Microbial Content

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 AAMI test methods for medical devices, ASTM testing standards, and other standard testing compendia. We also provide bioburden testing for industrial applications such as building materials, paints and coatings, surfaces and various other applications.

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.

Perritt Laboratories provides decades of experience and expertise in microbiological testing with a world-class quality system to back it all up. You can trust our data…..companies the world over have for over 40 years.

 

Our microbial content testing services include:

·         Harmonized Microbial Content (Microbiological Examination Of Non-sterile Products/Microbial Limits)

    • 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

·         AAMI/ANSI/ISO bioburden and bioburden recovery studies

·         Biological Indicator Studies

·         ASTM microbial enumeration studies

·         Method Development and Validation

·         ASTM bioburden studies

·         Custom studies and method development

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.