New GMP Requirements for Purified Water Equipment Systems

First, GMP on the overall requirements of purified water equipment system

Drug production water should be suitable for its use, should use at least drinking water as pharmaceutical water. All kinds of pharmaceutical production selection of pharmaceutical water should be consistent with "People"s Republic of China Pharmacopoeia 2010" requirements. Drinking water should be consistent with the relevant national quality standards, purified water, water for injection should be consistent with "People"s Republic of China Pharmacopoeia 2010" quality standards.

The design, installation and maintenance of the water treatment equipment and its delivery system should ensure that the pharmaceutical water meets the set quality standards. The operation of the water treatment equipment shall not exceed its design capability.

Purified water, water for injection and storage piping materials should be non-toxic, corrosion-resistant; tank ventilation openings should be installed without dehydrating fiber hydrophobic sterilization filter; pipe design and installation should avoid dead ends, blind tube. Should be on the regular use of pharmaceutical water and water quality monitoring, and a corresponding record.

Purified water, water for injection preparation, storage and distribution should be able to prevent the breeding of microorganisms, such as water for injection can be used above 70 ℃ insulation cycle.

Regularly disinfect purified water, water injection pipes, tanks and other necessary auxiliary pipelines (eg piping for cleaning, disinfection, production of temporary connection piping) and relevant records shall be carried out in accordance with the operating procedures. The operating procedures should also specify the limits of warning, corrective limits and the measures to be taken for microbial contamination of pharmaceutical water.

Second, GMP certification requirements for purified water equipment

1, the structural design should be simple, reliable, easy disassembly.

2, in order to facilitate the disassembly, replacement, cleaning parts, the implementation of the agency design as far as possible the use of standardized, generalized, systematic parts.

3, the equipment inside and outside the wall surface, requiring smooth and smooth, no dead ends, easy to clean, sterilization. Parts surface should be chrome and other surface treatment to corrosion, to prevent rust. Do not use paint outside the equipment to prevent peeling.

4, the preparation of purified water equipment should be used low-carbon stainless steel or other proven water pollution does not pollute the material. Equipment for the preparation of purified water should be cleaned regularly and verified for cleaning results.

5, water for contact with the injection of materials must be high-quality low-carbon stainless steel (such as 316L stainless steel) or other proven water pollution does not produce the material. Equipment for the preparation of water for injection should be cleaned regularly and verified for cleaning results.

6, purified water storage cycle should not be greater than 24 hours, the tank should be used stainless steel or proven non-toxic, corrosion-resistant, no leakage of contaminants of other materials produced. Protection of its vent should be installed without shedding fiber hydrophobic sterilization filter. The inner wall of the tank should be smooth and the pipe and the weld should not have dead ends and trachoma. Should be used does not form a stagnant water pollution display surface, temperature and pressure parameters such as the sensor. The tank should be regularly cleaned, sterilized, and the cleaning, sterilization effect verification.

7, the transport of pharmaceutical water

1) Purified water and pharmaceutical water should be easy to disassemble cleaning, disinfection of stainless steel pump delivery. In the case of purified water and water for injection with compressed air or nitrogen, compressed air and nitrogen must be purged.

2) Purified water should be transported by circulating piping. Pipeline design should be simple, should avoid the blind tube and dead ends. Piping should be made of stainless steel pipe or other non-toxic, corrosion-resistant, impermeable contaminants. Valves should be used without dead angle of the health level valve, delivery of purified water should indicate the flow.

3) transport of purified water and water for injection of the pipeline, the pump should be cleaned regularly, disinfection and sterilization, qualified before being put into use.

8, the design of pressure vessel shall be undertaken by a licensed unit and a qualified person and shall be handled in accordance with the relevant provisions of the national standard of the People"s Republic of China, "Steel Pressure Vessel" (GB150-80) and "Pressure Vessel Safety Technical Supervision" The