Validating Radiation Sterilization for Medical Products 2017
- Start Date:
- Thursday, 16 March, 2017
- End Date:
- Friday, 17 March, 2017 6:00pm
- Pain Management, Hepatology, Infectious Disease, Rheumatology, Internal Medicine, Emergency Medicine, Hematology, Pulmonary Medicine
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, ASTMSterilization validation and BioburdenShelf Life Test Methods - Accelerated Aging designTest DesignProduct DesignThe influences of product assembly (molding, automation, etc.)'Material selection and post irradiation degradationRegulatory Guidances - AAMI/ISO 11137, TIR #17Packaging Design and MaterialsBiological Polymers - Tissue, SerumWhy 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 radiationKeep color and odor out of your irradiated productsEnhance product and packaging designs to take advantage of radiationWhich modality (Gamma, E-beam, X-ray) will perform best for my productAreas Covered in the Session:Polymers Chemistry - choosing the best polymer candidateGamma, E-beam, X-ray sterilizationAccelerated AgingProduct QualificationSterilization Validation - Establishing the Minimum Sterilization dose (VDmax)Sterilization Modality Selection CriteriaBiocompatibilityPreventing Plastic Part Failure Post IrradiationWho will benefit:Medical product design Management and EngineersSterilization ExpertsQuality Management and EngineersRegulatory AffairsProject ManagersPurchasing and Supply Chain ManagersStaff evaluating risk, safety, and effectivenessR&D Staff - engineering and lab personnelProcess EngineersPackaging EngineersMaterials EngineersManufacturing EngineersAgenda:Day 1 ScheduleLecture 1:The Basics of Sterilization Modality Selection in Product Development AAMI TIR # 17, Irradiation Sterilization - History, OverviewLecture 2:The Basics of Irradiation Processing - Gamma, E-beam, X-ray, Conversion from other Sterilization ModalitiesLecture 3:Radiation and Polymer Chemistry, Material Selection, Polymer ChemistryLecture 4:Packaging Design and Materials, Strengths, LimitationsDay 2 ScheduleLecture 1:Sterilization Validation - Dose Setting, Bioburden, VD Max,Lecture 2:Product/Material Qualification Testing - Accelerated AgingLecture 3:Irradiation Processing of Radiation Sensitive Materials - Biological Tissues, SerumLecture 4:Summary, Alternate Sterilization Modalities, TIR # 17, Putting It All TogetherSpeaker: Mr.
Karl J. HemmerichPresident, 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 UniversityLocation: Chicago, IL Date: March 16th & 17th, 2017 and Time: 09:00 AM to 06:00 PM Venue: Four Points by Sheraton Chicago O'HareAddress: 10249 W Irving Park Road, Schiller Park, IL 60176, United States Price: Register now and save $200. (Early Bird) Price: $1,295.00 - Seminar Fee for One Delegate Until February 10, Early Bird Price: $1,295.00 From February 11 to March 14, Regular Price: $1,495.00 Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*Quick Contact:NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407Fax: 302-288-6884Email: email@example.com
Four Points by Sheraton Chicago O'Hare 10249 W Irving Park Road,
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