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 Guidance's - AAMI TIR # 17, ASTM
Sterilization validation and Bioburden
Shelf Life Test Methods - Accelerated Aging design
The influences of product assembly (molding, automation, etc.)'
Material selection and post irradiation degradation
Regulatory Guidance's - AAMI/ISO 11137, TIR #17
Packaging Design and Materials
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
Sterilization Validation - Establishing the baseline dose (VDmax)
Who Will Benefit:
Medical product design Management and Engineers
Quality Management and Engineers
Purchasing and Supply Chain Managers
Staff evaluating risk, safety, and effectiveness
R&D Staff - engineering and lab personnel
Karl Leinsing has experience with design and project management since 1988 and has been in the Medical Product Device Design and Development industry since 1992. His areas of expertise include full life cycle product development, product conception, polymer selection, thorough computer-aided product design, dynamic mechanical analysis and root cause analysis, molding and manufacturing, project organization, technical presentations and leadership, and cross-functional teamwork. Karl currently holds 19 patents (several patents pending), 5 design awards, was listed as one of "100 notable people in the Medical Device Industry" by Medical Device and Diagnostic Industry (MDDI), and was inducted into the Product Design & Development Engineer Hall of Fame.
Compliance4All DBA NetZealous,
Event Link : http://bit.ly/29nErWP
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