Analytical Microbiology Testing
- 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 test, USP 62 test , USP 51 test and USP 71 test all require suitability test . Microbial Suitability test is required only once per product unless the product formula or
manufacturing process has gone thru a modification. Turn around time for this
test is 7-14 days.
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.
For Microbial Analytical testing call 800-282-7102 or email support@accugenlabs.com.
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