protecting the quality, efficacy and efficiency of …life sciences solutions entegris, inc. 7 fluid...

Protecting the quality, efficacy and efficiency of your process

LIFE SCIENCES SOLUTIONS


2 ENTEGRIS, INC.

Why Entegris?For nearly 50 years, Entegris has provided products and systems that purify and protect critical materials in the most demanding industries. This expertise offers you capabilities in chemical delivery, process analytical techniques and materials science to ensure the safety and purity of your products throughout the supply chain, from raw materials to final products.

With a broad product offering, advanced manufac-turing capabilities, global infrastructure and technical support, Entegris provides solutions for

laboratory, pilot and process-scale applications. From concentration monitors, flow controllers and filtration, to scalable fluid handling solutions utiliz-ing FDA compliant materials, Entegris has solutions to meet your purity and process demands.

Enjoy confidence with solutions that reduce your extractable, leachable (E&L) and rouging issues, while increasing control over critical process parameters. Offering you the cleanest, easily scal-able and most reliable polymer solutions to protect your overall process quality, efficacy and efficiency.

Millipore 1954 | FoundedMembrane filtration

Fluoroware1966 | FoundedFluid and wafer handling

EMPAK1981 | FoundedWafer handling

Entegris 1999 | Founded through Fluoroware and EMPAK mergerPolymer science, process knowledge

Poco Graphite2008 | Acquired High-performance graphite and silicon carbide

PureLine2009 | Acquired Fluid handling componentmanufacturing in Korea

JetalonSolutions, Inc.2013 | Acquired Chemical concentrationsensors and analyzers

Mykrolis2001 | Founded through Millipore spin-offLiquid and gas purification, contamination control

Aeronex 2003 | AcquiredGas purification systems

NT International 2001 | AcquiredUltrahigh-puritysensing and control

2007 | Acquired Surmet’s semiconductorcoatings businessHigh-purity and specialty coatings

EntegrisPrecisionTechnology2012 | Acquired HDPE drum manufacturing in Taiwan

ATMI2014 | Acquired Advanced materialsand material deliverysystems

Extraction Systems2005 | AcquiredAirborne molecularcontamination control

Entegris 2005 | Entegris and Mykrolis mergerCombined entitybecomes industry’slargest contaminationcontrol company

A History of Innovation


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Experience You Can Count On

Contamination control is critical to your manufacturing processes and has a direct impact on production yields and manufacturing costs. Entegris focuses on understanding your processes and sources of contamination to develop material-enabled solutions, ensuring the cleanliness and integrity of your process.

To support your vital applications and ensure the correct material choice, Entegris utilizes 30 collab-orating product engineering laboratories focusing on separation and materials science including more than 200 methods and applications and 300 analytical instruments. Entegris separation science methodologies provide separation, purification and analysis of complex mixtures of organic and inor-ganic compounds. This information, coupled with our materials science expertise, provides thorough material analysis for E&L, material selection and processing, temperature, mechanical and chemical compatibility – resulting in solutions to improve your performance, cost of ownership and yield.

Proven Quality and PerformanceFocusing on raw material, supply chain and quality controls, Entegris provides the highest level of quality, performance and contamination control. To meet the quality specifications for the most demanding industries, our quality system routinely inspects incoming high-purity resins for extract-ables such as organics, anions and metals. Entegris also works directly with you to develop process knowledge that enables optimized design, innova-tion and efficiencies while mitigating risk.

Entegris ISO 9001 certified manufacturing sites utilize product performance standards and proven techniques such as documentation control, Lean Sigma processes, quality testing and cleanroom environments to increase your yield and process efficiencies. Each advanced manufacturing capability, material type and material grade have been developed, tested and improved to create innovative, durable, consistent and reliable prod-ucts. These capabilities, controls and techniques enable solutions to ensure the safety of your critical materials.

• Injection molding

• Rotational molding

• Blowmolding

• Extrusion

• Machining

• Welding and flaring

• 3D printing

• Overmolding

• Prototyping

• Tool design/making

To ensure product performance throughout the production process, we have extensive capabilities in chemical, mechanical and physical property analysis.

