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:
Recovery method suitability and verification testing
Bacteriostasis / Fungistasis (B/F) Testing
Sterility Testing
Media Fill Study Support
Media Growth Promotion
Population verification of Biological Indicators
Microbial Identification
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 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 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.
Ready to Get Started? Connect with our team to discuss your testing and development needs.