Seminar on Validating Radiation Sterilization for Medical Products

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.

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

Location: Los Angeles, CA Date: November 17th & 18th, 2016 and Time: 09:00 AM to 06:00 PM

Venue: DoubleTree by Hilton Hotel Los Angeles Downtown

Address: 120 South Los Angeles Street, Los Angeles, California, 90012, USA

Price:

Register now and save $200. (Early Bird)

Price: $1,295.00 - Seminar Fee for One Delegate

Until October 10, Early Bird Price: $1,295.00 From October 11 to November 15, Regular Price: $1,495.00

Register for 5 attendees   Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*

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