Conference — Session 404THURSDAY, FEBRUARY 16
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About the Chair
Karl Hemmerich, President, Ageless Processing Technologies
Karl J. Hemmerich is President of Ageless Processing Technologies, an engineering consulting network specializing in sterilization selection and program development and process validation. Before founding APT, Karl was Plant Manager of the Sandy, Utah Gamma Irradiation Facility and Customer Technical Support and Market Education Specialist for STERIS Isomedix Services. Karl also has previously worked with Ivac Corporation, Cutter Laboratories (Bayer), and Becton Dickinson.
Karl was selected as one of the 100 Most Notable People in the medical device industry (by MD&DI). He is a member of the Editorial Advisory Board for Medical Device and Diagnostic Industry magazine and is a member of the AAMI SWG96 that developed Technical Information Report # 17 covering materials selection, qualification / validation test techniques (i.e. accelerated aging), and quality processing methods. He has written and presented papers on Radiation Sterilization and Materials Selection for many corporations, universities, and professional organizations (including: MDDI, SPE, FDA, HIMA, & ASQC).
Issues in Sterilization Selection
About the Presentation
Introductory session covers a broad approach to the logic in selecting the optimal sterilization modality for a new or existing medical product, including combo products. This session will introduce attendees to the general concepts of sterilization as well as the FDA approved sterilization options.
- General Review of Sterilization
- Sterilization Processes covered in later sessions
- Validation Requirements
- Basic Microbiology
- What are the Current FDA Approved Processes
- EO, Radiation, Steam, Dry Heat, VHP, O3, NO2
- Optimal Modality/Method Selection Criteria
- Costs, SAL, Bioburden
- Product Design - Vented, Unique Materials, etc.
- Materials Choices
- Combo Products
- AAMI TIR # 17 for all Modalities
- Materials Selection and Qualification Testing Criteria
- Qualification Test Design
- Accelerated Aging Test Design
About the Speaker
Karl Hemmerich
See above.
A Look at Ethylene Oxide Sterilization
About the Presentation
Ethylene oxide (EO) is the number one method of industrial sterilization of healthcare products in the U.S. The primary reason for this is that EO has the highest material compatibility factor of all known sterilants. However, EO is the most complex of the primary sterilization methods as it has several variables that must be well controlled. This process will be examined from sterilization methodology selection to product release to the marketplace.
- General information
- Historical perspective
- Listing of all sterilization methodologies
- Primary sterilization methods comparison
- Method selection
- Estimated percent usage now and going forward
- Advantages and disadvantages
- Characteristics Standards & Technical Information
- Reports Equipment Variables
- Product flow Cycles
- Process release mechanisms
- Residuals Process validation
About the Speaker
Clark Houghtling, Director, Business Development, Synergy Health plc
Clark Houghtling is the Director, Business Development for Synergy Health, the second largest contract sterilization company in the world offering ethylene oxide, electron beam, and gamma sterilization services. His varied background includes extensive knowledge in sterilization technologies, finished goods testing, plant and quality management, medical device manufacturing, business development, sales, marketing, and regulatory affairs.
Prior to this position, Clark worked as the Manager, Sterility Assurance for Stryker Orthopaedics. Preceding that he worked as Director of Corporate Accounts & Senior Technical Advisor with Microtest, and before that at Cosmed Group, Inc. as the General Manager of their New Jersey location, then as National Director of Sales and Marketing, and finally as Vice President of Technical Affairs. After the purchase of Cosmed's Healthcare division by STERIS Isomedix, he then served as a Corporate Account Manager and Senior EO Technical Specialist for the company. Before joining Cosmed, Clark was Product Assurance Manager at Mallinckrodt Anesthesiology, and prior to that, Manager of Microbiology Laboratory Services at Ethox Corporation. He holds a Bachelor of Science degree in Biology from the State University of New York at Geneseo, and attended graduate school in Biology at Niagara University.
