Process Challenge Device Development for EO Sterilization
Instructor:
Gerry O Dell
Product ID: 703443
- Duration: 90 Min
Why Should You Attend:
Since Process Challenge Devices (PCDs) are used so commonly during both ethylene oxide (EO) validation and during routine processing, it is important to understand what the ultimate purpose of the PCD. Choosing the wrong PCD, i.e. one that is overly resistant, can result in additional cost and added time to the routine sterilization process. Whereas choosing the wrong PCD, i.e. one that is not resistant enough, can result in an inadequate sterilization process. While the former situation is undesirable for your business the latter situation can result in harm to the patient. This webinar will outline how to avoid both of these risks to your business.
Areas Covered in the Webinar:
- What is the purpose of the PCD?
- What makes an appropriate PCD?
- Are the requirements for PCDs different during validation versus routine processing?
- How can you ensure consistency in your PCDs?
- How should you evaluate or compare PCDs?
- When is requalification of PCDs required?
Who Will Benefit:
This webinar will provide valuable information to all companies that produce sterile products.
- QA personnel
- Validation specialists
- Manufacturing personnel involved in sterilization
- R&D specialists
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. Her over 35 years of experience in all the major sterilization methods, microbiology, environmental control, laboratory compliance, failure investigation, has enabled Gerry to successfully consult to companies ranging from small start-up operations to Fortune 500 companies. She has also played a significant role in sterilization standards development for over 25 years through her association with the American Association for the Advancement of Medical Instrumentation (AAMI).
Topic Background:
Process challenge devices (PCDs) are used in the validation process for most types of sterilization. Published guidance is available for PCDs related to moist heat sterilization but the guidance for PCDs to be used for ethylene oxide (EO) sterilization is limited.
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