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www.bakerco.com
The Baker Company is a worldwide leader in the fields of
isolation and containment technology. Baker designs and
manufactures isolators for aseptic pharmaceutical filling
lines, sterility testing, medical device manufacturing, and
aseptic processing. |
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www.walkerbarrier.com
Walker Barrier Systems engineers, fabricates, and installs
rigid and flexible wall isolators for sterility testing,
aseptic production equipment interfaces, and for the
containment of potent compounds. Information
on Walker's support services including Factory Acceptance
Testing that incorporates hydrogen peroxide gas distribution
studies inside an isolation system, Site Acceptance Testing,
and on-site training of customer personnel and can be found by
clicking on
www.walkerbarrier.com.
Isolator specs can be found here. |
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EnGuard Systems
www.enguardsystems.com
EnGuard Systems are ergonomically
integrated barrier isolators that allow maximum
interaction with the process. Our product range includes the
complete manufacturing process for solid dosage, aseptic
processing, sterility testing and custom applications.
Our focus is the pharmaceutical and biotechnology
operations associated with research, development and clinical
supplies manufacturing of products.
Our expertise is user based allowing us to understand
our customer's needs and develop functional systems that work.
Our fabrication facilities have provided products to the
pharmaceutical industry for over forty years and have an
excellent understanding of cGMP requirements.
Our commitment is to deliver a contained system that
protects people, product and the environment while providing
the best possible ergonomic interaction.
Our services include design, development, fabrication
and validation of each process including procedures for
decontamination and cleaning. |
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www.flanderscorp.com
Flanders Corporation markets a full range of air-filtration
products that include HEPA and ULPA filters, which are
utilized by many industries including pharmaceutical and
biotechnology. Flanders also manufacturers the
INFINITY™ Isolators (design patent pending), which are
stand-alone remote-access workstations designed for sterile
drug processing. |
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www.gloveboxes.com
Innovative Technology of Newburyport, MA designs and
manufactures both positive and negative pressure
isolators
for all applications.
Inert Atmosphere Glove Boxes are available for
applications where you need to eliminate oxygen and moisture
from the process. Equipment is offered in stainless steel,
Lexan®, as well as a variety of other plastics. Free standing
gas purifiers and oxygen & moisture analyzers are also
offered. In addition, Innovative Technology offers a range of
solvent purification systems to help deal with lab safety
issues. |
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www.lacalhene.com
la Calhène
designs and builds custom and standard rigid and flexible
wall isolators for aseptic processing (laboratory, clinical,
and production applications) and containment applications. In
addition, la Calhène manufactures DPTE Rapid Transfer Ports
(RTPs) that allow the aseptic transfer of materials, glove
supports for isolator decontamination, glove integrity tester,
and an isolator leak rate tester.
Isolator specs can be found
here. |
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www.laminarflowinc.com
Laminar Flow, Inc. designs and manufactures isolation glove
boxes for
containment
and
sterility testing and provides Alpha/Beta (double door)
technology for isolation transfer systems for pharmaceutical
and biotech applications. |
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www.mbraun.com
M Braun designs and builds
glove box systems for containment and isolator systems for
use in pharmaceutical research and production. M Braun
provides complete system integration, on-site installation,
and system training for customer personnel. |
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www.totesystems.com
Tote Kinetics is a sole source supplier of equipment and
systems to transport, store, and process dry materials in the
pharmaceutical, food, and chemical markets. Tote originated
the modular IBC (Intermediate Bulk Container) in 1947 and has
led the industry ever since. More recently, Tote has designed
and built a wide range of
isolation technology products for both containment and
sterile applications. For more information on Tote® Systems
Isolation Technology, contact a
Tote Representative. |
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www.bausch-stroebel.com
Bausch & Stroebel designs, builds and sells high-tech
packaging and production systems to the pharmaceutical,
cosmetic, and chemical industries and has the experience to
integrate its equipment into isolators. Bausch & Stroebel's
services include IQ/OQ execution of machines and production
systems, on-site testing for all areas of production, and
customer personnel training. |
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www.biopharminc.com
Bio-Pharm offers the
Bio-Phase-CD-2000 Generator that has been designed for the
decontamination of surfaces and is built to provide for a safe
and effective elimination of bioburden within enclosed spaces.
Disinfection with hydrogen peroxide gas is a faster, better
controlled, and an environmental friendly alternative when
compared to formaldehyde, chlorine dioxide, peracetic acid,
and other chemical agents.
