221

Tablet Press Offers Interchangeable Turret Design The Hata CVX press is equipped with a press control kiosk that is portable for space-savings and flexibility. The press control design is user-friendly with touch screen capability for ease of operation. The press is easy to disassemble both interior press parts and complete turret removal. The CVX Press is also designed with a manual wash-down capability for quick product change-over. The CVX-Series is offered in single-sided, double-sided and tri-layer models with a custom core-tableting option. ■ Elizabeth-Hata Int., North Huntingdon, PA 15642. www.eliz.com or call 412-829-7700 Booth No. 1337


Micro-Dosing System Precisely Dispenses As Low As 100 µg The Xceldose® S preci-sion micro-dosing system precisely dispens-es drug substances alone, as low as 100 µg, into capsules without excipients or bulking agents, eliminating costly and time consum-ing compatibility, stability and preformula-tion studies. The CFS1200™ will demonstrate filling and sealing liquid and semi-solids into two-piece capsules. ■ Capsugel, Peapack, NJ 07977. www.capsugel.com or call 908-901-8000 Booth No. 2827

Process Equipment/Engineering Services For Every Industry Segment Company provides GMP process solutions to nearly every segment of the biopharm and biotech industry. Company offers industry proven standard and custom equipment, process focused engineering services, and build-to-spec or design/build methods. ■

Techniserv, Inc., Berwick, PA 18603. www.techniservinc.com or call 570-759-2315 Booth No. 3237

Air-Operated Double-Diaphragm Pumps For A Wide Range Of Applications Air-Operated Double-Dia-phragm pumps are avail-able for a wide range of in-dustries and fluid transfer applications. Company is committed to the pursuit of excellence, customer sat-isfaction, R&D and market knowledge. ■ Wilden Pump & Engineering, Grand Terrace, CA 92313. www.wildenpump.com or call 909-422-1730 Booth No. 1776

PHARMACEUTICAL PROCESSING | MARCH 2009

H I G H L I G H T S

INTERPHEX2009™

When you choose a garment for your cleanroom operations, you need to feel certain that you aren’t compromising the quality of your product or the reputation of your company. Fortunately, Integrity® 1800 will help you avoid such costly setbacks. Garments made with this premier fabric feature triple barrier protection, exceptional comfort and peace of mind. To learn more about Integrity 1800 and other Integrity branded fabrics, visit www.precisionfabrics.com/Integrity1800 or contact:

Integrity is a registered trademark of Precision Fabrics Group, Inc.

PFG United StatesJohn Smith • 1.888.733.5759

[email protected]

PFG GermanyFalk Heim • +49 (0) [email protected]

Integrity® Fabrics are made in the USA for the world.Visit us at INTERPHEX New York, Booth No.245

Wire Cloth Laminate Allows Migration-free Filtration Porostar® is a sintered, multi-layered woven wire cloth laminate that allows migration-free filtration from less than 1 to 200 microns. Porostar® Filter plates and elements are engineered to customer specifications for durability and a long wear life. Stainless steel and other corrosion resistant alloys provide extended filtration media life with simple cleanup. Modern welding and forming techniques are used to combine these sheets into desired constructions, such as clean-in-place filter elements, filter plates, filter candles and pleated elements. A specially-designed HYPERFLO Porostar® Filter Media provides an additional 50% increase of flow capacity with minimum pressure drop. ■ W.S. Tyler, Mentor, OH 44060. www.wstyler.com or call 800-321-6188 Booth No. 1045

INTRODUCINGClass VI compliantDiaphragms for ITT®,Saunders® andGemu® valves!

Precision fit and designed forITT®, Saunders® and Gemu® valve

styles, our full line of diaphragmsdelivers worry-free operation in

today’s demanding pharmaceuticalprocessing environment. As always ,

you can count on Newman’sreputation for excellence,success and expertise in thepharmaceutical industry.For more information,contact us, or visit us atour booth.

BOOTH#

1381

P.O. Box 222, Lebanon, OH 45036Phone 513-932-7379 • Fax 513-932-4493

w w w . n e w m a n g a s k e t . c o m

Newman Sanitary Gasket Company (NSG) does not manufacturer or sell ITT®, Saunders®, or Gemu®

OEM diaphragms. Neither is NSG affiliated with nor their products endorsed by these companies.ITT® is a registered trademark of ITT Pure-Flo, Gemu® is a registered trademark of Gemu Valves andSaunders® is a registered trademark of Crane Process Flow Technologies Ltd.

■ 48

H I G H L I G H T S

INTERPHEX2009™

Disposable Bioreactor Uses Traditional Design In A Disposable Format The BIOSTAT CultiBag STR is a disposable bioreactor utilizing traditional stirred tank design in a disposable format. The scaleable mixing and geometry which mimics traditional systems offers many advantages over stain-less steel, including ease of use; prevention of cross-contamination; reduced qualification and validation and increased flexibility. ■ Sartorius Stedim North America Inc., Edgewood, NY 11717. www.sartorius.com or call 800-368-7178

Benchtop Filling Machine Of-fers Full Automatic Versatility The AdaptaFil™ Benchtop, is a semi-auto-matic filling machine that offers users a level of functionality and versatility seen only in fully automatic filling systems. The AdaptaFil™ Benchtop’s patent pending technology features four easy-change-over metering systems, and electronic networking capabilities. The AdaptaFil™ Benchtop promises to revolutionize and redefine semi-automatic filling opera-tions. ■ Filamatic, a division of National Instrument, LLC, Baltimore, MD 21215 www.filamatic.com or call 866-258-1914 Booth No. 2159



Clean-In-Place. cGMP piping. High-purity

piping. Portable vessels. Tanks. Formulation

skids. WFI. Buffer prep skids. Biokill

systems. Filtration skids. Process vessels.

You know your business. We know ours.

888.258.2789

www.abprocess.com

201 S. Wisconsin Ave

Stratford, WI 54484

YOUR COMPLETE process systems partner.

