What is the cost of a packaging failure?

Pharmaceutical & Medical Packaging News staff

By John Brosky, Contributing Writer

Punctures, abrasions, cracks on folds, burst packages. We've all seen the break downs in delivery of medical device packages on their way to end users through the processes called storage, handling, and distribution.

These are processes no one can control, right? So what are you going to do?

Nicole Kaller, a packaging engineer with DuPont de Nemours, believes she can put a number to what she bluntly calls a failure in the system. Translating the loss of devices in the value chain into a financial loss may bring some needed attention to improving the process to reduce product returns. Or worse, product recalls.

Other very dramatic and significant consequences of packaging failure include sterility loss, compromising patient safety, compromising aseptic presentation, and the less tangible but quickly felt impact of losing customer confidence.

At the Medical Packaging for Patient Safety and Health Care Effectiveness conference held in Helsinki, Finland, Kaller reported preliminary findings from a study she is preparing using calculations based on inputs from a European medical device manufacturer.

The follow-up to her presentation called, "Can we afford a packaging failure?" will be a whitepaper she is preparing for publication later this year.

Her premise is that a risk-based testing strategy appears essential for the production of a safe and reliable sterile barrier system (SBS).

"It may be better to pay for testing rather than accept the cost of failures," she offered as a conclusion.

In the example she presented, the cost impact over one year was calculated for one million injection devices shipped at a selling price of €10 each. She compared a form fill seal package using the incumbent 60 gram paper grid laquer coated material against an uncoated spunbonded polyolefine material.

The testing methodology is worthy of a clinical trial. Prior to physical testing, packaging was conditioned according to demanding requirements for worldwide transport, including batches frozen for 72 hours to simulate winter conditions and simmered for three days in a humid tropical climate.

The transport simulation test protocol included vibration, drop and compression. Criteria carefully determine packages for post transportation testing.

Key lessons include evidence that sterilization and conditioning of the pouches may have caused brittleness and reduced physical resistance and some candidates showed a weak performance due to the combination of physical and climate testing, which Kaller noted helps demonstrate differences in quality.

A key message, and one that will be explored further at the conference, is that package performance testing proves to be an effective way to detect issues before the product is on the market.

— John Brosky is currently on assignment at the Medical Packaging for Patient Safety and Health Care Effectiveness conference in Helsinki, Finland.

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