Raw Material Specification Changes Resolve Problem with Cured Silicone

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Silicone elastomers, foams, coatings, and adhesives are widely used in virtually all aspects of manufacturing, in construction, the automotive industry, and medical and personal care products. The properties that contribute to making silicones indispensable in many applications, such as their ability to repel water, their excellent heat stability and chemical resistance, are also responsible for […]

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Maintaining FDA Approval: Substitute Material

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FDA approval is required for everything from bedpans to pacemakers. And although a splintered tongue depressor is generally not life threatening, deterioration of the surface coating of a stent can present a more serious problem. Regardless of the application, the materials used in the production process of a medical device are critical to the product’s […]

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Failure Analysis Investigation Points to QC Solution to Maintain Profits and Customers

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Client Challenge Shatter-prone glass syringes pose any number of risks — to patients and health care workers — and costly, potentially dangerous waste. One well-known medical device manufacturer wanted reliable data on why syringes from an overseas manufacturer would shatter upon loading. RJ Lee Group Approach Our team examined failed and unused syringes, and reconstructed […]

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