News3

Industrial weighing and measuring

PharmaceuticalPreparations

Peace of mind with consistent tablet quality

At the CIMEX AG pharmaceutical manufacturing site, vali-dated weighing stations fitted with the dispensing software FormWeigh. Net®, guarantee formulation accuracy, failproof material handling and compliance with cGMP/GAMP and 21 CFR part 11.

Analysis of the specific require-ments and close cooperation between CIMEX AG and METTLER TOLEDO led to the seamless and smooth up-grade of CIMEX AG’s dispensing sys-tem to FormWeigh. Net®. Mohammed Ibrahim, Production Manager of non-penicillin based products man-ufacturing, underlines that “a cru-cial point was the integration of the available devices into the new system without suffering from production loss during the changeover. The goal was to bring the new system as close as possible to the system already in-place while introducing new func-tions.” The customizable functions of FormWeigh. Net® made this a straight-forward task.

CIMEX AG decided to use the valida-tion service that METTLER TOLEDO provides. The weighing stations were qualified, the software validated and all operators trained with no interfer-ence to the on-going production. The feedback after the Factory Acceptance Test (FAT) was very positive: “We were able to simplify the weighing proce-dure considerably because the inter-face is truly user-friendly”.

“The standard Computer System Validation (CSV) packages tremen-dously helped to minimize the vali-dation work.” The packages consist of two manuals. Pac 1 contains all relevant information and protocols for a successful supplier Audit, while

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PublisherMettler-Toledo AGIndustrialHeuwinkelstrasseCH-8606 NänikonSwitzerland

ProductionMarCom IndustrialCH-8606 NänikonSwitzerland

MTSI 44099003

Subject to technical changes© 01/2007 Mettler-Toledo AGPrinted in Switzerland

Pac 2 contains detailed protocols for the Installation, Operation and Performance Qualification (IQ, OQ, PQ) as well as applicable SOPs for disaster recovery, backup and system security.

Warehouse, data and recipes management-order generation

Courtesy CIMEX AG

Weighing station with ID30 industrial PC, barcode laser scanner, label printer and three scales connected.

Courtesy CIMEX AG Courtesy CIMEX AG

Network

advantages for CIMEX AG

Key benefits of FormWeigh.Net® dispensing software• User-friendly touchscreen• Unique labeling system• Graphical visualization of the

weight• Electronic batch records and

e-signature• Weighing and control at your

finger tips• Fully 21 CFR Part 11 compliance

CIMEX AG is a leader in the manu-facturing, packaging and distribu-tion of solid pharmaceuticals for the treatment of high blood pressure, prostate problems and Parkinson‘s disease. “Because of our global pres-ence, we require from our suppliers not only good solutions, but also good service and support, reliability, and competitive prices”, says Dr. Thomas Uhlmann, leader of the Production and Technic Dept. of CIMEX AG. METTLER TOLEDO is a qualified partner of CIMEX AG.

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Based on the great success of the project with METTLER TOLEDO, CIMEX AG plans to implement an ad-ditional FormWeigh.Net® system in its penicillin production soon.

METTLER TOLEDO Pharmaceutical Preparations News 3 3

Electronic batch documentationAll relevant batch information and the operator’s “signature” are electroni-cally documented. Protected access guarantees that sensitive data can only be seen and/or changed by the author-ized people.

Secure process with unique labeling system Every raw material is identified uni-quely with a barcode. FormWeigh. Net® recognizes the raw material by read-ing the barcode with a laser scanner, verifies its quality status and the ex-piry date.

The material information displayed helps operators to prepare the right in-gredients for the batch. Furthermore, safety precautions and handling pro-cedures are highlighted on the screen. FormWeigh. Net® confirms that each quantity is correct before the operator is allowed to start weighing.

Order overview: select your recipe and start weighingAn easy-to-read order list is displayed and the system is ready for produc-tion. The weighing of the required raw material can be started by simple selection.

Visualization of the weight FormWeigh. Net® shows you graphi-cally and numerically how far you are from the target weight. The required tolerances are clearly displayed as lim-its and weighing results that exceed or fall below these limits are shown in different colors. This helps to high-light potential problems and prevent mistakes.

