netzsch machinery for pharmaceutical applications
TRANSCRIPT
Grinding & Dispersing
NETZSCH Machinery for Pharmaceutical Applications
our technologyYOUR SUCCESS
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Micronization – Grinding and Dispersing for Pharmaceutical Applications
Pharmaceutical manufacturing processes require the utmost care and precision - from initial laboratory testing to full-scale production. In this tightly regulated industry, every step in the production process demands precision pharmaceutical-grade machinery.
NETZSCH understands special phar-maceutical requirements and respects your confi dentiality. When working with high-quality, high-cost mate-rials, there is no room for error or loss. There are standards: safe, cost-eff ec-tive, easy-to-clean equipment that provides precise, repeatable results with every batch.
As the global leader in particle-reduc-tion machinery, NETZSCH off ers the technology and machinery to provide true drug development solutions. We draw resources from our specialized Pharmaceutical Competency Center, 130 years of engineering experi-ence and NETZSCH locations world-wide. We are experienced in every aspect of pharmaceutical machinery testing, certifi cation, validation and documentation.
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More than 90% of drugs approved since 1995 have poor solubility, poor permeability, or both. Drug perfor-mance can be improved by reducing the particle size and at the same time increasing the specifi c surface area of the active pharmaceutical ingredients (API).
Therefore, however an API is admin-istered - in tablet, capsule, powder or liquid form –small particle sizes off er exciting advantages for pharmaceuti-cals. Known benefi ts include improved dissolution rate, increased bioavail-ability and higher activity, leading to lower dosages and a lower risk of side eff ects for the patient.
The Advantage of Ultra Fine Particles
NETZSCH grinding technology leads the way, expanding the new nano frontier for pharmaceuticals. DELTAVITA® bead mills are the top choice in high-tech applications, specifi cally designed for the pharmaceutical market.
NETZSCH provides industry-leading bead mills for consistent sized particle reductions, as well as dispersion mills for uniform dispersion of particles in formulation. Our engineers designed the DELTAVITA® grinding and disper-sion system specifi cally to achieve very narrow nanometer particle-size distri-butions with superior repeatability.
Nanotechnology Leadership & Technology
Advantages of Milling API’sNETZSCH Competency
With almost half of new chemical enti-ties (NCEs) impaired by poor water solubility, ultra fi ne particles are the solution. Reducing drug particles to nano size increases their surface area and subsequent solubility dramatically. Nanoparticles are also used in diag-nostic applications.
NETZSCH works with pharmaceutical companies to turn such promise into reality – for both healthcare and busi-ness advantages.
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The NETZSCH engineered DELTAVITA® mill, based on proven ZETA® Mill tech-nology, stands out in the world of ultra-fi ne nanoparticle applications. Through the effi cient use of energy, high fl ow-rate, multiple-pass grinding strategy, DELTAVITA® mills achieve excel-lent repeatability as well as homoge-neous dispersion. DELTAVITA® mills are fast, extremely versatile and designed to produce a very narrow range of ultra fi ne parti-cles in a homogeneous formulation. In the time it takes for an ordinary mill to complete one pass, DELTAVITA® mills cycle through as many as 10 passes. They are time, cost and energy effi -cient. Specifi c energy reductions of up to 30% can be realized.
The DELTAVITA® process eliminates excessive heat buildup and output blockage that plagues screen sepa-ration systems in other fi ne-bead
Particle size control by rapid circulation operation
DELTAVITA® Technology
NETZSCH Competency Center
NETZSCH is deeply committed to providing choices to the pharma-ceutical industry. Testing can be completed at our dedicated Phar-maceutical Competency Center in suburban Philadelphia. Our team is experienced in the industry-specifi c demands of the pharmaceutical market including
mills. The DELTAVITA® mill’s unique media separation technology demon-strates NETZSCH’s superior technical capabilities.Among other impressive qualities,DELTAVITA® advantages for
URS (User Requirement Specifi cation)
FRS (Functional Requirement Specifi cation)
DDS (Detailed Design Specifi cation)
FAT (Factory Acceptance Testing)
IQ (Installation Qualifi cation)
OQ (Operational Qualifi cation)
Assistance with PQ (Performance Qualifi cation).
pharma ceutical applications are a single-tank process to reduce contami-nation, precise temperature control, ease of use and easy-to-clean design.
NETZSCH works with the utmost respect for the confi dentiality of your proprietary process. The Competency Center off ers separate assembly areas specifi cally for phar-maceutical machinery.
