GMP certification of purified water pharmaceutical water purification equipment requirements

1, the structural design should be simple, reliable, easy to disassemble.

2, in order to facilitate the disassembly, replacement, cleaning parts, actuators are designed to try to use the standardization, generalization, systematic parts.

3, the equipment inside and outside the wall surface, the requirements of smooth and flat, no dead ends, easy to clean, sterilize. The surface of the parts should be done chrome plating and other surface treatment to resist corrosion and prevent rust. Avoid paint on the outside of the equipment to prevent peeling.

4, the preparation of purified water equipment should be used low-carbon stainless steel or other proven materials that do not contaminate the water. Preparation of purified water equipment should be regularly cleaned, and cleaning effect verification.

5, water for injection contact materials must be high-quality low-carbon stainless steel or other materials that have been verified not to pollute the water. Preparation of water for injection equipment should be cleaned regularly, and the cleaning effect of verification.

6, purified water storage cycle should not be greater than 24 hours, the tank should be made of stainless steel or verified non-toxic, corrosion-resistant, non-leakage of contaminated ions of other materials. Protection of its air vent should be installed without shedding fibers of hydrophobic sterilizing filter. Tank walls should be smooth, receiver and welds should not have dead ends and trachoma. Sensors that do not form stagnant water pollution should be used to display liquid level, temperature pressure and other parameters. The tank should be regularly cleaned, disinfection and sterilization, and cleaning, sterilization effect verification.

7, pharmaceutical water delivery

1) purified water and pharmaceutical water should be easy to disassemble cleaning, disinfection of stainless steel pump delivery. In the need to use compressed air or nitrogen pressure delivery of purified water and water for injection occasions, compressed air and nitrogen must be purified.

2) purified water should be used circulating pipeline delivery. Piping design should be simple, should avoid blind and dead ends. Piping should be used stainless steel pipe or verified non-toxic, corrosion-resistant, non-exudate contaminating ions of other pipe materials. Valves should be used without dead ends of sanitary valves, conveying purified water should be marked flow direction.

3) conveying purified water and water for injection piping, transfer pumps should be regularly cleaned, disinfected and sterilized, verified qualified before being put into use.

8, the design of the pressure vessel shall be a licensed unit and qualified personnel to undertake, shall be in accordance with the People's Republic of China **** and the national standard "Steel Pressure Vessel" (GB150-80) and the relevant provisions of the safety and technical supervision procedures for pressure vessels.