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USP <62> Tests For Specified Microorganisms

USP <62> Tests For Specified Microorganisms

USP <62> Tests For Specified Microorganisms

In certain scenarios, microbial enumeration testing for nonsterile products must go beyond simply detecting the presence and levels of microorganisms. In these scenarios, specific microorganisms must be identified, typically to ensure that particularly virulent, dangerous microbes are not present in products.

USP <62> is the pharmacopoeia standard for testing for the presence and growth of specific microorganisms in nonsterile products, usually found in the pharmaceutical, cosmetics, and personal care fields.

Boston Analytical features deep, extensive expertise in the testing of nonsterile products such as microbiome based therapeutics, investing in people, processes, and equipment in order to provide you with the greatest confidence and the highest levels of accuracy, with full coverage of validation, suitability, sample preparation, documentation, and any other requirements that you may need to stay in compliance.

Our equipment includes a state-of-the-art MALDI-TOF mass spectrometer for microbial identification, several MicroSeq® systems, a Roche LightCycler® for qPCR, and ambient and incubator anaerobic work stations. Our commitment to remaining on the cutting edge of technology and quality translates to successful end-to-end testing and monitoring services for you.

Which Microorganisms Does USP <62> Testing Detect?

USP Chapter <62> details testing protocol to detect the following microorganisms:

  • Escheria coli (E.coli)
  • Salmonella species
  • Staphylococcus aureus
  • Pseudomonas aeruginosa
  • Bile-tolerant gram negative bacteria
  • Candida albicans
  • Clostridia species

These microorganisms are highly virulent and can cause a number of adverse symptoms, including pulmonary infections, food poisoning, skin infections, fever, fungal infections, and more. Because the products being tested are often either consumed or are used on the skin – including around the eyes – it is critical to ensure that they are free of these pathogens.

What Steps Are Involved in USP <62> Methods?

The USP <62> testing methodology includes several components:

Collect a sufficient amount of sample: For USP <62>, sample requirements are based on the product type and batch size. Please contact us for specific sample requirements related to your product. Contact us.

Enrich the sample: The sample is inoculated in a broth.

Select the correct agar: In USP <62>, different agars are used to detect the presence of different specified microorganisms.

Streak the inoculated sample onto the agar and wait the required amount of time: Once the inoculated sample has been streaked onto the appropriate agar for the type of microbe to be detected, it is incubated under the appropriate conditions for specified periods of time.

Read the results and take the appropriate measurements: After the specified incubation time, determine whether any microorganisms are present in the testing medium, and if so, how many.

Conduct suitability and validation testing: To validate the results of the test, suitability testing must also be carried out to ensure that the testing medium is capable of supporting the growth of microorganisms.

With broad expertise in microbial enumeration testing, Boston Analytical is ready to assist you in all steps of the process, including helping you to develop a custom testing plan best suited to your applications and requirements.