Basics of Testing Associated with Sterilization Validation and Routine Processing

All sterilization methods require validation and during this validation they must demonstrate that products meet the required sterility assurance level, that the product remains function and is safe for use. Manufacturers do not always understand the scope of this testing, the applicable standards and how it should be applied to the product they produce with their designated sterilization method. Following validation during routine production some testing is required but often manufacturers are not sure of what testing is required, the frequency necessary and how much flexibility they have in the testing.

Various biological and product tests are used during the sterilization validation process and then as support to the routine sterilization process. These tests need to be defined and demonstrated to be compliant with the recognized standards. This presentation will review the FDA or ISO requirements for those tests. Emphasis is placed on the appropriate tests for validation, the appropriate routine tests and the frequency of testing. The types of testing may include bioburdens, bacterial endotoxin, residual analysis, functional tests, and sterility.

• What are the appropriate types of tests during sterilization validation.
• What standards should be used for the testing.
• What type of samples and sample sizes should be used.
• What testing needs to be performed routinely.
• What frequency of testing is recommended.
• What methods can be used to reduce testing.
• Important testing considerations for validations and routine testing.

This webinar will provide valuable information to all companies that produce sterile products.

• QA personnel
• Validation specialists
• Manufacturing personnel involved in validations
• R&D specialists

Instructor Profile:

Gerry O Dell

President, Gerry O’Dell Consulting

Gerry O'Dell, is owner and President of Gerry O'Dell Consulting, a consulting firm based in the United States with medical device and pharmaceutical clients around the world. Prior to starting Gerry O'Dell Consulting, she worked for Johnson & Johnson Medical, Inc. as the Manager of Laboratory & Sterilization Services which managed the sterilization program for J&J Medical in addition to providing laboratory testing services to several J&J companies. Before becoming a part of Johnson & Johnson Medical, Gerry was Manager of Sterilization Services at Critikon, Inc where she started as a Lab Technician. She holds both a Bachelor and Master of Science degree in Microbiology from the University of South Florida and has over twenty-nine years of experience in the medical device industry.