Microbial Enumeration Test
- Raw material Testing
- Finished Product Test
- In Process and Lot Release Testing
- Research and development sample testing
Accugen Laboratories analyse products from a wide varity of industries like Pharmacutical, Cosmetics, Antimicrobial, Textile, medical device etc.
Most common test standard used are USP testing standards for these type of products.
USP requires Suitability testing to validate the test method that will be used in routine microbial enumeration and Specified microorganism testing of the product.
The Microbial Suitability test demonstrates that the product does not inhibit the microorganisms that may be present. Diluted samples of the material are inoculated with separate, diluted cultures of Staphylococcus aureus, Bacillus subtilis, Pseudomonas aeruginosa ,,Candida and Aspergillus in case of USP 61 test and Staphylococcus aureus, E.coli, Pseudomonas aeruginosa ,Salmonella, Clostridium, Total Bile tolerant Gram negative bacteria and Candida albicans in case of USP 62 . By means of a challenge representative microorganisms, suitability testing demonstrates the ability of the test method to recover microorganisms that could be present on a product.
USP 61 Microbial Enumeration Test
This test is designed to determine total aerobic microbial count and yeast and mold count.
USP 62 Specified Microorganisms Test
This test demonstrates that the product is free of Staphylococcus aureus, Total Bile tolerant Gram negative bacteria, Escherichia coli, Ps.aeruginosa, Salmonella, Clostridium and C.albicans.
The test takes 5-7 days.
Microbial Confirmatory Test
Microbial identification is performed. Microbial Identification is commonly completed in 2-4 days.