Product Sterility Testing . . . To Test or Not to Test? That Is the Question.

Area of Science:

• Medical Device Sterilization
• Microbiology
• Quality Control

Background:

• Sterility testing applications for medical devices have evolved significantly.
• The science of product sterility testing has advanced with changing definitions of sterility assurance.
• Historically, sterility testing was used for sterilization validation, lot release, packaging, aseptic processing, and shelf-life determination.

Purpose of the Study:

• To outline appropriate applications for sterility testing in medical device manufacturing.
• To highlight current uses of sterility testing with significant data limitations.
• To identify risks associated with inappropriate sterility testing in medical device validation.

Main Methods:

• Review of historical and current applications of sterility testing in medical device industry.
• Analysis of the limitations and risks associated with traditional sterility testing methods.
• Comparison of traditional sterility testing with more robust validation methods.

Main Results:

• Sterility testing on fully processed finished products is often inappropriate for determining sterilization effectiveness, sterility assurance level, package integrity, or shelf life.
• Many historical applications of sterility testing lack the desired confirmation and assurance for medical devices.
• The industry has adopted more robust methods for validating sterilization and package performance.

Conclusions:

• Sterility testing has limited appropriate applications in medical device validation and routine control.
• Relying on traditional sterility testing for finished products introduces undesirable risk to data validity.
• Robust, validated methods are essential for assuring medical device sterility and package integrity.