Microbial Limits

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Microbial Limits and Bioburden Testing

Perritt Laboratories performs microbiological method qualification and microbial content and bioburden testing according to methods listed in the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur. or EP) and Japanese Pharmacopoeia (JP).

In addition, we perform testing according to other standard testing compendia (AAMI, ASTM, PCPC, and others). We also provide bioburden testing for industrial applications such as building materials, paints and coatings, surfaces and various other applications.

Perritt Laboratories provides decades of experience and expertise in microbiological testing with a world-class quality system to back it all up. Companies around the world have trusted our data for over 50 years.

What is Microbial Limits Testing?

Bioburden testing normally involves enumeration of aerobic, mesophilic bacteria, yeast and molds in everything from raw materials through to finished product. The tests are designed primarily to determine whether a substance or preparation complies with an established specification for microbiological quality such as USP Monographs, compendial specifications or a manufacturers acceptance criteria.

Whether testing to meet United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur. or EP), Japanese Pharmacopoeia (JP) or other compendial requirements, our full-service, cGMP, ISO 17025 accredited microbiological testing services can provide you with timely test results that you require, backed by a staff of dedicated professionals that have been at the forefront of testing since 1973.

Our Microbial Content Testing Services Include

  • United States Pharmacopeia (USP) <61>, Microbiological Examination of Non-sterile Products: Microbial Enumeration Tests and USP <62>, Microbiological Examination of Non-sterile Products: Tests for Specified Microorganisms
  • European Pharmacopeia (Ph. Eur. or EP) <2.6.12>, European Pharmacopeia (Ph. Eur. or EP) <2.6.13>
  • Japanese Pharmacopoeia (JP) <35>, Microbial Limit Test

Microbial enumeration studies are performed according to ASTM standards, providing accurate and reliable data for a wide range of products, including building materials, paints, and coatings.

Do you have unique testing needs? Specialization lies in method development and validation, creating customized microbiological testing solutions tailored to your specific products and processes. Experienced teams will work with you to develop and validate methods that meet your exact requirements.

Expertise and a Personal Touch

You may find larger laboratories, but you won’t find a testing lab that can match our recognized expertise and personal touch. We know our clients by name, not client number, and it shows in their satisfaction with our testing services.

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