ASTM Reorganizes Its Packaging Committee
Anticipating PACPAC, the society realigns its members to prepare for future standards work.
Pending FDA regulations on post-approval changes to pharmaceutical packaging have prompted the American Society for Testing and Materials (ASTM; West Conshohocken, PA) to reorganize its consumer packaging subcommittee.
Last year FDA published a guidance outlining what postapproval changes can be made to drug packages without prior agency approval. Now the agency and industry are working on a packaging version of the Scale-Up and Post-Approval Changes (SUPAC) guidance. This document, called PACPAC, will outline the tests that must be performed to show, for example, that a new supplier's material is essentially no different from that of the previous supplier, eliminating the need for new stability studies.
Some of the tests expected to be required, from thermoforming characteristics for blisters to closure seal integrity, do not have standards in place. The society anticipates that it will need to devise such standards.
ASTM expects the work to fall under the jurisdiction of Division 3 of Committee D10 on Packaging. Division 3 is devoted to various forms of consumer packaging. At ASTM's meeting held April 9–13 in Toronto, Division 3 reorganized to make one of its subcommittees, D10.32, responsible for addressing these new standards. Julie Clifford, chair of Division 3, said the reorganization should make clear what subcommittee those members who have never done work for ASTM before should join.
Under Division 3's old structure, there were four subcommittees: D10.31, "Child Resistant Packaging"; D10.32, "Consumer Packages"; D10.33, "Refuse Bags"; and D10.34, "Identification of Pharmaceutical Drug Product Containers."
The child-resistant packaging subcommittee is being left as is, and the refuse bags subcommittee is being dissolved. Significantly, D10.34 is being folded into D10.32, and the new D10.32 will be called "Consumer, Pharmaceutical, and Medical Packaging." Its mission statement is as follows:
"To develop standards, guidelines, practices, and specifications to assist in defining, quantifying, identifying, and evaluating consumer packaging systems and related testing equipment. To develop standards, guidelines, practices, and specifications of pharmaceutical drug product containers. This will include the promotion of the general base of knowledge and research of the means of identification of product containers and related systems of measurement."
The inclusion of "medical" in the title raises the question of whether Committee F02 on flexible barrier materials, which includes Subcommittee F02.60, "Medical Packaging," might one day be incorporated into the structure. That would bring all of the healthcare packaging groups under one committee.
This is not expected to happen in the near future, said leaders of both committees. However, the two groups did agree to schedule their future meetings together in order to encourage members of one to join the other. Subcommittee F02.60 has been very active in its own right, submitting new standards and revised versions of old ones to FDA in hopes that the agency will designate them as consensus standards. That, in turn, would likely mean fewer questions about packaging test methods during inspections of device manufacturers.
Both committees meet twice a year and are scheduled for joint events through the end of 2002. The next gathering is October 8–12 in Orlando, FL. Subsequent meetings are April 2–5, 2001, in Phoenix; October 2001 in Orlando (an exact date has not yet been set); April 15–18, 2002, in Pittsburgh; and October 7–10, 2002, in Hollywood, FL.
For further information, contact ASTM at 100 Barr Harbor Dr., West Conshohocken, PA 19428-2959, call 610/832-9585, or visit http://www.astm.org.