Sterilization Options for Challenging Products - Webinar By ComplianceOnline
Why Should You Attend:
Medical products are more complicated and have greater challenges for sterilization process than ever before. These products might include tissue-based products, combination products, devices with drug coatings, devices with batteries or equipped with integrated software, circuits or computer chips.
Each of these present their own challenges for sterilization starting with selecting a compatible process to developing the validation strategy and meeting the regulatory requirements for ensuring that the sterilization process is adequate for the medical product. Making a mistake can be costly not only in immediate costs but also in project delays and potentially in regulatory approval.
This presentation will review various sterilization processes and their general compatibility to various types of challenging medical products as well as some of the challenges that each of the various sterilization processes might present. In addition the methods that are available for validation will be addressed demonstrating how they may be applied to reduce the effects of the sterilization process.
Other methods such as aseptic processing and reduction of SAL will also be discussed along with their regulatory acceptance both in the United States and internationally.
Areas Covered in the Seminar:
What makes a medical product challenging for sterilization?
Challenges of radiation sterilization.
Challenges of ethylene oxide sterilization.
Challenges of moist or dry heat sterilization.
Challenges of novel sterilization methods.
Validation methods that are available.
Aseptic processing/reduction of SAL - is it an option?
Who Will Benefit:
This webinar will provide valuable information to all companies that produce sterile medical devices.
Manufacturing personnel involved in validations
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 27 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 15 years through her association with the American Association for the Advancement of Medical Instrumentation (AAMI).