Visit us

in Booth

#1928



H I G H L I G H T S

INTERPHEX2009™

Automated Tablet Testing System Can Be Directly Hooked Up To Any Tablet Press The SOTAX HT100 is a fully automated tablet physical testing system that measures tablet weight, thickness, hardness and tablet dimen-sions such as width and length or diameter. The SOTAX HT100 can measure hundreds of tablets without operator intervention. The sys-tem can also be directly hooked up to any tablet press for at-line auto-mated measurements. ■ SOTAX Corp., Horsham, PA 19044. www.sotax.com or call 215-442-1500 Booth No. 1418

Parenteral Contract Manufacturer Specializes In Complex Formulations Enzon Pharmaceuticals provides manufactur-ing, formulation, fill and finish and testing of parenteral products at its Indianapolis facility specializing in complex formulations includ-ing liposomal products. High speed vial filling and packaging lines are complemented by dual chamber vial filling. Staff has an average of 20 years experience in the manufacture of complex sterile formulations. From clinical to commercial products the company can provide the services you require. ■ Enzon Pharmaceuticals, Bridgewater, NJ 08807. www.enzon.com or call 908-541-8758 Booth No. 115

Milling Equipment Available In Portable Aseptic, Enhanced, And Basic Models Designed to operate reliably and efficiently at up to 30,000 psi process pressure, the M-110EH-30 enables the production of nano-suspensions and nano-emulsions liposomal encapsulation and cell disruption with the fewest number of passes. It comes standard with a diamond interaction chamber, pro-vides an average flow rate (with water) of 330 ml/min at 30,000 psi process pressure, and can easily handle batch sizes of up to several gallons. Minimum batch size is 200 ml, and batch to batch reproducibility is guaranteed. ■ Microfluidics, Newton, MA 02458. www.microfluidicscorp.com or call 800-370-5452 Booth No. 2214

Conveying Systems Feature 316L Polished Surfaces For Easy Cleaning Conveying systems for pharmaceutical ap-plications offer 316L stainless steel construction of all product contact areas with a polished surface for ease of cleaning and product flow. In addi-tion vacuum receivers are quick take apart without tools. Vacuum conveying systems range from simple up and in systems to more complex PLC based multi-ingredi-ent handling systems incorporating batch weighing. ■ VAC-U-MAX, Belleville, NJ 07109. www.vac-u-max.com or call 973-759-4600 Booth No. 1978

ECO-TRIPIt’s not just an . . .

22069 VAN BUREN STREET • GRAND TERRACE, CA 92313-5607 • (909) 422-1730 • FAX (909) 783-3440w i l d e n p u m p . c o m

It’s the world’s fi rst energyconsciousAir-OperatedDouble-DiaphragmPump (AODDP)

IIIIIIItttttt’’’’’ssss tttttthhhhhhhhhhheeeeeeeee wwwwwwwwwwoooooorrrrrrrlllllllldddddddd’’’’’’ssssssfififififififififi rrrrrrsssssstttttttt eeeeeeeennnnnnnneeeeeeeerrrrrrggggggggyyyyyyyyyyyccccccoooooonnnnnnsssssscccciiiiiiiioooooouuuuuussssssAAAAAAAAAAiiiiiiiiiirrrrrrrr-OOOOOOOOppppppppppeeeeeeeerrrrrrraaaaaaaatttttttteeeeeeddddddddddDDDDDDDDooooooouuuuuuuubbbbbbbbllllllllleeeeeeeee--DDDDDDDiiiiiiiiaaaaaaaapppppppppphhhhhhhhhhhrrrrrrraaaaaaaagggggggggmmmmmmmmmPPPPPPPPPPuuuuuuuuummmmmmmpppppppppp ((((((((AAAAAAAAOOOOOOODDDDDDDDDDDDDPPPPPPPP)))))))))

It’s the world’s fi rst energyconsciousAir-OperatedDouble-DiaphragmPump (AODDP)

p u m p s g . c o m


INTERPHEX2009™

Butterfly Valves Enable Sterile Powder Transfer The aseptic ChargePoint high containment split butterfly valve system can be sterilized in place enabling powder transfer without risk of prod-uct contamination or operator exposure. The unit enables products to be transferred in a ster-ile manner, by creating an intermediate cham-ber, which can be sterilized before each product transfer. This in situ sterilization capability ensures sterility of the split valve parts when fully docked. The intermediate docking position allows cleaning and irrigation of the intermedi-ate zone with HEPA filtered Nitrogen or air to achieve Grade A/Class 100 environment prior to sterilization with hydrogen peroxide vapor. ■ Powder Systems Ltd., Boise, ID 83713. www.powdersystems.com or call 208-376-7008 Booth No. 2264

Capsule Filler And Other Processing And Packaging Machinery On Display Company will be exhibiting its wide range of capsule fillers and other packaging machinery. One of the products will be the G250 Capsule Filler. With an output capability of 200,000 cap-sules per hour, the G250 is the world’s fastest capsule filler. Its features include precision han-dling and fill weight accuracy for powder, single pellet or dual pellet applications. In addition to capsule-filling machines, the company serves the end-of-line packaging needs of the pharma-ceutical industry in the U.S., Canada and Puerto Rico. ■ MG America, Fairfield, NJ 07004. www.mgamerica.com or call 973-808-8185 Booth No. 1519


The Metal Detectable Tuf-Steel® gasket will out perform and out last any elastomeric gasket by five times in the most demanding applications: SIP steam, constant heat of up to 500°F,

and extreme cold down to -20°F. With 3A compliance, USDA, FDA, ASME BPE and U.S.P. Class VI certifications, no other gasket can go the distance like Tuf-Steel®.

For more information about the Tuf-Steel® guarantee, contact Rubber Fab Technical Support at 973-579-3424 or e-mail at [email protected].

Pound for Pound, the ToughestGasket for the Toughest Conditions:

500 SIP Cycles: GUARANTEED!

www.rubberfab.com


H I G H L I G H T S

INTERPHEX2009™

BioPharmaceutical Grade Tubing Offers Betters Welds, Betters Seals, And Fewer Extractables AdvantaFlex complies with USP, ISO, FDA, and EP standards and is sterilizable by autoclave or gamma radiation. It’s free of silicone oils and animal-derived ingredients

Biological Testing Bottles Designed Specifically For Pharmaceutical Applications Line of biological testing bottles are ideal for applications that require storage, biological transfer, mixing or other applications in type 316L stainless steel bottles. These bottles have a large tri-clamp opening for easier ac-cess to material, validate, or clean the bottle and are polished to 12 Ra standard. These bottles can be custom modified to meet specific needs. ■ Eagle Stainless Container, Warminster, PA 18974. www.eaglestainless.com or call 215-957-9333 Booth No. 1237

and offers fewer extractables than other tubing. Applications include sterile filling, vaccine production, peristaltic pump trans-fer systems, sampling and delivery systems, bioreactor processes, cell media and har-vesting, pharmaceutical production and processing, high purity water transfer, and filtration. AdvantaFlex is manufactured from a biopharmaceutical-grade material for the pharmaceutical, biotech, medical, and critical processing industries and is ideal for single use applications. It may be welded directly to biobags and components for secure con-nections without the entrapment issues of fittings. AdvantaFlex is heat sealable for sam-pling usage. AdvantaFlex is documented lot traceable, offers documented quality control, and is available with complete validation and extractables test portfolios. ■ AdvantaPure®, Southampton, PA 18966. www.advantapure.com or call 888-755-4370 Booth No. 1555



