Seminar on Validating Radiation Sterilization for Medical Products

Course "Validating Radiation Sterilization for Medical Products" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

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

Speaker:

Mr. Karl J. Hemmerich

President, Ageless Processing Technologies

Mr. Karl J. Hemmerich, President of Ageless Processing Technologies, has over 35 years of experience in medical device product design, development, manufacturing, and sterilization. He specializes in sterilization method selection and program development with emphasis on component material selection, polymer processing, process development and automated assembly, and sterilization process validation. Karl has extensive experience in radiation sterilization with over 10 years in management of a gamma processing facility, as well as a technical resource for Customers with materials and dose related product issues. Karl has made numerous presentations at Customer sales seminars, industry technical conferences and the FDA. Some of the subjects covered included radiation compatibility and selection of materials, gamma processing, dosimetry, package design, validation test design, preventing part failure through enhancements in processing and product design, and accelerated aging.

In 2004 Medical Device and Diagnostics Industry selected Mr. Hemmerich as one of the 100 Most Notable People in the medical device industry. He has written and presented papers on sterilization and materials selection for many corporations, universities and professional organizations, including MDDI, SPE, FDA, HIMA, & ASQC. His paper on radiation effects on polymers published in Medical Device and Diagnostics magazine remains an industry standard (www.mddionline.com/article/polymer-materials-selection-radiation-sterilized-products ). He has taught courses in Radiation Sterilization of Medical Polymers and Preventing Plastic Part Failure through the College of Engineering, University of Wisconsin. He is a Co-Chair of the AAMI SWG96/ISO11137 "Compatibility of Materials Subject to Sterilization" working group that developed Technical Information Report # 17 as the guidance for materials selection, qualification/validation test techniques and quality processing methods for all common sterilization methods (i.e. radiation, EO, VHP, steam). Mr. Hemmerich is Co-director of the Editorial Advisory Board for MDDI magazine where he offers forward looking guidance as well as technical review for state-of-the-art articles prior to publication.

In addition to over a decade of consulting as a Product Development, Expert Witness, and Materials and Sterilization Specialist, Mr. Hemmerich has held various responsible positions in medical product R&D, manufacturing and sterilization operations with Becton-Dickinson, Cutter Laboratories (Bayer), IVAC Corporation and Steris Isomedix. He holds a Bachelor of Engineering degree from Stevens Institute of Technology, a Masters of Bio-Medical Engineering from the Polytechnic Institute of New York University, and a Masters of Business Administration from Fairleigh Dickinson University