Standards Development

Scope

This document gives guidance for the selection of a defined process challenge device (PCD) for moist heat sterilization processes which, in terms of penetration behaviour for the sterilizing agent (steam, or moist heat), is intended to represent a challenge equivalent or greater than a load or a load configuration when using the defined sterilization cycle.

NOTE The defined sterilization cycle used in this document is defined by the production sterilization cycle to be evaluated. The relationship of PCD to medical device and suitability of the PCD to process is only valid for processes and cycles evaluated in accordance with this document.

This document is not applicable for:

a) other sterilization process modalities;

b) the design and execution of type tests according to the currently published sterilizer standards i.e., EN 285 and EN 13060;

c) the material selection and/or design of PCDs;

d) other properties of PCDs which do not influence sterilizing agent penetration;

e) the selection of master product and product families used in validation for the sterilization process.

Purpose

Within the scope of validation according to ISO 14937 and the specific process validation standards derived from it, the use of PCDs is envisaged. According to ISO 14937:2009, 8.6, PCDs shall present a challenge equivalent to or greater than that at the position in product where it has been determined that sterilizing conditions are most difficult to achieve. However, the above-mentioned standards do not provide uniform criteria for selection and suitability of PCDs.

This document specifies a suitable procedure defined for determining and testing how it can be demonstrated that a PCD has a level of difficulty for achieving the sterilization conditions with regard to penetration by the sterilizing agent that is greater than that of the medical device or load configuration to be sterilized and can therefore be used as part of routine monitoring.