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Armed with this knowledge you just need to go to a testing lab and see what type of test they can offer. We'll e-mail you with an estimated delivery date as soon as we have more information. Pinholes, slits, cuts, and tears of pouch packages, as well as fractured thermoforms, can all compromise sterility (see Figures 1 and 2).These defects occur from impacts caused by dropping packages and from general handling or mishandling.Environmental conditioning, accelerated aging and distribution simulation provide a controlled means to expose a packaging system to the anticipated environmental and dynamic stresses that the packaging system may encounter in field.Package strength testing and package integrity testing provide the means to evaluate the packaging after such exposure. Whitehouse Laboratories is happy to assist customers to better understand the testing, the available options and how to execute packaging validation projects on time and on budget.
ISO 11607 is divided into two parts – Part 1, “Requirements for Materials, Sterile Barrier Systems and Packaging Systems” and Part 2, “Validation for Forming, Sealing, and Assembly Processes.” ISO 11607 improved the flow of package qualification and process validation by defining/harmonizing four key terms used throughout both parts of the standard: For sterile barrier packaging systems, ISO 11607 Part 1 Design and Development outlines four key requirements: ISO 11607 requires medical device manufacturers to demonstrate the efficacy of their proposed sterile barrier packaging .According to the FDA Quality System Regulations, manufacturers must ensure that "device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution." As specific as this statement is, the FDA does not provide instructions on how to achieve their standards.Validating Medical Packaging demystifies the validation procedure for medical device packaging by providing specific examples and templates for creating and maintaining a validation file.It is important to know what they are and how to avoid them.Sterility Is Paramount The most common defect resulting from subjecting packaged devices to manufacturing, sterilization, handling, and storage is loss of sterile integrity.