Molecular Diagnostics Services, Inc.
A Contract Research Organization

USP Microbial Limits Testing (<USP 61>)

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:
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.

Biological Indicator Survival/Kill Time Determination
The resistance of Biological Indicators to various sterilants is measured as described in individual USP monograph for Biological Indicators.

Accelerated/Real-time Aging Incubation and Testing
Packaged products are exposed to extreme conditions of temperature and humidity-the performance of the product and/or packaging is evaluated. Using specialized exposure chambers, we can expose products to the chosen accelerated aging conditions and at the conclusion of the exposure period evaluate the packaging and in the case of pharmaceutical products, perform stability indicating analyses of the active ingredients. Products that complete this exposure with no damage can be labeled with extended expiration dates, as described in ISO 11607 and AAMI TIR No. 17--1997.

Cell Aging Characterization of MCB
Aged cell banks (16 passage beyond MCB) will be compared with MBC for the following characterization studies: Package/Container Integrity Microbiology
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