USP Updates <61> and <62> for Microbial Testing of Non-Steriles

The effective date of the changes was May 1, 2009. The new USP <61> and <62> provide harmonization to existing European Pharmacopeia method for testing non-sterile pharmaceuticals.

Below is a brief summary of changes :

[b][COLOR=“purple”]USP <61> Microbial Enumeration Tests includes changes in pass/fail criteria and includes longer incubation durations than in previous editions.

The Preparatory Test is replaced by the Method Suitability for product inhibition. The growth promotion organisms and the methodology had been significantly updated to include more types of organisms and different growth medias.

The tests for specified microorganisms are included in USP <62>; the modifications change many microbiological medias utilized in testing for specific pathogens. Critical changes have also been made to incubation temperatures and duration.

More organisms have been specified in the new USP <62> chapter than in previous USP editions. Organisms such as Candida albicans, Clostridia species, and Bile-Tolerant Gram-Negative Bacteria may be required to be tested depending on specifications regarding product formulation.

No retests are allowed. [/color][/b]

Chemists from labs/Industry must now know which microorganisms are required to be absent. This requirement is based on the unique characteristics of the product based on formulation process, raw materials, etc. (Refer attached Table)

Acceptance Criteria include the following:

[b]COLOR=“blue” The average plate counts obtained from the test plates, for the total aerobic count and the total yeast and mold count, must be > 50% and < 200% of those obtained from the positive control inoculum verification plates.

(b) For verification of specified organisms typical growth in the presence of the sample must be received for all test organisms on selective medias as described in USPXXXI <62> Supplement.

© Positive control inoculums must be performed for each organism preparation and have an average value of (NMT) 100 CFU per total inoculated volume for the specified organism.[/color][/b]

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