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Stick with physical integrity tests

HealthPack hosted one of its largest--if not the largest--audiences ever last week in Albuquerque. While several speakers presented late-breaking updates on medical device packaging, such as the new TEQethylene HDPE blend from TEQ for thermoforming and DuPont's Tyvek Transition Program, much of the conference reinforced some long-standing principles guiding sterile barrier system (SBS) development.

For instance, in his opening keynote, John B. Kowalski, Ph.D. Principal Consultant for SteriPro Consulting, provided the audience with some guiding "critical to quality" requirements. These include ensuring that the SBS allows for efficient and consistent sterilization and the product and SBS survive the sterilization process.

While explaining these requirements and how to test packaging, he hit upon a topic that continues to puzzle some: "Never do a microbiology-based test when you can perform a physical test on a sterile barrier system," he said. "And never do a whole package microbial challenge test and test the product for sterility over time.”

Instead, “demonstrate package integrity--which ensures product sterility--using physical test methods,” he advised.

MDMs have a number of ASTM test methods available to perform such physical testing. Many of these are listed in ISO 11607’s Annex B, which is being reorganized in the standard’s pending revision, Jackie Daly Johnson, president of Beacon Converters, later told the audience during HealthPack’s Expanded Standards Update covering AAMI-ISO/ASTM/ISTA.

MDMs can trust these physical methods, experts say. Explained Kowalski during his keynote: “Dye penetration has been shown to be more reliable than whole package microbial challenge testing at finding defects.”

The dye penetration method is also facing a revision that may ease the process and minimize the mess. ASTM WK23814 would revise F1929-98 (2004) Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration, Mike Troedel later told the audience during HealthPack’s standards update. Also in progress is WK28919 ASTM WK28919, which is a revision of F2096 - 04 Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test).

Kowalski pointed the audience to several articles published nearly a decade ago in Medical Device & Diagnostic IndustryPMP News’s sister publication: “Toward a New Consensus on Sterile Device Packaging,” (Anthony Parisi et al., MD&DI January 1993); “In Quest of Sterile Packaging, Part 1: Approaches to Package Testing,” (Joyce Hansen et al., MD&DI August 1995); “In Quest of Sterile Packaging, Part 2: Physical Package Integrity Test Methods,” (Joyce Hansen et al., MD&DI September 1995). Among these authors are HealthPack Program Co-Chairs Curt Larsen and John Spitzley of Spartan Design Group and HealthPack speaker Mike Scholla, Global Director, Regulatory and Standards, DuPont Medical and Pharmaceutical Protection.

Scholla offered from the audience that MDMs could point these articles out to FDA should the agency ask for microbial testing of whole packages.

Stay tuned to for more HealthPack news. And be sure to add two new dates for upcoming HealthPack events: HealthPack Europe will be held October 8-9, 2012, in Dublin, Ireland; HealthPack 2013 will be held March 12-14, 2013, in Louisville, KY. For more details, visit

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