ASTM COMMITTEE F02 FLEXIBLE BARRIER PACKAGING Dhuanne Dodrill March 16, 2016
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ASTM INTERNATIONAL F02 Flexible Barrier Packaging (Primary Barrier Packaging) D10 Packaging (Transport & Distribution Packaging) D20 Plastics D20.19 Film, Sheeting, and Molded Products D20.95 Recycled Plastics 24 Packaging standards are FDA recognized consensus standards
7. Apparatus 7.1 Oxygen Gas Transmission Apparatus, as diagrammed in Fig. 1 with the following: F02.10 PERMEATION Chair: Mike Troedel F3136 Determine Oxygen Permeability using a Dynamic Accumulation Method (Fluorescent Decay) Oxygen sensor incorporates a fluorophore that fluoresces in response to light but is quenched in the presence of O 2. Standard was published in 2015. FIG. 1 A Practical Arrangement of Components for the Measurement of Oxygen Transmission Rate Using a Fiber Optic Oxygen Sensor
F02.10 PERMEATION Chair: Mike Troedel New Test Method for WVTR through Packages using a Modulated IR Sensor Extension of F1249 (sheets) Subcommittee Ballot conducted ILS will be the next step New Test Method for WVTR through Films Using an Electrolytic Detection Sensor Ideal for high barrier materials Subcommittee Ballot was conducted ILS in process
F02.15 CHEMICAL/SAFETY PROPERTIES Chair: Rick Clark F1608 Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method) Main Committee ballot underway Standard Equipment (nebulizer no longer available) Exposure chamber evacuation practice will be improved Titration methods will be improved
F02.15 CHEMICAL/SAFETY PROPERTIES Chair: Rick Clark F2638 Aerosol Filtration for Measuring the Performance of Porous Packaging as a Surrogate Microbial Barrier In the process of being updated for ballot Change direction of flow rates to low to high flow Define calibration procedure and material Addition of metal screen to prevent sample interference Pre-test method for determination of challenge concentration Use of precision accumulators Add range of acceptable particle sizes for use
F02.20 PHYSICAL PROPERTIES Chair: Marie Tkacik F2981 Verify Flexible Barrier Material Resistance to the Passage of Air (aka Impermeability test from ISO 11607-1 Annex C) Published in 2015 F1306 Slow Rate Penetration Resistance of Films and Laminates Precision and Bias statement updated Main Committee Ballot passed Expect update to be published soon
F02.20 PHYSICAL PROPERTIES Chair: Marie Tkacik F904 Bond Strength of Laminates Significant updates to the standard Main Committee Ballot just closed Want to conduct a new ILS planned for next year F2029 Making Heatseals Has been completely rewritten and now includes a practice for impulse seals Main Committee Ballot is underway
F02.40 INTEGRITY Chair: Philip Cooper F3039 Dye Penetration Nonporous Packaging Previously addressed detecting leaks (channels) in seals Method B was added to detect pinholes (through-holes) Method was refined to improve reproducibility of the method New ILS was completed assess limit of detectability (various holes sizes being used) 10µm hole Probability of Detection of 0.769 20µm hole Probability of Detection of 0.913 30µm hole Probability of Detection of 0.957 40µm hole and larger Probability of Detection of 1.000 Updated method was recently published. F1929 Dye Penetration Porous Packaging Updated to clarify some wording Updated method recently published
F02.40 INTEGRITY Chair: Philip Cooper New 95 Test Method on Leak Detection by Vacuum 96 Deflection 97 ILS was conducted X XXXX 4.2 A vacuum is then applied to the test chamber and each pocket measured again. Sealed pockets can be identified as the measurement between the first and second profiles will change. This is known as deflection and is caused by the pressure difference between the air inside the 98 Main Committee Ballot underway 99 pocket and the air in the chamber caused by the application of vacuum.(figure 2) 100 101 102 103 104 105 106 107 Figure 2 108 109 4.3 The deflection of a pocket with a gross hole will be minimal as the pressure difference
F02.40 INTEGRITY Chair: Nick Winters New Test Method on O 2 Analysis via Head Space Sampling Method being revised based on feedback from Subcommittee ballot Seeing more variation with pouches that needs to be resolved before ILS New Test Method for Nondestructive Detection of Leaks in Packages by Mass Extraction Method has been developed, ILS completed, subcommittee ballot expected soon
F02.50 PACKAGE DESIGN & DEVELOPMENT Chair: Dan Burgess F2097 Guide for Design and Evaluation of Primary Flexible Packaging Medical Products 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 Just balloted to add new standards
F02.50 PACKAGE DESIGN & DEVELOPMENT Chair: Dan Burgess F1980 Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices Additional guidance provided regarding humidity Ballot just closed AAF=Q -T )/10] 10 [(TAA RT
QUESTIONS? Dhuanne Dodrill Diane Trinsey dhuanne@rollprint.com dtrinsey@astm.org 630-405-7801 610-832-9661