Ethylene Oxide Sterilizer Validation: Basic Requirements
Instructor:
Mark Dott
Product ID: 700353
- Duration: 60 Min
Why Should You Attend:
Ethylene oxide/EO continues to be used to sterilize tremendous volumes of medical products worldwide. Its versatility has been employed for both in-house and contract sterilization for manufacturers, in addition to hospital and university applications. Sterilization is designated as a special validation process by both FDA and ISO, having unique requirements. FDA inspectors are instructed to review validations at companies that employ sterilization processes. This presentation will review the general requirements for performing EO validations via the "overkill" half-cycle method as described in ISO 11135.
Areas Covered in the seminar:
- General requirements of ISO 11135
- Items to be included in the validation protocol
- Equipment, materials, monitoring devices used during validation
- Activities performed during the execution of the study
- Items to be included in the final report
- Post-validation issues
Who Will Benefit:
- Validation staff that must cross-train for ISO sterilizer validations
- Laboratory staff involved with validation activities
- Quality or Regulatory staff now being assigned sterilizer audit responsibilities
- Supervisors of Manufacturing or Laboratory Departments responsible for sterilization processes
- Auditors responsible for reviewing contract sterilizer documents
- Anyone needing to gain a basic understanding of the requirements of EO validation process or documentation
Mark Dott has over 20 years industry experience, covering a wide range of medical devices, permanent implants, surgical disposables, pharmaceuticals, biologicals, biotech, and human tissue products. He has validated and supervised sterilization processes for gamma, EtO, and steam sterilization per AAMI and ISO guidelines, and has validated USP/AAMI microbiology test methods for use in medical device GMP laboratories (bioburden, sterility testing, LAL endotoxin, biological indicators, environmental monitoring of cleanroom and manufacturing areas, bacterial monitoring of purified water systems, B/F testing, etc.). He is also skilled in cleaning-resterilization process validations for reusable medical instruments, kits, & sets, and disinfectant validations for cleanrooms. Projects commonly include preparation of validation test protocols, execution of the validation studies, review and approval of data to insure compliance with published guidelines, preparation of final report(s), and training of client
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