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  • Medical Device Link .
    R. Neu and G. Strassmann Kobusch-Sengewald, Pregis Group, Warburg, Germany When selecting materials for packaging medical products various factors are considered. These include the shape, size and consistency of the product to be packaged, the requirement for sterility, and the packaging machine
  • Cheese Manufacturing Application
    with strong cleansers to maintain sterility. Even though bags of silica gel were stacked in the panels to try to protect the PCs from the moisture, the elements were still affecting the PCs as fans circulated air through them for cooling.
  • Whistleblower in Wyeth Case Speaks Out
    of front-line employees. This is especially true when it comes to compliance with safety regulations that have an impact on product quality. cGMPs -- or current Good Manufacturing Practices -- are the bedrock of regulatory requirements designed to assure the safety, integrity, sterility, quality, and purity
  • Medical Device Link .
    Achieving Efficacy and Sterility in Flexible Packaging Whether the priority lies in the sterilization method or the barrier level, packaging requirements can be easily met with a wide variety of material options. Karen Berger and Dhuanne Dodrill Packaging plays an important role in many industries
  • Medical Device Link .
    environments are also undergoing transformations. Concerns of manufacturers include shrinking the size of their finished products by integrating smaller valves, maintaining sterility, and preventing clogging during production. A wide range of valve types with a large selection of properties
  • Medical Device Link . CE Marking via Self-Declaration Understanding CE regulations poses a challenge even to Class I manufacturers.
    with the essential requirements of the directive. Manufacturers of active implantables and IVDs have separate directives to contend with. When auditing for compliance, the notified body will check a number of items in addition to a manufacturer's QA system, including technical files, sterility assurance
  • Medical Device Link .
    validation requirements and provide evidence of sterility and fitness-for-use over a product 's life cycle. For example, when a product needs a five-year shelf life to allow time for distribution, storage, and other constraints, the quality of the package-device combination should be monitored
  • Medical Device Link .
    that would compromise device sterility. A number of test methods have been used to measure such barrier properties, with varying degrees of success. Some of these include the ASTM F 1608 95 standard test method for microbial ranking of porous packaging materials (also known as the exposure chamber method

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