Life Sciences - Andon Specialties
Transcription
Life Sciences - Andon Specialties
LIFE SCIENCES SOLUTIONS Protecting the quality, efficacy and efficiency of your process Why Entegris? For more than 40 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. analyzers, flow controllers, filtration and scalable FDA and cGMP compliant fluid handling solutions for laboratory, pilot and process-scale applications – helping to meet your economic 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 scalable and most reliable polymer solutions to protect your overall process quality, efficacy and efficiency. With a broad product offering, advanced manufacturing capabilities, global infrastructure and technical support, Entegris provides concentration A History of Innovation Aeronex 2003 | Acquired Gas purification systems Mykrolis Millipore 1954 | Founded Membrane filtration 2001 | Founded through Millipore spin-off Liquid and gas purification, contamination control Extraction Systems 2005 | Acquired Airborne molecular contamination control 2007 | Acquired Surmet’s semiconductor coatings business High-purity and specialty coatings Entegris Precision Technology 2012 | Acquired HDPE drum manufacturing in Taiwan Entegris 2005 | Entegris and Mykrolis merger Fluoroware Entegris 1966 | Founded Fluid and wafer handling 1999 | Founded through Fluoroware and EMPAK merger EMPAK Polymer science, process knowledge 1981 | Founded Wafer handling Combined entity becomes industry’s largest contamination control company NT International Poco Graphite PureLine 2008 | Acquired 2009 | Acquired High-performance graphite and silicon carbide Fluid handling component manufacturing in Korea Jetalon Solutions, Inc. 2013 | Acquired Chemical concentration sensors and analyzers 2001 | Acquired Ultrahigh-purity sensing and control 2 ENTEGRIS, INC. Experience You Can Count On Proven Quality and Performance Focusing 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 extractables such as organics, anions and metals. Entegris also works directly with you to develop process knowledge that enables optimized design, innovation and efficiencies while mitigating risk. To ensure product performance throughout the production process, we have extensive capabilities in chemical, mechanical and physical property analysis. 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 materialenabled solutions, ensuring the cleanliness and integrity of your process. To support your vital applications and ensure the correct material choice, Entegris utilizes 17 collaborating 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 inorganic 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. ENTEGRIS, INC. From the moment materials are delivered to Entegris to the time they installed as products, you’re ensured that they meet stringent specifications. 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 products. These capabilities, controls and techniques enable solutions to ensure the safety of your critical materials. •Injection molding •Welding and flaring •Rotational molding •3D printing •Blowmolding •Overmolding •Extrusion •Prototyping •Machining •Tool design/making 3 Core Capabilities Over the last 40 years, Entegris has developed broad capabilities in contamination control, highpurity 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. CONTAMINATION CONTROL Sensing and control Fluid handling Containers Filtration Purification MATERIAL HANDLING Critical material transport Custom trays Process and transport carriers SPECIALTY MATERIALS Silicon carbide Specialty coatings Graphite 4 ENTEGRIS, INC. Close to You Our 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 materials science, engineering and R&D initiatives, we can recommend or develop indispensable contamination 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 laboratories that simulate your applications and provide product evaluation. Dresden Chaska Pleasant Hill San Diego Colorado Springs Billerica Bedford Franklin Decatur Limonest Moirans Beijing Yonezawa Seongnam-si Tokyo Wonju-si Osaka Shanghai Fukuoka Montpellier Kiryat-Gat Hsinchu Taoyuan Tainan Penang ENTEGRIS, INC. Kulim Singapore 5 Sensing and Control Fast 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 Sensing and control solutions maintain chemical integrity and allow for accurate, repeatable and reliable measurement. •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 2.5 cm •Pressure control of final fill applications •Sense presence and flow in liquid chromatography applications •Flow and pressure control for process sampling The miniaturized SRSensor™ offers scalable, fast, accurate and reliable analyzing of your buffer and CIP chemicals. 