Needle Trap System Prevents Needle-stick Injuries The Needle-Trap system features an integrated safety mechanism that is a compo-nent of the self-adhesive syringe label. This simple, economical design allows the needle to be safely and easily secured after it has been used and enables healthcare providers to use the same injection technique and dis-posal process as before. Needle-Trap can also provide optional detachable documentation labels to reduce the risk of medication errors. The Needle-Trap labels can be easily integrat-ed into conventional labeling systems and are adaptable to the most common syringe types. This integration makes it an effective, economical and convenient solution for the pharmaceutical industry as well as health-care providers. ■ Schreiner MediPharm L.P., Blauvelt, NY 10913. www.schreiner-medipharm.com or call 845-848-9000 Booth No. 467

www.sotax.com [email protected]

Automated Tablet Testing Systems

Visit the SOTAX Booth #1481 at Interphex, New York, March 17–19

The SOTAX HT 10 An ideal semi-automated solution for testing up to 24 tablets. It can test tablet hardness, thickness, width and length or diameter as standard with an option for weight measurement.

The SOTAX HT 100 A fully-automated solution where there is a requirement to test large sample volumes or unattended measurments. Tablet weight, hardness, thickness, width and length or diameter is measured. Includes a unique system that automatically separates different tablet shapes and sizes without operator intervention.

The SOTAX HT 100 with Automated Sampling from any Tablet Press or Deduster. A Complete automated production solution from tablet press to results.

SOTAX Corporation 411 Caredean Drive Suite A Horsham PA 19044 Phone (215) 442-1500 Toll Free 1 888 302-9925 Fax (215) 442-1514

SOTAX (Canada) Ltd. 1-335 Deerhurst Drive Brampton ON L6T 5K3 Phone (905) 494-0114 Toll Free 1 866 826-4448 Fax (905) 494-0723 Toll Free 1 866 767-6077 e-mail [email protected]



H I G H L I G H T S

INTERPHEX2009™

Gowning System Among Other Contamination Control Prod-ucts Offered Company is an EPA and FDA registered manufacturing facility. Company focuses on identification and control of contami-nation in classified areas and produces a complete range of sterile pharmaceutical grade disinfectants, sporicides, lubricants, and buffer solutions; Asepti-Cleanse sterile IPA/ hand sanitizer hands-free dispensers; Environmental Monitoring Systems; Core-2Clean Spray/Mop/Fog Systems. ■ Veltek Associates, Inc., Malvern, PA 19355. www.sterile.com or call 610-644-8336 Booth No. 1601

Tablet/Capsule Weight Sorter Operates At Faster Speeds The SADE SP220/SP120 and Bench Top SPB20 tablet/capsule weight sorters are now 50% faster than the previous SP models due to a new pre-weighing gate and improved sort-ing algorithms. With a 1 mg resolution, the SP220 twin sorter sorts up to 10,000 pieces per hour, while the SP120 and the SPB20 sorters sort up to 5,000 pieces per hour. ■ AC Compacting LLC, North Brunswick, NJ 08902. www.accompacting.com or call 800-524-0183 Booth No. 1969

IMA ACTIVE SOLUTIONS: HANDLING • GRANULATION • TABLETING • CAPSULE FILLING AND BANDING • WEIGHT CHECKING • COATING • WASHING

IMA NORTH AMERICA, INC. [email protected] • www.imanorthamerica.com • www.ima.it

Optimize your investment and achieve your objectives...[ In one move ROTO CUBE is the benchmark for high shear granulation and single-pot processing, which handles the complete mixing , granulation and vacuum drying process in total containment.

Accurate detection of the granulation end-point and the bowl tilting mechanism to enable gentle processing both ensure efficiency and premium quality granules.

Vacuum drying is enhanced by the GA.ST. system and microwave technology greatly reduces processing times without affecting product quality.

ROTO CUBE is high shear granulation at its safest, most efficient and best.

ROTO CUBE: ensures striking results

Solid Dose Solutions

New York - March 17-19, 2009Visit as at Booth # 2218



H I G H L I G H T S

INTERPHEX2009™

Bioreactor Accommodates Work-ing Volumes From 30 - 1000L Dual-use bioreactor can be used as a conven-tional, re-usable, stirred tank bioreactor or as a single-use bioreactor. Intended for cell culture, the scalable design accommodates working vol-umes from 30-1000L. It offers process flexibility as a batch, fed-batch, or perfusion system. The design allows for the addition of various gases and liquid process supplements. The system is comprised of three subsystems; vessel, piping, and instrumentation. ■ Biozeen North America, Inc., Allentown, PA 18109. www.biozeen.com or call 484 245-0506 Booth No. 1358

pH Sensors Designed For Use In High Temperature Applications The Model 3800 PUR-Sense™ autoclavable and steam sterilizable pH sensor is designed for use in applications with temperatures as high as 140oC. Building on AccuGlass® technology, the 3800 sensors exhibit unparalleled stability and long life after exposure to high temperature sterilization. For pharmaceutical manufactur-ers, this assures more reliable measurements and significantly reduced maintenance. The 3800VP has a PT100 ohm RTD mounted inside the pH glass stem for automatic temperature compensation, which allows for continuous monitoring, decreasing the probability of loos-ing a batch. ■ Emerson Process Management, Rosemount Analytical Inc., Liquid, Irvine, CA 92606. www.raihome.com or call 800-854-8257 Booth No. 2455

Automated Sampling System Monitors Pure Steam Quality This closed system will extract, condense and isolate the condensate sample for removal in a sealed container for subsequent analysis. The hands-off auto sampling method eliminates potential contamination of the sample and mini-mizes risk of injury too operating personnel. Automation of the activity provides consistency and repeatability while reducing the time re-quired to effect the sampling by plant person-nel. ■ Gemu Valves Inc., Atlanta, GA 30331. www.gemu.com or call 404-344-8970 Booth No. 2949

Particles sized less than 100 nanometers (nm) increase drugs’ absorptionand delivery efficiency in the human body. NETZSCH pharmaceutical-grademills let you produce consistent particle reductions to less than 200 nm—so you can use lessAPI or improve drug activity.

And,of course, your results are repeatable and scalable, from Phase I testingto Phase III full-scale production.

Discover the advantages of thinking small.The benefits are huge.

Call NETZSCH Fine ParticleTechnologyat 484-879-2020 or visit us onlineat www.netzsch-grinding.com.


