Biopharmaceutical water purification equipment including multi-media filters, activated carbon filters, softened water filters, precision filters. The host is mainly composed of high-pressure pump, membrane shell, imported reverse osmosis membrane components, online instrumentation, control and electrical components. The post-treatment part consists of polishing pure system, sterilization line sterilizer, 0.22 microporous filter.
Biopharmaceutical ultrapure water equipment process:
1, raw water - raw water pressurization pump - multi-media filter - activated carbon filter - water softener - precision filter - a reverse osmosis equipment - intermediate tank - intermediate pump - ion exchanger - purified water tank - pure water pump - ultraviolet sterilizer - microporous filters - point of use;
2, raw water - raw water pressurization pump Multi-media filter - activated carbon filter - water softener - precision filter - first-stage reverse osmosis - PH adjustment - intermediate tank - second-stage reverse osmosis - purified water tank - pure water pump - ultraviolet sterilizer - microporous filters - disinfection and sterilization - water points;
3. Raw water - raw water pressurizing pump - multi-media filter - activated carbon filter - water softener - precision filter - first-stage reverse osmosis - purified water tank - water purification pump - ultraviolet sterilizer - microporous filters - water points;
4. Precision filter - first stage reverse osmosis machine ------- intermediate tank - intermediate water pump - EDI system - purified water tank - pure water pump - ultraviolet sterilizer - microporous filter - disinfection and sterilization - water point;
4. Raw water - raw water pressurized pump - multi-media filter - activated carbon filter - water softener - precision filter - first stage reverse osmosis - PH adjustment - intermediate water tank - second stage Reverse osmosis - RO water tank - RO water pump - TOC decomposer ----EDI system - purification water tank - pure water pump - nucleus polishing purification - ultraviolet sterilizer - microporous filter - disinfection sterilization - point of use.
Biopharmaceutical ultrapure water equipment features:
Pre-treatment of all fully automatic filtration device.
RO host system adopts full-automatic control device, with automatic water production, automatic flushing, raw water shortage shutdown, water tank full shutdown, high pressure and low pressure alarm and other functions.
RO host is equipped with online display devices: such as pressure gauges, conductivity meters, flow meters and so on. And can realize online monitoring.
The pump of the water production system adopts the southern pump (made of SUS304), and the RO membrane adopts the imported brand (U.S.A. Hydronics).
Polishing mixed bed using imported resins, the system produces water with a stable resistivity of more than 15 megohms (conductivity less than 0.06μs/cm).
The pure water tank is made of SUS304 hygienic grade material (polished inside and outside), with respirator and spray ball.
The system has a compact structure, covers a small area and saves space effectively.
System energy consumption is low, effective energy saving.
Reliable operation of the system, closed water supply pipeline, stable water quality.
Biopharmaceutical ultrapure water equipment applications:
1, I.V. infusion, injection, oral solution and other preparations
2, extraction and washing of raw materials, injections, capsule production
3, ophthalmic solution and the production of nursing solution
4, blood dialysis room in hospitals, biochemical analysis room, operating room aseptic water
5, multi-effective distilled water, raw material water machine, bottle washing water
5, water, water and water, water and water, water and water. Machine raw material water, bottle washing water
6, cosmetic process water, detergent water
7, biochemical drug products, diagnostic reagents
Biopharmaceutical ultrapure water equipment water standards:
China 2010 version of the Pharmacopoeia purified water standards; in line with GMP standards.
China Pharmacopoeia 2010 Edition purified water standards
1, properties: colorless, tasteless, odorless clear liquid.
2, acidity and alkalinity: take 10ML of this product and add 2 drops of methyl red indicator solution, shall not show red, another 10ML, add 5 drops of bromo musk vanillin phenol orchid indicator solution, shall not show orchid color.
3, nitrate: take 5ML of this product in a test tube, cooled in an ice bath, add 10% potassium chloride solution 0.4ML and 0.1% diphenylamine sulfuric acid solution 0.1ML, shake well. Slowly drop the sulfuric acid 5ML, shake well, the test tube and 50 degrees water bath for 15 minutes, the solution produces a blue color with the standard nitrate solution (take potassium nitrate 0.163g, add water to dissolve and dilute to 100ML, shaking well, that is, every 1ML is equivalent to 1ugNO3) 0.3ML. add nitrate-free water 4.7ML, with the same method of treatment of color comparisons, shall not be darker ( 0.000006%).
4, nitrite: take 10ML of this product, placed in a natty tube, add p-aminobenzenesulfonamide dilute hydrochloric acid solution (1-100) 1ML with naphthyl ethylamine hydrochloric acid solution (001-100) 1ML, the resulting pink color, and the standard nitrite solution (take 0.750g of sodium nitrite (according to the dry product) dissolved in water, diluted to 100ML, precision measurement of 1M. Dilute with water to 100ML, shake well. And then precision measurement of 1M, diluted with water into 50ML, shake well, both (each 1ML equivalent to 1ugNO2) 0.2ML, plus no nitrite water 9.8ML, with the same method of color comparison after treatment, shall not be darker (0.000002%).
5, ammonia: take 50ML of this product plus alkaline potassium iodide test solution 2ML, leave it for 15 minutes, plus color development. Compare with ammonium chloride solution 2ML, plus distilled water without ammonia 48ML with alkaline potassium iodide mercury potassium test solution 2ML made of control solution, shall not be darker (0.00003%).
6, conductivity: should comply with the provisions of 25 degrees is not greater than 5.1μs/cm.
7, total organic carbon: shall not exceed 0.5mg/L.
8, easy oxidation: take 100ML of this product, add 10ML of dilute sulfuric acid, boil, add potassium permanganate solution (C (1/5KMnO4) = 0.1mol / L,) 0.10 ML and boil for another 10 minutes, the pink color shall not disappear completely. Note: Total organic carbon and easy to oxidize two optional one.
9, non-volatile matter: take 100ML of this product, placed in a weighing evaporation dish, evaporated on a water bath and dried at 105 ℃ to a constant weight, the residue shall not exceed 1mg.
10, heavy metals: take 50ML of this product, add 18.5ML of water, evaporate to 20ML, and let cool. Add acetate buffer (PH3.5) 2ML with the appropriate amount of water to make 25ML, add thioacetamide test solution 2ML. shake well, let stand for 2 minutes, and the standard lead solution 1.5ML with water 18.5ML with the same method of treatment of the color comparison, shall not be darker (0.00003%).
11, microbial limit: take the product, using membrane filtration method of treatment, according to the law, the total number of bacteria, molds and yeast per 1ML shall not exceed 100.