The shelf life of terminally sterilised medical devices should be validated using both accelerated and real-time ageing, according to ISO 11607. As we've discussed before on this site, the Arrhenius equation is used to determine the rate of accelerated ageing. The version of this equation given in ASTM F1980 uses a Q10 factor of 2. This is saying that the rate of a chemical reaction is doubled for every 10°C increase in temperature. This increase in the rate of chemical reaction is accelerating the ageing.
A new test method for detecting channel leaks, ASTM F3039 Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration, was approved at the last F02 meeting in Jacksonville, FL, and is now available from ASTM's Web site. The method is applicable for clear or opaque pouches made from materials such as film and foil. It could also be used with opaque blisters and cups with the same sensitivity, but they were not part of the initial scope.
Often during product development a device manufacturer will want commence packaging ageing studies before abundant quantities of product becomes available. After all to obtain five years Real Time Equivalence of Accelerated Ageing requires around 30 weeks in an environmental chamber. That is before testing even starts.
In Part 1, I introduced the FMEA methodology as a tool to prevent failures or defects in packages and reduce the risk of losing a customer or negatively impacting patients. It can be especially useful when “evaluating a new process prior to implementation and in assessing the impact of a proposed change to an existing process” (source: Institute for Healthcare improvement University of Chicago).
EN/ISO 11607-1 states that you should validate all test methods. Have you ever wondered just how do you validate a test method that is pass/fail?
PTI USA has been at work for several years to develop a more accurate and non-destructive method of evaluating the seal quality and integrity of pouches and flexible packaging. The result is their patented Seal-Scan technology. It utilizes non-contact airborne ultrasonic technology for seal integrity testing and seal quality analysis of pouches and flexible packaging.
The rapidly growing medical device market is creating fierce competition among MDMs. To be ahead in this race, it is important that time to market is less and MDMs stretch the limits of possibilities in this effort. Many times, this hurried approach may cause design flaws and may result in medical device recalls, which are real nightmares to the MDMs. Failure in the medical device packaging is also contributing to the product recalls.
Testing laboratory Westpak Inc. has added capacity to its San Diego facilty, expanding its temperature- and humidity-controlled room to 2200 cu ft. The expansion will further support medical device package validation preconditioning commonly required per ASTM D4169, ASTM F1980, and ISO 11607, the company reported in a release.
When testing the strength of your sterile package is it better to use a peel test or a burst test? The answer is not straightforward.
In my previous blog, I talked about how pouch materials impact your test results when an unsupported 90-degree method is used to measure seal strength. I also mentioned that, within the test method and technique selection, you can also do average or peak load. Average load calculates the average of multiple readings collected during the test procedure -- typically programmed to take out from the average calculation the values on the rampup and stepdown of a seal strength curve. The peak load records the highest value during the test procedure.