From the moment materials are delivered to Entegris to the time they installed as products, you’re ensured that they meet stringent specifications.


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Core CapabilitiesFor nearly 50 years, Entegris has developed broad capabilities in contamination control, high-purity materials and material handling to purify, protect and transport the critical materials that enable applications in many high-tech industries. This experience offers you life science solutions in sensing and control, fluid handling, containers and filtration to meet your needs and provide a single source of flexible product offerings.

MATERIAL HANDLING

Critical material transport

Custom trays Process and transport carriers

Silicon carbide Specialty coatings

Graphite

SPECIALTY MATERIALS

CONTAMINATION CONTROL

Filtration PurificationContainersFluid handlingSensing and control


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Close to YouOur global sales team, sales channel partners and local applications engineers give you support and expertise when you need it. This intimacy allows us to better understand your needs through direct feedback and collaboration. By aligning our materi-als science, engineering and R&D initiatives, we can recommend or develop indispensable contamina-tion control and high-performance solutions to improve your quality and manufacturing flexibility.

Entegris’ local field applications engineers work directly with you on product qualification and process improvements in your facilities. For local technical service and fast turnaround time, Entegris maintains regional applications laborato-ries that simulate your applications and provide product evaluation.

Colorado SpringsTempe

San DiegoDecatur

Round RockBurnet

FranklinBedfordDanbury

BillericaBloomingtonChaska

Dresden

Moirans

Kiryat-Gat

Montpellier

Limonest

Singapore

KulimPenang

OsakaTokyoXi’an

Yonezawa

Suwon

HwaseongAnseongBeijing

KyushuShanghai

Tainan

YangmeiHsinchuChutung Town

Wonju

Walnut Creek


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Sensing and ControlFast and accurate measurement of your CPPs (critical process parameters) ensures consistent and efficient processes while minimizing downtime. Entegris’ concentration analyzers provide real-time, accurate, in-line monitoring of CPPs, ensuring accurate mixing of chromatography buffers and CIP chemicals, as well as precise identification of critical process chemistries. From bench top to full-scale manufacturing, Entegris sensors utilize index of refraction (IoR) for the highest accuracy in concentration monitoring.

Entegris’ sensing and control products allow users to accurately measure and control liquids while monitoring process parameters. From pressure transducers to closed-loop flow control systems, these products enable you to ensure process integrity and improve yields.

Applications

• Quality control of buffer preparation

• Inline dilution of CIP chemicals

• Batch control for chemical spiking and blending

• On-demand chemical mixing for DNA and peptide synthesis processes

• Pressure control of final fill applications

• Sense presence and flow in liquid chromatography applications

• Flow and pressure control for process sampling

Features Benefits

Compact footprint Enables easy field installations in limited space

Closed-loop circuit controls Allows fast response rates for accurate flow rate and pressure measurement

Years of proven reliability Dependable accuracy, control and monitoring for critical applications

Multiple end connections available Allows easy installation to your existing system

Broad range of materials used as wetted surfaces

Enables optimization of chemical compatibility, mechanical strength and product purity for the specific application

Sensing and control solutions maintain chemical integrity and allow for accurate, repeatable and reliable measurement.

The miniaturized SRSensor™ offers scalable, fast, accurate and reliable analyzing of your buffer and CIP chemicals.

2.5 cm


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Fluid HandlingReduce your rouging and E&L contamination issues while protecting the quality, efficacy and yield of your bioprocess. Entegris high-purity components provide chemical compatibility and material stability in aggressive chemistries, as well as flexible configurations for operational efficiency and throughput. All wetted surfaces are fluoropolymer material for the utmost in purity and corrosion resistance. Valves range in size from 1⁄4" to 2" orifice, while numerous fitting configurations are available in sizes ranging from 1⁄16" to 2." Tubing is available in straight lengths or reels from 1⁄4" to 2" OD.

