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September/October 2009

Packaging for Medical Devices and Pharmaceuticals

The Work of ASTM Committees D10 and F02 Protects Medical Devices and Pharmaceuticals

The adhesive bandage you recently used to cover a cut and the corrugated container it shipped in to your local drug store share an important characteristic: packaging that protects the contents.

“Packaging can perform a function as simple as separating products into individual or multiple units and as complex as providing specialized environments for highly perishable items,” says Marie Tkacik, director of product development and optimization for Beacon Converters Inc., Saddle Brook, N.J., and a member of ASTM International Committees D10 on Packaging and F02 on Flexible Barrier Packaging.

The envelope around the bandage ensures its sterility; the shipping container protects all the bandages through transport from manufacturer to retail outlet. And Committees D10 and F02 provide the standards used to help gauge the packaging’s capability of accomplishing these objectives.

Committee F02 on Flexible Barrier Packaging develops standards related to testing both porous and nonporous materials and packages. Porous materials, usually medical paper or Tyvek spun-bonded polyolefin, surround the medical device and allow gas to sterilize the contents. Committee D10 on Packaging standards cover such materials as paperboard cartons and the corrugated shipping box that contain the primary device and its surroundings. Pharmaceutical standards, which address specific requirements related to tablets, also come under D10 in the work of Subcommittee D10.32 on Consumer, Pharmaceutical and Medical Packaging.

Standards for Manufacturer, Regulatory and International Use

ASTM International’s medical packaging standards respond to the needs of regulators and manufacturers both in the United States and internationally, and find broad use in primary packages, which maintain the sterility of the device, as well as their secondary shipping containers, which further protect the contents.

According to Hal Miller, current F02 chair and president of Pace Solutions LLC, Cape May, N.J., the U.S. Food and Drug Administration references all ASTM International test methods for sterile medical device packaging, and it publishes withdrawn, revised or new recognized voluntary consensus standards in the Federal Register at least once a year.

“When medical device manufacturers recognize F02 standards in their premarket submissions, the [FDA] Center for Devices and Radiological Health personnel will use the standards to ensure the premarket submission meets the requirements of the standards,” says Patrick Weixel, consumer safety officer, Office of Compliance, FDA CDRH. “Additionally, when device manufacturers include the requirements of F02 standards in their packaging procedures, FDA investigators typically review the standards to ensure the firms are complying with the standards.”

That has not always been the case. Before the work of F02, officials had no consensus standards to reference. “There was nothing that regulators could point to because it was a different story with every company they went into,” says Michael Troedel, founder of Troedel and Associates in Lake Villa, Ill., former F02 chair, and a D10 and F02 member.

Today, however, FDA staffers, along with industry representatives and academia, work together on standards that address such characteristics as seal strength, seal integrity and accelerated aging in these documents:

  • F88, Test Method for Seal Strength of Flexible Barrier Materials;
  • F1929, Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration; and
  • F1980, Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.

Similarly, the medical packaging industry essentially had no published consensus standards to show compliance with International Organization for Standardization (ISO) 11607, Packaging for Terminally Sterilized Medical Devices, according to Miller. To change that situation, F02 has worked for more than a decade to develop test methods supporting ISO 11607.

ISO 11607 cites standards that evaluate the entire package system, notes Patrick Nolan, D10 chair and chief operating officer at DDL Inc., Eden Prairie, Minn. “The international standards bodies have very little to offer as alternatives for evaluating packages,” Nolan says.

A D10 document addresses this need: D4169, Practice for Performance Testing of Shipping Containers and Systems, which describes how a laboratory can simulate the transport environment through numerous referenced tests. In addition, other D10 standards for package integrity and strength support the requirements of ISO 11607, including these two examples:

  • D3078, Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission; and
  • D903, Test Method for Peel or Stripping Strength of Adhesive Bonds.

Additional Significant Standards

“The most useful standard for most of the industry is F2097,” says Troedel. “To my knowledge, it is used by the vast majority of medical device manufacturers.”

ASTM F2097, Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products, provides information about a variety of standard tests commonly used to evaluate flexible medical packaging. The standard organizes ASTM methods developed by D10 and F02, plus ones from TAPPI (formerly the Technical Association of the Pulp and Paper Industry), into categories of safety, barrier, durability, package integrity and seal strength, visibility and appearance processing, and printed ink.

F2097 also provides the scope of each cited standard and its uses to steer people toward standards relevant for their purposes.

Two other examples of extensively used F02 standards include:

  • F1886, Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection, which can indicate package integrity and production sealing problems; and
  • F1140, Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages, which inflates a pouch with air until the seals burst and demonstrates the ability of a package to stay intact.

Among the many relevant D10 standards, D4169 stands out; it simulates the transport environment to evaluate the ability of the entire package system to travel from one place to another without damaging the contents. D7386, Practice for Performance Testing of Packages for Single Parcel Delivery Systems, also guides the evaluation of shipping units encountering the hazards of distribution.

And, under the jurisdiction of D10.32 are a number of labeling standards, including D4267, Specification for Labels for Small-Volume (100 mL or Less) Parenteral Drug Containers, which delineates orientation, type size and copy contrast to facilitate correct drug identification.

The Work Continues

Committees F02 and D10 continue to develop standards that will be useful to medical device manufacturers, packaging engineers, laboratories and regulators.

Under way now in F02 are methods for oxygen permeation, detecting pinholes in film, evaluating seal quality and nonporous packaging dye penetration.

In Subcommittee D10.32, according to Stuart De Jonge, president of De Jonge Associates, Deland, Fla., and chair of D10.32, a draft is under way to address an important labeling issue: “A new standard is being developed for user applied drug labels in anesthesiology. Currently the hospital down the street or in the next town or state can have a totally different syringe color-coding system. To address this potential problem a draft for color coding syringe labels will be presented at our next D10.32 meeting.”

Another D10.32 project is WK21601, Test Method for Measuring Water Vapor Transmission Rate of Bottles and Blisters by Gravimetric Method, a procedure to determine if moisture has affected a packaged pharmaceutical. That’s critical to knowing the effectiveness of a tablet, according to De Jonge, who gives the example of buffered aspirin, which is very sensitive to moisture.

These efforts respond to the ongoing need for standards that cover the package integrity, strength, aging and distribution. And, as Nolan says, “Standards smooth the playing field so that all medical device manufacturers are designing, developing and validating packages using the same principals, techniques and methods.”

Upcoming Meetings

Committee F02 will meet Oct. 6-8 in Prague, Czech Republic, as part of the ASTM International Technical Committee Meetings Event from Oct. 5 to 9. Highlighting the meetings is a Flexible Barrier Packaging Test Methods Workshop that will be held Wednesday, Oct. 7.

Committee D10 will meet Oct. 18-21 in Atlanta, Ga., during the October 2009 committee week.

ASTM International welcomes and encourages participation in the development of its standards. ASTM’s open consensus process, using advanced Internet-based standards development tools, ensures worldwide access for all interested individuals. For more information about Committees D10 and F02, please contact Kevin Shanahan, staff manager (phone: 610-832-9737).