Push-Through Test for Pharmaceutical Blister Packs
Pharmaceutical tablets and capsules are commonly packaged in blister packs that protect the enclosed tablets and capsules from moisture and contamination. This optimizes the product stability and maximizing its shelf-life. The two primary components of a blister pack are the rows of cavities, typically made of thermoplastic, and the lidding seals that can be made of paperboard, aluminum, or plastics. However, in pharmaceutical packages, aluminum foil is most frequently used. It is important for manufacturers to ensure that the blister pack does not break too easily but yet it needs to be brittle enough to allow consumers to break by hand in order to dispense the tablets or capsules.
We were asked to provide a solution to measure the force required to push a table through its blister pack. Our Engineered Solutions team designed a simple custom fixture to meet this application requirement. The top-down clamps are adjustable to suit different dimensions of blister packs and the lower base holder includes spacer plates with various cut out sizes to cater to different dimension tablets and capsules.
We performed the test using a 5965 table model frame and the 3®Bluehill Biomedical Materials and Medical Devices Application Module. We first fixed the blister pack onto the lower base holder with top-down clamps and then applied a force with a flat tipped probe (with a 10 mm diameter) at 20 mm/min to push the tablet out from the blister pack.
We recorded the maximum force required to press the tablet out from the blister pack in Bluehill 3 Software. From this, we can determine if the lidding material is too brittle or if the adhesive strength between the lidding backing and the plastic-formed cavity is strong enough.
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.
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The Bluehill 3 Biomedical Application Module includes a collection of pre-configured test methods and supporting documentation that cover a variety of internationally recognized industry standards; such as EN 455-2, ASTM F2516, ASTM F2256, ASTM F88, and more.
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