Understanding the difference between a Test of Sterility (ToS) and a Test for Sterility is essential when validating and maintaining sterilization processes.
In this TechTalk, Vicki Pearson, Laboratory Technical Manager at STERIS AST, explains the purpose of each test, their role within industry standards, and how they support dose establishment, validation activities, regulatory compliance, and patient safety.
11:27
Key Takeaways
In this video, you'll learn:
- The difference between a Test of Sterility and a Test for Sterility and when each is used.
- Why sterility testing is an important component of ISO 11137-2 irradiation dose establishment studies.
- The role of sterility testing in routine dose audits to support regulatory compliance, process control, and patient safety.
- How sterility testing is used during ISO 11135 ethylene oxide (EO) sterilization validation activities.
- Sample size considerations for irradiation dose establishment studies and sterilization validations.
Video Summary
The terms Test of Sterility and Test for Sterility are often used interchangeably, but they have distinct meanings and applications within sterilization science.
In this TechTalk, Vicki Pearson explains how a Test of Sterility is used as part of development, validation, and requalification activities to evaluate the effectiveness of a sterilization process, while a Test for Sterility is a pharmacopoeial test performed on products following aseptic processing or sterilization.
The video explores why sterility testing is required during ISO 11137-2 irradiation dose establishment studies, including Method 1, Method 2, and VDmax approaches. Viewers will learn how these studies support the selection and verification of sterilization doses and why simply irradiating a healthcare product is not sufficient to claim sterility without appropriate validation.
The discussion further explores the role of sterility testing during dose audits, highlighting its importance for maintaining process effectiveness, demonstrating regulatory compliance, and supporting patient safety. In addition, the video reviews how sterility testing contributes to ISO 11135 ethylene oxide validation activities and provides guidance on sample requirements for different dose establishment methods.
Whether you work in sterilization, microbiology, quality assurance, regulatory affairs, or medical device manufacturing, this TechTalk provides a practical overview of how sterility testing supports validated sterilization processes and sterility assurance programmes.
Learn More
STERIS AST offers a comprehensive range of laboratory testing and sterilization services to support product development, sterilization validation, routine processing, and compliance requirements.
Learn more about our testing capabilities and global sterilization services here.
Related Videos
Microbiological Perspective To Radiation Sterilization Validation Approach | STERIS AST TechTalk
Testing & Validation for Gas Sterilization | STERIS AST TechTalk
The Importance Of Bioburden Testing & Control | STERIS AST TechTalk