Process Challenge Device Development for EO Sterilization

This webinar will discuss the role of Process Challenge Devices (PCDs) both during ethylene oxide (EO) validation and during routine processing. It will explain the difference in requirements for PCD during both the processes.

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

Instructor Profile:

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. Gerry O'Dell Consulting works to assist companies to comply with requirements to assure that their product is sterile at all stages of the development and manufacturing process. Prior to starting Gerry O'Dell Consulting in 1998, she worked for Johnson & Johnson as a Manager of Laboratory & Sterilization Services which managed the sterilization program for J&J Medical in addition to providing laboratory testing services to several J&J companies. She holds both a Bachelor and Master of Science degree in Microbiology from the University of South Florida and has over thirty years of experience in the medical device industry.

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.