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4 Common Failure Points of Sterile Barrier Packaging …

    https://www.mddionline.com/packaging/4-common-failure-points-sterile-barrier-packaging-validations

    Defects to Avoid by Rightsizing Your Medical …

      https://www.oliverhcp.com/hubfs/NEW%20Website%20Content_2019/6%20Defects%20to%20Avoid%20by%20Rightsizing%20Your%20Medical%20Packaging.pdf
      there is not enough material at the end of the pouch to handle during the sealing process. If the space between the device and the end of the pouch is too short, the sealing process …

    ASTM F1886 - Sterile Barrier

      https://sterilebarrier.org/manufactures/validation-process/relevant-test-methods/astm-f1886/
      Visual seal characteristics and defects can bring forth evidence of sterile package integrity and production sealing problems. Visual seal defects will often be the initial indication of …

    Sterile barrier packaging: Common causes …

      https://www.packagingdigest.com/testing/sterile-barrier-packaging-common-causes-failures-and-how-correct-them
      Pointed, sharp, or heavy medical devices can also create pinhole failures caused by friction or impact with the packaging. Strength evaluation determines the …

    Understanding the factors affecting the seal …

      https://onlinelibrary.wiley.com/doi/full/10.1002/pts.2564
      These methods can be based on melting and joining of sealant layers using heat sealing or on the …

    A Guide to Understanding Medical Tray Sealing

      https://sencorpwhite.com/a-guide-to-understanding-medical-tray-sealing/
      EtO sterilization is the most common process used to sterilize medical devices packaged in sealed trays; however, it does require at least some part of the packaging material to be …

    Guide to Medical Device Packaging - RBC …

      https://rbccorp.com/medical-device-packaging/
      ISO 11607-1 also covers testing methods for sterile barrier systems. Testing methods include: Visual inspection Bubble leak tests Microbe challenge tests It is …

    Class III Medical Device Package Inspection | ASTM Test Methods

      https://www.pti-ccit.com/industries/medical-device-packaging-testing
      The medical device industry is fueled with an ongoing quest for providing better treatment and diagnostic methods to the healthcare sector. A wide range of packaging and …

    Testing the Integrity of Package Seals - IFT.org

      https://www.ift.org/news-and-publications/food-technology-magazine/issues/2019/july/columns/packaging-seals-tests-standards
      Likewise, packaging materials with reduced costs and alternate sealing methods are evaluated as a function of seal strength and confirm that seals do not …

    Common Medical Device Packaging …

      https://www.mdrg.org/2018/12/common-medical-device-packaging-mistakes/
      Packaging for medical devices plays a key role in safely delivering specialized treatment to patients. Most single use, sterilized medical devices can be opened …



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