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. All sterility testing is conducted in an ISO Class 5 environment.
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.
Bioburden and Sterility Testing Services
- Bioburden Validation / Testing
- Bacteriostasis / Fungistasis and Sterility Testing (Direct Transfer)
- AAMI/ISO Dose Audit
- Sample Item Portion Preparation (SIP)