Medical Device Link.

FLEXIBLE PACKAGING

In the event of a sterile barrier system failure, Annex F of TIR 22 helps to guide users through a series of methods to determine the root cause of the failure. It emphasizes the importance of analyzing the failure to determine the source or mode of failure. The first step is to evaluate the failure and then to determine its source. For example, is the failure caused by the device, process, protective packaging, people, or environmental effects? Next, the focus turns toward identifying the cause as either a mechanical or a chemical cause. Tools that help in the study of root cause can come from laboratory evaluations including microscopy, gas chromatography, infrared spectroscopy, and thermal analysis. If preparation steps for development included a Failure Modes and Effects Analysis (FMEA), as defined in Annex H of TIR 22, then a review of this information will help identify possible sources of error.