USP Microbial Examination of Non-Sterile Products: New White Paper is Roadmap of Regulations for Manufacturers
AGAWAM, MASS. – Manufacturers examining their microbial limits testing policies and assessing the impact of the recent harmonization of USP, EP, and JP requirements will find guidance in a new white paper titled “USP Microbial Examination of Non-Sterile Products: A Roadmap to the Regulations of the Non-Sterile Testing World.” It’s available for download from http://www.microtestlabs.com/microbial-examination-paper/default.asp.
Manufacturers required to evaluate the microbial content of their non-sterile products utilize the Microbial Limits Test used to determine the bioburden of the product and also if objectionable organisms are present. In 2009, the harmonized test method became effective, requiring manufacturers to meet the new guidelines set forth in it.
“The new white paper examines how the recent harmonization of USP, EP, and JP requirements affects the processing of raw materials and finished products by manufacturers. It also examines the considerations that manufacturers should examine when establishing a microbial limits testing policy,” said white paper authors James E.T. Gebo, B.S., M.P.A., RM (NRCM), Technical Representative, Laboratory Services; and Kimberly Kitch, A.S., Laboratory Technician II – both of Microtest Laboratories.
In the paper, Gebo and Kitch examine:
• The Affects of Harmonization
• Sample Requirements
• Sample Processing
• Suitability Testing v. Validation
• Essential Product Information Required for Testing
Download a free copy of “USP Microbial Examination of Non-Sterile Products: A Roadmap to the Regulations of the Non-Sterile Testing World,” from http://www.microtestlabs.com/microbial-examination-paper/default.asp.
Both authors are members of the Laboratory Services group at Microtest Laboratories. Gebo has had hands-on experience in regulatory microbiology and virology testing since 2004. He holds a B.S. in Biology, a Masters in Public Administration, and is a Registered Microbiologist (NRCM). Kitch has been employed by Microtest Laboratories since January, 2006, and has worked in Microbial Limits, Genetic Identification of Bacteria and Fungi, LAL/Biocompatibility, Bioburden Testing, and other areas. She holds an A.S. in Biology.
Follow Microtest Labs on Twitter: @MicrotestLabs at http://twitter.com/MicrotestLabs.
About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., 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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Manufacturers required to evaluate the microbial content of their non-sterile products utilize the Microbial Limits Test used to determine the bioburden of the product and also if objectionable organisms are present. In 2009, the harmonized test method became effective, requiring manufacturers to meet the new guidelines set forth in it.
“The new white paper examines how the recent harmonization of USP, EP, and JP requirements affects the processing of raw materials and finished products by manufacturers. It also examines the considerations that manufacturers should examine when establishing a microbial limits testing policy,” said white paper authors James E.T. Gebo, B.S., M.P.A., RM (NRCM), Technical Representative, Laboratory Services; and Kimberly Kitch, A.S., Laboratory Technician II – both of Microtest Laboratories.
In the paper, Gebo and Kitch examine:
• The Affects of Harmonization
• Sample Requirements
• Sample Processing
• Suitability Testing v. Validation
• Essential Product Information Required for Testing
Download a free copy of “USP Microbial Examination of Non-Sterile Products: A Roadmap to the Regulations of the Non-Sterile Testing World,” from http://www.microtestlabs.com/microbial-examination-paper/default.asp.
Both authors are members of the Laboratory Services group at Microtest Laboratories. Gebo has had hands-on experience in regulatory microbiology and virology testing since 2004. He holds a B.S. in Biology, a Masters in Public Administration, and is a Registered Microbiologist (NRCM). Kitch has been employed by Microtest Laboratories since January, 2006, and has worked in Microbial Limits, Genetic Identification of Bacteria and Fungi, LAL/Biocompatibility, Bioburden Testing, and other areas. She holds an A.S. in Biology.
Follow Microtest Labs on Twitter: @MicrotestLabs at http://twitter.com/MicrotestLabs.
About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., 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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Labels: microbial limits test, Microbial Limits Testing, non-sterile products
posted by Microtest Laboratories at
10:00 AM
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