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Microtest Labs Expands Clean Room, Contamination Testing Services
AGAWAM, MASS. – April 22, 2009 – Microtest Laboratories (www.microtestlabs.com) has added new technology and professional staffing to expand its position as a proven, one-stop provider of contamination and clean room testing services for manufacturers of medical devices or pharmaceuticals.
Microtest helps manufacturers maintain control of their controlled environment to ensure regulatory compliance as well as to achieve greater productivity. Microtest assists manufacturers to identify, assess and resolve a wide range of clean room and environmental contamination problems while ensuring little or no process disruption or downtime.
Microtest’s environmental services group is comprised of highly trained microbiologists with extensive experience applying modern testing technologies in all varieties of clean room and other controlled environments. Their work meets or exceeds applicable clean room testing requirements for regulatory regimes including the International Organization for Standardization (ISO), the European Union (EU) Annex, and the U.S. Food and Drug Administration (FDA).
Microtest offers the following testing and support services: ISO certification and clean room validation, to any ISO Class required, for all controlled environments, including clean rooms, laminar flow hoods, biological safety cabinets, compounding aseptic isolators, and fume hoods. HEPA filter repair, replacement, and installation for all controlled environments including clean rooms, laminar flow hoods, biological safety cabinets , compounding aseptic isolators, and fume hoods. Viable sampling, including evaluating for contamination of aerobic and anaerobic microorganisms, surface testing and analysis, active air sampling, and collecting passive air samples. In-house MicroSeq® DNA-sequence-based analyzers provide results as fast as 24 hours to speed isolation and elimination of the source. Disinfection validation, including dilution testing, phenol coefficient testing, sporicidal testing, and germicidal testing. Gowning validation as well as assistance with developing and demonstrating proper gowning procedures. Compressed air/gas testing, including nonviable air particulate testing; compressed air testing for aerobic, anaerobic, and fungal organisms; and testing for hydrocarbons and water vapors.
For more information about Microtest Laboratories’ complete offering of contamination and clean room testing services for manufacturers of medical devices or pharmaceuticals, visit Microtest at BIOMEDevice in Boston, April 22-23, 2009 at booth no. 1023. Or, visit the Microtest website www.microtestlabs.com, or call 1-800-631-1680.
About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries. Based in Agawam, Massachusetts, USA, the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.
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 Public Relations contact: Tiziani Whitmyre Inc. (http://www.tizinc.com/services/public-relations/index.html)
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 Technorati tags: clean room testing ISO certification clean room validation HEPA filter repair HEPA filter replacement Viable sampling Nonviable air particulate sampling Disinfection validation Gowning validation DNA-sequence-based microbial identification Compressed air testing Compressed gas testing
Labels: clean room testing, clean room validation, Disinfection validation, Gowning validation, HEPA filter, ISO certification, microbial identification, Nonviable air particulate sampling, Viable sampling
New White Paper Examines Advanced Mycoplasma Tests - How Real-Time PCR Analysis Helps Save Time and Money for Biopharmaceutical Manufacturers
AGAWAM, MASS. – Contamination by mycoplasmal organisms is an ever-present concern in biopharmaceutical manufacturing. Their properties make them ready sources of contamination, while rendering them difficult and time-consuming to detect. A new free white paper, examines how PCR mycoplasma tests and analysis, deployed by a cutting-edge laboratory, minimizes testing delays and enable safe, high-volume biopharmaceutical production. “Of all the threats that keep quality managers awake at night, mycoplasmas rank high. In a career performing quality control or quality assurance for biopharmaceutical manufacturing anywhere in the world, a QC or QA specialist will probably encounter mycoplasma contamination of a production facility at least once. The resulting devastation to the site’s output and schedules, as well as to its staff’s peace of mind, makes it urgent to avoid any repetition of the experience,” says Dennis Champagne, author of the white paper and Director of Lab Services at Microtest Laboratories, a leader in biopharmaceutical and mycoplasma tests and services. “Whereas the traditional direct cultivation method takes 28 days to provide results, modern real-time PCR mycoplasma tests and analysis in an experienced testing laboratory may be accomplished in an actual testing duration of only 24 hours, plus the time needed for sample collection, shipment, preparation, and handling,” he said. The white paper identifies the shortcomings of traditional identification methods, such as direct culture (for cultivable species), indirect culture (DNA fluorochrome staining — for noncultivable species), DNA probe, PCR, enzyme-linked immunosorbent assay (ELISA), autoradiography, and immunofluorescence. About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com/ or call 1-413-786-1680 or toll-free 1-800-631-1680. # # # Labels: PCR mycoplasma analysis, PCR mycoplasma tests
White Paper Details How DNA Sequencing Services Can Prevent Cleanroom Shutdowns at Medical Device and Pharmaceutical Manufacturers
