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Bioburden Testing

Validate Product Safety & Process Efficacy

Ensure the quality of your starting materials and the safety of your pharmaceutical and medical device products by assessing the microbial levels present and confirming absence of pathogens. We have expertise in a wide range of raw materials and product dosage forms. Our experienced microbiologists work closely with you to ensure the recovery methods are appropriate for the material/dosage form and are consistent with established specifications. We are also able to follow your lab’s established methods when needed.

Our Microbial Limits Testing (MLT) meets the requirements of the United States Pharmacopoeia (USP) general chapters <60>, <61>, and <62>, and harmonize with the requirements of European Pharmacopoeia (EP) general chapters 2.6.12 and 2.6.13. Additionally, our bioburden test procedure is performed in accordance with ISO 11737-1:2018 to determine the population of viable microorganisms in or on a pharmaceutical product, medical device, or component prior to sterilization.

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Bioburden Testing Procedure

Testing procedures in our FDA-registered sites adhere to the principles of current Good Manufacturing Practices (cGMP). Our quality systems are commensurate with pharmaceutical commercial manufacturing standards to ensure accurate and reliable results.
Quantitative Phase
Qualitative Screening Phase

Before testing any material or product we conduct a Recovery Method Suitability Test to verify the matrix does not have inherent microbial inhibitory properties that could lead to false negative results. If antimicrobial properties are observed, we adjust sample preparation steps to include appropriate measures such as dilution, filtration, neutralization, or inactivation to remove them before testing the product.

Quantitative Phase

We prepare the product sample according to specified guidelines and determine the total number of aerobic organisms, the Total Aerobic Microbial Count (TAMC) and the Total Yeast and Mold Count (TYMC). These procedures used to enumerate and quantify microorganisms may include membrane filtration, direct plating, spread plates, and serial dilutions, as necessary.

Qualitative Screening Phase

We perform the Test for Specified Microorganisms to determine the presence or absence of specific objectionable organisms in the product. We follow USP <62> / <60> and EP 2.6.13 testing procedures and we have capabilities for accurately confirming identity of suspect microorganisms.


We compare the results obtained from the microbial limits test with client and compendial specifications for microbial quality and determine whether the product complies with the specified standards.

Integrated Laboratory Services

When your team needs additional support, our scientists are ready. Our state-of-the-art facilities and highly trained experts add power to your project. 

Additional Resources

Pace® is a registered facility with the U.S. Food and Drug Administration (FDA), demonstrating our commitment to meeting regulatory requirements for quality and safety in the industries we serve.

Pace® holds a registration with the Drug Enforcement Administration (DEA), allowing us to handle controlled substances and support the specific needs of our clients in regulated industries.

Pace® adheres to current Good Manufacturing Practices (cGMP), ensuring that our laboratory facilities and processes meet the highest quality standards set by regulatory authorities for the pharmaceutical, biopharmaceutical, and medical device industries.

Pace® is accredited to ISO/IEC 17025, the international standard for competence in testing and calibration laboratories, validating our technical competence and commitment to delivering accurate and reliable results.