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  1. WingTipHsu

    SILICONE gaskets

    FDA doesn't approve materials of construction unless you are making a medical device and the material is implanted. Silicon happens to be highly permeable to oxygen. You may wish to consider a sanitary EPDM/PTFE envelope gasket. FYI, the "moral equivalent" of (incorrectly)...
  2. WingTipHsu

    FAT procedure for hygienic vessels

    Hi, John Here's a generic I recently drew up. "Factory Acceptance" is mechanically verifying that the purchased system will perform as specified, by checking the engineering subsystems. You may wish to consult the "pre-check" that most manufacturers use, because that...
  3. WingTipHsu

    Large SS vessel passivation

    Hello, stewbaby You can begin with any of the large stainless steel vessel purveyors (DCI, Precision Stainless, Mueller) or go directly to the contract passivation people (Hayward, Active, Oakley). It's not a problem, the trick (as always) is to properly prep (degrease) and select the right...
  4. WingTipHsu

    SOFTWARE VERIFICATION - "GAMP" STANDARDS

    Hello, manojkn The short answer to your questions is "no." The FDA governs pharmaceuticals, medical devices, blood products, foods and other systems and products directly affecting health. Their "Predicate Rule" clarification states that, if the FDA does not have...

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