BI & PCD Sterilization Supplies
Customers may purchase BI and PCD sterilization supplies from Nelson Labs and Sterigenics for validation and ongoing process monitoring of the validated sterilization cycle.
Biological Indicators (BIs)
Biological indicators are an essential sterilization process monitor with a known population of microorganisms on the spore strip, typically 10^6 for sterilization monitors, and with the most resistant organism (MRO) for the sterilization process.
Process Challenge Devices (PCDs)
Process Challenge Devices serve to provide biological monitors for terminal sterilization of single-use devices processed in a manufacturing setting. These PCDs are not intended to monitor sterilization processes used in health care facilities.
A PCD is the surrogate of product used for microbiological monitoring of both validation and routine sterilization cycles. It consists of a biological indicator within a specific configuration such as syringes, tubing, etc., that poses an increased resistance to represent a stringent challenge to the sterilization process.
Nelson Labs produces different configurations of PCDs designed with consideration to the various sterilization parameters. Their composition is based on different resistance levels to adapt to different cycle specifications.
- ISO 11135
- ISO 14161