Changes in USP <61> Microbial Limit Test

USP <61> Microbial Limit Test was revised on May 1, 2009 into two separate sections: USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests and <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms.

Clostridium sporogenes, Bile-tolerant Gram Negative Bacteria and Candida albicans are now included with Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, and Salmonella enterica ssp. enterica serotype typhimurium in the list of Specified Microorganisms to be tested.  Also, the incubation period for Total Aerobic Microbial Count has increased from 48 – 72 hours to 3 – 5 days.

In terms of method suitability, previously termed validation, the Total Aerobic Microbial Count requires the use of Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Bacillus subtilis, Candida albicans and Aspergillus niger.

Because of these and other changes, all previously validated test products will require a new method suitability to conform to the new USP <61> and/or <62>.  Please contact Geneva Laboratories’ customer service to inquire about the new changes in sample requirement and turnaround time.  Geneva Laboratories is dedicated to give our customers a smooth transition through this new time.