H I G H L I G H T S

INTERPHEX2009™

Solid Dosage Equipment Spans Entire Production Range Company will be exhibiting a full line of solid dosage equipment including the: OYSTAR Manesty Xpress® 500 Tablet Press with Ac-cuSpray™; the OYSTAR Manesty FLEXITAB® is a fully automated, single station tablet press with a multi-layer tablet function; the OYSTAR Manesty XSpress R&D Rotary Press provides R&D users with advanced instru-mentation and data acquisition software to analyze compression force, ejection force and punch displacement; the OYSTAR Hüttlin Unilab Fluid Bed System ; for drying, granu-lating, and coating/layering, the Unilab Fluid Bed System is a mobile system with an opera-tor panel, designed to process batches from 0.2 to 6 kg, and features process air engineer-ing and a control cabinet with built-in PLC for separate placement; the OYSTAR Hüttlin Mycromix High-Shear Mixer Granulator Sys-tem; with a 10 liter container volume, the My-cromix High-Shear Mixer Granulator System employs EKATO – Gentlewing® technology to ensure complete and thorough product mix-ing; and the OYSTAR Hüttlin Mycrolab: For pilot-scale batch sizes ranging from 0.05 to 1 kg. ■ OYSTAR USA Process Division, Fairfield, NJ 07004. www.oystarusa.com or call 973-227-5575 Booth No. 1365

Cleanroom Garments Feature Triple Barrier Protection Garments made with Integrity® 1800 fabric feature triple barrier protection and excep-tional comfort and peace of mind. Since Integrity 1800 is smooth and lightweight, and freely passes moisture vapor, users don’t have to sacrifice comfort for protection. ■ Precision Fabrics Group Inc., Greensboro, NC 27401. www.precisionfabrics.com or call 888-733-5759 Booth No. 245

T he hard two-piece cap-sule has always carried an allure of being modern and up-to-date despite the fact that

capsules have been in widespread use in the U.S. since the 1880s. They have stood the test of time because they have been continuously improved to meet the challenges posed by user demands for higher filling speeds, stricter quality goals and new types of formulations. Capsules have traditionally been made from gelatin that has perfect properties for manufacture as it changes from a liquid to a solid, thus forming a film, at a temperature just above ambient. It does have some drawbacks and now capsules are available made from other materials.

People tend to think that two-piece capsules are the same as they always have been but when examined closely it can be seen that they have been adapted to face modern day challenges.

CAPSULE SHELL MANUFACTURE The big expansion in the industrial filling of hard capsules

occurred in the 1950/1960s when filling machines were manu-ally operated at speeds of 20,000 to 25,000 capsules/hour. Since then, there has been a steady rise in machine speeds, with the fastest operating at >150,000 capsules/hour. To achieve this, capsule manufacturers have converted their plants to cGMP standards, have improved the controls and sensors fitted to their machines and in the latest models, such as those made by Technophar, have installed computer controls and replaced cams with servo-motors. If the quality levels of the capsules were still at their 1960s levels, the high-speed machines would be shutting down every few minutes due to blockages, which does not happen. Another aid to better processing has been the improvement in the quality of the gelatin: the manufacturers have gained a better understanding of their processes. This has resulted in greater uniformity within and between lots, which has enabled capsule manufacturers to control their machines better. This in turn has lead to better quality capsules with the attendant gain in filling machine output.

During this period the design of the capsule shells has been improved to help their filling performance. All capsule shells have molded into their surfaces features to ensure better han-dling. There are sets of indents on the cap, called pre-locks, to hold the empty capsules together during transit from the manufacturer until they are separated on the filling machine. After filling, the capsule parts are rejoined at high speed and the caps and bodies are modified to assist in this process. Air vents are built in to prevent a build-up of internal pressure inside the

capsule. When the capsules are closed to their correct joined

lengths, locking features hold the capsules securely together sufficient to with-

stand stresses during auto-matic packaging, distribution and final handling.

THE TYPE OF CAPSULE FILLS There are three popular solid oral dosage

forms: soft capsules, two-piece capsules and tab-lets. Of these, the most versatile is the two-piece capsule because it can be filled with formulations ranging from dry powders and pellets, through tablets, non- aqueous liquids and suspensions. The capsules themselves are robust, all filling machines handle them in the same way and the only difference is the dosing mechanism used, which can be eas-ily changed.

In the 1950s capsules were used only for dry powder fills be-cause the APIs were readily water soluble, given in reasonably-sized doses, and released their contents in the stomach. Since then the nature of APIs has changed; now many are very poorly soluble, are given in low doses and are required to be delivered to specific sites within the G.I. tract for absorption. To accom-modate this, formulation forms have changed. The 1960/1970s saw the filling of coated pellets or granules designed to prolong release of the active, tablets to separate incompatible sub-stances or to modify release, and semi-solid matrices as liquids. None of these required any radical changes to the capsule shell. The 1980s saw the introduction of a high-speed band sealing machine, the Qualicaps’ Hicapseal, designed to make a capsule liquid-tight after filling with mobile liquids.

NEW CAPSULE SHELL MATERIALS The change in formulations has required different types

of excipients to be used and some induce stresses in gelatin capsules because they are hygroscopic. One of the draw-backs of gelatin is that its water content acts as a plasticizer and when removed, capsules become brittle. This has been known since the 19th century but attempts to find suitable alternatives failed until the 1980s when G.S Technologies in the U.S. and Qualicaps in Japan started experimentation with hypromellose: a polymer widely used in pharmaceuticals with a well-established safety record. In order to form a film on a mold pin, solutions of this need to be converted into ‘setting’ systems. G.S. Technologies used the hot pin process,


■ P H A R M P R O . C O M■ C A P S U L E S

Time Capsules The hard two-piece capsule: A history of continuous change and improvement ■ By Brian E. Jones, Scientific Advisor, Qualicaps

Capsules filled with mini-tabs (miniture tab-

lets) were first created in the

1990's

developed by Eli Lilly in 1950, which relies on a rapid viscos-ity increase with heat to form a film, whereas to get the same effect Qualicaps added carrageenan as a network former and potassium chloride as a network promoter. Only the latter system produced a capsule with the correct kinds of proper-ties for pharmaceutical use, such as good acid dissolution. Other manufacturers now make hypromellose capsules but each have their own setting systems, and as a result, have slightly different properties. Hypromellose capsules have ad-vantages over gelatin in two main areas: water does not act as a plasticizer and thus they can be dried down to give a very low moisture environment inside the capsule if required and hypromellose does not undergo cross-linking reactions like gelatin and is thus unaffected by I.C.H. accelerated stor-age conditions (6 months at 40°C & 75% RH).

