Passivation Validation - Is passivation is considered a "special" process by the FDA?

[Tim Mosher]

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.

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[Don Winton]

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,

Don