1. Product features
Precision security filter: Folding filter element can effectively remove impurities and particles above 5 μ M;
Reverse osmosis device: It can remove salt, TOC, endotoxin, silicide, etc;
EDI device: It can deeply remove residual salt ions and silicides;
Hydrophobic respirator: It can remove particles and bacteria from ambient air (with heating jacket);
Control cabinet: Independent development of pure water control system, automatic operation, hot water sterilization, online monitoring function.
Water related materials: All 316 or 304 stainless steel
Automatic valve: Pneumatic diaphragm valve
Processing: Automatic argon arc welding, whole distillation tower pickling and passivation
Test: Air tightness test
2. The preparation process of pure water for biomedicine is as follows:
Traditional process: raw water - raw water pressure pump - multi media filter - activated carbon filter - softener - precision filter - primary reverse osmosis equipment - intermediate water tank - intermediate water pump - ion exchanger - purified water tank - pure water pump - ultraviolet sterilizer - microporous filter - water consumption point new process: · Raw water - raw water pressure pump - multi media filter - activated carbon filter - softener - precision filter - primary reverse osmosis machine - intermediate water tank - intermediate water pump - EDI system - purified water tank - pure water pump - ultraviolet sterilizer - microporous filter - water consumption point Raw water - raw water pressure pump - multi media filter - activated carbon filter - water softener - precision filter - first stage reverse osmosis - pH regulation - intermediate water tank - second stage reverse osmosis (reverse osmosis membrane surface with positive charge) - purified water tank - pure water pump - ultraviolet sterilizer - micro pore filter - water consumption point new process: · raw water ― Multi media filter - activated carbon filter - salt tank - softening filter - softened water tank - medicine washing water tank - security filter - primary reverse osmosis device - secondary reverse osmosis device - RO pure water tank - EDI ultra pure water device - ultra pure water tank - distilled water device - water point
Purified water equipment conforming to GMP certification in pharmaceutical industry:
The monomer and pipeline equipment meet the requirements of GMP (such as back-end treatment equipment such as sterilizer, membrane filter, terminal water tank and pipeline of pretreatment equipment adopt UPVC pipe) · water quality meets the requirements of Pharmacopoeia 2000 and GMP. The equipment is fully automatic operation and conditional automatic treatment procedures (such as backwashing, regeneration and disinfection procedures)
3. GMP certification requirements for pharmaceutical water
1. Requirements of GMP for the preparation of biological water equipment:
（1） 1. The structure design should be simple, reliable and easy to disassemble. 2. In order to facilitate the disassembly, replacement and cleaning of parts, the actuator design should adopt standardized, universal and systematic parts as far as possible. 3. The surface of internal and external walls of the equipment shall be smooth, flat, free of dead angle, easy to clean and sterilize. The surface of parts shall be treated with chromium plating to prevent corrosion and rust. Avoid using paint on the outside of the equipment to prevent spalling. 4. Low carbon stainless steel or other proven materials that do not pollute the water quality shall be used for the preparation of purified water equipment. The equipment for preparing purified water should be cleaned regularly and the cleaning effect should be verified. 5. The materials in contact with water for injection must be high-quality low-carbon stainless steel (such as 316L stainless steel) or other verified materials that do not pollute the water quality. The equipment for preparing water for injection should be cleaned regularly and the cleaning effect should be verified. 6. The storage period of purified water should not be longer than 24 hours, and the storage tank should be made of stainless steel or other materials that have been verified to be non-toxic, corrosion-resistant and do not exude polluting ions. Hydrophobic filter with no fiber shedding should be installed to protect the vent. The inner wall of the storage tank shall be smooth, and there shall be no dead angle and sand hole in the connecting pipe and welding seam. The sensor which will not form stagnant water pollution should be used to display the parameters such as liquid level, temperature and pressure. The storage tank should be cleaned, disinfected and sterilized regularly, and the cleaning and sterilization effect should be verified. Pressure vessels < 50-7 pressure vessels shall be subject to the pressure vessel supervision regulations of the people's Republic of China. 8. Transportation of pharmaceutical water 1) purified water and pharmaceutical water should be transported by stainless steel pump which is easy to be disassembled, cleaned and disinfected. When the purified water and water for injection need to be delivered by compressed air or nitrogen pressure, the compressed air and nitrogen must be purified. 2) the purified water should be transported by circulating pipeline. The pipeline design should be simple and avoid blind pipe and dead angle. The pipeline shall be stainless steel pipe or other proven non-toxic, corrosion-resistant and non exudating pollution ions. The valve should be sanitary valve without dead angle, and the flow direction of purified water should be indicated. 3) the pipelines and pumps conveying purified water and water for injection should be cleaned, disinfected and sterilized regularly, and can be put into use only after passing the verification.
