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This thread is carried over and continued in the Current Elsmar Cove Forums |
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This thread is carried over and continued in the Current Elsmar Cove Forums |
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 The Old Elsmar Cove Forums
 FDA and Medical Devices
 Passivation Validation
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| Author | Topic: Passivation Validation |
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Tim Mosher Lurker (<10 Posts) Posts: 5 |
posted 26 July 2000 06:00 PM
   
Could anyone guide me through the steps needed to validate a standard passivation system. Also, does anyone know for sure if passivation is considered a "special" process by the FDA? Thank you very much. ------------------ IP: Logged |
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Don Winton Forum Contributor Posts: 498 |
posted 28 July 2000 10:42 AM
Tim, Any process that cannot be inspected subsequent to the operation is a special process. To validate such a process you must demonstrate that the process is capable of meeting specifications. How you do this is up to you. At a previous employer, I used objective evidence that the process was operating within controlled parameters (temperature, deposition time, chemical composition, etc.) that were the same (statistical) as when the process was validated. Hope this helps. Never can tell with the FDA. Regards, [This message has been edited by Don Winton (edited 28 July 2000).] IP: Logged |
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