Download the PDF of the presentation here.
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PRODUCT & PACKAGE TESTING VIBRATION & SHOCK Dec 2015 Herb Schueneman Chairman, WESTPAK, Inc. RIVETING REVISIONS OF MEDICAL PRODUCT PACKAGE TEST PROCEDURES Katie Tran Laboratory Manager WESTPAK, INC. June 2016
Transcript of Download the PDF of the presentation here.
PRODUCT & PACKAGE TESTING VIBRATION & SHOCK
Dec 2015
Herb Schueneman Chairman, WESTPAK, Inc.
RIVETING REVISIONS OF MEDICAL PRODUCT PACKAGE TEST PROCEDURES
Katie Tran Laboratory Manager
WESTPAK, INC. June 2016
PRODUCT & PACKAGE TESTING VIBRATION & SHOCK
Dec 2015
Herb Schueneman Chairman, WESTPAK, Inc.
RIVETING REVISIONS OF MEDICAL PRODUCT PACKAGE TEST PROCEDURES
Katie Tran Laboratory Manager
WESTPAK, INC. June 2016
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Agenda
• ISO 11607 • Popular Test Methods (ISO 11607 Part 1 – Annex B) • ASTM F1929
– Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
• ASTM F3039 – Standard Test Method for Detecting Leaks in Nonporous Packaging or
Flexible Barrier Materials by Dye Penetration
• ASTM D642 – Standard Test Method for Determining Compressive Resistance of
Shipping Containers, Components, and Unit Loads
• ASTM F88 – Standard Test Method for Seal Strength of Flexible Barrier Materials
What is ISO 11607?
• Guidance document for validating terminally sterilized medical devices
• Recognized by FDA
• If you have a sterilized medical device, which must perform efficiently, safely, and effectively in the hands of the users.
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ISO 11607
• Packaging for terminally sterilized medical devices
– Part 1
• Requirements for materials, sterile barrier systems and packaging systems
– Part 2
• Validation requirements for forming, sealing and assembly process
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Popular Test Methods
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ISO 11607 Part 1 – Annex B Annex B
Accelerated Aging
Conditioning
Integrity
Internal Pressure
Performance Testing
Puncture
Seal Strength
Visual Inspections
Annex B - Integrity
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• Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration (ASTM F1929)
• What is porous?
– Tyvek®/paper
ASTM F1929 – Scope
• To detect and locate a leak equal to or greater than a channel formed by a 50 µm (0.002 inch) wire in package edge seals formed between a transparent material and a porous sheet
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• 2015 - Released March 2016
• 2012
• 1998 (2004)
• 1998
ASTM F1929 – Revision History
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ASTM F1929 – 2015
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Previous Revision
2012
Changes 1. No changes to testing procedure
Questions?
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Annex B - Integrity
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• Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration (ASTM F3039)
• What is nonporous?
– Tray (thermoformed tray with foil/poly lid)
– Pouch (foil/foil, poly/poly)
ASTM F3039 – Scope
• To detect and locate a leak equal to or greater than a channel formed by a 50 µm (0.002 inch) wire in the edge seals of a nonporous package
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• 2015 - Released March 2016
• 2013
ASTM F3039 – Revision History
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ASTM F3039 – 2015
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Previous Revision
2013
Changes 1. Labeled Method A for channels or leaks in seals 2. Added another method for testing (Method B) 3. Method B - To detect and locate a leak equal to
or greater than 10 µm (0.00039 inch) diameter in a nonporous flat sheet (checking area of interest)
ASTM F3039 – 2015 (cont.)
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2013
ASTM F3039 – 2015 (cont.)
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2013
ASTM F3039 – 2015 (cont.)
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2015
Questions?
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Annex B - Performance Testing
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• ASTM D4169
• Standard Test Method for Determining Compressive Resistance of Shipping Containers, Components, and Unit Loads (ASTM D642)
• Vehicle Stacking
• Compression
ASTM D642 – Scope
• To measure the ability of the container to resist external compressive loads applied to its faces, to diagonally opposite edges or to corners
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• 2015 - Released June 2015
• 2000 (2010)
• 2000 (2005)e1
• 2000 (2005)
• 2000 Initial Release
ASTM D642 – Revision History
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ASTM D642 – 2015
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Previous Revision
2000
Changes 1. Recommend ASTM D4332 for transit simulation testing 2. Recommend ASTM D685 for quantification of box compression strength
ASTM D642 – 2015 (cont.)
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2000
ASTM D642 – 2015 (cont.)
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2015
ASTM D642 – 2015 (cont.)
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Introduced another standard
ASTM D685 – Scope
• Defines the standard atmospheres for normal preconditioning, conditioning, and testing of paper and paper products, paperboard, fiberboard, and containers made from them
• Specifics procedures for handling these materials in order that they may reach equilibrium with the respective atmosphere
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ASTM D685 – Revision History
• 1993 (2002)
• 1993 (1998)
• 1993 Initial Release
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Questions?
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Annex B - Seal Strength
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• Standard Test Method for Seal Strength of Flexible Barrier Materials (ASTM F88)
ASTM F88 – Scope
• To measure the strength of seals in flexible barrier materials
• Definition of flexible: a material with flexural strength and thickness permitting a turn back at an approximate 180 degree angle – Trays with Tyvek® lid
– Pouches
• Applicable on seals between a flexible material and a rigid material
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• 2015 – Released January 2016
• 2009
• 2007a
• 2007
• 2006
• 2005
• 2000
ASTM F88 – Revision History
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ASTM F88 – 2015
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Previous Revision
2009
Changes 1. Updated verbiage for report section
ASTM F88 – 2015 (cont.)
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2009
ASTM F88 – 2015 (cont.)
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2015
Conclusions
• ASTM F88-15 (seal strength / peel)
• ASTM F1929-15 (dye penetration – porous)
• ASTM F3039-15 (dye penetration – nonporous)
• ASTM D642-15 (vehicle stacking / compression)
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Previous Webinar Recap
• ASTM D4332-14
• ASTM D4169-14
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http://www.westpak.com/page/resources/webinars WESTPAK’s webinars link
Questions?
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About WESTPAK, INC.
Two Locations:
San Jose Laboratory San Diego Laboratory
83 Great Oaks Boulevard 10326 Roselle Street
San Jose, CA 95119 San Diego, CA 92121
408-224-1300 858-623-8100
http://www.westpak.com
Contact Us
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THANK YOU !
Please Contact Us with any questions or testing assistance needs. We are here to help you!
Katie Tran Laboratory Manager
WESTPAK, INC.
