The medical device industry primarily uses pre-packaged disposable devices and surgical instruments to minimize risks associated with the sterilization of reusable products. The tensile strength of the adhesives used for this packaging is typically assessed by following a standard such at ASTM F88, the Standard Test Method for Seal Strength of Flexible Barrier Materials. However, this standard specifically refers to materials testing, rather than to testing 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 thicknesses. When testing an adhesive to a thick substrate, standard grips result in a misaligned specimen. The advanced screw 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 action grips and pneumatic side action grips employ a patented "quick change" 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 who need to meet 21 CFR Part 11 compliance, we offer ComplianceBuilder™ to track all additions, modifications, and deletions to all relevant Bluehill Universal files.
The System Support guide details the requirements, specifications, handling instructions, installation procedures, and maintenance details.
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Instron® 2712-04x Series Pneumatic grips, packed with features to enhance gripping performance, usability, and operator safety.
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Screw action grips provide a very simple and effective method for holding test specimens in a wide range of applications. The dual-action design of 2710-200 series grips means that jaw faces can be independently adjusted to accommodate different specimen thicknesses and geometries, ensuring that the line of tensile force remains concentric with the grip body. They can be equipped with a selection of optional jaw faces with a choice of surfaces including smoothground, rubber-coated, serrated and wave profile.
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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.
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Instron® Bluehill Universal is the latest offering of material and component testing software. Built from the ground up for touch interaction, Bluehill Universal offers a new layout and enhanced features, giving users a simpler, cleaner interface for their testing system. The large touchpoints and intuitive touch gestures of Bluehill Universal offer a renewed, yet familiar software environment for all Instron users. Instron’s Bluehill Universal Operator Dashboard includes both the hardware and software necessary to get you on the path to simpler testing routines and refreshingly faster workflows.
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