The
generator offers special features like continuous duty
operation, PLC control options, higher injection and airflow
rates than competitive machines, and a large sterilant
reservoir. The stand-alone unit is mobile on four lockable
casters and can decontaminate rooms up to 300 m3 in internal
volume with optional systems having a 600 m3 capacity. An
integrated system can decontaminate volumes of up to 50 m3. |
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www.bioquellpharma.com
Bioquell Pharma's bio-decontamination equipment is based
around "duel loop" Clarus technology, which delivers carefully
controlled micro-condensation of hydrogen peroxide vapor onto
microorganisms, thereby achieving bio-deactivation. BIOQUELL
Pharma uses the pharmaceutical industry standard
bio-deactivation test of achieving a 6-log kill of Bacillus
stearothermophilus spores.
BIOQUELL Pharma's
Clarus C bio-decontamination technology is unique as it
uses state-of-the-art instrumentation to ensure that
parametric control and hence parametric validation can be
achieved for processes. The
Clarus L small gas generator is optimized for rapid
bio-decontamination of small laboratory equipment, minimizing
equipment downtimes while offering a safe alternative to
formaldehyde. All Clarus equipment uses the patented "duel
loop" which has been engineered to reduce the amount of
hydrogen peroxide used and hence reduce cycle times. |
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www.boschpackaging.com
Bosch Packaging Technology designs and manufactures packaging
and processing equipment for the pharmaceutical,
biotechnology, and related industries. Bosch's liquid
packaging equipment includes modular and integrated isolator
systems for aseptic filling. Bosch's
MAFS®
Mini Aseptic Filling System that encloses an entire filling
area within an isolator has one FDA-approved (November 2000)
installation at the Pharmacia Corporation in Kalamazoo, MI. |
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www.clordisys.com
Chlorine Dioxide technology is again available to meet your
decontamination and sterilization needs. ClorDiSys Solutions
of Lebanon, NJ has come out with a broad line of
products
to decontaminate isolators, rooms, and pass-throughs, as well
as to terminally sterilize your products or components. All of
their products include a sophisticated real-time CD monitoring
system that is fully integrated to provide precise feedback
and control of gas concentration. This provides for a very
repeatable and reliable process independent of temperature or
dew point. In addition aeration time is very quick due to CD
being a true gas at ambient temperatures, thereby eliminating
any issue of condensation.
The company has recently introduced the Steridox™ line of
Chlorine Dioxide Sterilizers that are designed for use in any
pharmaceutical, manufacturing, laboratory, research or
surgical setting. The units provide a rapid and highly
effective method to sterilize medical devices, sterile
products, instruments, and components at ambient temperatures.
It features a sophisticated sterilant concentration monitoring
system to assure a tightly controlled sterilization process
facilitating parametric release. All instrumentation,
including the photometer for concentration monitoring, is
easily calibrated to traceable standards. The process is
apparently easy to validate due to tight process control and a
highly accurate sterilant monitoring system. |
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www.despatch.com/pharmaceutical.asp
Despatch Industries is a proven market leader in providing
depyrogenation ovens/tunnels and isolator pass-throughs
(ultraviolet decontamination chamber) for pharmaceutical
applications. Despatch has experience interfacing its
depyrogenation equipment with isolators. |
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www.dynamicdesignpharma.com
Dynamic Design Pharma manufactures a number of devices,
which support aseptic processes with barrier isolation
systems, such as:
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The
Non-Rotating Canister is a rigid RTP canister that
does not require rotation to dock onto the RTP port. Due
to its non-rotating feature, the NRC permits reliable
transfer of delicate components into and out of isolators
without the risk of parts tumbling within the canister.
The NRC permits safe transport of sterile parts within the
aseptic filling facility and is compatible with industry
standard RTP ports.
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A
Lift Transport Cart interfaces with both the NRC and
standard rigid RTP canisters. The cart's design permits
hands-off interface of the RTP canister to isolator
systems of various heights and docking angles.
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The
DECON
System is a stand alone RTP canister that can be
decontaminated when used in conjunction with a standard
hydrogen gas generator such as Bioquell Pharma's Clarus
"L". The unit permits off-line, rapid decontamination of
the RTP canister without requiring an autoclave or
transfer isolator.
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The
Glove Support System accurately positions glove and
sleeve assemblies of the barrier isolator system during a
decontamination process. The system positions the glove
and the sleeve in such a way as to prevent any contact
with adjacent surfaces and places the glove well into the
air stream.
Dynamic
Design Pharma also provides engineering and design services to
support customization of its proprietary devices to best fit
the customer's operational needs.