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 6 ENTEGRIS, INC. Fluid Handling Reduce your rouging and E&L contamination issues while protecting the quality, efficacy and yield of your bioprocess. Entegris high-purity components and cGMP compliant sanitary 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 Entegris’ fluid handling solutions maximize productivity, improve yields and reduce cost of ownership. •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 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 llows scalability from laboratory, to pilot plant to full-scale process and A 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 ENTEGRIS, INC. 7 Chemical Containers Entegris’ chemical containers help you safely handle critical reagents and solvents from storage and transport to point-of-use. High-purity PFA containers deliver safety and purity as you handle corrosive and hazardous chemicals from storage and transport to point-ofuse in lab scale, utilities and packaging processes. Entegris’ FDA and USP Class VI tested PFA bottles provide high purity and cold temperature reliability in drug substance storage applications. A full suite of chemical containers, 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 protein synthesis, API manufacture, fermentation and reaction processes and LC applications •PFA bottles for high-purity drug substance storage and freeze/thaw applications Features Benefits Ultrapure fluoropolymer wetted surfaces Universal compatibility with reagents, solvents, acids and bases inimizes organic, metallic and particle contamination, maintaining M chemical purity Eliminates rouging DOT and UN approved Ensures product reliability and safety when transporting hazardous chemicals Patented quick connect system P rovides a safe method of connecting FluoroPure® containers to fill/dispense systems ssures against unsafe chemical mixing and minimizes human A exposure to chemicals and fumes, improving safety PFA bottles conform to FDA and USP Class VI requirements Qualifies them as suitable for use in validated biopharm applications Translucent material Allows for visual identification 8 ENTEGRIS, INC. Liquid Filters and Purifiers Process chemistries vary and the appropriate filtration and purification technologies need to be applied to achieve the most efficient and cost-effective solution. Entegris’ FDA compliant* 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. 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 process 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 *Certifications vary by application and product configurations; please consult product-specific datasheets. ENTEGRIS, INC. 9 Custom Solutions Standard solutions are great – when they solve your challenges. But sometimes, a custom solution offers the best approach. The first step in developing 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 optimized 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. FDA and USP VI compliant PFA dip tubes 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 chemicallycompatible, low E&L solution. 10 ENTEGRIS, INC. Critical Material Transport Solutions It’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 packaging, critical material transport and precision cleaning services that offer flexibility and proven performance 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. Offering inspection, maintenance, packaging and precision cleaning services, Entegris ensures traceability 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 For your purest applications, ECP offers particle removal as low as 0.2 microns. ENTEGRIS, INC. 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. Uniformity, high purity and robust performance of implantable graphites ensure safety and efficacy in your process. Entegris specialty coatings provide scratch resistance, low friction and wear, and eliminate corrosion on most substrate materials. The biocompatibility, safety and efficacy of these coatings protect your surgical instruments by reducing particles, contamination and risk. Entegris specialty coatings offer biocompatibility, safety and efficacy to protect your surgical instruments. 11 Take the Risk out of Risk Management Enjoy confidence with solutions to reduce your E&L and rouging issues, while protecting the quality, efficacy and yield of your overall process. Discover how 40+ years of proven materials science experience in the most demanding industries offers you the cleanest, scalable and most reliable polymer solutions to improve your manufacturing flexibility while mitigating risks. •Sensing and control •Valves, fittings and tubing •Chemical containers •Liquid filters and purifiers •Custom solutions For More Information Visit 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 development costs and decrease your time to market. Terms and Conditions of Sale All 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. Entegris®, the Entegris Rings Design®, Creating a Material Advantage®, Fluorogard®, FluoroPure®, i-Tray™, POCO® and SRSensor™ are trademarks of Entegris, Inc. ENTEGRIS, INC. Corporate Headquarters | 129 Concord Road | Billerica, MA 01821 USA Customer Service Tel. +1 952 556 4181 | Customer Service Fax +1 952 556 8022 In North America 800 394 4083 | www.entegris.com ©2007–2014 Entegris, Inc. All rights reserved Printed in USA 9000-7560CRE-0114
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