NETZSCH invests in the resources to ensure the right choice for pharma-ceutical applications. We are an ISO 9001 certifi ed facility working under the guidelines of FDA, cGMP and all regulatory compliances governing the pharmaceutical industry. All machines are either UL or CE certifi ed.
Particle size control by rapid circulation operation
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DELTAVITA® 15 - 300
R&D in small batches is an essential part of the new drug development process. The market demands the ability to confi rm process feasibility without wasting scarce, costly mate-rials. NETZSCH provides it. NETZSCH’s laboratory equipment is ideal for testing where only the smallest batch sizes are needed to achieve signifi cant test results with minimal product loss in a short period of time.
NETZSCH’s laboratory equipment off ers:
Repeatable results batch after batch
Scalability to full-size production equipment
Easy to clean and sterilize off line
NETZSCH’s DELTAVITA® 15 - 300 labora-tory equipment is ideal for feasibility studies in very small batches, from 50 ml to 1 000 ml. They achieve consistent particle reductions to below 200 nm.
DELTAVITA® – Laboratory and Pilot Plant Sized Machines
NETZSCH DELTAVITA® 15
Features
ZETA® grinding system with improved centrifugal separa-tion system using small grind-ing media
The smallest grinding media from 0.05 mm – 2 mm for reduction to the nanometer range
Scalability
Double-acting mechanical seal
Safe, simple and clean operation
Variable-speed drive via fre-quency inverter
Flexible mode of operation suit-able for continuous-pass and circulation operation
A selection of four grinding chamber volumes – 15 ml, 50 ml, 150 ml and 300 ml
Operator management with password protection on diff er-ent levels
Optional data acquisition available
IP 65 machine stand for com-plete wash down
Optional NETZSCH-CERAM Z, 316 stainless steel, PA/PE or NETZSCH-CERAM N grinding chamber designs
Documentation required for validation supplied with the machine
Training and seminars
NETZSCH DELTAVITA® 15
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DELTAVITA® 600
The DELTAVITA® 600 provides the ready solution with batch sizes of 1 liters to 6 liters to support clinical trial phase.
NETZSCH DELTAVITA® 600
Technical dataLaboratory series Pilot series
DELTAVITA® 15 DELTAVITA® 50 DELTAVITA® 150 DELTAVITA® 300 DELTAVITA® 600
Grinding chamber volume ml 15 51 142 286 600
Drive power kW 1.5 1.5 1.5 1.5 3
Speed range min-1 1 000 - 4 200 1 000 - 4 200 1 000 - 4 200 1 000 - 4 200 1 000 - 4 500
Batch size (min.-max. suggested) ml 50 - 150 90 - 300 200 - 500 300 - 1 000 1 000 - 6 000
Grinding media diameter mm 0.05 - 0.8 0.05 - 0.8 0.05 - 1.2 0.05 - 1.2 0.1 - 2.0
Features
Interchangeable agitating systems
Optional explosion-proof design for installation in haz-ardous areas
PLC control with optional inter-face for data acquisition
Optional CIP and SIP ready
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DELTAVITA® – Production Sized MachinesMaterials
NETZSCH DELTAVITA® 60000
DELTAVITA® range is scalable from the DELTAVITA® 300 to full scale production batches up to 4 000 liters.
The production systems are off ered in two frame designs. The fl exible portable design is a complete machine located within the process suite. The fi xed installation option is a split frame design with all mechanical compo-nents outside the clean room and only the wetted components in the process suite.
