Pharmaceutical and Medical Packaging News
Magazine
PMPN Article Index
Originally Published PMPN July 2005
NEWS
Making Sense of Sterile Package Defects
One of the major reasons for packaging-related recalls in the device industry is listed as “defective packaging: potential for breach in sterility.” Since medical device manufacturers are in the business of improving public health, they have to err on the side of safety when it comes to voluntarily recalling sterile packages that are believed to be defective.
“Potential” is the operative term, says Randall Troutman, project manager, global packaging development, at Smith & Nephew Inc. If a manufacturer finds a defect, the packaged product is removed from distribution. It is removed because there is a potential breach of integrity, not a known one, he says. As a safe, but costly approach, the entire lot is likely to be pulled if a defect is detected. These types of recalls have many root causes including, but not limited to, machinery issues, material concerns, and the rigors of distribution.
To help reduce confusion related to this subject matter in the future, the Institute of Packaging Professionals’ (IoPP’s) Medical Device Packaging Committee has formed a task group to study sterile package hole sizes. (PMP News covered the group’s progress in the May 2005 news story, “Task Group Hopes Test Method Becomes a Standard.” For some clarifications on that effort, see the correction on p. 17 of this issue.)
The goals of enhancing patient safety and reducing costs surrounding packaging-related recalls have inspired the IoPP task group to apply science to answer the question: “What defect size presents a danger in medical device packages?” Little is known about precisely what size defect will allow for a breach of sterility, and what size breach poses no threat to the patient. The question will be answered so that:
• Patient safety is maximized
• Informed decisions can be made in the event of a potential recall
• A sensitivity benchmark is established for integrity testers
• Costs are minimized (products are not thrown out unnecessarily).
The subcommittee has agreed to the following experimental objectives:
• Identify the minimum hole size(s) through which Bacillus athrophaeus (previously named Bacillus subtilis) and E. coli K-12 penetrate a rigid tray when temperature and relative humidity (RH) are standard and gravity serves as the driving force across the breached barrier
• Identify the minimum hole size(s) through which Bacillus athrophaeus and E. coli K-12 penetrate a rigid tray when temperature and RH are standard and the package is subjected to pressure differentials that simulate those recorded during flight
The results and conclusions of these tests will help to establish sterile packaging benchmarks for years to come. Companies that have contributed to the start-up effort include:
• Amcor Flexibles
• Belco Packaging Systems
• Cardinal Health
• C.R. Bard
• DuPont
• GWY Technologies
• Medtronic
• Mocon
• Perfecseal
• Sabin
• Sencorp Inc.
• Smith & Nephew Inc.
To continue the work, equipment, personnel, and monetary donations are necessary. It is estimated that the proposed experiments will cost approximately $400,000. The School of Packaging at Michigan State University is serving as the research agent to create, conduct, and document the test sequences. Companies interested in getting more involved should contact Karen Polkinghorne at DuPont at Karen.Polkinghorne@usa.dupont.com or Troutman at Smith & Nephew Inc. at randall.troutman@smithnephew.com. Contributors will be provided with an executive summary of relevant findings.
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