ID30 user-friendly touchscreen flat panelThe operators select or place the order directly at the weighing station and control it simply with a light touch of the screen.

Weigh and control at your finger tips with the ID30 industrial PC

A weight within the target limits is shown in green

A weight below the limits is shown in blue

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ents 1.25kg is 1.25kg – Now and forever?

Our services keep your APIs active

Quality lies in consistently manufacturing to your exact formula, regardless of when you make it, who the operator is, and despite any potential change in manufacturing conditions.

Measurement reliability and minimum weightThe accuracy of a precision instru-ment, such as a scale, can be affected by many factors. Accuracy and repeat-ability of weighing operations are not accidental – they result from wise equipment choices and correct instal-lation, calibration and use.

Quality and consistency can be built into your solids or liquids by ensuring that your measurements are always within acceptance tolerances. But how do you get the peace of mind that your weight measurements are reliable?

The relative uncertainty of a meas-urement increases exponentially with decreasing weight values. As a conse-quence, a minimum weight limit ex-ists for every scale, below which the measurement uncertainty becomes larger than the tolerance specified for the weighing process.

In every new METTLER TOLEDO in-dicator is embedded the MinWeigh® function that warns the operator when the weight is below the minimum weight threshold. Ask your service technician to activate MinWeigh® for increased safety in your processes.

The MinWeigh® service also includes:• On-site determination of measure-

ment uncertainty of the weighing system within your process envi-ronment conditions

• Calculation and documentation of the minimum weight in relation to the process tolerances

• Easy and fast recalculation of the minimum weight, since tolerances may change from one process to the next

The flashing of this red icon on the new IND780 indicates that the weight is below the minimum weight threshold. Furthermore the weight is displayed in red as long as the weight is below the minumum.

METTLER TOLEDO Pharmaceutical Preparations News 3 �

Courtesy Eisai

IPac means “in-spec” scale performanceEquipment Qualification (EQ) is much more than just complying with GMP requirements. EQ ensures the accuracy and consistency that you require from your equipment. From equipment selection, installation and calibration, to thorough operational qualification, IPac provides services to ensure that your scale, in your production setting, delivers certified weighing performance to your speci-fications. Furthermore, with IPac your operators receive training to maxi-mize weighing efficiency while main-taining accuracy and safety. IPac also helps you document appropriate peri-odic test procedures to confirm per-

formance during routine operation. Finally, IPac provides ready-to-file equipment qualification documents designed to comply with your qual-ity system.

Great value for your money – quality for your customers• Certified weighing precision to

ensure the 1.25kg or any weight that contributes to your product’s success

• Determination of the minimum weight ( MinWeigh®)

• Improved productivity with correct equipment set-up and user training

• Cost savings through use of an OEM-developed qualification protocol

• Best-practice documentation to your quality system requirements means smooth and timely cGMP compliance

METTLER TOLEDO Pharmaceutical Preparations News 36

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n Unrivalled detection sensitivity,easy GMP compliance

Metal detection plays a vital role in supporting and ensuring the high standard of quality control.

There are a number of critical points in the production process where con-tamination may arise, including the sifting process, the tablet pressing and the packaging. Each of these steps may demand a different type of metal detection.

SSL International, a leading health-care company, which owns global market brand leaders in foot care, condoms and powder-free surgi-cal gloves, Scholl, Durex and Regent Biogel respectively, has been using METTLER TOLEDO Safeline metal detection systems for many years. Due to operational success, SSL purchased three further METTLER TOLEDO Safe-line detectors to monitor solid dose

medicines for its OTC pharmaceutical production plant in Peterlee, UK.

The highly sensitive Safeline Tablex metal detectors consistently detect fragments of metal contamination, including non-magnetic stainless steel and aluminium, at inspection rates of more than 10 000 tablets per minute.These metal detectors also ensure peace of mind by complying with GMP regulations. Performance vali-dation software assists QA personnel with step-by-step instructions through the test routine. Evidence that QA pro-cedures have been followed can be pro-vided quickly and easily by download-ing and printing the data.

