Microbial Limits Testing:
The presence and quantity of microorganisms in nonsterile pharmaceuticals can reduce the product's effectiveness and detrimentally impact the end user’s health. While non-sterile products are not expected to be completely free of all microorganisms, manufacturers must ensure that total product bioburden is kept below acceptable limits determined by the United States Pharmacopeia (USP) and Food and Drug Administration (FDA). Manufacturers must also ensure that certain objectionable organisms are not present in products.
ChRi laboratories perform Microbial Limits testing to determine Total Aerobic Microbial Count (TAMC) or Total Yeast and Mold Count (TYMC) of microbial contamination levels in non-sterile pharmaceutical products.
ChRi laboratories execute a rigorous suitability test on each product submitted for microbial limits testing to ensure that the specific product's methods are appropriate. Selective microorganisms are used in the suitability process to ensure that antimicrobial agents that may affect the reliability of the test are neutralized. Once a suitable method is validated, routine microbial limits testing can then be performed according to that method to determine whether a product complies with established specifications for microbial quality. The microbial limits testing performed at ChRi laboratories conform to USP Chapter <61>, which is currently harmonized with both the European Pharmacopeia and Japanese Pharmacopeia standards.
ChRi laboratories perform standard dilution and plating techniques to determine total viable counts of microorganisms present in a product. ChRi laboratories can assist you with determining the appropriate process for determining viable counts of your samples.
ChRi laboratories perform microbial identification of unknown microbial isolates in collaboration with Charles River using AccuGENX-ID bacterial and fungal Microbial Sequencing. DNA sequencing of 16S rRNA genes in bacteria and the ITS2 rRNA region in fungi is internationally recognized as the most accurate and reliable method for identifying unknown microorganisms. This identification can be performed on both viable and non-viable samples with rapid, reproducible results.