For medical devices and health care products that must be sterilized before use, the appropriate sterilization cycle parameters must be determined through a sterilization validation process. This process is one of the most common types of GMP medical device testing. Since all products have unique designs, material densities, and packaging configurations, sterilization conditions that are sufficient and appropriate for one device may prove inadequate for another. Thus, all sterilization processes must be validated based on the device.
Various ANSI/AAMI/ISO standards describe the procedures for sterilization cycle validations based on the type of sterilization to be used. Generally, the procedure involves inoculation of a device or product with bacterial spores prior to performing a sterilization cycle. The device or product is then tested for sterility to determine whether the required Sterility Assurance Level (SAL) is achieved.
Radiation Sterilization Validations
Two of the most common types of sterilization validation testing performed at Pacific BioLabs are radiation sterilization validations, and steam sterilization validations. Radiation sterilization validations use either gamma radiation or electron beam (e-beam) radiation, and are performed by dosing a representative sample of devices with a verification dose, and then testing those devices for sterility.
For this testing, Pacific BioLabs works with an outside facility that doses the devices with radiation, after which PBL performs the microbiological analysis. These procedures are performed according to the ISO 11137 standards.
Steam Sterilization Validations
Steam sterilization validation testing is performed completely in-house at PBL, using our own autoclaves. For this testing, devices are inoculated with a known population of microbes, and the devices are then autoclaved and tested for sterility.
Medical Device Testing at PBL
The Pacific BioLabs microbiology lab facility contains a dedicated sterility testing suite. The suite is constantly maintained under positive pressure that cascades from the core cleanroom through a gowning room, a sample disinfection room, and an ambient pressure entrance area. Walk-in and reach-in incubator rooms are also integrated into the sterility testing suite.
Sterility audits are performed in HEPA-filtered hoods by fully gowned test technicians. Sterility rooms are HEPA-filtered as well. All test media is sterilized in validated autoclave cycles and tested for growth promotion. All incubators are continuously monitored by a Rees monitoring system, which provides audible and phone alerts in the event of temperature excursions beyond defined parameters.
Sterilization Validation Services
- BI Population Verification
- BI Sterility Testing
- Product Inoculation
- Sterilization Validations
- Radiation Sterilization (gamma and e-beam support testing)
- Ethylene Oxide (support testing)
- Steam Sterilization at 121°C to 132°C
- Flash, Gravity, and High Vacuum Cycles
- Liquid Chemical Sterilization
- Dry Heat Sterilization and Depyrogenation