Others materials have been used. In Japan a significant number of capsules are made using Pullulan, which has similar moisture content properties to gelatin. It has been used there more than other countries because hypromellose was not permitted for use in foods and nutraceuticals. Capsule manu-facturers are still looking for alternative polymers with the cor-rect properties: ones that have been investigated are Pondac (polyvinyl alcohol copolymer), Chitosan and Carrageenan, but none have resulted in capsules in wide-spread use.

NEW TYPES OF CAPSULE FORMULATIONS It takes a long time from the conception of a new formula-

tion technique to its use in approved products because of the inherent conservatism of the pharmaceutical industry and the length of time it takes to get a new product to the market place. Liquid-fills for capsules are now getting more attention in R&D groups because of the increasing numbers of very poorly soluble compounds. These formulations are lipid-based and utilize the normal process of fat digestion and absorption to get these compounds through the intesti-nal wall into the blood stream. The excipients used are mix-tures of solvents, surfactants, glycerides etc. Some of these interact strongly with the capsule shell. Work is underway by the capsule manufacturers to see how they can improve the mechanical strength of capsules to cope with these stresses.

Capsules filled with pellets and tablets have been used for

many years: the former produces a multiparticulate system to avoid the problem of dose-dumping, as single pellet failure is not a problem. Tablets have advantages because of their lower surface to weight ratio that makes it much easier to apply a uniform coat and uses significantly less material In the 1990s the idea of a mini-tablet (diameters 1.0–2.0 mm) was proposed as an intermediate between the previous two; a multiparticulate with a mini-mum of surface area. The problem for filling them into capsules was none of the machines could count them quickly and accurately enough. Qualicaps in collaboration with one of their customers designed the LIQFILsuper40 that was able to count groups of 16 mini-tablets and feed them into capsules in the time available.

Many new APIs are peptides or protein fragments and oral delivery presents a significant challenge because of the di-gestive system. Much work has been undertaken looking at delivering these to the colon where there are no proteolytic enzymes. One solution filled material into low-moisture con-tent hypromellose capsules and coated them with a glassy amylase-based polymer that is broken down only by colonic enzymes. Another potential route is pulmonary delivery using powder-filled capsules in dry-powder inhalers. Capsules need first to be cut or punctured to release the powder into the patient’s inspirational air-stream, which must be done without parts of the shell breaking off. Hypromellose capsules for inha-lation have the correct properties for this application because of their lack of brittleness if they loose moisture and they shed significantly less particles than gelatin when cut or punctured.

SUMMARY Hard two-piece capsules have a history of continuous

evolution to meet the changing demands of the users. The innovations come from the manufacturers of empty cap-sules, filling machines and other ancillary equipment. They continue to be adapted with improved quality. ■



■ C A P S U L E S

Top: Prior to filling capsules must be thor-oughly dried.

Bottom:The Qualicaps HICAPSEAL 40, is an example of a fully automatic hard capsule sealing machine.

Two piece capsules being formed on a mold pin.

T o meet ever-increasing industry regulations, pharma-ceutical companies need to employ strict inspection and verification tools during product manufacturing and packaging processes. While simple sensors can

be used for presence detection on the automated production line, to achieve accurate results in more sophisticated pharmaceutical applications - such as those requiring analysis of more than one product feature at a time - vision sensors can deliver a more com-prehensive and cost-effective solution.

Determining whether a vision sensor is required for the appli-cation at hand involves several decision criteria. First, if the appli-cation requires sensing a large area rather than a single point, vi-sion generally provides a more complete solution. Vision sensors are also helpful when more than one feature must be inspected

on a single part. For example, while a photoelectric sensor may be able to determine vial fill level, a vision sensor can confirm that both the level and vial stopper alignment are correct. Some vi-sion sensors also prove advantageous on high-speed production lines and for identifying color, translucency or other features of interest.

Along with these benefits, some vi-sion sensors also have the ability to read, verify, and/or grade bar codes. Industry requirements have been estab-lished for pharmaceutical manufactur-ers to identify and track manufactured products, and bar codes offer a cost-effective method to implementing this traceability. However, unless the bar

code is legible in the produc-tion process and throughout the supply chain, this tool is useless. Some vision sensors can both read bar code infor-mation - tracking products and identifying rejects on the pro-duction line - as well as grade

bar codes to determine whether or not the code will be able to be identified further down the production line.

The following scenarios depict how the appropriate vision sys-tem can be used to solve common pharmaceutical applications.

INSPECT FOR COMPLETE BLISTER PACKS

Vision sensors serve multiple purposes when used for verify-ing blister pack contents and packaging integrity. Vision inspec-tion tools allow users to set parameters for the inspection and specify which features of interest within the blister pack must be identified. This teaches the sensor to inspect the packs for tablet presence, verify that no tablets are broken, and alert operators of any blisters that are empty or contain foreign, unwanted debris.

To perform this task, the vision sensor is taught to identify a known “good” reference part - a correctly filled blister pack - from a “bad” part, rejecting all defective packaging and product. Once the inspection region and features of interest have been properly illuminated to create the highest contrast possible, the sensor acquires the image by a 2-dimensional CMOS or CCD im-ager chip. Next, the vision sensor compares this acquired image to the stored “good” part and notes any discrepancies between the two, thereby allowing users to quickly identify rejects and divert them from the production line.

Color vision sensors take this technology to the next level with the ability to identify a specific color and simply differentiate be-tween three or more colors. A special optical filter is placed over the imager chip that allows the sensor to distinguish between two colors that would appear identical to a grayscale sensor. These sensors may be used in applications where a tablet of a specific color must be identified, or they can be employed to inspect a group of tablets for correct color - detecting slight hue variations that could mean the difference between a good and bad product.

ACCURATE, EFFICIENT VIAL INSPECTION

Another common use for color vision sensors is in vial packag-ing, in cases where the vials’ cap color must be verified. Once all the vials are placed into a tray based upon the vials’ color-coded lids, a color vision sensor “sees” the color pattern of each, allow-ing the sensor to identify each vial’s cap color and verify that they are correctly placed.

To verify vial fill level as well as stopper seal and alignment, a high-speed vision sensor can deliver results right on the line. The sensor captures the image of each vial, then compares it to the image of a good part - a correctly filled and capped vial - that is taught to the sensor. This comparison allows the vision sensor to identify improperly filled or capped vials and reject them.

Using Vision to Your Advantage Vision sensors are ideal for inspecting and tracking pharmaceutical products to improve product integrity and satisfy industry quality standards. ■ By Steve Wong, Business Development Manager, Banner Engineering Corporation


■ P H A R M P R O . C O M■ I N S P E C T I O N

Top: To identify a missing tablet, the vision sensor is taught the param-eters of a “good” blister pack. Bottom: Vision inspection of phar-maceutical products and packages is key in meeting industry quality standards.