AGAWAM, MASS. – Contamination by an unknown organism often calls for total shutdown of a cleanroom’s operation until that organism can be identified and eliminated. Such shutdowns can have catastrophic effects on the schedules and productivity of medical device and pharmaceutical manufacturers alike. A new white paper, “The Microbial ID Breakthrough: How DNA Sequencing Services Help Prevent Catastrophic Cleanroom Shutdowns,” outlines common sources of contamination, discusses problems and delays associated with traditional methods of identifying those contaminants and highlights breakthrough solutions to these difficulties. The white paper is available, free, for download at: http://www.microtestlabs.com/microseq. “Modern cleanrooms used for the manufacture of medical devices, pharmaceuticals, or combination products face widespread, persistent threats of contamination. Much of this contamination comes from the people working in these environments. They carry in invasive organisms on themselves –as well as on the equipment and materials they bring into the environment,” says Dennis Champagne, author of the white paper and Director of Lab Services at Microtest Laboratories. With more than 13 years' experience in regulatory microbiology and contract laboratory operations, Champagne leads Microtest's microbiology, contract analytical chemistry, laboratory support, and virology departments. He holds a B.S. degree in microbiology from Iowa State University, and is a nationally-registered microbiologist. “Fast action is vital. To get the cleanroom back up and running as quickly as possible, the extent and location of areas affected must be determined, and the exact organism responsible identified,” Champagne said. The white paper identifies the shortcomings of traditional identification methods, such as only identifying bacteria or yeast only; requiring live, isolated colonies; demanding colonies grown in specific media to match library; delivering subjective results; requiring matches against appropriate library for accurate ID; providing library IDs based on multiple strains/species for each entry; and long turnaround times. As opposed to traditional methods, DNA sequencing for microbial identification has proven highly accurate and is ideal for testing applications, Champagne explains in the white paper. These include pharmaceutical quality assurance/quality control labs, finished product and in-process testing, media fill failure investigations, sterile medical products, opthalmics, medical devices, cosmetics, and nutritional supplements. Once the organism is positively identified, managers can much more easily deduce the source or sources of contamination, and take swift corrective action to enable the resumption of manufacturing production. Download the new white paper, “The Microbial ID Breakthrough: How DNA Sequencing Services Help Prevent Catastrophic Cleanroom Shutdowns,” at http://www.microtestlabs.com/microseq/ About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries. Based in Agawam, Massachusetts, USA, the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. # # # Public Relations contact: Tiziani Whitmyre Inc., http://www.tizinc.com/services/public-relations Labels: analytical laboratory, analytical services, medical device, Microseq, Microtest, release testing, sterility validation
White Paper Explains Aspects of Testing From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product
AGAWAM, MASS. – Biopharmaceutical manufacturers, responsible for an extensive repertoire of products – including recombinant proteins, monoclonal antibodies, and vaccines – are faced with many aspects of testing specific to the type of product being assessed. A new whitepaper from Microtest Laboratories discusses the typical routine sampling and testing requirements associated with the aseptic processing of a biopharmaceutical from the perspective of a contract aseptic manufacturer and provider of contract manufacturing testing services.
Specifically, the white paper discusses establishing the testing “where and when” (and in some instances the “why”) for manufacturing formulation and fill/finish activities and how the approach is also applicable, for the most part, to small molecule drug products formulation and fill/finish.
In the white paper, the authors:
Warn to test only when necessary to reduce interventions. Explain to test using methods that give data as quick as fittingly possible to condense processing times. Discuss how to utilize a client’s knowledge of the product, the contractor’s knowledge of formulation and aseptic manufacturing to develop the most appropriate formulation and F/F process.
The white paper is authored by John Dobiecki, Vice President of Manufacturing Operations, and Alex Mello, Director of Project Management, Manufacturing, both of Microtest Laboratories ( http://www.microtestlabs.com/), a contract manufacturer and provider of contract manufacturing testing services.
About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries. Based in Agawam, Massachusetts, USA, the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com/ or call 1-413-786-1680 or toll-free 1-800-631-1680. # # # Labels: aseptic processing, purified bulk drug substance, sterile final drug product, testing, white paper, whitepaper
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Technorati tags: clean room testing ISO certification clean room validation HEPA filter repair HEPA filter replacement Viable sampling Nonviable air particulate sampling Disinfection validation Gowning validation DNA-sequence-based microbial identification Compressed air testing Compressed gas testing 
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