Sterilization Options for Challenging Products 2011

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?

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