NEWS: Task Group Hopes Test Method Becomes a Standard
The Sterile Barrier Integrity Task Group of the Institute of Packaging Professionals ( IoPP; Naperville, IL) has introduced a new test method that it hopes will be accepted as a standard.
The task group, led by researchers from the Michigan State University School of Packaging, presented the method at a recent meeting of the IoPP Medical Device Packaging Technical Committee. Seeking to answer the question, “What hole size presents a danger in medical device packages?” the group has proposed a method involving the aseptic filling of a tray with sterile agar through a self-sealing septum using a needle and syringe.
As its working hypotheses, the group sought to demonstrate that aseptic introduction of appropriate agar growth medium into a sterile package will not result in unwanted contamination of the package, and that such aseptic introduction will result in the ability to measure package integrity after packages have been subjected to a microbial challenge.
In the first experiment associated with the test method, the task group aseptically introduced agar growth, using a Perfecseal PETG tray provided by Cardinal Health and E. coli bacteria provided by Medtronic.
The group’s study looked at four test groups:
- Injection of the bacteria through the contaminated area without using an alcohol swab.
- Injection of the bacteria through the contaminated area using an alcohol swab.
- A noncontaminated injection using a full aseptic technique.
- A positive-control injection through the contaminated area with no septum and without sealing the hole.
All test groups showed no growth of the bacteria, which led the researchers to conclude that aseptic introduction of agar growth will not result in unwanted packaging contamination. The task group will soon present the test method to ASTM F-02 for consideration as a standard, say representatives. At that point, more funding will be sought so the group can proceed to its next set of tests. Those involve a second experiment, which looks at what hole size allows penetration when Brownian motion drives. With that test, the group seeks to identify the minimum hole size through which certain bacteria penetrate a rigid tray when temperature and RH are standard and gravity serves as the driving force across the breached barrier. A third experiment will address the same question when flight is simulated.