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15 October 2011

New ANSI/ AMMI Publication on Selecting a Sterility Assurance Level (SAL)

The 2011 ANSI/AAMI ST67:2011, Sterilization of health care products – Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled ‘sterile’ was published 2 August 2011. Originally published in 2003, this revised American standard now includes guidance on selecting an SAL other than 10-6 based on a risk assessment.

There are many reasons for considering SALs other than 10-6 that include:

  • optimizing clinical benefits of new/emerging products by minimizing sterilization effects on product performance, thus facilitating development of increasingly complex, next-generation healthcare products that combine pharmaceutical, biological, electronic and bio-absorbable components;
  • reducing healthcare costs; and
  • minimizing environmental effects by use of less of the sterilizing agent and energy.

The Path Forward: What needs to be done?

1. Continue to develop meaningful ways to assess the true risk to a patient of terminally-sterilized products with an SAL other than 10-6.

2. Understand the sterility assurance benefits of using terminal sterilization versus aseptic manufacturing when possible, even at SALs other than 10-6.

3. Develop a document on sterility assurance / SAL through TC 198 to address the subject of sterility assurance on a worldwide level.

The reasons and path forward was extracted from a presentation on SAL at IMRP Montreal by Trabue Bryans, which is soon to be available in the members-only section of the iiA website. We can anticipate more interesting and provocative discussions at the upcoming ISO meeting in Washington and going forward.