Flexible Packaging Films
NEW!!! Taber Flexible Material Abrasion Kit Aids Selection of Medical Device Packaging Films
Situation:
When packaging sterilized medical devices or products, the integrity of the film is essential to ensure sterility of the device until usage. Film companies are spending considerable amounts of time and money optimizing complex film designs with the required durability properties, while competitive forces continue to drive customers to use thinner gauge films. With this trend, the risk of abrasion-induced failures increases dramatically. Taber’s Flexible Material Abrasion Kit allows engineers to analyze the variables that influence the abrasion resistance of packaging films to better understand and predict failures.
Analysis:
It is the manufacturer’s responsibility to ensure the selected packaging option will withstand the typical events associated with product handling, distribution and storage. During distribution and handling, movement between a medical device and packaging film and any secondary packaging may occur. Shock, vibration or repetitive rubbing allows the device to wear through the cross-section of the film, thus increasing the potential for the sterile barrier to be compromised. Although standardized tests have been established to ensure packaging integrity is maintained, there currently is no widely accepted test method to compare the abrasion resistance of packaging films. Therefore, abrasion failures are usually caught after distribution testing or customer complaints.
In 2007, Perfecseal Corporation was contacted by a customer asking for assistance to select a film that would provide optimum abrasion resistance. The customer had experienced issues with abrasion related pinholes in bags and had been tasked to identify a replacement film that would eliminate these complaints. The film converter commissioned a study with Taber Industries to evaluate the abrasion resistance properties of 6 different bag films using the Linear Abraser Model 5750 with the Flexible Material Abrasion Kit.
Benefit:
The test results provided a ranking of abrasion resistance that correlated with the expected performance of the film samples. This provided the quantitative data to support the converter’s recommendation for an optimal film and confirmed the test approach as a viable means.
Incorporating abrasion resistance data generated by the Flexible Material Abrasion Kit enabled the decision makers to streamline the material selection process. Plus, it provided the added confidence the selected film should pass the ISTA distribution testing requirements.
NOTE: Taber Industries is working with ASTM subcommittee F02.20 on Flexible Barrier Packaging Physical Properties to develop an industry accepted test standard using this procedure. If you are interested in participating in this project, please contact Alan Jaenecke.
