Pharmacopoeia requires preparatory testing to validate the test method that will be used in routine microbial limit testing of the product. By means of a challenge of 6 representative microorganisms, preparatory testing demonstrates the ability of the test method to recover microorganisms that could be present on a product.
Microbial limit validation test is required only once per product unless the product formula or manufacturing process has gone thru a modification. time required for this test is 8 days.
IP/BP/ USP Microbial Limit Test
This test is designed to evaluate total aerobic microbial count and yeast and mold count. This test demonstrates that the sample is free of Staphylococcus , Escherichia , Pseudomonas , Salmonella , C.albicans and A.niger.
To confirm the presence or absence of Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Salmonella ,C.albicans and Aspergillus niger, microbial identification is performed..It can be tests like coagulase test and oxidase tests or complete microbial identification. Microbial Identification is completed in 2-4 days.