Another standard we follow, as a biological indicator manufacturer, is ISO 11138-1. This is titled “Sterilization of health care products – Biological indicators”. According to the standard, “This part of ISO 11138 specifies general requirements for production, labeling, test methods and performance requirements for the manufacture of biological indicators including inoculated carriers and suspensions intended for use in validation and monitoring of sterilization processes.”
ISO 11138-1 is broken into 5 parts:
- Part 1: General
- Part 2: Biological indicators for ethylene oxide sterilization processes
- Part 3: Biological indicators for moist heat sterilization processes
- Part 4: Biological indicators for dry heat sterilization processes
- Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
The General chapter (Part 1) has sections that include definitions of key terms, manufacturing requirements, determination of resistance, and culture conditions. There are also six Annexes, which cover the following topics: determination of viable count, determination of growth inhibition by carriers and primary packaging materials exposed to sterilization processes, D-value determination by survivor curve method, D-value determination by fraction negative method, survival-kill response characteristics, and relationship between components of biological indicators.
Let’s talk biological indicators!
Talk with one of our experts to get your questions answered and see how we can help you solve your BI pain points.