Vials can also be inspected for overall quality, ensuring that they contain no chips or cracks before and after the automated liquid filling station. This inspection is performed using the vision sensor’s Geometric Count tool that allows users to search the im-age obtained for the pattern of a good vial. In this case, the vial’s top rim is uniformly illuminated using an on-axis light and the pattern consists of edge outlines of the inside and outside diam-eters of the vial opening. If this edge is chipped, the tool recog-nizes that the edge is not continuous, and the vial is rejected.

READ, VERIFY, AND GRADE BAR CODES

The vision-based Bar Code Reader (BCR) tool is particularly useful for identifying and tracking pharmaceutical products. Since bar codes are comprised of light and dark patterns, a vision sen-sor with the BCR tool can scan a bar code pattern as an image, then compare it to the taught good bar codes stored in the sen-sor. In this way, the sensor can determine if the bar code read is legitimate and, if so, “translate” the symbol into encoded informa-tion - generally a string of numbers or letters.

In the pharmaceutical industry, vision sensors are used to read bar codes to identify and track batches of product on the produc-tion line. If a product’s bar code pattern does not match up with what the sensor has been taught is acceptable the product is re-jected. This ability also proves useful for grading bar codes, in or-der to ensure the symbols can be read by other devices through-

out the production process and downstream in the supply chain. The vision sensor is programmed to assign a letter grade - A through F - to each passing symbol based upon parameters speci-fied in the IEC standard. For instance, if the device marking the bar codes runs low on ink, the vision sensor can report the low quality grade and stop the process.

SIMPLIFY INSERTS AND OUTSERTS VERIFICATION

Along with confirming product integrity and quality control, vision sensors can verify that a product insert is included with each unit. The sensor is mounted above a packaging line and checks each passing package for the information leaflet, using the Geometric Find vision tool to look for the insert within a defined search area. This tool allows the sensor to identify the insert despite its orientation, and any packages that do not contain the leaflet are diverted from the production line.

A similar method is used to ensure that an outsert is included with each package. The vision sensor can be taught to let only bottles with an outsert attached to the cap pass the inspection. As each bottle passes on the production line, the vision sensor captures and analyzes an image of the bottle cap to verify the outsert’s presence. This vision sensor capability, combined with the other tools for image acquisition and analysis, allows these sensors to deliver a comprehensive inspection and verification solution for a broad range of pharmaceutical applications. ■


■ I N S P E C T I O N

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Manually applying labels to a large number of items is a slow process, and most companies try to automate their labeling whenever pos-sible. However, some items can’t be labeled

using traditional equipment because they are too small, too delicate, or too awkwardly shaped. Technicians at the company’s lab were bogged down by hand-applying labels

to small vials containing drug sam-ples. They wanted to automate the process, but no off-the-shelf equip-ment could handle the tiny vials.

A solution to its labeling woes was found with a custom-built

printer-applicator that has cut the time it takes to label samples by 60%. This new solution has reduced the amount of staff required for la-beling, and reduced the possibility

of errors in the labeling process. The drug development services

company helps pharma manufacturers test and commercialize new medications. At the company’s laboratory, dose determination testing is performed using tiny 2mil vials. These vials had always been hand-labeled after being filled and frozen, a process that took an average of twenty min-utes for a box of 96 vials. The labeling was time consuming and open to potential errors.

CHANGE IS IN THE AIR“We needed to make a change,” says the lab manager. “It was

either request more staff or find a better way to label the vials. ” A set of known samples to the pharmaceutical company

samples is compared in order to determine dosage. Staff scan the bar coded labels on the vials to ensure they have selected the correct batch of known samples for analysis.

“We used to apply these labels by hand, which was really cumbersome,” added the lab manager. “Our goal was to have a machine apply them so we could free up staff and reduce the amount of time spent labeling. We knew from the start this would be a custom solution.”

The company searched for an automated solution, receiving proposals from several different companies, and eventually se-lected Label Mill/CSI to develop a custom printing and labeling solution that could automate the process. “They were the only ones who were flexible enough to do what we needed done,” ac-cording to the lab manager.

Label Mill/CSI received vial, label and rack samples from the company along with an explanation of how the ideal machine would work. Within approximately two months, Label Mill/CSI created the Label Mill 3501 Vial Labeler using SATO America’s M8485Se high-speed print engine and applicator technology from Label Mill. The new machine can quickly and accurately pre-label an entire rack of vials in six minutes.

Test information is sent to the labeler from the laboratory in-formation management system (LIMS). Staff members place the entire rack of vials into the 3501 Labeler, start the machine and move on to other tasks while the labeler operates. The machine lifts each vial into place, prints and applies the label, then blows the vial back into the rack. It can work with full or partially-full racks. “They don’t have to watch it while it’s labeling,” says Rob Wienhoff, director, systems group at Label Mill/CSI.

“You just put the rack in there, press a button and away it goes,” says Wienhoff. “It’s not an elaborate solution, but it saves us a huge amount of time and effort.”

FROZEN PRODUCT DEMANDS SPECIAL LABEL AND ADHESIVE

Because the vials are frozen at -70º Celsius after being filled, a special label and adhesive is used that can handle the freez-ing process. The approximately one-inch-by-one-inch labels in-clude a linear bar code and human-readable information. The data on the label is unique depending on the tests being run, but can include assay name, concentration level, preparation date, expiration date, and a unique database identifier assigned by the company’s software systems. Scanners from Intermec Technologies Corp. are used to scan the labels.

The labeler was integrated with the LIMS and was up and running in a matter of hours. “Because it’s so self-contained, the training mostly focused on upkeep of the printer,” says Wienhoff. “There was very little they had to know about the movement of the vials and tubes. It’s an intelligent print sys-tem, so if a vial is not where it needs to be, the machine faults out before the label is misapplied or the vial breaks.”

Also, the company had to re-design its vial-handling pro-cess to accommodate the automated labeling system. In the past, the vials were hand-labeled after being filled. There was always the possibility of mixing samples. Now, the automated solution labels the vials before being filled and frozen, which has helped ensure the correct samples are used for testing.