Applications

• DNA, peptide and protein synthesis

• Reagent and API manufacture

• Downstream final fill and finish fluid transfer

• Transfer of process reagents and fluids

• Laboratory equipment plumbing and drains

• High-salt and low-pH buffer applications

• Chromatography/purification processes

• Solvent and hazardous chemical transfer

• Large and small organic molecule laboratory and pilot plants

Entegris’ fluid handling solutions maximize productivity, improve yields and reduce cost of ownership.

Features Benefits

Ultrapure fluoropolymer wetted surfaces

Universal compatibility with reagents, solvents, acids and bases

Nonmetallic and low TOC extraction maintains ultrapure environment

Material flexibility is ideal for product fill and transfer applications

Eliminates rouging

Broad size range Allows scalability from laboratory, to pilot plant to full-scale process and process monitoring applications

Multiple connection configurations Enables design flexibility for sanitary, industrial and high-purity applications

Worldwide installed base Proven product reliability, safety and quality in field applications

Translucent material Allows for visual identification


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Chemical Containers

Entegris’ chemical containers help you safely handle critical reagents and solvents from storage and transport to point-of-use.

Features Benefits

Ultrapure fluoropolymer wetted surfaces Universal compatibility with reagents, solvents, acids and bases

Minimizes organic, metallic and particle contamination, maintaining chemical purity

Eliminates rouging

DOT and UN approved Ensures product reliability and safety when transporting hazardous chemicals

Patented quick connect system Provides a safe method of connecting FluoroPure® containers to fill/dispense systems

Assures against unsafe chemical mixing and minimizes human exposure to chemicals and fumes, improving safety

Made of FDA compliant materials and USP Class VI tested

Qualifies them as suitable for use in validated biopharm applications

Translucent material Allows for visual identification

High-purity PFA containers deliver safety and purity as you handle corrosive and hazardous chemicals from storage and transport to point-of-use in lab scale, utilities and packaging processes. Made of FDA compliant materials, and USP Class VI tested, Entegris’ PFA bottles provide high purity and cold temperature reliability in drug substance storage applications. A full suite of chemical con-tainers, including dispense and bulk chemical products, provides safety, purity and reliability in your process.

Applications

• Transport, storage and dispense of critical reagents and solvents for DNA, peptide and pro-tein synthesis, API manufacture, fermentation and reaction processes and LC applications

• PFA bottles for high-purity drug substance storage and freeze/thaw applications


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Liquid Filters and PurifiersProcess chemistries vary and the appropriate filtration and purification technologies need to be applied to achieve the most efficient and cost-effective solution. Entegris’ filtration and purification solutions offer broad chemical and temperature range compatibility to enhance yield, reduce downtime, deliver high flow rates, simplify installations, stabilize processes and lower total cost of ownership. Certifications and FDA compliant materials of construction vary by application and product configuration; please consult the specific product data sheet or your Entegris representative.

Applications

• Bulk chemical filtration of pH balance and kill chemicals in fermentation processes

• Particulate removal of active pharmaceutical ingredients, reagents and medias

• Clarification of solvents and alcohols prior to final fill

• Pre-RO water filtration

Entegris’ Fluorogard® AT and ATX cartridge filters offer high-flow capability and all-PTFE construction for enhanced cleanliness and broad chemical and temperature range capability.

Features Benefits

Broad range of materials and technologies: UPE (ultrahigh molecular weight polyethylene), PES (polyethersulfone), PP (polypropylene), PTFE membrane materials or depth media available

Effectively match the optimal filter technology and pro-cess performance requirements

Retention ratings from 50 µm to 0.05 µm

Prewet cartridges available Allows quick installation and reduced change-out time

Large membrane area filter cartridges available Minimizes pressure drop, provides high flow and delivers longer filter life

Highly retentive, high flow and clean filter design Increases yield, throughput and filtration speed and construction


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Custom SolutionsStandard solutions are great – when they solve your challenges. But sometimes, a custom solution offers the best approach. The first step in develop-ing these solutions is working with you to fully understanding your specific requirements. Then, applying our core capabilities in chemical delivery, process analytical techniques and materials science to your requirements enables solutions with opti-mized design, innovation and efficiencies while mitigating risk.

