Three-Part Webinar Series on the New Global Standard for Sterile Medical Device Packaging - ANSI/AAMI/ISO 11607 - Part 1 and 2
Based on the following industry standards, the three webinars examined the requirements and test methods for materials and preformed sterile barrier systems and covered validation requirements for forming, sealing, assembling, and packaging medical devices that are terminally sterilized:
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ANSI/AAMI/ISO 11607-1:2006 – Packaging for terminally sterilized medical devices-Part 1: Requirements for materials, sterile barrier systems, and packaging,
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ANSI/AAMI/ISO 11607-2:2006 – Packaging for terminally sterilized medical devices-Part 2: Validation requirements for forming, sealing, and assembly processes, and
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AAMI TIR22:2007 – Guidance for ANSI/AAMI/ISO 11607-Packaging for terminally sterilized medical devices-Part 1 and Part 2:2006.
PROGRAM-AT-A-GLANCE
SESSION I (two hours)
- Brief history and overview of the ANSI/AAMI/ISO 11607 series
- ANSI/AAMI/ISO 11607:1997, 2000, and 2006
- Relationship to EN 868-1 and the Medical Device Directive
- Examination of ANSI/AAMI/ISO 11607 – Part 1
- Scope and normative references
- Terms and definitions
- General requirements such as EN 868 2-10 series, quality system, sampling, test methods, and documentation
- Materials requirements for sterile barrier systems including general requirements, microbial barrier properties, compatibility with the sterilization process, compatibility with the labeling system, and storage and transport
SESSION 2 (two hours)
- Examination of ANSI/AAMI/ISO 11607 – Part 1
- Design and development requirements for packaging systems including general requirements, design, packaging-system performance testing, and stability testing
- Annex A – Guidance on medical packaging
- Annex B – Standardized test methods and procedures
SESSION 3 (two hours)
- ISO/EN Background
- Historical purpose of ANSI/AAMI/ISO 11607 – Part 2
- Commonality between ANSI/AAMI/ISO 11607 – Part 1 and 2
- Review of ANSI/AAMI/ISO 11607 – Part 2
- Validation of packaging processes including Installation qualification (IQ), process parameter development, operational qualification (OQ), performance qualification (PQ), process control and monitoring, and revalidation
- Packaging system assembly including environmental control, label control, and assembly of procedure kits and packs
- Use of reusable sterile barrier systems
- Sterile fluid-path packaging
SPEAKERS
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Curtis L. Larsen, Packaging Consultant, Spartan Design Group and DuPont Medical Packaging
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Harold F. Miller, Consultant, PACE Solutions, LLC
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Michael Scholla, Ph.D., Senior Consultant, DuPont Nonwovens
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John Spitzley, Consultant, Spartan Design Group
TARGET AUDIENCE
Instruction was targeted towards packaging, manufacturing, quality, and regulatory professionals involved with the validation of packaging processes and the design, development, and testing of medical device packaging systems.
WEBINAR CD - Receive a discount if you order all three programs!
- Includes handout material and CD.
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If you purchase a CD for one, two or each program separately, you pay a fee per CD of: $295 for webinar registrants | $395 for non-registrants
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If you purchase a CD for all three programs together, you pay a fee of: $750 for webinar registrants | $1005 for non-registrants
- Please note that domestic and international shipping rates apply.
THREE WAYS TO REGISTER
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Phone - 1-877-249-8226 / 240-646-7031 to order with a credit card.
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Fax - Select and download the order form and fax to 240-396-5781 .
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Mail - Select and download the order form and mail with payment to:
Packaging Webinar CD
AAMI Publications
PO Box 0211
Annapolis Junction, MD 20701-0211
QUESTIONS?
For questions about ordering the CD, please contact AAMI's Publications at 1-877-249-8226 / 240-646-7031.