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The Baker Company

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.
 



Walker Barrier Systems

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.
 

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.
 


Flanders Corporation

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.

 


Innovative Technology, Inc.

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.

 



la Calhène

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.
 


Laminar Flow, Inc.
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.
 


M Braun
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.
 


Tote Kinetics
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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Decontamination and Process Equipment Manufacturers
 


Bausch & Stroebel
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.
 


Bio-Pharm, Inc.
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.
 


BIOQUELL Pharma
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.
 


Bosch Packaging Technology
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.
 


ClorDiSys Solutions, Inc.

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.
 


Despatch Industries

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.
 


Dynamic Design Pharma

www.dynamicdesignpharma.com

Dynamic Design Pharma manufactures a number of devices, which support aseptic processes with barrier isolation systems, such as:
  • 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.
  • 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.
  • 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.
  • 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.

 


National Instrument Company, Inc.
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.
 


Groninger & Co. GmbH
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.
 


The IMA Group
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.
 



M&O Perry Industries
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.
 


Masy Systems, Inc.
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.
 


Millipore Corporation
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.
 


STERIS Corporation
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.
 


Usifroid
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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Accessories and Laboratory Supplies
 
 
Apex Laboratories
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.
 
 

Becton Dickinson Diagnostic Systems
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.
 
 

Bio Test Diagnostics Corporation
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.
 
 

Dräger
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.
 
 

Guided Wave, Inc.
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.
 
 
Latex Technology, Inc.
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.
 
 

Millipore Corporation
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.
 
 

Particle Measuring Systems
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.
 
 

Pacific Scientific Instruments, Inc.
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.
 
 

Renco Corporation
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.
 
 

Rosemount Analytical
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.
 
 

Sigma-Aldrich
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.
 
 

STERIS Corporation
www.steris.com

STERIS Corporation provides a variety of products for use with their VHP® Biodecontamination Systems.
 
 

Steritool
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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Contract Service Providers
 
 
BioReliance
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.
 
 

Lancaster Laboratories
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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