Water production indicators of pharmaceutical purified water equipment
Release time:2022-07-25
1. Water production indicators
Chemical indicators: meet the requirements of the 2022 edition of the Pharmacopoeia of the People's Republic of China for pharmaceutical purified water
Hygiene examination: Microorganisms 100CFU/100ml
Internal factor 0.25EU/ml, conductivity ≤ 5.1 μ S/cm (25 ℃)
2. Basic technical characteristics of the equipment
The system adopts fully automatic control (manual control can also be used), and automatic backwashing and regeneration programs can be set during system operation; The first and second level reverse osmosis systems are equipped with reflux pipelines, and the reverse osmosis equipment is equipped with chemical cleaning and disinfection devices; A pH adjustment device is installed between the primary and secondary reverse osmosis to ensure that the conductivity of the purified water equipment meets the requirements of the pharmacopoeia; The secondary reverse osmosis membrane adopts a positively charged anti pollution reverse osmosis membrane to ensure the long-term stable operation of the reverse osmosis equipment; The first stage reverse osmosis pipeline is made of 304 stainless steel material, and the second stage reverse osmosis is made of 316L stainless steel material; Both the first and second stage reverse osmosis equipment are equipped with online conductivity detection instruments, and the conductivity of the produced water can be observed at any time; There is a low-voltage protection switch before the first level reverse osmosis, and low-voltage and high-voltage protection switches before the second level reverse osmosis; The first and second level reverse osmosis water recovery rates can be adjusted. The first level reverse osmosis recovery rate is 70% -75%, and the second level reverse osmosis recovery rate is 85%; The pipelines between equipment are made of SUS304 pipes. The purified water storage tank is equipped with a breathing filter, and the conveying pipeline is equipped with ultraviolet sterilizers and microporous filters to ensure that pure water meets hygiene requirements.
3. Equipment design, production, installation, and operation comply with GMP certification requirements
(1) The structural design should be simple, reliable, and easy to disassemble.
(2) For the convenience of disassembly, replacement, and cleaning of parts, the design of the actuator should use standardized, universal, and systematic components as much as possible.
(3) The inner and outer wall surfaces of the equipment should be smooth, flat, without dead corners, and 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.
(4) The 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.
(5) The 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.
(6) The storage period of purified water should not exceed 24 hours, and its 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.
(7) Transportation 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 without dead corners, 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.