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Sterility Testing

Ensure Product Safety and Compliance

Ensure product safety and safeguard your patients with our sterility testing. Our comprehensive sterility testing services adhere to pharmaceutical, biopharmaceutical, and medical device industry standards by following the guidance from the United States Pharmacopoeia USP <71> and ISO 11737-2.

Our technical teams have extensive experience and demonstrated proficiency with a wide range of dosage forms, including small- and large-volume parenterals, aseptically compounded products, terminally sterilized medical devices, and a range of combination products and custom configurations.

To meet your sterility testing needs, we offer traditional membrane filtration, closed filtration using the Steritest™ system, and direct inoculation methods. This sterility testing is carried out in ISO Class 5 hoods in an ISO Class 7 clean room. Our sterility testing services include:

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Intentional Preparation for Reliable Data

Any antimicrobial properties of formulation components must be neutralized to ensure an effective sterility test. The product formulation, manufacturing and fill-finish processes, post-fill processing and even the laboratory handling procedures can inflict stresses that compromise recovery of viable organisms. Our experienced microbiologists work closely with you to ensure an effective recovery method verification is performed appropriately for each product formulation and configuration prior to testing finished products.  

Internally, established laboratory and facility procedures ensure low risk of incidental contamination and dramatically reduce potential for false-positive results. Our systems include robust training procedures, effective use of positive and negative controls, rigorous facility cleaning with sensible use of disinfectants, and a comprehensive environmental monitoring program with appropriate tracking, trending, and alerts.

Sterility Testing Methods

USP <71> provides thorough guidance for sterility testing of pharmaceuticals, including the number of samples to be tested, based largely upon batch size, and other sample preparation and testing considerations. Exceptions and alternatives may be appropriate in certain circumstances when supported by an effective risk assessment. 

Sterility testing generally utilizes two separate growth media, to support any potential bacterial or fungi growth, and requires a 14-day incubation period. Visual observations are made at regular intervals during incubation, with a final assessment upon completion. 

One of two common sample preparation and growth media exposure methods are generally used in sterility testing:

Membrane Filtration

Membrane filtration is a good option for a range of large and mid-volume products, combination products, and in many other applications. Traditional membrane filtration and closed-system filtration retains organisms on a filter, allows rinsing to remove formulation components, and enables effective evaluation of large volumes. Filters are then incubated with appropriate exposure to growth media.

Direct Inoculation

Direct inoculation is a good option for small-volume products, combination products, medical devices, and certain other applications. Samples, generally, require limited additional manipulation, though combination products may require device actuation and certain medical devices may require sample size reduction. Samples are introduced directly to the sterile growth media and then incubated.

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.