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www.filamatic.com
National Instrument Company, Inc. designs and manufactures
liquid filling, capping, and monobloc machines for the
pharmaceutical, personal care, and chemical specialty
industries. NIC's
custom
products group is developing expertise in the area of
integrating its filling equipment with isolation technology. |
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www.groninger.de
Groninger & Co. GmbH produces highly developed processing
equipment for the pharmaceutical, cosmetic, and chemical
industries. In 1994 Groninger designed and built its first
isolator-compatible vial filling machines. Groninger also
markets its unscrambling and feeding systems as being isolator
compatible. Groninger offers its customers the required
documentation for the qualification and validation of its
equipment plus offer intensive training programs for customer
personnel. |
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www.ima.it
The IMA Group consists of 8 divisions of which the Liquids
and Powder Filling Division has experience integrating its
aseptic liquid filling and closing machines with isolation
technology. |
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www.moperry.com
M&O
Perry serves the pharmaceutical, biotech, diagnostic,
medical device and animal health markets. The company
provides both standard and custom equipment for filling
powder and liquid products in sterile environments. M&O
Perry Industries offers their P2100 series isolator
filling system designed for use in research, clinical, or
low speed batch production applications; and can also be
provided for filling of potent, cytotoxic, radioactive, or
other hazardous products. |
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www.masy.com
The team at Masy Systems (Pepperell. MA) performs precise
temperature mapping analysis including empty chamber heat
distribution studies and load penetration validation
studies on a wide variety of thermal processing
equipment, such as autoclaves, incubators, cold rooms,
and freezers. Masy Systems has also formed a
rental division to fill the growing requirements for
validation equipment. The firm offers complete certified
validation systems for rent, which include a
pre-programmed validation datalogger with pre-calibrated
thermocouples along with temperature, pressure, or
humidity sensors. Masy Systems will also
calibrate
your validation equipment and process controls traceable
to NIST, including chart recorders, dataloggers,
temperature reference baths, temperature reference
standards, and relative humidity sensors and standards. |
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www.millipore.com
Millipore's Safepass™ Sterile Transfer System assures the
safe transfer of components and materials required for
aseptic filling, including but not limited to, stoppers,
needles, needle assemblies, and overseals. The
SafePass System consists of a transfer port with a
patented UV sterilizing source that provides secure,
sterile access to an isolator or clean room, and specially
designed expendable containers to transfer components and
materials. |
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www.steris.com
STERIS
Corporation is a global provider of contamination control
systems, products, and services for the pharmaceutical,
biotech, medical device, laboratory research, production
and industrial markets. The value-added STERIS total
systems solution is a complete facility planning,
equipment, supplies, validation support, education, and
maintenance offering. Additionally, STERIS Technical
Service experts stand ready around the world and around
the clock to help customers maintain their systems’ peak
performance.
Since the introduction of STERIS Corporation’s VHP®
(vaporized hydrogen peroxide) low temperature
biodecontamination technology in 1991, VHP systems have
become the predominant choice and industry standard for
pharmaceutical aseptic processing applications. Over 800
VHP systems are installed worldwide. The VHP process is
fully controlled, repeatable and reliably validated. This
patented “dry” process utilizes low vapor concentration to
achieve safe, fast biodecontamination with excellent
material compatibility.
A family of VHP generators are currently in use for
biodecontamination of rooms, pass-throughs, filling line
and sterility test isolators, glove boxes and biological
safety cabinets in research, biological safety, and
production applications. |
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www.usifroid.com
Usifroid markets full cGMP lyophilizers for R&D, pilot
production, and full production applications to the
pharmaceutical and biotech industries. Usifroid has
experience interfacing its freeze drying equipment with
isolators. |
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www.apexlaboratories.com
Apex Laboratories provides Bacillus stearothermophilis
spore suspension (ATCC 12980) and pre-packaged Bacillus
stearothermophilis BIs for the validation of the
hydrogen peroxide vapor decontamination process that is used
with isolation technology. |
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www.bd.com
Becton Dickinson Diagnostic Systems markets prepared
culture media utilized for environmental monitoring and
QA/QC applications in the pharmaceutical and biotech
industries. BD provides BBL™ Isolator Pack Plated Media,
which is protected from exposure to vaporized hydrogen
peroxide inside an isolator system during a decontamination
cycle. |
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www.biotestusa.com
BioTest offers a variety of microbial air and sampling
devices for your environmental monitoring needs.
HYCON® Contact Slides are used for the detection of
contamination on surfaces by bacteria, yeasts and molds.
They are particularly appropriate for use in isolators and
aseptic cleanrooms since their individual self-contained
packaging prevents potential contamination and they are
resistant to multiple gas decontamination cycles. The
RCS Microbial Air Sampler has also been shown to be
quite resistant to chemical attack by hydrogen peroxide gas
while the
RCS Agar Strips have been validated in isolator systems
without concern over "false negative" results. |
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www.draeger.com
Dräger markets mobile gas detection technology for both
short- and long-term measurements. The Dräger family of
products includes
tubes
and
sensors, which can be used to measure the quantity of
hydrogen peroxide vapor either inside an isolator/enclosure
or in the surrounding room. The electrochemical
DrägerSensors® are designed to be used with the Dräger
Polytron 2 transmitter. |
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www.guided-wave.com
Guided Wave produces and markets a turn-key solution for
real time measurement of
Hydrogen Peroxide and Water Vapor concentrations during
the decontamination process in the isolator/enclosure.