Clark has taught many courses and is a frequent lecturer to many varied groups including the Food and Drug Administration (FDA), the Association for the Advancement of Medical Instrumentation (AAMI) (where he serves as an instructor for the Industrial Sterilization for Medical Devices and the Industrial Ethylene Oxide Sterilization for Medical Device courses), the International Society For Pharmaceutical Engineers (ISPE), the Center For Professional Advancement (CPA), and for various companies. He is a member of the Sterilization Standards Committee at AAMI, the American Society for Microbiology (ASM), and a senior member of the American Society for Quality (ASQ). In addition, Mr. Houghtling served as Vice President of the Ethylene Oxide Sterilization Association (EOSA) and was an ASQ Certified Quality Auditor (CQA).
Radiation: Gamma, E-beam, and X-ray
About the Presentation
General review of why to select radiation, and what modality (gamma, E-beam, X-ray) would be the best choice for a new product design.
- History of Radiation
- Background
- Basic Requirements
- Validation
- Radiation Modalities
- Gamma
- E-beam
- X-ray
- Radiation Characteristics
- Dose Distribution/Dosimetry
- Temperature
- Material Considerations
- Color, Embrittlement, Odor, Toxicity, Stiffness
- AAMI TIR # 17 - Radiation Tolerance Chart
About the Speaker
Karl Hemmerich
Karl J. Hemmerich is President of Ageless Processing Technologies, an engineering consulting network specializing in sterilization selection and program development and process validation. Before founding APT, Karl was Plant Manager of the Sandy, Utah Gamma Irradiation Facility and Customer Technical Support and Market Education Specialist for STERIS Isomedix Services. Karl also has previously worked with Ivac Corporation, Cutter Laboratories (Bayer), and Becton Dickinson.
Karl was selected as one of the 100 Most Notable People in the medical device industry (by MD&DI). He is a member of the Editorial Advisory Board for Medical Device and Diagnostic Industry magazine and is a member of the AAMI SWG96 that developed Technical Information Report # 17 covering materials selection, qualification / validation test techniques (i.e. accelerated aging), and quality processing methods. He has written and presented papers on Radiation Sterilization and Materials Selection for many corporations, universities, and professional organizations (including: MDDI, SPE, FDA, HIMA, & ASQC).
Working with VHP – Micro Gamma/ Steris/ASP
About the Presentation
Vaporized Hydrogen Peroxide (VHP) has been used in aseptic filling processes in the pharmaceutical industry since the early 1990''s. Its use is also widespread in hospitals. Novel applications continue to be developed. This presentation will cover multiple the essentials of the process and multiple application types.
- Process essentials
- Atmospheric process
- Vacuum process
- Packaging considerations
- Flash decontamination
- Integrated systems
About the Speaker
John Klostermyer Ph.D., VHP Applications Engineer, Applications Project Management, Steris Corporation
John Klostermyer is a VHP Applications Developer with STERIS Corp., a leading supplier of decontamination and disinfection solutions. His work involves, developing: novel applications, best practices and new markets in the areas of containment, aseptic manufacturing and research. John has also worked in Europe and the US in the specialty chemical and medical device fields. He holds a. M.S. in Plant Pathology from Rutgers and a Ph.D. in Agricultural Science from University of Goettingen, Germany.
Steam and Dry Heat
About the Presentation
The basic principles of saturated steam and dry heat sterilization will be discussed in the topic of thermal processes. The presentation will include a discussion of the mechanism of delivered lethality, the quantitative assessment of delivered lethality and the application of the thermal processes to medical devices.
- Fundamentals of thermal processes
- Basic principles of saturated steam and dry heat sterilization processes
- Application of the processes to medical devices
About the Speaker
Robert Reich, President, LexaMed, Ltd.