（2） Equipment selection and installation (drug GMP implementation and certification p168) (for pharmaceutical factories) Article 31 the design, selection and installation of equipment shall meet the production requirements, easy to clean, disinfect or sterilize, convenient for production operation, repair and maintenance, and can prevent errors and reduce pollution. Article 32 the surface of equipment in direct contact with drugs shall be smooth, flat, easy to clean or disinfect, corrosion-resistant, and shall not have chemical changes with drugs or absorb drugs. The lubricants and coolants used in the equipment shall not pollute the drugs or containers. Article 33 the name and flow direction of materials in the main fixed pipelines connected with the equipment shall be indicated.
Article 34 the preparation, storage and distribution of purified water and water for injection shall prevent the breeding and pollution of microorganisms. The materials used in storage tanks and pipelines shall be non-toxic and corrosion-resistant. Dead angle and blind pipe shall be avoided in the design and installation of pipeline, and cleaning and sterilization cycle shall be specified for storage tank and pipeline. The vent of water for injection tank shall be equipped with hydrophobic sterilization filter without fiber shedding. The water for injection can be stored at temperature above 80 ° C, heat preservation cycle above 65 ° C or storage below 4 ° C. Article 35 the scope of application and precision of instruments, meters, measuring tools, weighing instruments, etc. used for production and inspection shall meet the requirements of production and inspection, have obvious conformity marks, and be calibrated regularly. Article 36 production equipment shall have obvious status marks, and shall be regularly repaired, maintained and verified. The installation, repair and maintenance of the equipment shall not affect the quality of the products. If possible, unqualified equipment should be moved out of the production area, and there should be obvious marks before moving out. Article 37 the use, repair and maintenance records of production and inspection equipment shall be kept and managed by special personnel.
（3） Equipment cleaning requirements equipment cleaning procedures should follow the following principles: 1. There is a clear washing method and washing cycle. 2. Define the cleaning verification method of key equipment. 3. Relevant data of cleaning process and inspection after cleaning shall be recorded and kept. 4. The cleaning of sterile equipment, especially the parts and components directly in contact with drugs, must be sterilized, and the date of sterilization should be marked. If necessary, microbiological verification should be carried out. Sterilized equipment should be used within three days. 5. Some mobile equipment can be moved to the cleaning area for cleaning, disinfection and sterilization. 6. When the same equipment continuously processes the same sterile product, it is necessary to clean and sterilize between each batch; when the same equipment processes the same non sterilized product, comprehensive cleaning shall be carried out at least weekly or after three batches of production. The standard of purified water quality: resistivity: ≥ 0.5m Ω· cm, conductivity: ≤ 2 μ s, ammonia ≤ 0.3 μ g / ml, nitrate ≤ 0.06 μ g / ml, heavy metal ≤ 0.5 μ g / ml
4. Classification and water quality standard of pharmaceutical water:
1. Classification of pharmaceutical water (process water: water used in pharmaceutical production process, including drinking water, purified water and injection water) 1) potable water: usually tap water or deep well water supplied by the water company, also known as raw water, and its quality must meet the national standard gb5749-85 < sanitary standard for drinking water ". According to the Chinese Pharmacopoeia of 2005, it can not be used as drinking water. 2) purified water: it is the pharmaceutical water prepared by distillation, ion exchange, reverse osmosis or other appropriate methods, without any additives. Purified water can be used as the solvent or test water for the preparation of common pharmaceutical preparations, and should not be used for injection preparation. Purified water prepared by non heat treatment such as ion exchange, reverse osmosis and ultrafiltration is generally also called deionized water. The purified water prepared by distillation method with a specially designed distiller is also known as distilled water. Water for injection was prepared by water for injection. Water for injection can be used as a solvent for injection preparation. 4) sterile water for injection: water for injection prepared according to the injection production process. Sterile water for injection a solvent used for sterilizing powder or diluent for injection.
2. Water quality standards for pharmaceutical water: 1) drinking water: it should conform to the national standard of the people's Republic of China < sanitary standard for drinking water "(gb5749-85); 2) purified water: it should conform to the standard of purified water in < 2010 Chinese Pharmacopoeia. In the water making process, the resistivity value of purified water is usually measured on-line to reflect the concentration of various ions in water. The resistivity of purified water in pharmaceutical industry should be more than or equal to 0.5m Ω· cm / 25 ℃, and that of purified water for injection and eyedrop container flushing should be ≥ 1m Ω. Cm / 25 ℃. 3) water for injection: it should conform to the standard of water for injection in 2005 Chinese Pharmacopoeia.