Guided Wave also produces other NIR-based monitoring
instrumentation for monitoring multiple locations along with
other gases and liquids. Gas cells and fiber optic
instrument cable links provides flexibility for in-situ
measurement location. |
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www.latextechnology.com
Latex Technology, Inc (LTI) produces natural rubber and
synthetic rubber products for the medical, military, space,
nuclear, pharmaceutical and sports industries. LTI
specialize in manufacturing the widest array of drybox and
isolator
gloves
available. With their parent company
Piercan, located in France, and their new state of the
art facility in San Marcos California, LTI can supply a
customer's critical order in a timely fashion. |
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www.millipore.com
Millipore has offered the
Steritest Integral 316 II System that has been used
within isolator environments for several years. Technical
documents are available on the use of Steritest canisters in
isolators that have been decontaminated with
hydrogen peroxide gas and
peracetic acid.
Millipore recently began offering the M Air T Isolator
System brings the convenience and performance of the M Air T
concept to isolators and barrier environments. This portable
system consists of a programmable pump that remains outside
the controlled area and an independent sampling head, which
uses pre-filled M Air T agar cassettes.
TSA Isolator Plates are specifically designed to permit
their use in enclosures that may contain hydrogen peroxide
residuals.
Click here to obtain a review of the pertinent test
results. |
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www.ionpro.com
Particle Measuring Systems is a leading edge scientific,
engineering and production firm with more than 15 years
experience in ion mobility spectrometry (IMS) and other
direct measurement technologies. The firm specializes in gas
monitoring systems optimized for a wide variety of markets
including continuous emission, process control, ambient air,
and semiconductor airborne contamination. The Dual-range ProSentry-IMS™ Analyzer can
detect between 0.1 and 20 ppm, as well as 20-2000 ppm of
hydrogen peroxide. The oxidant must be in the vapor phase
and delivered to the analyzer at atmospheric pressure at a
minimum of 200 cc/min. |
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www.particle.com
As the world leader in particle counting, Pacific Scientific
Instruments (Grants Pass, OR) is one of the principal
players in ensuring damage due to particle contamination is
minimized. Their products and technologies are in use at
virtually every global leader engaged in the manufacture of
semiconductors, microelectronics, pharmaceuticals, and
hydraulic systems. Pacific
Scientific Instruments, with the Met One, HIAC, HYT, and
Royco brands, is a leader in virtually every market it
addresses. Met One particle counters have also been
installed in production isolator applications over the past
decade due to their compatibility with many of the chemical
sterilants used within such systems. |
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www.rencogloves.com
Renco Corporation sells isolator replacement
gloves
along with accordion and straight design glove port
sleeves. Replacement gloves and sleeves are available in
hydrogen peroxide compatible materials. |
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www.EmersonProcess.com
Rosemount Analytical markets the AOTF (Acousto-Optic Tunable
Filter)-NIR
analyzer
that will measure the vapor concentrations of hydrogen
peroxide and water during the decontamination process inside
an isolator/enclosure. |
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www.sigmaaldrich.com
Sigma-Aldrich markets Sigma brand biochemicals and reagents
for Life Science Research. Sigma sells Catalase
#C9322
an enzyme, which is used to activate the decomposition of
hydrogen peroxide into water and oxygen. Catalase is a
product that may be required during the PQ of a hydrogen
peroxide decontamination cycle or during a D-value study. |
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www.steris.com
STERIS Corporation provides a variety of products for use
with their VHP® Biodecontamination Systems. |
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www.steritool.com
Steritool, a division of Nautitool in Brooklyn, NY,
specializes in high quality stainless steel hand tools
designed for use in sterile clean rooms and/or in corrosive,
radioactive, or other critical environments. The tools are
fully autoclavable and offer an unsurpassed level of
corrosion resistance. |
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www.bioreliance.com
BioReliance, a leading provider of contract services to
the biopharmaceutical industry, is dedicated to meeting
a company's manufacturing needs for the production of
viral therapeutics, cell therapeutics and microbially
expressed protein products. BioReliance's current Good
Manufacturing Practices (cGMPs) production facilities
and extensive technical and regulatory expertise provide
the support needed for efficient product development and
the guidance to achieve regulatory approval. They
provide analytical testing along with a comprehensive
package of services. |
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www.lancasterlabs.com
Lancaster Laboratories, Inc., is one of the largest
single-site commercial testing laboratories in the
nation. They provide quality independent analytical and
research services in the environmental and
pharmaceutical sciences. Lancaster Labs has more than
650 employees and a 175,000-square-foot facility with
its state-of-the-art instrumentation, which allows them
to handle projects of virtually any size and scope. |
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