Process Validation and Process Controls: Radiation Sterilization
Instructor:
Lisa Foster
Product ID: 700180
Training Level: Advanced
- Duration: 60 Min
Whether radiation sterilization is performed in-house or with a contract sterilizer the product manufacturer must be informed as to the process validation and process control requirements associated with the radiation process.ANSI/AAMI/ISO 11137 and AAMI TIR 27 define the requirements and standard practices for validation of the irradiation process and the process controls required during routine processing. This presentation will review these requirements and practices for gamma and electron beam irradiation in a practical manner so the product manufacturer can better understand the application of the ANSI/AAMI/ISO 11137 and AAMI TIR 27 as it relates to process validation and routine process control.
Areas Covered in the seminar:
- What encompasses process validation of a product entering a radiation sterilization process.
- Review of Product Loading Configuration and Product Dose Mapping (gamma and electron beam)
- Dose distribution: gamma and electron beam
- Process controls in irradiation processing from receipt of product to shipment of product
Who Will Benefit:
This seminar will provide valuable assistance to all regulated companies that are using or considering using radiation as their method of sterilization, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologic fields. The employees who will benefit include:
- End-users responsible for sterility assurance
- QA Managers and personnel
- Validation Specialists
- Consultants
- Quality System Auditors
Ms. Foster began her medical device career at Sterigenics International in 1989. Throughout her tenure, Ms. Foster has held various quality assurance positions at both the facility and Corporate levels where she has served as Vice President of Quality Assurance responsible for Sterigenics’ worldwide network of sterilization facilities and is currently Vice President of the SteriPro Consulting and Labs division of Sterigenics. Ms. Foster is an Executive Committee Member of the AAMI Sterilization Standards Board, a member of the AAMI Sterilization Standards Committee, serves as Co-Chair and ISO delegate to AAMI/ISO/TC 198/WG2 Radiation Sterilization Working Group, served as co-chair for the AAMI Radiation Process Control Task Group, which developed TIR 29, Guide for Process Control in Radiation Sterilization, and is an active member of several other AAMI Sterilization Working groups.
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