DELTAVITA® 2000 - 60000
Technical dataProduction series
DELTAVITA® 2000 DELTAVITA® 4000 DELTAVITA® 10000 DELTAVITA®25000 DELTAVITA® 60000
Grinding chamber volume ml 1 600 4 000 10 000 25 000 62 000
Drive powerkW 5.5 15 18 / 22 37 / 45 75 / 90
HP 7.5 20 25 / 30 50 / 60 100 / 125
Speed range min-1 1 200 - 2 500 900 - 1 800 700 - 1 300 550 - 900 350 - 700
Batch size (min.-max.) l 4 - 50 8 - 100 20 - 500 50 - 2 000 120 - 4 000
Grinding media diameter mm 0.1 - 2.0
Features
Fully CIP and SIP capable
PLC control
Optional data recording and process formulation management
Double acting mechanical seal
Choice of wetted components and grinding tools
Batch sizes from 4 liters to4 000 liters
NETZSCH DELTAVITA® 60000
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Materials & Surface Finish
Stainless steel with surface fi nish of Ra = 0.4 μm
High tech and high strength ceramic materials for metal con-tamination free processing - NETZSCH-CERAM A - NETZSCH-CERAM Z - NETZSCH-CERAM C - NETZSCH-CERAM N
All wetted parts can be sterilized with SIP or autoclave (depending on machine size)
Food / pharma grade elastomers and lubricants
NETZSCH DELTAVITA® 10000 production machine
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CONJET® High Density Bed Jet Mill
*) based on 8 bar (abs.) and 20 °C
Technical data CONJET® 10 CONJET® 16 CONJET® 32 CONJET® 50
Capacity factor - - 0.35 1
Airfl ow capacity *) m3 h-1 50 96 330 960
Number of milling nozzles pcs. 6 6 6 6
Nozzle diameter mm 1.5 1.7 3.5 6
Classifi er drive capacity kW 0.55 1.5 4 7.5
Speed min-1 18 000 12 000 7 000 5 100
Features
Operates practically residue-free at the end of the process making ideal for processing high value materials
Low energy use and high fi neness
Choice of product contact parts
Stainless steel with surface fi n-ish of Ra = 0.6 μm
High tech and high strength ceramic materials for metal contamination free processing - Zirconium oxide classifi er wheel and grinding chamber
Product contact parts can be sterilized with autoclave (depending on machine size)
Food / pharma grade lubricants and elastomers
The CONJET® High Density Bed Jet Mill is a spiral jet mill design with an internal
CONJET® 32 High Density Bed Jet Mill
Dry Grinding Equipment for Pharmaceutical Processing
dynamic air classifi er. The variable speed classifi er can micronize to 1 μm
to 40 μm with infi nite control and precision without oversize particles.
CONJET® 32 High Density Bed Jet Mill
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CONDUX® Impact Mill
*) Data based on pin disk
Technical data *) CONDUX® 100 CONDUX® 150 CONDUX® 250 CONDUX® 300
Capacity factor - 0.38 0.7 1
Diameter mm 100 150 250 330
Speed min-1 21 000 16 000 12 000 9 200
Drive Power kW 1.1 4 11 18.5
Air volume (nom.) m3 h-1 120 410 760 1 100
Features
Exchangeable grinding ele-ments for versatility
Size reduction to d50 ~ 20 μm to 500 μm
Pin discs for size reduction by impact
Counter-rotating pin discs for the highest fi neness possible
Blast rotor and wing beater for size reduction by impact and shear
Attrition grinding discs for size reduction by shear
The CONDUX® Impact Mill can be used for a wide range of applications in the pharmaceutical industry. It can be
CONDUX® 150 Impact Mill
equipped with various grinding tools and stators, to optimize any process. The CONDUX® Impact Mill combines all
the advantages of modern grinding technology in a practical, fl exible and highly-effi cient machine design.
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CFS/HD-S High Dispersion Air Classifi er
Technical data CFS 5 HD-S CFS 8 HD-S CFS 30 HD-S CFS 85 HD-S
Capacity factor - - 0.35 1
Air volume (max.) m3 h-1 75 180 455 1 300
Speed max. min-1 18 000 12 000 7 000 5 100
Power classifi er kW 0.55 1.5 4 7.5
Features
High dispersion takes place in near proximity to the classifi er wheel for eff ectively separation
No intermixing of fi ne or coarse material with new feed material
High yield
Lowest possible pressure drop for low energy use
Sharpest cut-point with -value up to 0.8 possible
Air classifi cation of pharmaceutical materials can enhance or even replace micronization in some applications. Air
CFS 85 HD-S High Dispersion Air Classifi er
Additional Machinery
classifi ers are used to modify particle size distributions. The CFS/HD-S is a modern air classifi er that can provide
cut sizes in the range of 1 μm to 40 μm with infi nite control and precision.
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NETZSCH Vacuum De-Aerator
The MAXSHEAR Inline Disperser is an effi cient, low maintenance, low cost unit compact enough to be used at any point in the process. Its extremely high shear performance and powerful dispersing action generate the best premix possible.The MAXSHEAR’s unique single processing stage reduces down-stream work and eliminates the product bypassing typical of most single stage units. Applications for the MAXSHEAR include pharmaceutical and cosmetic formulations.
