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 September 2007

MARIE TKACIK is the director of technology for TOLAS Healthcare Packaging. A member of ASTM International since 1995, she is chair of Subcommittee F02.20 on Physical Properties for Flexible Barrier Packaging and is chairperson for the FPA Sterilization Packaging Manufacturers Council Technical Committee.

Fifty Years of Standardizing Flexible Barrier Materials

For some of us, turning 50 can mean a self-scrutinizing transition, filled with a growing awareness of mortality and urgings toward a second childhood. On the more positive side, the American Association for Retired Persons calls turning 50 a new start on the second half of your life. (See sidebar showing F02 timeline.)

This October, ASTM International’s Committee F02 on Flexible Barrier Packaging (see sidebar About Committee F02) will be facing its 50th year with a brilliant list of accomplishments, a newly reorganized group of subcommittees and a committed group of volunteers. At its celebration event in October in Tampa, Fla., the committee will relive the past in historic timelines, new and old friendships, recognized leadership and working relationships that enable a steady supply of new standards and a continuous improvement of the old. This past year the subcommittees of F02 began meeting under a newly organized structure. This restructure expands the leadership in important areas, providing a different perspective to the regular members and creating the opportunity for leaders to develop more new standards for an ever-changing marketplace.

F02 and Its Subcommittees

(See sidbebar on F02 Subcommittee Scopes and Chairs.)

Subcommittee F02.10 on Permeation currently has 11 standards and four active projects. These projects cover standards for measuring the permeability of flexible barrier packaging using oxygen, carbon dioxide and water vapor, for example. Some of the projects address technique issues such as measurements at various relative humidities, samples and using high transmitters. Interlaboratory round robin studies support the standards and provide an avenue for comparison of different methods and techniques. This subcommittee openly invites and encourages new technologies and proposals of interest to those in the field of flexible packaging permeation and measurement.

In the area of Chemical and Safety, F02.15 standards are written for extractables, biocompatibility, additives, leachables, microbial barriers and microwaves. One of the first standards approved in F02 (1963) was a practice for constructing a test cell for liquid extraction of flexible packaging materials. F 2475, a more recent guidance document, was approved to address biocompatibility in packaging. Subcommittee F02.15 is responsible for 12 standards and is currently balloting a method that is designed to provide an alternative to F 1608, Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method). This working document includes process diagrams and testing studies that reflect measures of flow and penetration of particles through a porous barrier material. This new document along with any others under ballot can be reviewed by signing up to participate on Committee F02.

F02.20’s Subcommittee on Physical Properties looks at the durability of packages by testing flex, puncture resistance and hot tack; the measurement of packages with thickness, linear dimension and coating weight; the printablity of packages with anchorage and chemical resistance; and the sealing of packages through the determination of heat-sealability. Of all the physical testing methods, however, the subject of seal strength holds the most interest and standards cover bond strength, ply adhesion and the measured value of seals through the use of tensile and burst equipment. Standard F 88, Test Method for Seal Strength of Flexible Barrier Materials, was initially approved in 1968 and today is the standard with the highest number of copies purchased — over 560 in the last two years.

There are nine standards that address the subject of Package Integrity in Subcommittee F02.40 and four active projects. Several of these are among the top 15 in terms of the sales volume of F02’s 54 standards. These are leak testing standards using various methods that include helium, carbon dioxide, dye penetration, visual inspection, pressure decay, vacuum decay and bubble emission. Standard F 1929, Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration, ranks third in the list and generates a lot of interest in the industry. This method is used to test seals for continuity. The user places a liquid dye along the seal edge and observes for leaks that would cause the package to lose its sterile barrier. These standards include a precision and bias statement that helps to identify the sensitivity of the method when used as instructed.

The F02.50 Package Design and Development subcommittee handles seven current standards that provide specifications, guidance documents and terminology standards to the flexible barrier packaging industry. This subcommittee’s standard F 17, Terminology Relating to Flexible Barrier Materials, was first approved in 1961. It has become very active recently in an effort to consolidate terminology from other F02 documents and to include terms used in other international standards such as ISO 11607, Packaging for Terminally Sterilized Medical Devices. This newly updated ISO standard references as recommended-for-use many Committee F02 standards in its annex. New definitions are also being added, such as environmental challenging and accelerated aging.

Subcommittee F02.50 is also steward of F 1980, Guide for Accelerated Aging of Sterile Barrier Systems Medical Devices. This guide was recently updated to clarify the use of humidity relative to temperature in aging protocols versus environmental challenges and to create appropriate tolerances for maintaining temperature and humidity conditions in a test chamber. A guidance document worthy of noting here is F 2097, Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products. Within this document is a method to guide packaging professionals through the many standards. It provides an organized listing of documents with descriptions and applicability for developing rationales for use.

The Top Standards

When these subcommittees work together, they recognize the common ground in package testing that blurs the line between the medical device, food and consumer product industries. The result is a combined effort by government, academia and companies from different markets, providing input to standards throughout the ballot process and in committee week meetings, producing material and product samples for task groups developing standards, volunteering lab testing time for interlaboratory studies, and editing documents to include real-world technical experiences that reflect those seen in the field.

Nowhere was this more apparent than in the ILS conducted in 2004 for standard F 88, Test Method for Seal Strength of Flexible Barrier Materials. Eighteen different labs volunteered various services in order to make this happen. Necessary tasks included coordinating activities, organizing information, providing materials, preparing samples, performing tests as instructed, collecting and analyzing the data, reviewing the results and resolving inconsistencies, drafting the new statement and approving the new standard in 2005. The interest level in this document (measured in number of copies sold) increased from 2004 to 2005 by 160 percent and by another 29 percent the following year, making this document Committee F02’s number one standard by a wide margin.

F 1980, Guide for Accelerated Aging of Sterile Barrier System Medical Devices, has run a close second to F 88 in terms of package industry interest. In this test, accelerated aging protocols are run in order to speed up the development time and the release-to-market of products specifically in the medical device industry. Often products are expected to have a long shelf-life of two to five years or more and the guidance provided by this document aids in developing protocols for accelerated aging. This provides an indicator of how well a package keeps a product safe and ready for use without having to wait for the results of the real-time testing that runs concurrent to the study. The calculation used is based upon the concept that the effects of time on a package double for every 10 degrees Celsius above ambient storage conditions.

The most recent approved version of this document recognizes that relative humidity can affect the results of the study and includes a chart to help the user understand measures of humidity (water load) relative to temperature. The standard emphasizes the importance of differentiating between accelerated aging to determine shelf-life and environmental challenging to expose packages to possible climate extremes that may exist in their distribution channels.

This article touches on just a few of the 54 standards Committee F02 has developed, expanded, updated and approved over the last 50 years under the leadership of volunteers. Industry producers, users of packaging and packaging materials, consultants experienced in various fields and members from general interest backgrounds have all played a part in creating this impressive history of consensus standards. It takes time to create a standard and for it to have an impact in a global market. It takes a constant flow of new volunteers, a mix of experience and education, a group of people who can listen and learn to share their knowledge in a way that is not strictly self-serving but geared toward responsible stewardship of the packaging industry. It is not difficult or expensive to become a part of this process. Take hold of the opportunity to write, comment on, vote and approve an international standard by joining Committee F02 on Flexible Barrier Packaging and become a part of the next 50 years. //