ASTM International’s Committee on Technical Committee Operations (COTCO) is considering a name change voted in by members of ASTM International Committee F02 “Flexible Barrier Packaging” earlier this year. If approved, ASTM F02 would be known as “Primary Barrier Packaging.”
Dhuanne Dodrill, chair of ASTM F02 and also president of Rollprint Packaging Products, tells PMP News that “the goal of the F02 name change was to better reflect the main focus of the Committee. This name change acknowledges the standards that currently exist in F02 that are specific to rigid primary barrier packaging (e.g. bottles) and the many standards in F02 that apply to both flexible and rigid primary packaging.”
Another objective “was allow potential new members to more easily assess whether F02 reflects their interests,” she explains.
The name change and associated update to the F02 scope was approved by F02 members in a ballot that concluded on April 9th, she says.
Dodrill says that the committee’s work has been focused on primary packaging. “I anticipate that will see some new activity around barrier packaging particularly as it relates to integrity testing,” she says. “Secondary packaging has been the responsibility of D10 Packaging and will continue to be so.” (D10 is planning to update its scope. For more details, click here.)
With the name change comes the relocation of some standards. “Committee F02 requested that the standards that were the responsibility of D10.32 Consumer, Pharmaceutical, Medical, and Child Resistant Packaging and the non-aerosol standards from D10.33 Mechanical Pump Dispensers be moved to F02,” Dodrill says. So “the standards from D10.32 and the mechanical pump dispenser standards from D10.33 have been officially moved to F02. Some of the standards fell within the activities of current subcommittees – for example standards that dealt with integrity were moved into Subcommittee F02.40 Integrity. To address the balance of the standards, we created two new subcommittees, F02.25 Rigid Container Closure Systems and F02.30 Mechanical Dispensers.”
Dodrill says that regardless of which committee has responsibility for these standards, a number of them are in danger of being withdrawn due to lack of activity. “We are actively looking for people that are interested in container closure systems, child resistant packaging, drug labeling, and mechanical pump dispensers to review and provide input on the existing standards and provide suggestions for new standards. I would love to hear from anyone who is interested in participating.”
ASTM F02 will be meeting October 4-5, 2016, in Vienna, Austria. Speakers and topics include:
F02.90 Executive: Overview of the ASTM Standards Development Process
Diane Trinsey, ASTM International
F02.10 Permeation: Challenges in High Barrier Film Development
Dr. Klaus Noller, Fraunhofer Institute for Process Engineering and Packaging
F02.15 Chemical/Safety Properties: The Latest in Microbial Barrier Testing
Dr. Jane Severin, DuPont Protection Techologies
F02.20 Physical Properties: Techniques for Measuring Seals During Package Development
Dan Burgess, Boston Scientific
Topic: Developing seal strength specs based on product design
Vipul Rajpara, Edwards Lifesciences LLC
Topic: Measuring package designs for aseptic presentation
F02.40 Package Integrity: Headspace Gas Analysis
Davide Formenti, Bonfiglioli Engineering S.r.l.
F02.50 Package Design and Development: Test Method Validation
Dan Burgess, Boston Scientific
F02.80 Liaison: Proficiency Testing, a Permeation Case Study
Dr. R. Rangaprasad, Hemetek Techno Instruments Pvt & Laboratory Testing Division at Hemshell Services Lab
To get involved in ASTM Committees D10, F02, and others, please visit http://www.astm.org.
At MD&M Minneapolis on September 22, attendees are invited to attend a free panel discussion on medical device package testing standards and requirements. Held at Center Stage, the discussion is titled “Medical Packaging Testing Strategies to Meet New Standards." Click here to register and here for an article with more details.