USP Microbial Limits Testing

Often, it is necessary to evaluate a non-sterile test article for the presence of objectionable organisms, depending on the intended use of the material. 

MDS offers Microbial Limits Testing (MLT) services for the evaluation of objectionable organisms to evaluate the bioburden (total aerobic organisms as well as the total number of yeasts, and molds) of given pharmaceutical manufacturing samples. The samples are tested per U.S. FDA criteria for "objectionable organisms." For minimum coverage, these criteria require testing for the following:

• The bacteria Escherichia coli (E. coli)
• The bacteria Staphylococcus auseus (S. auseus)
• The yeast Candida albicans (C. albicans)
• The bacteria Pseudomonas aeruginosa (Ps. aeruginosa)
• The fungus Aspergillus niger (A. niger)

Validation methods are in place to ensure that the product has no inhibitory effect on the recovery of organisms. If the total aerobic and total yeast and mold counts are acceptable and no objectionable organisms are found, then the release of the product or raw material will be pursued.