Purified water is mainly used in the biopharmaceutical, medical devices, and in vitro diagnostic reagent industries as raw material production, separation and purification, finished product production, cleaning, and washing water. According to regulatory requirements, the water quality indicators of purified water must meet the requirements of the pharmacopoeia.

GMP standard requirements for purified water storage and distribution systems:

As mentioned in Article 99, "The preparation, storage, and distribution of purified water and injection water should be able to prevent the growth and contamination of microorganisms."

Article 101 states that "The design, installation, and maintenance of water treatment equipment and its conveying system shall ensure that pharmaceutical water meets the set quality standards. The operation of water treatment equipment shall not exceed its design capacity."

Article 102 states that "The materials used for purified water, injection water storage tanks, and transportation pipelines should be non-toxic and corrosion-resistant. The ventilation ports of the storage tanks should be equipped with hydrophobic sterilization filters that do not shed fibers. The design and installation of pipelines should avoid dead corners and blind pipes."

Therefore, when customizing purified water equipment and configuring storage tanks, the following factors should be considered:

1. Priority should be given to using vertical storage tanks, which are relatively easy to meet the water level requirements of the conveying pump; The fast water flow in the tank is beneficial for preventing the formation of biofilms.

2. The design of the structure and pipe opening should consider the natural drainage of the water tank, and the length of the pipe opening dead angle should not exceed 2D.

3. Choose a suitable capacity to meet the production water demand and ensure the turnover/emptying rate of the water tank. Avoid long-term storage of purified water.

4. The material of the water tank is made of 316L or 304 stainless steel material. The internal surface of the storage tank should be mechanically polished or electrolytic polished, and the roughness of the internal surface of the storage tank should be less than Ra=0.6 μ The standard for m (25 Ra).

5. Avoid multi tank design and prevent low flow rate operation of fluid in the connecting pipes between tanks.

If necessary, nitrogen sealing can be used to maintain positive pressure inside the tank and reduce contact between purified water and air.

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