RIVETING REVISIONS OF MEDICAL PRODUCTPRODUCT PACKAGE & PACKAGE TEST PROCEDURES TESTING VIBRATION &

Herb KatieSchueneman Tran Chairman, 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 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 , 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 , 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? – ®/

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 ) – 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 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 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, , 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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