Download Validating Medical Packaging by Ronald Pilchik PDF

By Ronald Pilchik

In keeping with the FDA caliber approach rules, brands needs to make sure that "device packaging and transport bins are designed and built to guard the machine from alteration or harm through the regular stipulations of processing, garage, dealing with, and distribution. As particular as this assertion is, the FDA doesn't offer directions for the way to accomplish their criteria. this convenient reference demystifies the validation method for clinical equipment packaging via delivering particular examples and templates for growing and conserving a validation dossier.

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In that case, the file is reopened and repeated, in total, to allow for the change and resulting outcome. While much of the information is contained in this file, it may also be in other locations such as: Material/component specifications in purchasing Audit reports in quality assurance/regulatory affairs Packaging process descriptions and flowcharts in production Verification lots in the device history record It is important to consider this file as a core technology file for the organization, where all the necessary information pertaining to packaging of the device, or family of devices is located in one place for easy reference by any designated corporate entity.

As above, if the deviations persist during attempts at verification, the process validation must be reconsidered. All batches, those that meet requirements and those that do not, must be permanently located in the file. Section VII presents the shipping tests used to ensure package design. The protocols used to validate the design are described in Chapter 1. A note on post-sterilization testing. If the criterion for valid packaging design is not using the protocols described in Chapter 1, than it is appropriate to not use a post-sterilization evaluation of the routine production runs.

SYSTEM DESCRIPTION ............................................................................................... 5. RESPONSIBILITIES........................................................................................................ 6. PROCEDURE .................................................................................................................. 7. ACCEPTANCE CRITERIA............................................................................................ 8. REFERENCES..................................................................................................................

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