ASTM F02 Flexible Barrier Materials. Dhuanne Dodrill March 12, 2014

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1 ASTM F02 Flexible Barrier Materials Dhuanne Dodrill March 12, 2014

F02 Flexible Barrier Packaging flexible package any package with at least one flexible component that can be bent back or folded back upon itself*

2 F02 Flexible Barrier Packaging flexible package any package with at least one flexible component that can be bent back or folded back upon itself* 58 Standards of which 42 are Test Methods 8 additional standards under development 23 F02 Standards are FDA recognized consensus standards *ASTM F17

3 FDA Recognized Consensus Standards The intent is to simplify and streamline the premarket review process Can be used to assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. dards/search.cfm and search on: Standards Organization: ASTM Specialty Task Group Area: Sterility ASTM Interlaboratory Studies (ILS) can aid in demonstrating conformance

4 Interlaboratory Studies All ASTM Test Methods are required to have a precision and bias statement Based upon an interlaboratory study Includes repeatability and reproducibility Includes sensitivity when appropriate Associated Research Reports contains the supporting data Ensures that the tests are robust Allows users to assess usefulness in a proposed application

5 F02 Flexible Barrier Packaging 5 Subcommittees F02.10 Permeation F02.15 Chemical & Safety F02.20 Physical Properties F02.40 Integrity F02.50 Package Design & Development

Ballot ILS planned New Test Method to Verify Flexible Barrier Material Resistance to the Passage of Air (aka Impermeability test from ISO 11607-1 Annex C) ILS Completed Final ballot planned 5.

6 F2476 CO 2 TR ILS completed F02.10 Permeation Chair: Mike Troedel Updated Method successfully balloted. New Test Method to Determine Oxygen Permeability using Fluorescent Decay Written and had 1 st Subcomm. Ballot ILS planned New Test Method to Verify Flexible Barrier Material Resistance to the Passage of Air (aka Impermeability test from ISO Annex C) ILS Completed Final ballot planned 5.1 For high barrier applications, the Oxygen Transmission Rate is an important determinant of packaging protection afforded by packaging materials. For high oxygen transmission applications (i.e. low barrier applications), the package must deliver an appropriate amount of oxygen to satisfy the needs of the packaged product. 6. Interferences 7. Apparatus 7.1 Oxygen Gas Transmission Apparatus, as diagrammed in Fig. 1 with the following: FIG. 1 A Practical Arrangement of Components for the Measurement of Oxygen Transmission Rate Using a Fiber Optic Oxygen Sensor

7 F02.15 Chemical/Safety Properties Chair: Rick Clark F34 Practice for Construction of Test Cells for Liquid Extraction Update successfully balloted New version has been published

a warning that seal strengths may vary depending upon whether they are MD or TD Annex on how to

8 F02.20 Physical Properties Chair: Marie Tkacik Test Method for Abrasion Resistance Under ballot at Subcommittee level ILS to follow F88 Seal Strength is in the process of being updated Include a warning that seal strengths may vary depending upon whether they are MD or TD Annex on how to convert from lb/in to N/15mm Appendix demonstrating that seal strength varies directly with width

F02.40 Integrity Chair: Nick Winters New Test Method F3004 Airborne Ultrasound just published New Test Method F3039 Dye Penetration Nonporous Packaging just published Method only

9 F02.40 Integrity Chair: Nick Winters New Test Method F3004 Airborne Ultrasound just published New Test Method F3039 Dye Penetration Nonporous Packaging just published Method only address detecting leaks (channels) in seals ILS for pinholes (through holes) in a material being redone New Test Method on Head Space Analysis Subcommittee ballot just completed ILS planned

F02.50 Package Design & Development Chair: Matt Gibney Guide for Test Method Validation under development F2095 Guide for Design and Evaluation of Primary Flexible Packaging Medical Products being

10 F02.50 Package Design & Development Chair: Matt Gibney Guide for Test Method Validation under development F2095 Guide for Design and Evaluation of Primary Flexible Packaging Medical Products being updated Compendium of commonly used test methods and standards Organized into 8 categories Safety Visibility & Appearance Barrier Processing Durability Printed Ink Package Integrity & Seal Strength Package Performance

11 Get Involved! Individual Membership is $75 Access to one volume of standards (15.10) Participate in ballots Access to members only section Go to astm.org

12 Get Involved! Next F02 meetings April 8-9, 2014 East Lansing, MI April 8: Joint Conference with D10 Morning has a series of speakers Afternoon consists of a tour of MSU School of Packaging and poster presentations by graduate students April 8: F02 Meetings September 23-24, 2014 Belfast, Northern Ireland April 29-30, 2015 Anaheim, CA

13 Contact Information Dhuanne Dodrill: Mike Troedel: Rick Clark: Marie Tkacik: Nick Winters: Matt Gibney:

ASTM F e1 Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery

ASTM F e1 Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery ASTM F2825-10e1 Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery Do we really need another conditioning standard? Hal Miller PACE Solutions, LLC hfmiller2@att.net