Biological Indicators and Process Challenge Devices for Nitrogen Dioxide Sterilization.

Area of Science:

• Microbiology
• Sterilization Science
• Medical Device Reprocessing

Background:

• Limited data exists on biological indicators (BIs) for nitrogen dioxide (NO2) sterilization.
• Assessing BI performance under various real-world conditions is crucial for sterilization validation.

Purpose of the Study:

• To evaluate the performance and reliability of biological indicators (BIs) for nitrogen dioxide (NO2) sterilization processes.
• To determine the impact of transport, storage, self-contained BI (SCBI) integration, post-sterilization handling, and incubation on BI efficacy.

Main Methods:

• Biological indicators (BIs) were subjected to transport simulations and stored for up to 12 months.
• Self-contained BIs (SCBIs) were used as external process challenge devices (PCDs) during NO2 sterilization cycles.
• Post-sterilization handling times (up to 48 hours) and incubation periods (as short as 42 hours) were evaluated.

Main Results:

• BIs maintained performance characteristics after transport and up to 12 months of storage.
• SCBIs reliably functioned as external PCDs for NO2 sterilization.
• Holding external PCDs for up to 48 hours post-sterilization did not compromise results.
• BI growth results were achievable in as little as 42 hours.

Conclusions:

• Biological indicators demonstrate consistent reliability for nitrogen dioxide sterilization.
• The findings support the use of BIs for both validation and routine monitoring of NO2 sterilization processes.
• SCBIs are effective external PCDs, and post-sterilization handling times do not negatively impact BI performance.