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
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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
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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
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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
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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
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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.
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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.
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
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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.
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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.
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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.
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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
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All rights reserved
Printed in USA
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