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  • Medical injection water purification equipment zl-zsj001

    Source: Medical injection of water purification equipment: the blue Time: 2015-08-27 Views: Times

    Medical injection water purification equipment

    Medical injection water purification equipment

    Basic equipment configuration:
    Product name: Medical injection water purification equipment
    Model: zl-zsj001
    Rated frequency: 50 (Hz)
    Rated power: 2000 (w)
    Water inlet pressure: 0.3 (Mpa)
    Water supply: 5000 (L / h)
    Dimensions: 8000 * 3000 * 20000 (cm)
    Voltage: 380 (V)
    Net weight: 1000

    Classification of pharmaceutical water and water quality standards
    1. Classification of pharmaceutical water (process water: water used in pharmaceutical production process, including drinking water, purified water, water for injection) 1) Drinking water (Potable-Water): usually tap water or deep well water supplied by water companies, also known as The quality of raw water must meet the national standard GB5749-85 "Sanitary Standards for Drinking Water". According to the 2000 Chinese Pharmacopoeia, drinking water cannot be used directly as a preparation or test water for preparations.
    2) Purified Water: It is the pharmaceutical water made from raw water by distillation, ion exchange, reverse osmosis or other suitable methods, without any additives. Purified water can be used as a solvent or test water for the preparation of common pharmaceutical preparations. It can not be used for the preparation of injections. Purified water prepared by non-heat treatment such as ion exchange method, reverse osmosis method and ultrafiltration method is generally also called deionized water. Purified water prepared by the distillation method using a specially designed still is generally called distilled water.
    3) Water for Injection: Water obtained by purifying water as raw water, distilling it through a specially designed distiller, condensing and cooling, and filtering through a membrane. Water for injection can be used as a solvent for the preparation of injections.
    4) Sterile Water for Injection: Water prepared for injection water according to the production process of injection. Sterile water for injection is a solvent or thinner for sterilizing powders.
    2. Water quality standards for pharmaceutical water 1) Drinking water: should comply with the national standard of the People's Republic of China "Sanitary Standards for Drinking Water" (GB5749-85)
    2) Purified water: It should meet the standards for purified water contained in the 2000 Chinese Pharmacopoeia.
    In the water production process, the size of the resistivity value of the purified water is usually detected online to reflect the concentration of various ions in the water. The resistivity of purified water in the pharmaceutical industry should generally be ≥0.5MΩ.CM / 25 C, and the resistivity of purified water for injection and eye drops container washing should be ≥1MΩ.CM / 25 C.
    3) Water for injection: It should meet the standards for water for injection contained in the 2000 Chinese Pharmacopoeia.

    GMP requirements for pharmaceutical water preparation equipment
    1. The structure design should be simple, reliable, and easy to disassemble.
    2. In order to facilitate disassembly, replacement, and cleaning of components, the design of the actuator is standardized, generalized, and systematic components as much as possible.
    3. The surface of the inner and outer walls of the device must be smooth and flat, without dead corners, and easy to clean and sterilize. The surface of parts should be treated with chrome plating to prevent corrosion and prevent rust. Avoid painting on the outside of the device to prevent it from peeling.
    4. Preparation of purified water equipment should use low carbon stainless steel or other materials that have been verified not to pollute water quality. 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 materials that have been verified not to cause water pollution. Equipment for the preparation of water for injection should be cleaned regularly and the cleaning effect verified.
    6. The storage period of purified water should not be longer than 24 hours, and its storage tank should be made of stainless steel or other materials that have been verified to be non-toxic, corrosion-resistant, and not to leak out polluted ions. A hydrophobic sterilizing filter should be installed to protect the air vent. The inner wall of the storage tank should be smooth, and there should be no dead corners or trachoma in the connection and weld. Sensors that display parameters such as liquid level, temperature, and pressure that do not form water pollution should be used. The storage tank shall be cleaned, disinfected and sterilized regularly, and the cleaning and sterilization effects shall be verified.
    7. Transportation of pharmaceutical water 1) Purified water and pharmaceutical water should be transported by stainless steel pumps that are easy to disassemble, clean and disinfect. Where purified water and water for injection need to be delivered with compressed air or nitrogen pressure, the compressed air and nitrogen must be purified.
    2) The purified water should be transported by circulating pipes. The piping design should be simple, and blind pipes and dead ends should be avoided. The piping should be stainless steel or other pipes that have been verified to be non-toxic, corrosion-resistant, and not to leak contaminated ions. The valve should be a sanitary valve without dead corners. The flow direction of purified water should be indicated.
    3) Pipes and pumps that transport purified water and water for injection should be cleaned, disinfected and sterilized regularly, and they can be put into use only after passing the verification.
    8. The design of the pressure vessel must be undertaken by a licensed unit and qualified personnel, and must 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 the "Pressure Vessel Safety Technical Supervision Regulations" .

