Microbial Limits

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Microbial Content Testing

Microbial content testing measures viable organism counts and protects the health of your consumers as well as your product from foul odors, premature spoilage, recalls, shortened shelf life, and compliance failures caused by objectionable microorganisms. 

This test must be performed under highly controlled conditions, which is why global companies turn to Perritt Laboratories for accurate, defensible data. Our FDA-registered, cGMP-compliant, and ISO 17025:2017 laboratory and more than 50 years of experience in testing, means you receive reliable results that regulators trust, including results that meet ASTM, PCPC, and other standard testing compendia.

What Is Microbial Content Testing?

Microbial content is typically assessed through bioburden and microbial limit tests

Bioburden testing performed on an unsterilized product determines the types and numbers of microorganisms present in a batch or product. After microbiologists ensure the testing method is valid, verify that the agar can support microbial growth for a microbial content test, and perform other checks, they incubate plates so they can count the microorganisms. 

A microbial limit test quantifies microbial load (total count) and the presence of objectionable organisms (specific pathogens) against regulatory or compendial standards. 

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Our Testing Types and Compendia

We offer finished product testing to provide documentation about the safety of your products and raw material testing to help you evaluate whether specific ingredients are high-risk for your formulations. Our laboratory also offers:

  • Microbial enumeration studies: In compliance with ASTM standards, these quantitative laboratory tests use validated methods to quantify viable microorganisms. 
  • Testing in compliance with United States Pharmacopeia (USP): This includes testing under USP <61> and <62> for total viable aerobic count (TAMC) of bacteria, total combined yeast/mold count (TYMC), and for viable microorganisms such as Staphylococcus aureus, Salmonella, Pseudomonas aeruginosa, and E. coli.
  • Testing according to the methods of EP: This includes European Pharmacopeia (Ph. Eur. or EP) <2.6.12>, which outlines methods for enumerating TAMC and TYMC for nonsterile pharmaceutical products, and European Pharmacopeia (Ph. Eur. or EP) <2.6.13>, which tests for Salmonella, Candida albicans, and other objectionable microorganisms.
  • Testing in accordance with the methods of JP: We use the Japanese Pharmacopeia (JP) <35>, a microbial limit test.

Industries We Serve

Our team works collaboratively with the following industries:

Many products in this space may have antimicrobial properties, and we know how to neutralize them during testing for accurate results.

Our team identifies viable microorganisms that could interfere with the performance of paints, building materials, coatings, and other products. 

Whether you are creating cleaners, baby products, or other products, we can test raw materials, formulations, and other components that come into contact with your product. 

Contact Us for Microbial Content Testing

At Perritt Laboratories, our microbial content and bioburden testing and microbiological method qualification come with robust documentation and a collaborative approach to provide you with defensible, actionable data. Contact our team today to review your testing needs.

Contact Us
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