Medical Device Sterility Testing

MEDICAL DEVICE 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.

Initially, devices must undergo bioburden testing to determine their microbiological load. This 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 measures whether a device inhibits the growth of bacteria or fungi, which may lead to false negatives during sterility testing.

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 microbiologists at Pacific BioLabs are 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 Sterility Assurance and Sterility Testing Services
Sterility testing is performed in an ISO Class 5 Sterility Suite