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Sterilization Supplies (BIs, PCDs, & TestPacks)

BI, Testpack, and PCD Sterilization Supplies

Customers may purchase BIs, Testpacks and PCD sterilization supplies from Nelson Labs 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 106 for sterilization monitors, and with the most resistant organism (MRO) for the sterilization process.

Process Challenge Devices and Testpacks (PCD/TP)

Process Challenge Devices and Testpacks serve to provide biological monitors for terminal sterilization of single-use devices processed in a manufacturing setting. These products are not intended to monitor sterilization processes used in health care facilities.

PCDs and Testpacks are surrogates 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 and Testpacks designed with consideration to the various sterilization parameters. Their composition is based on different resistance levels to adapt to different cycle specifications.

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Applicable Standards

  • ISO 11135
  • ISO 14161

Testing Locations

Study Outline

Biological indicators are generally a spore strip or disc inside a glassine envelope. Manufacturers of the BI have validated the known population of the spore strip, typically 106 for sterilization monitors, and with the most resistant organism (MRO) for the sterilization process.

PCDs and Testpacks are prepared by placing a biological indicator of known resistance inside a specific configuration such as syringes, tubing, etc. Each device represents a different degree of resistance that is greater than the BI alone. Each PCD is labeled with the lot number and expiration dates of the BI, as well as with its brand name. In addition, each label contains a chemical indicator that changes color after exposure to EO for easy traceability and indication of cycle processing.

If you have additional questions about BI, PCD, & TP sterilization supplies, don’t see the product you need or would like to consult with the experts at Nelson Labs before making a purchase, just send us a request or call us at +1 (800) 826-2088.