The company has plans to deploy additional machines at other facilities and has talked to Label Mill/CSI about developing a version of the 3501 that can label slightly larger vials. ■

Pharma Testing Laboratory Eliminates Manual Labeling Automated solution saves time, labor for pharmaceutical testing facility


■ P H A R M P R O . C O M■ L A B E L I N G

The Label Mill 3501 Vial Labeler uses

SATO America’s M8485Se high-

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technology from Label Mill. The

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■ N E W P R O D U C T S



Label Print And Apply System Can Print On Various Materials The Ultimate PAH automat-ed print and apply system features a rugged all steel chassis and a modular de-sign that can be configured to match user requirements. Providing a typical place-ment tolerance of 0.25mm, it is designed for demanding environments such as high-speed industrial production lines and can dispense via tamp, tamp-blow, roll-on, and corner-wrap tech-nologies. Suitable for fully automated- or stand-alone operation, the Ultimate PAH Automated Print & Apply

System can be interfaced with networks and PCs using USB, Ethernet, RS422, RS485, and other popular connections. Applications range from small product- to outer box labeling at 300 dpi or 600 dpi print resolution. Label sizes range from 0.25” W x 0.157” L to 4.5” W x 9.8” H. ■ Industrial Labeling Systems Corporation, Chelmsford, MA 01824. www.ils-barcode.com or call 978-250-4414

Just 25¢ of every $1 you spend on information tech-nology goes to new projects; the rest of your money simply keeps the lights on. Is it any wonder that less than 15% of pharmaceutical executives see informa-tion technology departments (IT/ICT) as enabling business success?1 In a tight global economy, with pharmaceutical companies facing a steep revenue de-cline over the next two years, IT needs to improve its image – something that will be increasingly difficult as companies trim capital investments and IT budgets

face cuts of 18% or greater. Improving IT’s overall return on investment (ROI) is beyond

the scope of any column – many books have been written and academic studies undertaken in pursuit of IT’s ROI – but what we can cover are ways to improve the cost effectiveness of IT in regulatory and quality systems compliance.

ROLE OF IT IN COMPLIANCE For several years now, I’ve been a guest lecturer at various

Virginia business schools on the role of IT in compliance (you can get a recorded version of one talk at http://www.cerule-anllc.com/seminars). Under a conservative interpretation, IT’s

role is limited to automation (and thus the purchase of new software systems and computer hardware) and administration of that automation (often resulting in outsourcing to lower costs). While this “glorified mechanic” role of IT may suit technology vendors and consultants, it does not sit well with a single one of the up and coming executives I’ve counseled.

I n my lectures and workshops, I advocate a more advanced service role where IT’s emphasis is less on technology and more on information stewardship. As a I point out in my pre-sentation, there are no legal statutes governing technologies or computers, but there plenty of rules and requirements gov-erning information integrity, controls and retention. To quote the words of one newly risen Chief Information Officer (unwit-tingly echoing FDA officials), “We cannot buy compliance.”

And therein lies the key to unlocking a greater IT return on

■ PHARMA IT


Improving IT Compliance Return On Investment

■ By John Avellanet, Managing Director, Cerulean Associates LLC


investment when it comes to regulatory compliance pharma-ceutical quality systems.

THREE THINGS MONEY CAN’T BUY As I note in my talks, and in counseling management teams

and quality systems executives struggling to put in place rea-sonable 21 CFR Part 11 strategies, there are three tactics you can adopt that will cost you next to nothing but pay big divi-dends when the inspector shows up: garbage prevention, accu-rate documentation, and up to date policies and procedures.

Garbage Prevention. Push aside all the complicated legal wordsmithing of statutes, set down the guidance documents and regulatory preambles. If you had to define compliance in plain English, what are you left with? Compliance is valid proof (e.g., documents, records, data, signatures) of following the rules. The records are the facts, the proof of your intent to play by the rules. Under this simplified approach, IT’s role is to safeguard the electronic integrity of this proof.

There is an old adage in IT, “Garbage in, garbage out.” A good IT compliance strategy with a high rate of return revolves around a single question: How will this XYZ activity/project/technology keep good proof from becoming garbage? Put it in

a real world context: How will buying a new laboratory infor-mation management system (LIMS) keep your laboratory data from becoming corrupted, lost or manipulated?

You are the only who can force this threshold question. Requiring an answer to this question will help you gain the confidence, the know-how and the understanding of how to prevent garbage in the context of your organization. Just requiring an answering to this question alone will put you above the majority of your competitors.

Accurate Documentation. No one wakes up in the morn-ing excited about getting to work documenting anything – at least I’ve never met them. In all my years in IT, coming up through the help desk ranks all the way up to CIO, I had to drag myself kicking and screaming to write the documenta-tion for any system or project – much less keep it up to date.

In a tight global economy, with pharmaceutical companies facing a steep revenue decline

over the next two years, IT needs to improve its image – something that will be increasingly

difficult as companies trim capital investments and IT budgets face cuts of 18% or greater.

As a result, many IT organizations jeopardize their cred-ibility by adopting what I call the “driver’s license” model of documentation. Think of your driver’s license. Are you really that weight on your license or did you skim a few pounds? Did you add an extra half-inch of height? Do you still have that much hair? The same holds true for computer system documentation (e.g., the proof that your system is capable of maintaining other records with integrity). More often than not, computer system documentation is woefully out of date.

One of the best ways to improve efficiency, particularly when dealing with validated systems, is too keep that docu-mentation up to date. When money is tight, decisions are of-ten delayed. Chances are, you have a project or support team or two with time to fill. Document, document, document.

Up-to-Date Policies and Procedures. The same driver’s license model can be applied to your policies and standard op-erating procedures (SOPs). As part of the best practices I recom-mend to my clients, use an IT departmental annual quality sys-tems management review to regularly assess your policies and procedures. Identify the ones that need to be updated, written or retired. You can see a simple, straightforward method to tackle this in my recorded seminar, Best Practices for Quality Systems Management Reviews (http://www.ceruleanllc.com/seminars).

FINAL THOUGHTS The same computer economics report I cited at the be-

ginning of this article also stated the number one benefit agreed upon by non-IT executives of good IT compliance: the improvement of business processes. Unfortunately, as long as IT departments center themselves on technology commodities, IT will never achieve a high standing in the boardroom.

Focus on the goal of IT compliance: electronic proof integ-rity. Craft an IT compliance strategy of record integrity, docu-mentation accuracy, and policy and SOP currency to achieve better results, better compliance, and a better bottom line.

Are you ready? ■

About the Author John Avellanet is the founder of the regulatory intelligence and lean compliance program for executives and business owners, SmarterCompliance™. He is the author of more than 30 articles on lean compliance and quality systems, a co-author of the book, Best Practices in Biotechnology Business Development, and a frequent speaker with FDA officials. He can be directly reached through his independent adviso-ry firm, Cerulean Associates LLC, on the web at http://www.ceruleanllc.com.

REFERENCES 1 “IT Spending, Staffing & Technology Trends: Pharmaceutical

and Medical Device Sector,” Computer Economics, 2007.


