This sterilization validation process training webinar will review the FDA or ISO requirements for tests following validation and emphasis is placed on the appropriate tests for validation, the appropriate routine tests and the frequency of 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.
Why Should You Attend:
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.
Areas Covered in the Webinar:
- 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.
Who Will Benefit:
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
Course Provider
Gerry O Dell,
