Draft Revision to Antimicrobial Effectiveness Test Released by USP

Scott Sutton, Ph.D.

Microbiology Network, Inc.

Note: The opinions expressed in this blog are those of the author and should not be interpreted as the positions or policies of USP or any other organization.

Petri Dishes - TSA

A new draft revision to USP <51> Antimicrobial Effectiveness Testing has been published in the Jan-Feb 2014Pharmacopeial Forum at http://www.usppf.com.  After the free registration process, go to USP PF volume 40, number 1.

According to the USP briefing:

“The Microbiology Expert Committee of the Council of Experts in the United States Pharmacopeial Convention proposes to revise this chapter, which provides procedures to demonstrate the effectiveness of antimicrobial preservatives. The purpose of the revision is to align the content, layout, and format with other general chapters such as Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests 61 , Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms 62 , and Sterility Tests 71 . The revision provides greater clarity in preparation and use of test organisms, including the use of standardized microbial cultures; growth promotion; and method suitability. This proposed revision also clarifies the definition of “no increase” and method execution. Product categories that require testing and acceptance criteria are unchanged.
Additionally, minor editorial changes have been made to update the chapter to current USP style.”

The deadline for comments on this revision is March 31, 2014.

The Microbiology Network will be presenting a webinar on this revision on January 28, 2014 where the changes from the current chapter will be reviewed and background on the test as a microbial quality control test provided.  More information on the webinar, and registration ($299 per location) are available here.

Register for Webinar

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