Harry Shaffer, Sterilization Consulting Services, is a leader in the development of the sterilization standards and sterilization validation for the industry. He has been a member of AAMI for more than 30 years. His extensive experience in the development and validation of industrial sterilization processes, has assisted numerous clients to initiate, maintain and improve the sterilization process, both in terms of regulatory compliance and cost.
- Ethylene Oxide
- Electron Beam
Services provided include:
- Preparation of validation protocols
- Managing the execution of the protocols
- Review of the data to insure compliance with AAMI/ISO guidelines
- Writing of the Final report(s)
- Implementation of the Sterilization Release process, including the necessary Procedures for cycle review.
- Developing the Procedures for Sterilization deviations and product adoptions
- Establishment of Sterilization Processing Categories
- Determination of EO residuals
- Evaluation of Sterile Packaging systems