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Pharmaceutical water equipment manufacturers' requirements for purified water machines
- 2019-11-07-

Pharmaceutical water equipment manufacturers' requirements for purified water machines

The quality of the produced water complies with the new Pharmacopoeia standards of 2010 and the provisions of the GMP

Purified water machine has fully automatic operation and fully automatic processing procedures (such as backwashing, regeneration, pickling, disinfection procedures) reverse osmosis pure water machine monomers and pipeline equipment meet GMP requirements (such as back-end processing equipment such as sterilizer, membrane Filter, terminal water tank, pipeline are made of 316L material, and RO reverse osmosis pretreatment equipment pipeline is made of UPVC pipe)

Shanghai pharmaceutical water equipment manufacturers' requirements for process water

The process water used by pharmaceutical manufacturers mainly refers to the water used in the processes of bottle washing, batching and other processes in the production of pharmaceutical preparations, as well as in the process of refining and washing of APIs. The name of water should not be related to the water manufacturing process, such as deionized water, demineralized water, and distilled water. Namely, the water manufacturing process is decoupled from its name, but the water is classified according to quality indicators from a chemical and microbiological perspective ( For example, the Chinese Pharmacopoeia stipulates that purified water can be prepared by three different methods, and there may be better methods in the future).

Water for injection is generally made from purified water by distillation (also reverse osmosis and ultrafiltration) with a chemical purity of 99.999% and no pyrogens. Because the process of preparing pure steam is the same as the process of preparing water for injection with distilled water, the same multi-effect distilled water machine or a separate pure steam generator can be used, so pure steam is discussed together with water for injection.

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