Location: Webinar

Steam Sterilization: A Commentary on Air Removal and Verification 

Date: Thursday, January 31st, 2019, 9:00 am EST

Presenter: Aaron Mertens, Technical Services Manager, Microbiologist, STERIS Life Sciences

Overview:  Steam as a sterilization modality has been well studied since the advent of the autoclave by Charles Chamberland in 1884. Additionally, regulations guiding the use of autoclaves in the pharmaceutical, biotechnology, and medical device industry have been greatly harmonized across the globe. However, the European Medicines Agency and the United States Food and Drug Administration are not perfectly aligned regarding expectations for air removal and verification in pre-vacuum style autoclaves. This webinar discusses the differences in regulations and proposes a compliant testing strategy based on risk.

The presence of air in an autoclave sterilization cycle can adversely affect steam penetration and contact to materials being sterilized. Saturated steam condensing onto a surface is essential to eliminate and kill microorganisms that may be present on the surface. This presentation discusses the importance of routinely performing an air removal test in the autoclave to ensure entrapped air does not impede the steam sterilization process.

An air removal test can be one of many forms, including a Bowie Dick Test Pack and a Daily Air Removal Test (DART). These tests challenge the autoclave pre-vacuum cycle for sufficient air removal, as well as indicate leaks in the chamber and/or associated piping. It is not only important to remove air prior to steam sterilization, but also ensure air is not being drawn in to the autoclave during the process. 

Frequency of performing the air removal test is determined by evaluating the quality, business and regulatory risk. The impact of a failed test must be taken into consideration, as the sterility of all materials processed from the last passing test up until the failed test is called into question. The compliance and business risk is evaluated and a mitigation plan is discussed.       

Key Points:
  • Importance of air removal in steam sterilization
  • Regulatory expectations
  • Benefits of air removal verification tools
  • Compliance and business risk mitigation
Who Will Benefit:
  • Quality Assurance
  • Quality Control
  • Validation
  • Production
  • Engineering
  • Maintenance