Medical Sterilization Methods: Offering Alternative Guidance for Accelerated Testing of PVC Performance

June 14, 2014

Thousands of miles of medical tubing are used every day in hospitals, physician practices, blood drives and more, primarily to deliver intravenous medication and to circulate blood.

Like every medical device, any change in materials to improve the performance of this tubing needs to undergo a battery of testing. Before leaving the manufacturing facility, medical tubing is sterilized in its packaging – which can induce a chemical reaction in the PVC molecule, cause visual discoloration, and degrade the product.  As tubing is made less flexible, it becomes more susceptible to this molecular degradation.

Yet medical packaging tests, such as ASTM F-1980, are often inappropriate and create extreme conditions – such as 60-degree Celsius temperatures for more than 30 days – under which every product will consistently fail.  This gives manufacturers essentially meaningless data in their research and development cycles.

Softening test conditions drastically – down to 50 degrees Celsius for 48 hours – gives a reliable ranking of performance and allows development teams to screen out unsuitable materials.

Click to view how several formulations performed under these conditions for accelerated testing of Gamma radiation exposure.  Of course this is an unconventional test, and we welcome peer review and input.