AGAWAM, MASS. – April 22, 2009 – Microtest Laboratories (http://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.
- Nonviable air particulate sampling and testing to ISO 14644 guidelines, the EU Annex, or both.
- 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.
- DNA-sequence-based microbial identification utilizing in-house MicroSeq® Microbial Identification Systems for fast, precise and reliable bacteria, mycoplasma, and mold identification.
- 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 http://www.microtestlabs.com/, or call 1-800-631-1680.
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.
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