IoPP Education Track Conference Medical Device Packaging Determining “Barrier Shelf Life” of a Package

Pack Expo: Las Vegas, NV September 28, 2011 Karen Greene, Life Packaging Technology LLC Carlsbad, CA karen@lifepacktech.com

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MDPTC: Mission Statement

• Provide a forum for packaging professionals representing the Medical Device Industry for discussion, exchange and development of information on issues that affect them in areas of organization, problems and technical issues, regulations, standards and new technologies.

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MDPTC: Vision Statement

• Provide the latest information on national and international regulatory requirements as they affect the packaging of medical devices.

• Provide a forum to voice the device industry packaging position on issues that affect them.

• Provide education to new members entering the medical device area of package engineering.

• Provide a timely list of tools and documents (guides, test methods and standards) that are helpful when performing the tasks related to the package engineering of medical devices.

• Exchange non- proprietary information regarding new materials, equipment and systems, which can improve the overall performance and quality of the medical device packaging industry.

• Act as a liaison for technical and regulatory updates between organizations of mutual interest such as AAMI, ISO, ASTM, ISTA and the U.S. FDA.

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MDPTC: Subcommittees • Labeling

– Dave Olson – AdvancedWeb

• Industry Standards & Regulatory Liaison – Hal Miller, Pace LLC / Alison Tyler, Beacon Converters

• Education

– Jennifer Neid Benolken, St. Jude Medical/Jennifer Blocher, Sealed Air Medical—Nurses Panel– need European Nurses for MDPTC Packaging User panel

• ESD – Robert Vermillion, RMV Technology Group LLC

• Sustainability

– Daphne Allen, Pharmaceutical and Medical Packaging News

• Sterilization – Michael Tokarski, KCI Medical

• Combination Products

– Jim Butschli, Health Care Packaging

Agenda

• An anonymous medical device packaging case study – Project definition

– Regulatory landscape

• The Challenge: Determining the Barrier Shelf Life of a Package

• The Selected Solution: Targeted technologies and a focused development process

• Lessons Learned and Highlights/Lowlights

• Recap

• Questions and Answers

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Our High Barrier Packaging Project

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•Surgical device composed of high carbon steel

•Corrosion prone

•Terminally sterilized medical device—gamma radiation

•Compliance to ISO 11607

•Pkg design inputs

•FFS—flexible pkg design

•Maintain current FFS configuration

•Printable top web

•5 year shelf life for sterility and corrosion

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Regulatory Framework

• To ensure safe and effective packaging start with the regulations – ISO 11607 -1: Packaging for terminally sterilized medical

devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems (2007)

– ISO 11607 -2: Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes (2007)

– FDA regulatory requirements for your device, http://www.fda.gov/cdrh/devadvice/overview.html

– FDA Quality system regulation for medical devices • CFR Part 820 (21 CFR 820)

The Barrier Shelf Life Determination

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•We have tools for sterility shelf life

•What is the mechanism of corrosion, should we

be modeling that?

•If we measure permeation rates of the package,

how can we translate data to a corrosion shelf

life

Our Development Process

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Analysis of Testing Results

• Verification of flat film permeation results

• Films machinability analysis

• Whole package permeation testing

• Researched an appropriate temperature and humidity for our accelerated “corrosion” testing

• Whole package accelerated “corrosion” testing

• Analysis of permeation test results and “corrosion” testing results

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• Understand temperature and humidity effects on materials use, prior to initiating the aging study

• Arrhenius equation (from ASTM F1980)

• Q10 factor understand

• Room Temperature 20º to 25º C

Accelerated Conditions Testing

Accelerated Conditions Testing

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Accelerated Conditions Testing

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• ASTM F 1980, “Accelerated Aging of Sterile Barrier Systems for Medical Devices”

– And the Use of Humidity with elevated temperature

Testing Conclusions • Whole package permeation testing:

– provided promising data on “extremely low” oxygen and moisture permeation rates for specific film combos

– Translate permeation rate into a prediction of “corrosion shelf life”--modeling

• Whole package corrosion testing results:

– M.A.P. vs. non-M.A.P. results • Low oxygen and low moisture starting environment was

helpful

– Application of the Arrhenius Equation for modeling of “corrosion” shelf life • This model really models the effect of time on the

permeation of the package

• Select reasonable temperatures and humidities to avoid damaging packaging 14

Next Steps for Implementati0n

• Review of Design Inputs

• Quality Audit of Film Suppliers

• Costing Review

• Manufacturing Review

• Execution of Test Plan for Validation in Compliance with ISO 11607:2006, Part 1

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Lessons Learned

• Define Design Inputs Thoughtfully

• Focus on Testing Methodologies – Human tendency to blast the package with apocalyptic

worst case conditions!

• Partner with experts – Testing experts, modeling expertise

– Regulatory expertise

– Equipment

• Define Project Risks and Mitigation Plan

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Resources—Experience, Tools and Team

• Consultants

• Laboratories

• Instrument Suppliers

• Regulatory Bodies

• Industry Trade Groups

Recap/Summary

• Define Project Objective

• Define Packaging Design Inputs—Document and obtain team buy-in

• Define a Package Development Process – What resources do we need to achieve our goal?

– Targeted testing with experts is key

– Expert analysis of results • Include expertise to develop non-standard and apply

standard test methodologies to the problems

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Thank You

Questions??

Determining “Barrier Shelf Life” of a Package

References Works Cited

• "ASTM D4169 -09 Standard Practice for Performance Testing of Shipping Containers and Systems." ASTM International - Standards Worldwide. Web. 19 Oct. 2010. <http://www.astm.org/Standards/D4169.htm>.

• "ASTM D4728 -06 Standard Test Method for Random Vibration Testing of Shipping Containers." ASTM International - Standards Worldwide. Web. 19 Oct. 2010. <http://www.astm.org/Standards/D4728.htm>.

• "ASTM D5276 -98(2009) Standard Test Method for Drop Test of Loaded Containers by Free Fall." ASTM International - Standards Worldwide. Web. 19 Oct. 2010. <http://www.astm.org/Standards/D5276.htm>.

• "ASTM D6344 -04(2009) Standard Test Method for Concentrated Impacts to Transport Packages." ASTM International - Standards Worldwide. Web. 19 Oct. 2010. <http://www.astm.org/Standards/D6344.htm>.

References Works Cited

• ISO 11607, Packaging for Terminally Sterilized Medical Devices, Parts 1 and 2. 2006th ed. AAMI, 2006.

• "Medical Devices." U S Food and Drug Administration Home Page. 07 June 2009 <http://www.fda.gov/MedicalDevices/default.htm>.

• TIR 22, Guidance For ANSI/AAMI/ISO 11607, Packaging for Terminally Sterilized Medical Devices, Part 1 and Part 2:2006. Tech. no. TIR 22. AAMI.

Acronym Definitions • ISO, International Standards Organization, European based. EN,

European National, is a designation for a standard considered as required in the European Union.

• CE, a mark without an exact word meaning, is generally considered a certificate of compliance to European Union regulations or standards for product sold in Europe.

• FDA, Food and Drug Administration, a USA regulatory group charged with public safety of medical devices for this paper.

• USA, United States of America. • AAMI, Association for the Advancement of Medical Instrumentation, is a

group dedicated to developing good medical device guidelines, practices, and standards for medical device/equipment use. Sterilization standards are developed within the group which developed into packaging as a method to maintain product sterility.

• TIR22, Technical Information Report, a guideline document for compliance to the ISO 11607-1 & -2 standards from AAMI.