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sterility testing


For devices to be labeled as sterile, they must undergo testing to ensure that the sterilization process used is effective. Sterility testing is performed during sterilization validations, and is also part of routine quality control.

Bioburden Testing of Medical Devices

Initially, devices must undergo bioburden testing to determine their microbiological load. This device bioburden level is used in sterilization validations to calculate the dose or sterilization time a device may need. Additionally, as part of quality control, quarterly bioburden testing is done to determine whether the microbiological load on a device has changed.

Bacteriostasis and Fungistasis

Bacteriostasis and Fungistasis measures whether a device inhibits the growth of bacteria or fungi, which may lead to false negatives during sterility testing.

ISO 11137 Dose Audits

Quarterly dose audits are performed according to ANSI/AAMI/ISO 11137 and are done as a check to ensure that the sterilization process is still producing adequately sterilized products.

The microbiology lab at Pacific BioLabs is experienced in preparing and testing a wide variety of devices, from small needles to large, complex devices. For large devices, Sample Item Portion (SIP) preparation may be necessary. This consists of cutting a device into pieces for testing, or selecting the most appropriate parts of a device for testing.

To learn more about sterility testing, visit our detailed Learning Center area on Sterility Assurance Tests.

Available Medical Device Sterility Testing Services
(Sterility testing is performed in an ISO Class 5 Sterility Suite)

Intertek Logo PBL is FDA registered and ISO 9001:2008 and ISO 13485:2003 certified by Intertek. AAALAC Logo Our animal science operations are accredited by AAALAC.

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