RIVETING REVISIONS OF MEDICAL PRODUCTPRODUCT PACKAGE & PACKAGE TEST PROCEDURES TESTING VIBRATION & SHOCK
Herb KatieSchueneman Tran Chairman,Laboratory WESTPAK, Manager Inc . WESTPAK, INC. DecJune 2015 2016 RIVETING REVISIONS OF MEDICAL PRODUCTPRODUCT PACKAGE & PACKAGE TEST PROCEDURES TESTING VIBRATION & SHOCK
Herb KatieSchueneman Tran Chairman,Laboratory WESTPAK, Manager Inc . WESTPAK, INC. DecJune 2015 2016 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
3 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.
4 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
5 Popular Test Methods
ISO 11607 Part 1 – Annex B Annex B Accelerated Aging Conditioning Integrity Internal Pressure Performance Testing Puncture Seal Strength Visual Inspections
6 Annex B - Integrity
• Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration (ASTM F1929) • What is porous? – Tyvek®/paper
7 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
8 ASTM F1929 – Revision History
• 2015 - Released March 2016 • 2012 • 1998 (2004) • 1998
9 ASTM F1929 – 2015
Previous 2012 Revision Changes 1. No changes to testing procedure
10 Questions?
11 Annex B - Integrity
• 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)
12 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
13 ASTM F3039 – Revision History
• 2015 - Released March 2016 • 2013
14 ASTM F3039 – 2015
Previous 2013 Revision 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)
15 ASTM F3039 – 2015 (cont.)
2013
16 ASTM F3039 – 2015 (cont.)
2013
17 ASTM F3039 – 2015 (cont.)
2015
18 Questions?
19 Annex B - Performance Testing
• ASTM D4169 • Standard Test Method for Determining Compressive Resistance of Shipping Containers, Components, and Unit Loads (ASTM D642) • Vehicle Stacking • Compression
20 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
21 ASTM D642 – Revision History
• 2015 - Released June 2015 • 2000 (2010) • 2000 (2005)e1 • 2000 (2005) • 2000 Initial Release
22 ASTM D642 – 2015
Previous 2000 Revision Changes 1. Recommend ASTM D4332 for transit simulation testing 2. Recommend ASTM D685 for quantification of box compression strength
23 ASTM D642 – 2015 (cont.)
2000
24 ASTM D642 – 2015 (cont.)
2015
25 ASTM D642 – 2015 (cont.)
Introduced another standard
26 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
27 ASTM D685 – Revision History
• 1993 (2002) • 1993 (1998) • 1993 Initial Release
28 Questions?
29 Annex B - Seal Strength
• Standard Test Method for Seal Strength of Flexible Barrier Materials (ASTM F88)
30 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
31 ASTM F88 – Revision History
• 2015 – Released January 2016 • 2009 • 2007a • 2007 • 2006 • 2005 • 2000
32 ASTM F88 – 2015
Previous 2009 Revision Changes 1. Updated verbiage for report section
33 ASTM F88 – 2015 (cont.)
2009
34 ASTM F88 – 2015 (cont.)
2015
35 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)
36 Previous Webinar Recap
• ASTM D4332-14 • ASTM D4169-14
WESTPAK’s webinars link http://www.westpak.com/page/resources/webinars
37 Questions?
38 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
39 THANK YOU !
Please Contact Us with any questions or testing assistance needs. We are here to help you!
Katie Tran Laboratory Manager WESTPAK, INC.
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