Seminar on Validating Radiation Sterilization for Medical Products

OVERVIEW:
Review of basic polymer chemistry and changes in polymer characteristics can be anticipated and designed for. Learn how to plan for post radiation resistance and lifetime functionality. All radiation modalities (gamma, e-beam, x-ray) will be reviewed for a basic understanding of the sterilization process and the influences that product design and assembly can have on success.

The following subjects will be covered in detail:

• Materials Guidances - AAMI TIR # 17, ASTM
• Sterilization validation and Bioburden
• Shelf Life Test Methods - Accelerated Aging design
• Test Design
• Product Design
• The influences of product assembly (molding, automation, etc.)'
• Material selection and post irradiation degradation
• Regulatory Guidances - AAMI/ISO 11137, TIR #17
• Packaging Design and Materials
• Biological Polymers - Tissue, Serum

Why should you attend?
"Do it right the first time", choose the most functional and radiation resistant materials for your medical device instead of going through the post launch cycle of product revisions. Also learn the basis for choosing the optimum sterilization modality based on materials, product design, bioburden, and logistics.
Learn how to "think like a molecule" and plan and design around radiation induced changes in materials qualities (color, odor, brittleness). How to avoid the materials that are "APT" to fail.
Learn how to:

• Identify the materials that perform best upon radiation
• Keep color and odor out of your irradiated products
• Enhance product and packaging designs to take advantage of radiation
• Which modality (Gamma, E-beam, X-ray) will perform best for my product

Areas Covered in the Session:

• Polymers Chemistry - choosing the best polymer candidate
• Gamma, E-beam, X-ray sterilization
• Accelerated Aging
• Product Qualification
• Sterilization Validation - Establishing the Minimum Sterilization dose (VDmax)
• Sterilization Modality Selection Criteria
• Biocompatibility
• Preventing Plastic Part Failure Post Irradiation

WHO WILL BENEFIT:

• Medical product design Management and Engineers
• Sterilization Experts
• Quality Management and Engineers
• Regulatory Affairs
• Project Managers
• Purchasing and Supply Chain Managers
• Staff evaluating risk, safety, and effectiveness
• R&D Staff - engineering and lab personnel
• Process Engineers
• Packaging Engineers
• Materials Engineers
• Manufacturing Engineers

AGENDA:
Day 1 Schedule
Lecture 1: The Basics of Sterilization Modality Selection in Product Development AAMI TIR # 17, Irradiation Sterilization - History, Overview
Lecture 2: The Basics of Irradiation Processing - Gamma, E-beam, X-ray, Conversion from other Sterilization Modalities
Lecture 3: Radiation and Polymer Chemistry, Material Selection, Polymer Chemistry
Lecture 4: Packaging Design and Materials, Strengths, Limitations
Day 2 Schedule
Lecture 1: Sterilization Validation - Dose Setting, Bioburden, VD Max,
Lecture 2: Product/Material Qualification Testing - Accelerated Aging
Lecture 3: Irradiation Processing of Radiation Sensitive Materials - Biological Tissues, Serum
Lecture 4: Summary, Alternate Sterilization Modalities, TIR # 17, Putting It All Together

Others Details

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