Key benefits:• Unrivalled detection sensitivity• High throughput• Easy to operate• Integrated reject systems includ-

ing side diverter and lift flap mechanisms

• Mobile design allows for installa-tion in confined spaces

• Sealing to IP65 or IP66 standards available

• Designed and manufactured for 21 CFR parts 210 & 211

• Ready for 21 CFR part 11 compliance

Courtesy Zambon Courtesy SSL International

METTLER TOLEDO Pharmaceutical Preparations News 3 7

Customised checkweighing solutions

AstraZeneca and METTLER TOLEDO in partnership have developed a leading-edge checkweighing, print and verification solution for use on a brand new product packaging line.

Already the preferred checkweighing technologies provider for AstraZeneca in Macclesfield, METTLER TOLEDO has installed fifteen Checkweigh-ers for the company over recent years. AstraZeneca returned to METTLER TOLEDO requesting a sys-tem that would scan, batch/date print and checkweigh “prescription-sized” packages of their Zomig® migraine medicine.

Highest levels of accuracy and integrated solution AstraZeneca required a solution that ensured the highest levels of scanning accuracy, cost-effective print capabil-ity and a checkweighing tolerance of +/- 200mg; a level sufficient to deter-mine whether the correct dosage in-structions were contained within the packaging.

Working together, AstraZeneca and METTLER TOLEDO developed a cus-tomised solution to suit their needs. The solution consists of the already proven S2 Pharma checkweigher with top and bottom belt system, which guarantees the highest reliability of feeding. This is integrated with a sen-sor able to recognise the given number of pixels in a specified print area and an appropriate printer, chosen for its cost-effective replacement print heads.

The system implemented ensures that only correctly-filled and batch/ date-printed Zomig® packs progress toward shipping, with any pack that fails to contain dosage instructions being ejected for re-filling. “Devel-oping this highly innovative solution for AstraZeneca, requiring the highest levels of accuracy and technology, was a very rewarding challenge for METTLER TOLEDO and AstraZeneca”, so comments Steve George, Sales Ac-count Manager of METTLER TOLEDO Product Inspection.

Key benefitsSpecially developed for the pharma-ceutical environment, the S2 Pharma Checkweigher features:• Easy-to-use with touchscreen color

display• Great flexibility for easy integra-

tion into every production line• Secure operations with reject catch

bin and open flap detection options• Quality assurance with unique sta-

tistics and data storage capability• Equipment qualification and vali-

dation support

Courtesy Weleda

The top and bottom belt system ensures highest reliability of feeding

www.mt.com/ind-pharmaFor more information

Mettler-Toledo AGCH-8606 GreifenseeSwitzerlandTel. + 41 44 944 22 11Fax + 41 44 944 30 60

Your METTLER TOLEDO contact:

Moisture determinationfully pharmacopeia-compliant

METTLER TOLEDO moisture solution package provides fast and reliable moisture analysis in compliance with GMP.

According to the pharmacopeias, e.g. USP, moisture determination with dry-ing oven is the established reference method. However, process time is very long and requires many complex proc-ess steps. In contrast, moisture deter-mination with the METTLER TOLEDO Halogen Moisture Analyzer HR83 is a significantly faster and easy-to-use solution.

Cross-validation experiments have shown that moisture results obtained with the HR83 method excellently match the pharmacopeia-compliant drying oven results. This solution is al-ready in use and approved by an FDA-inspected pharmaceutical company.

Key benefits• Time to result is reduced from

hours to minutes• Save 3-5 hours of process time for

the majority of all measurements• Outstanding results reproducibility

and reliability• High resolution of 0.1mg – same

resolution as required by Pharma-copeia for balances when using reference method

METTLER TOLEDO provides the entire solution for the HR83, including: • Reference SOP & documentation• Exemplary methods for the 10 most

often used pharma excipients cov-ering the majority of all moisture measurements

• Qualified installation (IQ, OQ,PQ) with IPac moisture

• Temperature calibration of HR83 exactly at point of use