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Pure steam generator pharmaceutical
The verification of the pure steam generator is similar to the verification of the one-effect distiller of the multi-effect distilled water machine, that is, it should be confirmed that the distiller of the pure steam generator, as a shell and tube heat exchanger, has the possibility of leakage in the cooling water and distilled water. When the double-ended tube sheet structure is strictly prevented from possible cross-contamination.
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The verification of the pure steam generator is similar to the verification of the one-effect distiller of the multi-effect distilled water machine, that is, it should be confirmed that the distiller of the pure steam generator, as a shell and tube heat exchanger, has the possibility of leakage in the cooling water and distilled water. When the double-ended tube sheet structure is strictly prevented from possible cross-contamination.
The quality of pure steam should have the same quality index as its condensed water and distilled water. At the same time, it should be confirmed that the steam pressure of the steam produced by the pure steam generator meets the specifications specified by the equipment and meets the needs of sterilization of equipment and pipelines in the entire water for injection system.
When pure steam is also used in pharmaceutical processes other than the water for injection system, the confirmation of its steam production and pressure should also include the requirements for the use of pure steam in the process. Since ultra-pure steam at high temperature is highly corrosive to stainless steel pipes, heavy metal indicators that are not required by the Pharmacopoeia should be strictly tested as additional items.
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