Entegris’ custom solutions utilize expertise in machining and 3D printing, combined with a broad range of options for material type, size, temperature capability, chemical compatibility and surface characteristic variables. From configurable options for transfer of critical process chemicals to safely managing pressure to high-purity flow control solutions, Entegris provides fast turnaround custom solutions to protect your overall process quality, efficacy and efficiency. USP Class VI PFA dip tubes, made from FDA compliant

materials, are configurable and provide low E&L performance, decreasing the risk of process, product or media contamination during chemical transfer.

Utilizing PFA and PTFE in custom manufacturing and design, a surge tank with cleaning spray, fill/dispense dip tube and vent with valve distribution manifold provides a chemically compatible, low E&L solution.


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Biomaterials and Coatings The proven biocompatibility, safety and efficacy of implantable graphite allow Entegris biomaterials in U.S. FDA Class II and III applications such as mechanical heart valves, orthopedic prosthetics and cancer treatments. Offering ideal coefficient of thermal expansion properties, uniformity, high purity and robust performance in high temperature applications, Entegris materials ensure that your devices meet difficult dimensional, quality and implant requirements. Furthermore, Entegris’ POCO® fine grain graphite provides unique acoustic properties to ensure that ultrasonic equipment delivers performance in your next- generation probes.

Critical Material Transport SolutionsIt’s hard enough producing devices and materials without worrying about the risk of contamination impacting safety and efficacy. With this in mind, Entegris provides a broad offering of device packag-ing, critical material transport and precision clean-ing services that offer flexibility and proven perfor-mance for reduced operational costs, decreased time to market and reduced risk.

Utilize the interactive Entegris i-Tray™ Designer for your custom tray applications. These custom solutions provide reliable operation and superior device protection, while decreasing your time to market and minimizing your shipping and storage costs.

Simply use the online designer tool to specify basic dimensional and material information to create a viewable engineering drawing.

For your purest applications, ECP offers particle removal as low as 0.2 microns.

Uniformity, high purity and robust performance of implantable graphites ensure safety and efficacy in your process.

Entegris specialty coatings offer biocompatibility, safety and efficacy to protect your surgical instruments.

Offering inspection, maintenance, packaging and precision cleaning services, Entegris ensures trace-ability and the highest level of cleanliness. Located in Montpellier, France, Entegris Cleaning Process (ECP), an Entegris Company, offers sand-blasting, passivation and cryogeny to protect your materials and reduce risk

Entegris specialty coatings provide scratch resis-tance, low friction and wear, and eliminate corro-sion on most substrate materials. The biocompati-bility, safety and efficacy of these coatings protect your surgical instruments by reducing particles, contamination and risk.

ENTEGRIS, INC. Corporate Headquarters | 129 Concord Road | Billerica, MA 01821 USACustomer Service Tel. +1 952 556 4181 | Customer Service Fax +1 952 556 8022 In North America 800 394 4083 | www.entegris.com

©2007–2015 Entegris, Inc. All rights reserved Printed in USA 9000-7560ENT-1215

Entegris®, the Entegris Rings Design®, Creating a Material Advantage®, Fluorogard®, FluoroPure®, i-Tray™, POCO® and SRSensor™ are trademarks of Entegris, Inc.

Take the Risk out of Risk ManagementEnjoy confidence with solutions to reduce your E&L and rouging issues, while protecting the quality, efficacy and yield of your overall process. Discover how nearly 50 years of proven materials science experience in the most demanding indus-tries offers you the cleanest, scalable and most reli-able polymer solutions to improve your manufactur-ing flexibility while mitigating risks.

• Sensing and control

• Valves, fittings and tubing

• Chemical containers

• Liquid filters and purifiers

• Custom solutions

For More InformationVisit www.EntegrisLifeSciences.com and select the Customer Service link for the Regional Customer Service Center nearest you. You’ll learn how to reduce your validation time, lower your develop-ment costs and decrease your time to market.

Terms and Conditions of SaleAll purchases are subject to Entegris’ Terms and Conditions of Sale. To view and print this information, visit www.entegris.com and select the Legal Notices link from the footer.

protecting the quality, efficacy and efficiency of …life sciences solutions entegris, inc. 7 fluid...

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