New Guide for Verifying and Monitoring Critical Process Parameters in NO2 Sterilization Processes
1. Scope
This guide describes methodologies for verifying and monitoring critical process parameters in NO2 sterilization processes. It includes guidance on ensuring the accuracy, repeatability, and control of critical process parameters, including NO2 concentration, relative humidity, temperature, dwell time, and pressure, to meet defined process specifications during validation, requalification, and routine operation.
Keywords
qualification; PPQ; gas sterilization; medical device sterilization; validation; routine sterilization; process parameters
Rationale
The standard is needed to support the use of NO2 sterilization for medical devices. Because the NO2 sterilization process involves chemical reactions that occur inside the sterilization chamber, it is important to provide methods for how to verify and monitor critical process parameters, especially NO2 concentration and percent relative humidity. Providing clear guidance on how to assess the accuracy, repeatability, and control of these parameters will help ensure consistent and reliable performance of NO2 sterilization systems.
The title and scope are in draft form and are under development within this ASTM Committee.
Work Item Status
Date Initiated: 09-23-2025
Technical Contact: Delaney Lisco
Item: 000
Ballot:
Status: