Equipment basic configuration:
Product name: medical injection water purification equipment
Model: zl - zsj001
Rated frequency (50 Hz)
Rated power (2000 w)
Feed water pressure (0.3 Mpa)
Water supply (5000 L/h)
Shape size 8000 * 3000 * 20000 (cm)
Voltage (380 V)
Containing 1000

　　Pharmaceutical water classification and water quality standard
1, pharmaceutical water, process water, water used in the pharmaceutical production process, including drinking water, purified water, water for injection)
1) drinking Water (Potable Water) : usually a tap Water supply tap Water or deep well Water, also known as raw Water, the quality must conform to the national standard GB5749-85 "drinking Water health standards".According to the provisions of the Chinese pharmacopoeia 2000 drinking water cannot be directly used for preparation of water preparation or test.
2) Purified Water (Purified Water) : for the raw Water by distillation, ion exchange, reverse osmosis, pharmaceutical or other appropriate method, the use of Water, do not contain any additives.Purified water mixture can be used as ordinary drugs solvent or water test, shall not be used for the preparation of the injection by ion exchange method, the heat treatment such as reverse osmosis and ultrafiltration method preparation of purified water is also called the deionized water in general.The use of special design of distillation distillation for preparation of purified water is also called the distilled water in general.
(3) Water for Injection Water for Injection) : is the purified Water as raw Water, specially designed alembic distilled, condensing cooling after preparation and Water by membrane filtration.Water for injection can be used as mixed injection with solvent.
4) sterilizing Water for Injection (Sterile Water for Injection) : for Water for Injection according to the income of Water Injection production process preparation.Sterilized water used for the sterilization of powder injection solvent or injection of diluent.
2, pharmaceutical water water quality standards
1) drinking water: should comply with the national standard of the People's Republic of China "drinking water health standards" (GB5749-85)
2) purified water: should comply with the "2000 China pharmacopoeia contains purified water standard.
Usually used in water making process the size of the resistivity value of on-line detection of purified water, to reflect the concentration of all kinds of ions in water.Purified water resistivity of the pharmaceutical industry should normally acuity 0.5 M omega. CM / 25 ℃, for injection, eye drops container flush with the resistivity of purified water should be 1 M or more omega. CM / 25 ℃.
3) water for injection: should comply with the Chinese pharmacopoeia 2000 contains standard of injection water.

　　GMP requirements for pharmaceutical water preparation device
1, the structure design should be simple, reliable, easy tear open outfit.
2, to facilitate tear open outfit, replacement, cleaning parts, the design of the actuator to the standardization, generalization, systematic parts.
3, equipment inside and outside wall surface to smooth level off, no dead Angle, easy cleaning and sterilization.Parts surface should be chrome plated surface treatment, such as in corrosion resistance, prevent rust.Equipment to avoid outside paint to prevent spalling.
4, the preparation of purified water equipment should be low carbon stainless steel or other experience card do not pollute the water quality of the material.Preparation of purified water equipment should be cleaned regularly, and the cleaning effect.
5, injection water contact materials must be of high quality low carbon stainless steel (316 l stainless steel, for example) or other experience card not pollute water quality of the material.Preparation of water for injection equipment should be cleaned regularly, and the cleaning effect validation.
6, purified water storage period should not be more than 24 hours, the appropriate USES stainless steel storage tank or verified non-toxic, corrosion resistance, no leakage pollution ions of other materials.To protect its vent shall be installed off fiber hydrophobic aseptic filter.Tank inner surface should be smooth, take over and weld should not have a corner and trachoma.Will not form a stagnant water pollution should be adopted according to parameters such as liquid level, temperature and pressure sensors.For tank cleaning, disinfection, sterilization, regularly and tested for cleaning and sterilization effect.
7, pharmaceutical water transport
1) purified water and pharmaceutical should be easy to remove with water cleaning and disinfection of the stainless steel pump.In need of compressed air or nitrogen gas delivery of purified water and water for injection, compressed air and nitrogen purification treatment.
2) purified water appropriate USES circular pipe.Piping design should be simple, should avoid blind pipe and blind Angle.Piping shall be of stainless steel tube or verified non-toxic, corrosion resistance, no leakage pollution ions of other pipes.Valve should adopt the health level of no dead Angle valve, transmission of purified water should indicate the direction.
3) delivery of purified water and water for injection pipe and pump should be regular cleaning, disinfection, sterilization, verify qualified rear can put into use.
8, the design of the pressure vessel, shall be borne by the units licensed and qualified personnel, to be prepared in accordance with the national standard of the People's Republic of China (GB150-80) "steel pressure vessel" and "pressure vessel safety technology and supervision code" of the relevant regulations.

　　A typical preparation of purified water system
Reverse osmosis: reverse osmosis pure water preparation technology is a new technology developed in the '60 s.Due to its simple operation process, salt and heat removal efficiency is high, and more economic.The journal of the American pharmacopoeia since 19 edition contains this method, one is the legal method of the preparation of water for injection.
Mechanism: reverse osmosis is the inverse process of infiltration, refers to the aid of certain thrust (such as pressure, temperature, etc.) force solution through appropriate solvent component in a semipermeable membrane and detention by a process of solute component.

　　The process flow
Preparation of injection water reverse osmosis process is: the raw water to pretreatment, level of high-pressure pump to the first-level reverse osmosis devices, ion exchange resin and the secondary high pressure pump to secondary reverse osmosis device, pure water

　　Equipment selection installation(drug GMP implementation and certification P168) (for pharmaceutical factory)
Article 31 the equipment design, selection and installation shall conform to the requirements of the production, easy cleaning, disinfection or sterilization, facilitate the operation and maintenance, maintenance, and can prevent errors and reduce pollution.
Article 32 a direct contact with drugs of equipment surface should be smooth, level off, corrosion resistant, easy cleaning or sanitizing doesn't change or adsorption drugs and drug.Equipment used in lubricant and coolant shall not cause pollution to drugs or container.
Article 33 the main fixed pipe should be connected to the equipment indicate the name of the tube material, flow.
Article 34 the preparation of purified water, water for injection, storage and distribution should be able to prevent microbes breeding and pollution.Storage tank and pipeline materials should be non-toxic, corrosion resistance.Design and installation of pipelines should avoid blind Angle, blind pipe storage tank and piping to clean, the sterilization cycle.Injection of water tank vent shall be installed off fiber hydrophobic aseptic filter.Injection water storage can be used more than 80 oc, heat preservation, more than 65 oc thermal cycle or deposited under 4 oc.

　　Water for injection
check
PH: 1 should be 5.0 ~ 7.0.
2 ammonia: take this product 50 ml, adding alkaline potassium iodide mercury test solution 2 ml, placed 15 minutes;Such as color, and ammonium chloride solution no ammonia (ammonium chloride 31.5 mg, plus a moderate amount of dissolving and diluted into 1000 ml) 1 ml, with no ammonia 48 ml and alkaline potassium iodide mercury test solution control fluid is made of 2 ml, shall not be deeper (0.00002%).
Three bacterial endotoxin: every 1 m endotoxin content should be less than 0.25 in the EU.
4 chloride, sulfate and calcium salt: take this product, the three test tubes, each tube first tube to add 50 ml nitric acid 5 drops and silver nitrate solution 1 ml, the second tube adding barium chloride solution 2 ml, add ammonium oxalate third tube test solution 2 ml, turbidity shall not occur.
5 nitrate: take this product 5 ml tube, cool in the ice bath, and 10% potassium chloride solution 0.4 ml with diphenylamine 0.1% sulfuric acid solution 0.1 ml, shake well, slowly add sulfuric acid 5 ml, shake well, placing tube in 50 oc water bath for 15 minutes, the solution produced by blue and standard of nitrate solution [0.163 g of potassium nitrate, add water to dissolve and diluted to 100 ml, shake well, precision measuring 1 ml, diluted into 100 ml of water, then water precision measuring 10 ml to 100 ml, shake well, for a quick (each 1 ml of 1 mu gNO3)] 0.3 ml, add water 4.7 ml without nitrate, after processing of color comparison with the same method, shall not be deeper (0. 000006%).
6 nitrite: take this product 10 ml, nessler's tube, plus a dilute hydrochloric acid solution of amino benzene sulfonamide (1-100) 1 ml and hydrochloric acid naphthalene ethylenediamine solution 1 ml (0.1-100), the pink, with standard nitrite solution [take 0.750 g sodium nitrite (calculated on dry goods), add water to dissolve, diluted to 100 ml, shake well, precision measuring 1 ml, water to 100 ml, shake well, precision measuring 1 ml, again add water dilute into 50 ml, shake well, for a quick (each 1 ml of 1 mu gNO2)] 0.2 ml, with no nitrite water 9.8 ml, in the same way after processing of color comparison, shall not be deeper (0.000002%).
7 carbon dioxide: take this product 25 ml, stuffed with 50 ml graduated cylinder, adding calcium hydroxide solution 25 ml, dense vibration wave and placed, shall not occur turbidity in 1 hour.
Eight yi oxide: take this product 100 ml, add 10 ml dilute sulphuric acid, after boiling, add potassium permanganate standard solution (0.02 mol/L) 0.10 ml, then boil for 10 minutes, pink may not disappear completely.
9 no volatiles: take this product 100 ml, 105 oc constant weight of evaporating dish, boiled in water bath, and in 105 oc drying to constant weight, legacy residue shall be 1 mg.
10 heavy metals: take this product 40 ml, add acetate buffer (pH3.5) 2 ml and thioacetamide test solution 2 ml, shake well, placed for 2 minutes, 2.0 ml water 38 ml and standard lead solution after processing of color comparison with the same method, shall not be deeper (0.00005%).

　　Sterilizing water for injection
check
PH: 1 should be 5.0 ~ 7.0.
2 ammonia: take this product 50 ml, adding alkaline potassium iodide mercury test solution 2 ml, placed 15 minutes;Such as color, and ammonium chloride solution no ammonia (ammonium chloride 31.5 mg, plus a moderate amount of dissolving and diluted into 1000 ml) 1 ml, with no ammonia 48 ml and alkaline potassium iodide mercury test solution control fluid is made of 2 ml, shall not be deeper (0.00002%).
Three bacterial endotoxin: every 1 m endotoxin content should be less than 0.25 in the EU.
4 chloride, sulfate and calcium salt: take this product, the three test tubes, each tube first tube to add 50 ml nitric acid 5 drops and silver nitrate solution 1 ml, the second tube adding barium chloride solution 2 ml, add ammonium oxalate third tube test solution 2 ml, turbidity shall not occur.
5 nitrate: take this product 5 ml tube, cool in the ice bath, and 10% potassium chloride solution 0.4 ml with diphenylamine 0.1% sulfuric acid solution 0.1 ml, shake well, slowly add sulfuric acid 5 ml, shake well, placing tube in 50 oc water bath for 15 minutes, the solution produced by blue and standard of nitrate solution [0.163 g of potassium nitrate, add water to dissolve and diluted to 100 ml, shake well, precision measuring 1 ml, diluted into 100 ml of water, then water precision measuring 10 ml to 100 ml, shake well, for a quick (each 1 ml of 1 mu gNO3)] 0.3 ml, add water 4.7 ml without nitrate, after processing of color comparison with the same method, shall not be deeper (0. 000006%).
6 nitrite: take this product 10 ml, nessler's tube, plus a dilute hydrochloric acid solution of amino benzene sulfonamide (1-100) 1 ml and hydrochloric acid naphthalene ethylenediamine solution 1 ml (0.1-100), the pink, with standard nitrite solution [take 0.750 g sodium nitrite (calculated on dry goods), add water to dissolve, diluted to 100 ml, shake well, precision measuring 1 ml, water to 100 ml, shake well, precision measuring 1 ml, again add water dilute into 50 ml, shake well, for a quick (each 1 ml of 1 mu gNO2)] 0.2 ml, with no nitrite water 9.8 ml, in the same way after processing of color comparison, shall not be deeper (0.000002%).
7 carbon dioxide: take this product 25 ml, stuffed with 50 ml graduated cylinder, adding calcium hydroxide solution 25 ml, dense vibration wave and placed, shall not occur turbidity in 1 hour.
Eight yi oxide: take this product 100 ml, add 10 ml dilute sulphuric acid, after boiling, add potassium permanganate standard solution (0.02 mol/L) 0.10 ml, then boil for 10 minutes, pink may not disappear completely.
9 no volatiles: take this product 100 ml, 105 oc constant weight of evaporating dish, boiled in water bath, and in 105 oc drying to constant weight, legacy residue shall be 1 mg.
10 heavy metals: take this product 40 ml, add acetate buffer (pH3.5) 2 ml and thioacetamide test solution 2 ml, shake well, placed for 2 minutes, 2.0 ml water 38 ml and standard lead solution after processing of color comparison with the same method, shall not be deeper (0.00005%).
11 other: should comply with the relevant injection under the provisions of (pharmacopeia, 2000 edition of the People's Republic of China P appendix 6)