    Typical purified water preparation system
    Reverse osmosis: The technology of preparing pure water by reverse osmosis is a new technology developed in the 1960s. Due to its simple operation process, the efficiency of removing salt and heat is high, and it is relatively economical. This method has been included in the 19th edition of the United States Pharmacopeia and is one of the legal methods for preparing water for injection.
    Mechanism: Reverse osmosis is the reverse process of osmosis, which refers to the process of forcing a solvent component in a solution through an appropriate semi-permeable membrane to retain a certain solute component with a certain thrust (such as pressure difference, temperature difference, etc.).

    Process flow
    The process for preparing water for injection by reverse osmosis method is: raw water → pretreatment → first-stage high-pressure pump → first-stage reverse osmosis device → ion exchange resin → second-stage high-pressure pump → second-stage reverse osmosis device → pure water

    Medical injection water purification equipment

    Medical injection water purification equipment

    (药品GMP实施与认证P168)(对于药厂来说) Equipment selection and installation (implementation and certification of pharmaceutical GMP P168) (for pharmaceutical companies)
    Article 31 The design, selection and installation of equipment shall comply with production requirements, be easy to clean, disinfect or sterilize, facilitate production operations and repair, maintenance, and prevent errors and reduce pollution.
    Article 32 The surface of equipment in direct contact with medicines shall be smooth, flat, easy to clean or disinfect, and resistant to corrosion without chemical changes or adsorption of medicines. Lubricants, coolants, etc. used in the equipment must not contaminate medicines or containers.
    Article 33 The main fixed pipeline connected to the equipment shall be marked with the name and flow direction of the materials in the pipeline.
    Article 34 The preparation, storage and distribution of purified water and water for injection shall prevent the breeding and contamination of microorganisms. Materials used in storage tanks and pipelines shall be non-toxic and resistant to corrosion. The design and installation of pipelines should avoid dead corners, and the cleaning and sterilization cycle of blind tanks and pipelines should be specified. The vent of the water injection tank should be installed with a hydrophobic bacteria-removing filter that does not shed fibers. Water for injection can be stored at a temperature above 80oC, a temperature above 65oC, or below 4oC.

    Water for Injection
    Check 1 pH value: 5.0 ~ 7.0.
    2 Ammonia: Take 50ml of this product, add 2ml of alkaline potassium potassium iodide test solution, and leave it for 15 minutes; if color is developed, and ammonium chloride solution (take 31.5mg of ammonium chloride, add appropriate amount of ammonia-free water to dissolve and dilute to 1000ml) ) 1ml, compared with the control solution made of 2ml of basic mercury potassium iodide test solution with 48ml of ammonia-free water, it must not be deeper (0.00002%).
    3 Bacterial endotoxin: The amount of endotoxin per 1m should be less than 0.25EU.
    4 Chloride, sulfate and calcium salt: Take this product and divide it into three test tubes, each with 50ml of each tube, add 5 drops of nitric acid and 1ml of silver nitrate test solution, and add barium chloride test solution to the second tube 2ml, 2ml ammonium oxalate test solution was added to the third tube, and no turbidity occurred.
    5 Nitrate: Take 5ml of this product and place it in a test tube, cool in an ice bath, add 0.4ml of 10% potassium chloride solution and 0.1ml of 0.1% diphenylamine sulfuric acid solution, shake well, slowly add 5ml of sulfuric acid slowly, shake well, Place the test tube in a 50oC water bath for 15 minutes. The blue and standard nitrate solution produced by the solution [take 0.163g of potassium nitrate, add water to dissolve and dilute to 100ml, shake well, take 1ml accurately, dilute to 100ml with water, and then precision Measure 10 ml with water and dilute it to 100 ml. Shake to obtain 0.3 ml (1 ml is equivalent to 1 μg of NO3 per 1 ml). Add 4.7 ml of nitrate-free water. Compare the color after treatment with the same method. %).
    6 Nitrite: Take 10ml of this product and place it in a Nessler tube, add 1ml of dilute hydrochloric acid solution (1 → 100) of p-aminobenzenesulfonamide and 1ml of naphthaleneethylenediamine hydrochloride solution (0.1 → 100), the resulting pink color And standard nitrite solution [take 0.750g of sodium nitrite (calculated as dry product), add water to dissolve, dilute to 100 ml, shake well, take precise 1 ml, add water to dilute to 100 ml, shake well, and then measure accurately Take 1 ml, dilute to 50 ml with water, shake to obtain (0.2 ml of 1 μg NO2 per 1 ml)] 0.2 ml, add 9.8 ml of nitrite-free water, and compare the color after treatment with the same method, not darker (0.000002 %).
    7 Carbon dioxide: Take 25ml of this product, put it in a 50ml measuring cylinder with a stopper, add 25ml of calcium hydroxide test solution, shake it tightly, and leave it to stand for 1 hour without turbidity.
    8 easy oxide: take 100ml of this product, add 10ml of dilute sulfuric acid, add 0.10ml of potassium permanganate titration solution (0.02mol / L) after boiling, and boil for 10 minutes, the pink color must not completely disappear.
    9 Non-volatile matter: Take 100ml of this product, place it in a 105oC constant weight evaporating dish, evaporate to dryness on a water bath, and dry to constant weight at 105oC. The residual residue should not exceed 1mg.
    10 heavy metals: take 40ml of this product, add 2ml of acetate buffer solution (pH3.5) and 2ml of thioacetamide test solution, shake well, leave it for 2 minutes, treat it with 2.0ml of standard lead solution and 38ml of water in the same way After the color comparison, it must not be darker (0.00005%).

    Sterilized water for injection
    Check 1 pH value: 5.0 ~ 7.0.
    2 Ammonia: Take 50ml of this product, add 2ml of alkaline potassium potassium iodide test solution, and leave it for 15 minutes; if color is developed, and ammonium chloride solution (take 31.5mg of ammonium chloride, add appropriate amount of ammonia-free water to dissolve and dilute to 1000ml) ) 1ml, compared with the control solution made of 2ml of basic mercury potassium iodide test solution with 48ml of ammonia-free water, it must not be deeper (0.00002%).
    3 Bacterial endotoxin: The amount of endotoxin per 1m should be less than 0.25EU.
    4 Chloride, sulfate and calcium salt: Take this product and divide it into three test tubes, each with 50ml of each tube, add 5 drops of nitric acid and 1ml of silver nitrate test solution, and add barium chloride test solution to the second tube 2ml, 2ml ammonium oxalate test solution was added to the third tube, and no turbidity occurred.
    5 Nitrate: Take 5ml of this product and place it in a test tube, cool in an ice bath, add 0.4ml of 10% potassium chloride solution and 0.1ml of 0.1% diphenylamine sulfuric acid solution, shake well, slowly add 5ml of sulfuric acid slowly, shake well, Place the test tube in a 50oC water bath for 15 minutes. The blue and standard nitrate solution produced by the solution [take 0.163g of potassium nitrate, add water to dissolve and dilute to 100ml, shake well, take 1ml accurately, dilute to 100ml with water, and then precision Measure 10 ml with water and dilute it to 100 ml. Shake to obtain 0.3 ml (1 ml is equivalent to 1 μg of NO3 per 1 ml). Add 4.7 ml of nitrate-free water. Compare the color after treatment with the same method. %).
    6 Nitrite: Take 10ml of this product and place it in a Nessler tube, add 1ml of dilute hydrochloric acid solution (1 → 100) of p-aminobenzenesulfonamide and 1ml of naphthaleneethylenediamine hydrochloride solution (0.1 → 100), the resulting pink And standard nitrite solution [take 0.750g of sodium nitrite (calculated as dry product), add water to dissolve, dilute to 100 ml, shake well, take precise 1 ml, add water to dilute to 100 ml, shake well, and then measure accurately Take 1 ml, dilute to 50 ml with water, shake to obtain (0.2 ml of 1 μg NO2 per 1 ml)] 0.2 ml, add 9.8 ml of nitrite-free water, and compare the color after treatment with the same method, not darker (0.000002 %).
    7 Carbon dioxide: Take 25ml of this product, put it in a 50ml measuring cylinder with a stopper, add 25ml of calcium hydroxide test solution, shake it tightly, and leave it to stand for 1 hour without turbidity.
    8 easy oxide: take 100ml of this product, add 10ml of dilute sulfuric acid, add 0.10ml of potassium permanganate titration solution (0.02mol / L) after boiling, and boil for 10 minutes, the pink color must not completely disappear.
    9 Non-volatile matter: Take 100ml of this product, place it in a 105oC constant weight evaporating dish, evaporate to dryness on a water bath, and dry to constant weight at 105oC. The residual residue should not exceed 1mg.
    10 heavy metals: take 40ml of this product, add 2ml of acetate buffer solution (pH3.5) and 2ml of thioacetamide test solution, shake well, leave it for 2 minutes, treat it with 2.0ml of standard lead solution and 38ml of water in the same way After the color comparison, it must not be darker (0.00005%).
    11 Others: should comply with the relevant provisions under the injection (Policy of the People's Republic of China 2000 Edition Two P Appendix 6) Medical injection water purification equipment

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