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The Advertisers Index is provided as a reader service. Although every attempt has been made to make this index as complete as possible, the accuracy of all listings cannot be guaranteed.

A & B Process Systems . . . . . . . . . . . . .49Advanced Scientifi cs . . . . . . . . . . . . . . .35AdvantaPure . . . . . . . . . . . . . . . . . . .20Anderson Instrument Company Inc . . . . . . .36Arizona Instrument LLC . . . . . . . . . . . . .48Busch LLC. . . . . . . . . . . . . . . . . . . . .37Capsugel . . . . . . . . . . . . . . . . . . . . .41Central States Industrial . . . . . . . . . . . . .39Elizabeth Companies . . . . . . . . . . . . . . .33Enguard Systems . . . . . . . . . . . . . . . . .45Enzon Pharmaceuticals. . . . . . . . . . . . . . 7Fette America . . . . . . . . . . . . . . . . . .68Fluid Metering Inc . . . . . . . . . . . . . . . .61Fristam Pumps USA . . . . . . . . . . . . . . .11Gemu Valves . . . . . . . . . . . . . . . . . . .15IMA North America Inc . . . . . . . . . . . . . .54

Jet Pulverizer Company . . . . . . . . . . . . .21Labconco Corporation . . . . . . . . . . . . . .38MG America Inc . . . . . . . . . . . . . . . . .17MicroThermics Inc . . . . . . . . . . . . . . . .59Netzsch Inc . . . . . . . . . . . . . . . . . . . .55Newman Sanitary Gasket Company . . . . . . .48Nilfi sk cfm . . . . . . . . . . . . . . . . . . . .51O'Hara Technologies Inc . . . . . . . . . . . . .43Oystar USA . . . . . . . . . . . . . . . . . . . .27Powder Systems Ltd . . . . . . . . . . . . . . .44Precision Fabrics Group Inc . . . . . . . . . . .47Rotronic Instrument Corporation . . . . . . . .46Rubber Fab Technologies Group . . . . . . . . .52Sartorius Stedim Biotech. . . . . . . . . . . . .31schenck AccuRate . . . . . . . . . . . . . . . .44Silverson Machines Inc . . . . . . . . . . . . . .67

Sony Visual Imaging Products . . . . . . . . . .13Sotax Corporation . . . . . . . . . . . . . . . .53St Gobain Performance Plastics . . . . . . . . .23TechniServ Inc . . . . . . . . . . . . . . . . . .25Terra Universal . . . . . . . . . . . . 14, 20, 21, 61Tuthill Vacuum & Blower Systems . . . . . . . .63Vac-U-Max . . . . . . . . . . . . . . . . . . . .42Veltek Associates Inc . . . . . . . . . . . . . . . 5VNE Corporation . . . . . . . . . . . . . . . . .40Vorti-Siv Industries. . . . . . . . . . . . . . . .61W L Gore & Associates . . . . . . . . . . . . 2, 29W.S. Tyler . . . . . . . . . . . . . . . . . . . . .14Western States Machine Co . . . . . . . . . . .38Wilden Pumps . . . . . . . . . . . . . . . . . .50Yorkshire Forward . . . . . . . . . . . . . . . . 3

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� Drum Lifting System Assists With Blending Operations This automated drum lift system, when used in conjunction with Rota-Cone or Rota-Vee Blenders, reduces operator exposure and is less labor inten-sive. The drum loading system uses a pneumatical-ly operated, retractable drum tray which includes a roller conveyor to simplify moving the drums onto and off of the tray. The drums are automati-cally positioned on the tray and then, with a single push of a button, the complete drum unloading or filling operation is carried out. This automatic operation allows all controls to be placed outside the gated area. The operator stands outside the gated area while operating the system, entering only to place and remove drums from the drum tray. ■ Paul O. Abbe, Bensenville, IL 60106. www. pauloabbe.com or call 800-524-2188

� Vibrating Mixer Ideal For Preparation Of Sterile Emulsions And Solutions Unit accomplishes mixing through vibration transmitted from an elec-tro-magnetic drive to a perforated plate with several conical holes. Due to the Bernoulli effect, this vibration causes the liquid to be pumped up-ward or downward through the holes. It can be in open or closed tanks under sterile conditions and vacuum. Since there is no rotating stirrer shaft, a simple membrane seal in various different materials prevents leakage or contamination. Materials of construction for various sizes of stirrer shafts and plates can be 316 stainless steel, Hastelloy, Titanium, Plexiglass or Polypropylene. ■ BioPro International, Inc., Farmingdale, NY 11735. www.biopro.com or call 516-249-0099

Pipeline Mixers Operate At Tight Tolerances For High-Shear Axial Mixing � Greerco® pipeline mixers are designed for continuous high-speed, high-shear processing for applications involving homogenization, mixing, disper-sion and emulsion. The mixer features a patented skewed turbine/stator unit which operates at tight tolerances to produce high-shear axial mixing. With pumping capacities from 10 to 1,300 gpm, the mixer is used in pharmaceutical and other industries for a wide range of applications. Standard models feature 316 stainless steel construction and single mechanical seals with other options available. ■ Chemineer, Inc., Dayton, OH 45401. www.chemineer.com or call 937-454-3379

� Helical Dryer Ideal For Scale-Up To Production Size Batch Mixers/Dryers The Helical Dryer Model HD 40 is fully mobile and provided with a PLC based control panel including wireless data logging for operation in hazardous material areas. With a batch work-ing capacity of 40 liters, the unit can be used as a small production dryer or for test trials for scale-up to production size batch mixer/dryers. Key features include a heatable shaft/mixing as-sembly, bottom discharge, only one mechanical seal, easy access for inspection, full cleanablility with CIP spray devices and compact dimensions to fit into kilo-labs and pilot-plants. ■ KMPT USA, Inc., Florence, KY 41042. www.kmpt.net or call 859-547-1100

Silverson’s high shear Batch mixers don’t just mix; they emulsify, homogenize, solubilize, suspend, disperse and disintegrate solids. Every high shear Batch mixer in our range significantly outperforms conventional mixers by cutting processing times by up to 90% while improving quality, product consistency and process efficiency.

Silverson High Shear Batch Mixers will:

• Process from 1 to 8000 gallons

• Eliminate agglomerates and fish eyes

• Create stable emulsions and suspensions

• Reduce particle size • Rapidly dissolve solids

• Accelerate reactions

For more information or a free trial give us a call @

800.204.6400

Mixing at the speed of

silverson.com


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From the initial stages of product development up to the full throttle speed of

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pharmaceutical processing - march 2009

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