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Process Challenge Devices

Process Challenge Devices

PCDs 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 Process Challenge Device (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.

NLI 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.

Order PCDs:

Applicable Standards

  • ISO 11135
  • ISO 14161

Test Options

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Code Test Request Quote
PCD105 Sterilization: PCD - Preparation (Sponsor Supplied), each Add
PCD110 Process challenge device for sterilization process monitoring - preparation & loading Add
PCD701 Sterilization: PCD - Delivery to Local Contract Sterilizer Add
PCD705 Sterilization: PCD - Minimum order charge (per set) Add
PCD105 - Sterilization: PCD - Preparation (Sponsor Supplied), each
PCD110 - Process challenge device for sterilization process monitoring - preparation & loading
PCD701 - Sterilization: PCD - Delivery to Local Contract Sterilizer
PCD705 - Sterilization: PCD - Minimum order charge (per set)

Study Outline

PCDs are prepared by placing a biological indicator (BI) 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. The PCD is then placed in a tyvek pouch and sealed for containment. Each PCD is labeled with the lot number and expiration dates of the BI, as well 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.
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