In some advertisements for dissolution equipment that use a heating jacket instead of a water bath to maintain the dissolution medium in the vessels at the appropriate temperature. Are they in compliance with USP?
The manufactures should provide documentation tracing the source of parts, supplies, and materials, including lubrication and gaskets all in compliance with FDA regulations for incidental contact.
For compliance with USP the equipment must be validated by a protocol and test program in design, construction, operation, cleaning, and maintenance. If the manufacturer has done the correct actions the documents should be available with no delay or excuses.
When the manufacturer doesn't have all of the essential documents, the purchaser must create the documents through investigation and testing.
If the equipment is validated it must still be qualified for the intended purpose which is an additional protocol.
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