The medical device industry primarily uses pre-packaged disposable devices and surgical instruments to minimize risk associated with the sterilization of re-usable products. The tensile strength of the adhesives used for the packaging is typically assessed by following a standard such as ASTM F88, the Standard Test Method for Seal Strength of Flexible Barrier Materials. However, this standard specifically refers to materials testing, rather than testing of a part that has already been packaged.
The challenges of testing to this standard are:
- Data rate used to capture peaks and troughs
- Gripping materials of varying thickness
- Eliminating slippage throughout the test
- Data rate used to capture peaks and troughs – Instron’s 5900 Series frames enable data capture of up to 2.5 kHz to ensure that all fast changing test events are captured. Too low of a bandwidth may “dull” the system and lead to missed peaks and troughs, resulting in lower average strength values.
- Gripping materials of varying thickness – When testing an adhesive to a thick substrate, standard grips result in a misaligned specimen. The advanced screw side-action grips can be adjusted to offset to ensure that the specimen remains centered in the load string.
- Eliminating slippage throughout the test – The advanced screw side-action grips and pneumatic side-action grips employ a patented quick-release jaw face design, which enables operators to easily change jaw faces to accommodate the needs of their materials. Pneumatic grips are also able to maintain consistent gripping pressure throughout the test for materials which may be susceptible to slipping during the test.
For customers that need to meet 21 CFR Part 11 compliance, we offer ComplianceBuilder™ to track all additions, modifications, and deletions to all relevant Bluehill® Universal files.