Hebei GMP certified purified water equipment

Hebei GMP certified purified water equipmentHebei GMP certified purified water equipment

gmpCertified purified water equipment

GMPRequirements for Certified Pharmaceutical Purified Water Equipment

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

2In order to facilitate disassembly, replacement, and cleaning of parts, the design of the actuator should use standardized, universal, and systematic components as much as possible.

3The inner and outer wall surfaces of the equipment are required to be smooth, flat, and have dead corners that are easy to clean and sterilize. The surface of the parts should be treated with chrome plating or other surface treatments to resist corrosion and prevent rusting. Avoid using paint on the outside of the equipment to prevent peeling.

4The preparation of purified water equipment should use low-carbon stainless steel or other materials that have been verified to not pollute water quality. The equipment for preparing purified water should be regularly cleaned and the cleaning effect should be verified.

5The material in contact with injection water must be high-quality low-carbon stainless steel or other materials that have been verified not to pollute the water quality. The equipment for preparing injection water should be regularly cleaned and the cleaning effect should be verified.

6The storage period of purified water should not exceed24The storage tank should be made of stainless steel material or other materials that have been verified to be non-toxic, corrosion-resistant, and do not leak out pollutant ions. A hydrophobic sterilization filter with non shedding fibers should be installed to protect its ventilation port. The inner wall of the storage tank should be smooth, and there should be no dead corners or sand holes in the connecting pipes and welds. Sensors that do not cause stagnant water pollution and display parameters such as liquid level, temperature, and pressure should be used. Regularly clean, disinfect and sterilize storage tanks, and verify the effectiveness of cleaning and sterilization.

7Transportation of pharmaceutical water

1）Purified water and pharmaceutical water should be transported using stainless steel pumps that are easy to disassemble, clean, and disinfect. In situations where purified water and injection water require compressed air or nitrogen pressure delivery, the compressed air and nitrogen must be purified.

2）Purified water should be transported through a circulating pipeline. The pipeline design should be concise and avoid blind pipes and dead corners. The pipeline should be made of stainless steel pipes or other pipes that have been verified to be non-toxic, corrosion-resistant, and do not leak pollutants. Valves should be sanitary grade valves with blind spots, and the flow direction of purified water should be indicated.

3）The pipelines and pumps used for transporting purified water and injection water should be regularly cleaned, disinfected, and sterilized before being put into use.

8The design of pressure vessels must be undertaken by licensed units and qualified personnel, in accordance with the national standard of the People's Republic of China "Steel Pressure Vessels"（GB150-80）And'Supervision Regulations for Safety Technology of Pressure Vessels'The relevant regulations for handling.