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Pharmaceutical TestingMicrobial Limit Test
Pharmaceutical Testing: Microbial Limit Testing
Microbial Limit Preparatory Testing (USP)
USP requires preparatory testing to validate the test method that will be used
in routine microbial limit testing of the product.
Microbial limit 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, Escherichia coli, Pseudomonas
aeruginosa ,Salmonella,Candida and Aspergillus. 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. Turn around time for this
test is 7-8 days.
USP Microbial Limit Test
This test is designed to determine total aerobic microbial count and yeast and mold count. This test demonstrates that the product is free of Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa , Salmonella , C.albicans and A.niger. This test takes 7-8 days.Microbial Limit Confirmatory Test
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.
Methods Of Testing
We use standard methods such as those of ASTM or methods recommended by US FDA of Health Canada. We routinely use Laboratory Procedure MFLP-10 for enumeration of total aerobic bacteria in food froducts and food ingredients.Should you have a question concerning microbial limit test or any pharmaceutical test that we have not listed, please call 905-290-9101.
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