MAXSHEAR Inline Disperser
In the NETZSCH Vacuum De-Aerator, micronized gases are removed from fl uids with a wide range of viscosi-ties. By means of the VTR Principle (vacuum - thin-fi lm - rotary process), it is possible to process products from topical gels and creams, for example, to a wide variety of free-fl owing compounds. The throughput is product and viscosity dependent and can range from 500 kg/h to 4 000 kg/h. This machine can be used to de-gas both small quantities, from interchangeable tanks in batch operation, and large batches in continuous operation.
NETZSCH Vacuum De-Aerator DA 602
MAXSHEAR 3 Inline DisperserMAXSHEAR 3 Inline Disperser
Sanitary Confi guration: all stain-less steel construction with sanitary type connections.
Self-contained pressure reservoir for mechanical seal with inte-gral pumping ring for special applications.
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Plant EngineeringNETZSCH Application Laboratory
Total engineered solutions – grinding and mixing process for full production
NETZSCH – Exemplary Quality Machinery
NETZSCH is an ISO 9001:2000 manu-facturer. We follow cGMP, the current good manufacturing practices of the FDA, and build our systems in accor-dance with current GAMP.
Pharma-grade NETZSCH grinding machinery is made with the fi nest materials and built in compliance with the stringent regulatory require-ments that control the pharmaceutical industry. Every machine is rigorously
tested, validated for specifi cation compliance, and fully documented for your pharmaceutical needs.
To prove our commitment to your success, we take the utmost care at every stage – from equipment design to manufacture to one-on-one service support. NETZSCH off ers total engi-neered solutions to increase the productivity of the entire production process.
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In 2008, NETZSCH Premier Technologies opened a dedicated pharmaceutical lab equipment testing facility in Exton, PA. NETZSCH invites members of the phar-maceutical industry to test their processes on lab-sized grinding and dispersion equipment with the one-on-one support of a NETZSCH technician. An addi-tional 1,200-square-foot area is dedicated to pharmaceutical assembly and factory acceptance testing (FAT). The Technical Center provides a diverse range of processing machines including:
High speed dispersion and mixing equipment
Horizontal media mills
Bench-size, pilot plant and production-size mills
Particle size analysis
Technical Center Features:
16,500-square-foot, two-story technical center
Pharmaceutical equipment production & certifi cation suite
Four processing suites for application testing
Isolated hazardous material storage area
Analytical laboratory
Client training and conference rooms
Following proven testing in our laboratory pilot plant, NETZSCH guarantees that our supplied equipment will operate exactly as promised. We stand behind every machine we manufacture.
NETZSCH Premier Technologies, LLC.The Pharmaceutical Competency Center within the Business Unit Grinding & Dispersing
www.netzsch.com G&
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NETZSCH-CONDUX Mahltechnik GmbHRodenbacher Chaussee 163457 HanauGermanyTel.: +49 6181 506-01 Fax: +49 6181 506 [email protected]
NETZSCH-Feinmahltechnik GmbHSedanstraße 7095100 SelbGermanyTel.: +49 9287 797-0 Fax: +49 9287 797 [email protected]
The World’s Leading Grinding Technology
The Companies of the Business Unit Grinding & Dispersing
NETZSCH-Feinmahltechnik GmbH, Selb, Germany
NETZSCH-CONDUX Mahltechnik GmbH, Hanau, Germany
NETZSCH Premier Technologies, LLC., Exton PA, USA
NETZSCH Indústria e Comércio de Equipamentos de Moagem Ltda., Pomerode, Brazil
NETZSCH (Shanghai) Machinery and Instruments Co., Ltd., Shanghai, China
NETZSCH Mastermix Ltd., Lichfi eld, Great Britain
NETZSCH España, S.A., Terrassa/Barcelona, Spain
ZAO NETZSCH Tula, Tula, Russia
NETZSCH Makine Sanayi ve Ticaret Ltd. Sti., Izmir, Turkey
The Business Unit Grinding & Dispersing is part of the NETZSCH Group.
The NETZSCH Group is a mid-sized, family-owned German company engaging in the manufacture of machinery and instrumentation with worldwide production, sales, and service branches.The three Business Units – Analyzing & Testing, Grinding & Dispersing and Pumps & Systems – provide tailored solutions for highest-level needs. Over 3 000 employees at 163 sales and production centers in 28 countries across the globe guarantee that expert service is never far from our customers.