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We perform the following Microbiology tests:

Microbial Limit testing for aerobic plate count, yeast count, and mold count.  We also test for the indicator organisms E. coli, S. aureus, Psd. aeruginosa, Salmonella and Bile tolerant gram-negative bacteria.

If the product is to be run by USP Method, the product will have to undergo Suitability Testing to verify the specific method that will be used in a routine microbial limit test of the product.  This test is generally required only once (per product) until a change is made in the product formula or manufacturing process.  If there is a vendor microbiology method for the product, a Suitability Test would not be required.  We also run Antimicrobial Preservatives Effectiveness Testing on aqueous pharmaceutical products.  A preparatory test procedure is required before running the Antimicrobial Preservatives Effectiveness Test to determine if any bacteriostatic activity is produced by the carry-over of the preservatives in the product.

Microbiology Content
Microbial Limit Testing

Microbial limit testing determines if products comply with established specifications for microbial quality. MAL offers a full suite of testing services to evaluate products to determine if harmful pathogens are present. Our tests include:

  • USP <60> Microbiological Examination of Nonsterile Products Tests for Burkholderia Cepacia Complex
  • USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration tests (Total Aerobic Microbial Count, Total Yeast and Mold Count)
  • USP <62> >Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms (E. coli, S. aureus, P. aeruginosa, Salmonella, Bile-Tolerant Gram-Negative Bacteria)

Suitability Testing

One-time suitability validation for new products, ensuring the microbial limit testing method is appropriate. Not required if a current vendor microbiology method exists.

Preservatives Effectiveness (AMPET) Testing

USP <51> Antimicrobial Effectiveness Testing

MAL is able to perform Antimicrobial Preservatives Effectiveness Testing on aqueous pharmaceutical products. Suitability testing of the counting method in the presence of product must be performed for every new product.
As an extension of your business, MAL understands the need for timely turnaround. We work closely with clients to fully understand their requirements.