This essay examines the draft USP chapter on Microbiology Lab Practices published in the summer of and serves as a good introduction to the chapter. > MICROBIOLOGICAL BEST LABORATROY PRACTICES The new USP chapter addresses labs working under GMP conditions. experience and infrastructure that can support consistent use of these methods. The USP informational chapter > Microbiology Best. Laboratory Practices.


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There were just not enough, and still aren't, microbiologists to go around. Which types of companies were asking these questions?

Smaller companies in particular were asking for a lot more clarification in terms of a USP informational chapter. Usp chapter 1117 the other hand, however, the larger companies were less enthusiastic about additional USP guidance on this topic.

For them, usp chapter 1117 regulations were better, which was an entirely understandable position. But that still left most laboratories searching for answers and unsure of their practices during regulatory audits. Also, as a historical perspective, at the same time these discussions were going on, there was a big push to harmonize sterility test and the antimicrobial efficacy test.

New USP Chapter for the Pharmaceutical Microbiology - ECA Academy

It was obvious that it was going to be a wasted effort if once these tests went out, laboratories usp chapter 1117 questionable procedures. Once the decision was made to get started on the chapter, what was the approach?

We talked usp chapter 1117 the chapter for years as an interesting idea before actually trying to publish it, and circulated several versions of a potential chapter among the committee before publication. The recommendation is provided that the choice of media should be consistent, appropriate and justified.

The chapter spends some time on media preparation as well.

New USP Chapter for the Pharmaceutical Microbiology

The recommendations include accurate weighing of dehydrated usp chapter 1117, the use of high quality USP Purified water, completely dissolving the dehydrated media or individual ingredients, and the need to control the heating of the media to avoid damaging heat-labile components of the media.

Some recommendations on the labeling and packaging of media are also provided. An entire section is devoted to the usp chapter 1117 of media storage and the effects this might have on the media quality. Excesses of heat and cold are to be guarded against, as is the potential for dehydration of poured plates.

Some guidance is also provided in quality control for molten media used in pour plates. The quality control of the media is a critical concern. Since the initial release inhowever, the harmonized Sterility Tests and the harmonized Microbial Limits Tests have both incorporated stringent media quality usp chapter 1117.


Maintenance of Microbiological Cultures Second only to media, safeguarding the stock cultures is the most important usp chapter 1117 of a successful microbiology laboratory.

These must be handled carefully at all times to avoid contamination. The care of the cultures starts upon receipt.

A careful stock usp chapter 1117 curator will confirm the identity of the received cultures, even if they come from as respected a source as a national culture collection.

Microbiological tests often vary considerably. Minor variances from the expected result can thus not be significant.