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Validating Radiation Sterilization webinar by Compliance4all

Start Date:
Thursday, 19 January, 2017
End Date:
Thursday, 19 January, 2017 11:00am
Health & Nutrition

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, ASTMSterilization validation and BioburdenShelf Life Test Methods - Accelerated Aging designProduct designThe influences of product assembly (molding, automation, etc.)'Material selection and post irradiation degradationRegulatory Guidances - AAMI/ISO 11137, TIR #17Packaging 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. Areas Covered in the Session:Polymers Chemistry - choosing the best polymer candidateGamma, E-beam, X-ray sterilizationAccelerated AgingProduct ValidationSterilization Validation - Establishing the baseline dose Who Will Benefit:Medical product design engineersSterilization ExpertsQuality Management and EngineersRegulatory AffairsSpeaker Profile: Karl J Hemmerich 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, process development and sterilization process validation.


161 Mission Falls Lane,
Suite 216

Organizer Details

Conference organized by Compliance4ALL

Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. .Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.

161 Mission Falls Lane, Suite 216

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