GMP requirements for pharmaceutical water preparation devices

GMP's requirements for pharmaceutical water preparation devices1, structural design should be simple, reliable, easy to disassemble.
2, in order to facilitate the disassembly, replacement, cleaning parts, the design of the executive body as far as possible to use standardized, general, systematic components.
3, equipment inside and outside the wall surface, requires smooth and flat, no dead end, easy to clean, sterilization.
parts should be treated with chrome and other surfaces to protect against corrosion and rust.
paint on the outside of the equipment to prevent peeling off.
4, the preparation of purified water equipment should use low-carbon stainless steel or other materials verified not to pollute water quality.
preparation of purified water should be cleaned regularly and the cleaning effect verified.
5, injection water contact materials must be low-carbon stainless steel (e.g. 316L stainless steel) or other materials that have been verified not to pollute water quality.
equipment for the preparation of injection water should be cleaned regularly and the cleaning effect should be verified.
6, purified water storage period should not be greater than 24 hours, its storage tank should be made of stainless steel materials or other materials that have been verified to be non-toxic, resistant to corrosion and do not seep out contaminated ions.
the hydrophobic sterilization filter that does not shed the fiber should be installed to protect its air port.
the inner wall of the tank should be smooth, and the takeover and weld should not have dead ends and err eye.
should use sensors that do not form parameters such as liquid surface and temperature pressure that do not form stagnant water pollution.
tank should be regularly cleaned, disinfected and sterilized, and the effect of cleaning and sterilization verified.
7, pharmaceutical water transport 1) pharmaceutical purified water equipment should be easy to remove clean, disinfection of stainless steel pumping.
water and purified water are used in injections, compressed air and nitrogen when compressed air or nitrogen pressure is used.
2) Purified water should be transported through a circulating pipe.
pipeline design should be simple, should avoid blindness and death.
pipe should be stainless steel pipe or other pipe, non-toxic, corrosion-resistant, non-corrosive, pollution.
valve should use a dead-end sanitary valve, the delivery of pure water should indicate the flow.
3) to provide pure water and water injection tube, delivery pump should be regularly cleaned, disinfected and sterilized, verified qualified before it can be put into use.
4) The design of pressure vessels shall be carried out by units and licensed qualified personnel in accordance with the relevant provisions of the China National Standard for Steel Pressure Vessels of the People's Republic of China (gb150-80) and the safety technical supervision procedures for pressure vessels.