GMP pharmaceutical water purification equipment system

GMP certification of water purification equipment requirements are as follows, specific design examples can view the Corui environmental protection related cases.

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

2, in order to facilitate the disassembly, replacement, cleaning parts, actuator design as far as possible 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 using 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 cleaned regularly, and the cleaning effect is verified.

5, water for injection contact materials must be high-quality low-carbon stainless steel (such as 316L stainless steel) or other materials that have been verified not to contaminate the water quality. Equipment for the preparation of water for injection should be cleaned regularly, and the cleaning effect is verified.

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-exudate 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, disinfected and sterilized, 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 to circulate 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 contamination ions of other pipe materials. Valves should be used without dead ends of sanitary valves, delivery of purified water should be marked flow direction.

3) Conveyance of 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 licensed units and qualified personnel to undertake, according to the People's Republic of China **** and the national standard "Steel Pressure Vessel" (GB150-80) and "Pressure Vessel Safety Technology Supervision Regulations," the relevant provisions of the process. 1, the structural design should be simple, reliable, easy to disassemble.

2, in order to facilitate disassembly, replacement, cleaning parts, actuators, the design of the standardization, generalization, systematic parts as far as possible.

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 using 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 cleaned regularly, and the cleaning effect is verified.

5, water for injection contact materials must be high-quality low-carbon stainless steel (such as 316L stainless steel) or other materials that have been verified not to contaminate the water quality. Equipment for the preparation of water for injection should be cleaned regularly, and the cleaning effect is verified.

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-exudate 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, disinfected and sterilized, 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 to circulate 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 contamination ions of other pipe materials. Valves should be used without dead ends of sanitary valves, delivery of purified water should be marked flow direction.

3) The pipeline for conveying purified water and water for injection, 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, according to the People's Republic of China **** and the national standard "Steel Pressure Vessel" (GB150-80) and "Pressure Vessel Safety Technology Supervision Regulations," the relevant provisions of the process.