ASTM F88 Adhesive Strength of Medical Packaging
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.
5900 Universal Testing Systems are engineered for precision, built for durability, and offer the flexibility for changing requirements. They are designed with standard and optional features that increase testing efficiency and improve the testing experience for the operator. A wide range of models are available for testing capacities from < 100N up to 600kN.
- 2.8 MB
Instron® 2712-04x Series Pneumatic grips, packed with features to enhance gripping performance, usability, and operator safety.
- 1.1 MB
Screw side-action grips provide a very simple and efficient method for holding test specimens in a wide range of applications. The dual - acting design of 2710-100 series grips means that jaw faces can be adjusted to accommodate different specimen thicknesses. This ensures that the line of tensile force remains concentric with the grip body. They can be equipped with a selection of interchangeable grip jaw faces in various sizes and choice of surfaces including smooth ground, rubber-coated and serrated. Line contact and special coated faces are also available.The unique ‘snap-on’ jaw face attachment makes changing faces extremely quick and simple.
- 1.3 MB
Bluehill Universal Software is built from the ground-up for touch interaction and an intuitive user experience. Discover simpler and smarter testing with features such as pre-loaded test methods, QuickTest in seconds, enhanced data exporting: and Instron Connect – a new feature that provides a direct communication link to Service. Users of previous versions of software such as Bluehill 2 and Bluehill 3 can easily upgrade to the newest version of Bluehill.
- 1.4 MB
For Medical Device and Pharmaceutical companies, records management compliance with FDA 21 CFR § 11 is non-negotiable. ComplianceBuilder™ (CB) is a stand-alone, add-on compliance solution that can be integrated with Instron’s Bluehill® Software to provide features necessary to meet the latest FDA 21 CFR § 11 regulations.
- 0.5 MB