Product Details

USP Microbial Limit Validation

Date: June 9, 2003
Test device: Scissors, Forcep, TSB, LCB, TSA, SDA, TTB, Selenite Cystine Broth, MacConkey Agar, Baird Parker Agar, Cetrimide Agar, BSA (Bismuth Sulfate Agar), Brilliant Green Agar, XLD Agar.

This procedure validates the test results obtained from the performance of the Microbial Limits Test. Recovery of the appropriate positive colonies on the selective agars is considered to validate Mircobial Limits test results for that product and any other product with the same active ingredient at a lower concentration. This validation should be conducted on any unique product, or any product that is significantly changed.

If the appropriate positive colonies on the selective agars are not recovered, the validation test may be repeated. In this case, the Microbial Limits Test procedure is modified to ensure maximum recovery of the challenge organism. If a procedure modification cannot eliminate the bactericidal activity of the product, then the product is not likely to be contaminated with the given species.

RESULT

Safe and free from micro organisms.