Jon R. Voss
ISPE, September 1999 In the hopes that sharing a test procedure from our library of ValPro™ procedures will get others to do the same, I submit the following procedure for your use. Let us know what you think! Coverage Test-CIP/COPObjective:The objective of this test is to verify that the sprayballs/wands/bars associated with the system are capable of delivering cleaning solutions to all exposed product contact surface areas. Often spray ball coverage testing is performed as part of the final vessel factory acceptance test. Coverage testing may be performed on-site using the actual equipment that will be used to clean the vessel.
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validation refers to establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its pre-determined specifications and quality attributes
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