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.
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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.
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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.
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