Robert Reich is a microbiologist with over 35 years experience in the healthcare industry in the areas of Management, Validation, Quality and Regulatory Affairs. Extensive experience in both pharmaceuticals and medical devices. Pharmaceutical experience in aseptic processing, anti-neoplastic products, terminal sterilization of ampoules and vials, establishment environmental monitoring programs for both sterile and non-sterile dosage forms, OOS/CAPA investigations, cGMP and technical training, equipment and process validations including isolators, ovens depyrogenation tunnels, washers, etc. Medical device experience in contract sterilization, contract laboratory services, packaging, biological indicators, medical device manufacturing, environmental control and microbiologically related quality control, R&D, OOS/OOL investigations, regulatory submissions, and coordination regulatory inspections. He has been co-chair of HIMA technical committees on packaging validation and sterilization monograph review, as well as a member of task groups drafting guidelines on biological and chemical indicators, bioburden quantitation and microbiological methods for the assessment of packaging integrity. He has served a co-chair of ANSI/AAMI Industrial EO committee as well as a member of ISO/ANSI/AAMI technical standards committee on Biological Indicators, product EO residuals, alternative chemical sterilants, packaging, microbiological methods and aseptic filling. He has served as a member of the PDA task force drafting guidelines on the validation of dry sterilization and depyrogenation processes.
Human Tissue
About the Presentation
Until the turn of the century it was more common that human tissue for transplantation (allografts) were distributed using what the tissue industry called "aseptic processing", meaning that there was not a terminal sterilization process in place. After the turn of the century it became increasingly more common to utilize radiation as a terminal sterilization step for allografts. This presentation is intended to provide the sterilization modality selection process which the tissue industry underwent and some of the issues which had to be overcome in order to use radiation. Also some general concepts and guidance which were learned in this instance will be shared which can be used for similar situations.
- Review sterilization selection process with human tissue-based products
- Review issues which arose during the validation process and subsequent solutions
- Provide general concepts and guidance for similar situations
About the Speaker
Martell Winters, Senior Scientist, Nelson Laboratories
Martell Winters received a B.S. in microbiology with a minor in chemistry from Brigham Young University. He has been at Nelson Laboratories for 18 years and spent most of that time in the Radiation Sterilization group, which is responsible for bioburden testing and radiation validation studies. He is currently a Senior Scientist for Nelson Laboratories. Mr. Winters serves many AAMI Working Groups related to sterilization and is currently a co-chair for working group 8, Microbiological Methods. He is also on the AAMI Sterilization Standards Committee and is the AAMI liaison to the AATB Standards Committee. In 1995 he received his Registered Microbiologist (RM) certification, and in 2001 his Specialist Microbiologist (SM) certification in consumer products and quality assurance microbiology from the National Registry of Certified Microbiologists.
Combination Products
About the Presentation
Sterilization of sensitive combination devices is often no longer as simple as ABC. Traditional mechanical medical devices were often compatible with several terminal sterilization technologies; selection of the technology was based on operational optimization. Sensitive combination devices are a different story. Medical devices combined with active agents, bioabsorbable materials and/or active electronics may not be compatible with any traditional sterilization technologies. The sterilization industry has developed some creative responses to this undesirable situation.
Abbott Vascular had developed terminal sterilization solutions to two different drug-eluting coronary devices. A metallic drug-eluting stent is ethylene oxide sterilized and a bioabsorbable drug-eluting scaffold is electron beam radiation sterilized. Sterilization strategy and material compatibility results are presented.
We will cover:
- Sensitive combination devices
- Active agents - pharmaceuticals and biologics
- Bioabsorbable materials
- Active electronics
- Improve material compatibility
- Gentle sterilization cycles and validation methods
- Aseptic processing of combination devices
- Sterility Assurance Level of combination devices
- Drug-eluting stents
- Bioabsorbable drug-eluting vascular scaffolds
- Ethylene oxide sterilization
- E-beam sterilization
About the Speaker
Byron Lambert, Sr Assoc Research Fellow, Sterilization Science, Abbott Vascular
Byron Lambert has been with Abbott Vascular for 21 years. He currently works in R&D as a Sr. Associate Research Fellow, Sterilization Science. His current product responsibilities focus on the development of a bioabsorbable drug coated coronary scaffold. His sterilization responsibilities focus on developing terminal sterilization solutions for combination devices. He is Convener of the ISO Radiation Sterilization Working Group. His previous responsibilities at Abbott Vascular have included managing sterilization operations and microbiology, chemistry, calibration and reliability testing laboratories. He has published numerous journal articles and book chapters and is on the organizing committee of major sterilization related conferences. His Ph.D. is in Chemical Engineering, radiation and polymer science, from the University of Maryland.
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