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  • Medical Device Link .
    of the product to be packaged, the requirement for sterility, and the packaging machine that will be used to manufacture the product. All these factors are addressed in ISO EN 11607. Part I of ISO EN 11607 deals with requirements for materials, sterile barrier systems and packaging systems and replaces Part 1
  • Cheese Manufacturing Application
    room with a thick condensation. Because of the requirements of the food manufacturing process every surface is hosed down each day 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
  • Validating Medical Heat Sealers: Process Control that Goes Beyond Time, Temperature, and Pressure
    Packaging plays a vital role in assuring the sterility of. medical devices and instruments from manufacture. to point of use. Applying effective heat seals to the. package of terminally sterilized medical devices is. arguably the most critical step to ensure the aseptic. presentation of a product
  • Medical Device Link .
    that it is in compliance with applicable regulatory requirements regarding operating procedures. Whenever a sterility failure occurs during a validated production cycle, all previous lab audits should be reviewed and the need to conduct a new audit should be evaluated. In addition, the device manufacturer
  • Medical Device Link .
    Sterile Packaging: Sample Sizes and Statistics Determining appropriate sample sizes for operational qualifications can help manufacturers ensure sterility of medical device packaging. Dennis Gilliland, Laura Bix, Hugh Lockhart, and Nick Fotis It seems so simple; sterile medical devices must
  • Medical Device Link .
    Filters find many uses in medical device manufacturing From clearing smoke from operating rooms to protecting sensitive electronics, filters are essential parts of medical devices. They are also used in manufacturing processes to help ensure sterility. What follows is a roundup of some advances
  • Package Performance Testing Conundrum: Solved!
    of sterility, product breakage, etc.) for the package system design performance validation must be established prior to testing. DDL :: Package Performance Testing Conundrum: Solved!. CUSTOMER LOGIN. CONTACT. BLOG. PACKADVICE |. NON-MEDICAL. PACKAGE TESTING. ISO 11607. VALIDATION TESTING. MEDICAL
  • Medical Device Link .
    need to determine the maximum fixed-load requirements for their specific system before validating the isolator. Fixed-load configurations will vary depending on isolator size and specific functional requirements. In a sterility test system, for example, the isolator would contain sterility test

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