We perform the following Microbiology tests:
Microbial Limit testing for aerobic plate count, yeast count, and mold count. We also test for the indicator organisms E. coli, S. aureus, Psd. aeruginosa, Salmonella and Bile tolerant gram-negative bacteria. If the product is to be run by USP Method, the product will have to undergo Suitability Testing to verify the specific method that will be used in a routine microbial limit test of the product. This test is generally required only once (per product) until a change is made in the product formula or manufacturing process. If there is a vendor microbiology method for the product, a Suitability Test would not be required. We also run Antimicrobial Preservatives Effectiveness Testing on aqueous pharmaceutical products. A preparatory test procedure is required before running the Antimicrobial Preservatives Effectiveness Test to determine if any bacteriostatic activity is produced by the carry-over of the preservatives in the product.