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GMP requirements for pharmaceutical purified water equipment?

Jan 25, 2019

6, purified water storage cycle should not be more than 24 hours, the storage tank should be made of stainless steel materials or proven non-toxic, corrosion resistance, no leakage of contaminated ions of other materials.

A hydrophobic degerming filter that does not shed fiber shall be installed to protect the vent.

The inner wall of the storage tank should be smooth, and there should be no dead Angle and trachoma in the nozzles and welding seams.

Sensors showing liquid level, temperature, pressure and other parameters that will not cause stagnant water pollution should be used.

The storage tank should be regularly cleaned, disinfected and sterilized, and the cleaning and sterilization effect should be verified.

reverse osmosis equipment

7. The design of pressure vessels shall be undertaken by licensed units and qualified personnel in accordance with the relevant provisions of the national standard of the People's Republic of China "steel pressure vessels" (gb150-80) and "pressure vessel safety technical supervision regulations".

8. Transportation of pharmaceutical water

1) purified water and pharmaceutical water should be transported by stainless steel pump which is easy to disassemble, clean and disinfect.

Compressed air and nitrogen shall be purified in cases where purified water and water for injection are required to be delivered by compressed air or nitrogen.

2) purified water should be transported by circulating pipeline.

Piping design should be concise, should avoid blind pipe and dead Angle.

Stainless steel pipe or other pipe with proven non-toxic, corrosion resistance and no seepage of contaminated ions shall be used.

Valve should use no dead Angle of the sanitary valve, conveying purified water should indicate the flow direction.

3) pipelines and pumps conveying purified water and water for injection shall be cleaned, disinfected and sterilized regularly, and put into use after verification.