New White Paper: Meeting Regulations and Achieving Effective Microbial Control for Pharmaceutical and Medical Device Manufacturers
AGAWAM, MASS. – June 8, 2010 – Environmental testing and monitoring programs are essential elements in pharmaceutical and medical device manufacturing. Companies must understand industrial sterilization and contamination control procedures to bring products to market on time and on budget.
In attempting to meet regulatory demands from sources such as the U.S. FDA and the European Pharmacopoeia, the greatest challenge for medical device and pharmaceutical manufacturers may be determining what exactly is required for compliance. How must manufacturers design, implement, certify, and maintain correct sterilization and environmental monitoring programs?
Unfortunately, there is no single reference document that U.S. manufacturers may rely upon to help them design, validate, and demonstrate room class compliance. Nor, given the monumental scope of the task, is it likely that one will be drafted anytime soon.
But a new, free white paper titled “Environmental Monitoring and Certification in Controlled Environments: Meeting Regulations and Achieving Effective Microbial Control for Pharmaceutical and Medical Device Manufacturers,” available for free download at www.microtestlabs.com/environmentpaper, may help.
The white paper reviews the key elements of a best-practice environmental testing program, including sterilization standards, FDA requirements, and the critical factors in maintaining controlled environments. Topics include: What Is Required; Viable vs. Nonviable Particulates; Sampling Plans; Validation Management; Sterilization Programs; Cost/Product Savings; Critical Factors; and The Benefits of Experience. The paper also discusses how these challenges may be met with the assistance of an update-to-date testing laboratory.
The white paper is authored by Steven Wieczorek, Supervisor, Environmental Sciences, who leads the Environmental testing, monitoring, and certification groups at Microtest Laboratories, a leading provider of regulatory microbiology and contract laboratory services based in Agawam, Mass.
Download the new, free white paper, “Environmental Monitoring and Certification in Controlled Environments: Meeting Regulations and Achieving Effective Microbial Control for Pharmaceutical and Medical Device Manufacturers,” at http:/www.microtestlabs.com/environmentpaper.
Or, obtain a free copy of the white paper from Microtest Laboratories at MD&M East, booth #1251, June 8-10, 2010 in New York City.
Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.
About Microtest
Microtest Laboratories offers reliable, accurate programs for testing of product bioburdens; viable aerobic, anaerobic, or fungal microorganisms; and nonviable air particulates. The company’s expertise at characterizing, controlling, and understanding environmental bioburden levels and trends are the cornerstones to defining and implementing a solid Environmental monitoring program which fully supports sterilization validation and release activities. Microtest, a leader in aseptic processing contract manufacturing and contract manufacturing testing services for the medical device, pharmaceutical, and biotechnology industries, is based in Agawam, Massachusetts, USA. 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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In attempting to meet regulatory demands from sources such as the U.S. FDA and the European Pharmacopoeia, the greatest challenge for medical device and pharmaceutical manufacturers may be determining what exactly is required for compliance. How must manufacturers design, implement, certify, and maintain correct sterilization and environmental monitoring programs?
Unfortunately, there is no single reference document that U.S. manufacturers may rely upon to help them design, validate, and demonstrate room class compliance. Nor, given the monumental scope of the task, is it likely that one will be drafted anytime soon.
But a new, free white paper titled “Environmental Monitoring and Certification in Controlled Environments: Meeting Regulations and Achieving Effective Microbial Control for Pharmaceutical and Medical Device Manufacturers,” available for free download at www.microtestlabs.com/environmentpaper, may help.
The white paper reviews the key elements of a best-practice environmental testing program, including sterilization standards, FDA requirements, and the critical factors in maintaining controlled environments. Topics include: What Is Required; Viable vs. Nonviable Particulates; Sampling Plans; Validation Management; Sterilization Programs; Cost/Product Savings; Critical Factors; and The Benefits of Experience. The paper also discusses how these challenges may be met with the assistance of an update-to-date testing laboratory.
The white paper is authored by Steven Wieczorek, Supervisor, Environmental Sciences, who leads the Environmental testing, monitoring, and certification groups at Microtest Laboratories, a leading provider of regulatory microbiology and contract laboratory services based in Agawam, Mass.
Download the new, free white paper, “Environmental Monitoring and Certification in Controlled Environments: Meeting Regulations and Achieving Effective Microbial Control for Pharmaceutical and Medical Device Manufacturers,” at http:/www.microtestlabs.com/environmentpaper.
Or, obtain a free copy of the white paper from Microtest Laboratories at MD&M East, booth #1251, June 8-10, 2010 in New York City.
Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.
About Microtest
Microtest Laboratories offers reliable, accurate programs for testing of product bioburdens; viable aerobic, anaerobic, or fungal microorganisms; and nonviable air particulates. The company’s expertise at characterizing, controlling, and understanding environmental bioburden levels and trends are the cornerstones to defining and implementing a solid Environmental monitoring program which fully supports sterilization validation and release activities. Microtest, a leader in aseptic processing contract manufacturing and contract manufacturing testing services for the medical device, pharmaceutical, and biotechnology industries, is based in Agawam, Massachusetts, USA. 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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Labels: Contamination control, environmental monitoring, environmental testing, industrial sterilization, medical device manufacturing, pharmaceutical manufacturing
posted by Microtest Laboratories at
2:26 PM
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