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Standards Development
This document provides guidance on an alternative approach to parametric release which would be supplemental to the method described in the requirements of ISO 11135:2014 that apply when parametric release is used to release the product after exposure to the ethylene oxide sterilization process It provides a path for transition of existing ethylene oxide sterilization cycles, as well as a path for the development and implementation of a parametric release specification for a new ethylene oxide sterilization cycle. Additionally, it highlights the advantages/disadvantages of this method versus the existing ISO 11135 requirements and the application of risk assessment.
Parametric release is not commonly used in in ethylene oxide (EO) processing, despite the benefits.
These benefits include, but are not limited to:
1. Increased resolution to detect potential risks of a non-conforming cycle, through the measurement
and documentation of additional physical process parameters.
2. Quicker turnaround times for product release. Traditional biological indicator (BI) incubation requires
multiple days, whereas a review of parametric data can be automated or completed immediately after
cycle completion.
3. Reduction of resource investment compared with BI release, which includes BI purchasing and
storage, placement, and retrieval; shipping; testing; and analysis. These steps are not needed for
parametric release processes.
4. Eliminates the risk of false-positive BI results.
5. Process trending of routine runs allows earlier identification of trends that could lead to process
failures.
6. Reduction of unnecessary overkill (EO utilised) via removal of an additional layer/hierarchy of
microbiological challenge i.e. external PCD
One such reason for the lack of uptake is the additional process output measurement requirements of
ISO 11135 when utilising parametric release and the variability of such measurements that can lead to
difficulty in achieving process capability. ISO/TS 21387:2020 currently gives limited guidance on this.
It is proposed that in utilising existing controlling parameters i.e. pressure, along with secondary
qualitative confirmation of gaseous inputs, there is sufficient data to demonstrate the repeatability of a
validated process. Therefore, an additional "direct" measurement of EO concentration may not be
required, where there is sufficient data available for product release, fulfilling the normative requirement of ISO 11135:2014 Section 11.1. Further analysis to support this can be found in:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10764061/
This guidance document will define an approach for parametric release to fulfil requirements of 11.1,
ultimately encouraging the use of Parametric release. This guidance document will outline how to
assess and establish this.
Ultimately, this proposal will reduce the barriers to entry of parametric release within EO sterilization.
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