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Biological Indicator Testing

Life Sciences / Central Laboratory Services / Microbiology / Biological Indicator Testing

Validate Your Sterilization Process with Confidence

Achieve peace of mind in your biological indicator testing requirements with our expert guidance. Biological indicator testing is essential to prove your sterilization process effectiveness, but the evaluation procedure is often challenging with certain products due to design or sterilization requirements.

Biological indicators are used in the validation, performance verification, and/or with-use verification of cleaning and sterilization processes, such as steam sterilization, ethylene oxide sterilization, and gamma irradiation. They typically contain a high concentration of bacterial endospores that are the most resistant to sterilization and are available in many formats corresponding to their use.

We have years of experience testing on many biological indicator configurations. Our microbiological population verification assesses biological indicators per methodology stated in USP <55> or following instructions provided by the manufacturer. Our lab personnel apply the highest level of quality and attention to detail to your project to assure your biological indicator testing is successfully executed and minimizes any chance of a false positive.

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Satisfy Industry Standards

Our Biological Indicator testing services meet the requirements outlined in the following industry standards.

USP <55>

This U.S. Pharmacopeia (USP) standard provides guidelines for conducting a microbial enumeration test to determine the total viable aerobic microbial count in non-sterile pharmaceutical preparations, substances, and ingredients. It outlines the procedures, acceptance criteria, and recommended testing methods for assessing the level of microbial contamination present in pharmaceutical products. It aims to ensure that the microbial load is within acceptable limits to maintain product quality, safety, and efficacy.

ISO 11138 Series

These International Organization for Standardization (ISO) standards provide guidelines and requirements for the biological indicators used to validate sterilization processes. The 11138 series outlines specific requirements for the production, testing, and use of biological indicators, such as spore strips or ampoules, which are used to monitor and validate the effectiveness of sterilization processes.

Biological Indicator Testing Procedure

Experience our streamlined process for biological indicator testing, which is meticulously designed to instill confidence and ensure your utmost satisfaction.
Sterilization Process
Growth Evaluation
Report Results
Sterilization Process
  • Your product, accompanied by the attached indicators, undergoes your preferred sterilization method, ensuring real-world simulation.
  • For validation purposes, we may employ Process Challenge Devices (PCDs), ensuring the reliability of the sterilization process.
Growth Evaluation
  • We carefully place the biological indicators into a suitable growth medium, adhering to the organism's specific requirements, and incubate them at the appropriate time and temperature.
  • Incubation conditions vary based on the sterilization process and the instructions provided by the indicator manufacturer.
Report Results
  • If any growth occurs during incubation, it indicates that the sterilization method employed is inadequate. We take immediate action to address and rectify any issues identified.
  • Our comprehensive approach ensures reliable and actionable results, empowering you to make informed decisions and maintain the highest standards of product safety.

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.