Medical pure water equipment

1Equipment Introduction

《Chinese pharmacopoeia》（2000The annual version stipulates:“Purified waterTo adoptdistillation、Ion exchange method、Reverse osmosis methodperhapsOther suitable methods can be used to produce water for medicinal purposes.”And no longer limited to“distillation”This process. The change in pharmacopoeia is a major progress in the development history of pharmaceutical water production in China, aligning with the pharmacopoeias of advanced countries around the world. ButUSPContinuously in7The version clearly stipulates anti infiltration（reverse osmosis,RO）The law can serve as a legal method for producing injection water, demonstrating people's confidence in using membrane technology to produce pharmaceutical water. The membrane separation method for producing pharmaceutical water is an inevitable trend in the development of pharmaceutical water technology.Medical Ultra Pure Water EquipmentEDIThe pure water system, also known as continuous electric desalination, superstitiously integrates electrodialysis technology and ion exchange technology. Through the selective permeability of cations and anions and the infectious effect of ion exchange resin on ion exchange in water, it completes the directional migration of ions in water under the infectious effect of electric field, thus achieving deep pollution desalination of water. The hydrogen ions and hydroxide ions produced by water electrolysis are loaded into the processresinEnd of continuous regeneration, thereforeEDIThe entire water production process of the pure water system does not require the regeneration of acidic or alkaline chemicals.

Rongda Environmental Protection followsGMPDesign and purify water equipment using the most advanced technology available todayRO+EDITechnology, used in conjunction with pre-processing, utilizingReverse osmosis principleEffective desalination and removal of impurities;The equipment adopts fully automatic operation control, which has the advantages of advanced technology, stable water quality, easy operation, low operating costs, environmental protection and pollution-free, and convenient maintenance.

2、 Classification and water quality standards

1Pharmaceutical water(Process water: Water used in pharmaceutical production processes, including drinking water, purified water, and injection water)classification

1）Drinking water（Potable-Water）The tap water or deep well water, also known as raw water, usually supplied by water companies must meet national standards for qualityGB5749-85Sanitary Standards for Drinking Water. press2010According to the Chinese Pharmacopoeia, drinking water cannot be directly used as preparation or testing water for formulations.

2）Purified water（Purified Water）Pharmaceutical water produced by distillation, ion exchange, reverse osmosis or other suitable methods from raw water, without any additives. Purified water can be used as a solvent or test water for preparing ordinary pharmaceutical preparations, and should not be used for the preparation of injections

Purified water prepared by non heat treatment methods such as ion exchange, reverse osmosis, and ultrafiltration is generally referred to as deionized water.

Purified water prepared by distillation using a specially designed distiller is generally referred to as distilled water.

3）Injection water（Water for Injection）Purified water is used as raw water, distilled by a specially designed distiller, condensed and cooled, and then prepared by membrane filtration.

Injection water can be used as a solvent for preparing injections.

4）Sterilized injection water（Sterile Water for Injection）Water prepared for injection according to the injection production process.Sterilized injection water is used as a solvent for sterilizing powders or as a diluent for injection solutions.

2Water quality standards for pharmaceutical water

1）Drinking water: It should comply with the national standard of the People's Republic of China, "Sanitary Standards for Drinking Water"（GB5749-85）

2）Purified water: should comply with《2015The purified water standards included in the Chinese Pharmacopoeia.

In the water production process, online detection of the electrical resistivity value of purified water is usually used to reflect the concentration of various ions in the water. The electrical resistivity of purified water in the pharmaceutical industry is usually≥0.5MΩ. CM/25℃,The electrical resistivity of purified water used for flushing injection and eye drop containers should≥1MΩ. CM/25℃.

3）Injection water: should comply with2015The standards for injection water included in the Chinese Pharmacopoeia.

National regulations require:2010The Chinese Pharmacopoeia specifies the requirements for pure water, injection water, and sterilized injection waterpHConductivity, total organic carbon(TOC)The following requirements are proposed for the testing:

①Pharmacopoeia forpHNew requirements for testing:pHThe value should be at5.0～7.0.

②New requirements for conductivity testing in pharmacopoeia: Adjust the temperature of the sample to be tested to25℃The indicated loading quantity is10mlperhaps10mlThe conductivity limit is25μS/cmThe indicated loading quantity is10mlWhen above, the conductivity limit is5μS/cmIf the measured conductivity value is not greater than the limit value, it is judged to comply with the regulations; If the conductivity value is greater than the limit value, it is judged as non compliant with the regulations.

③Pharmacopoeia on Total Organic Carbon(TOC)New requirement: Total organic carbon(TOC)The value should be less than0.5μg/mL.

1Total organic carbon(TOC)The measurement technology should be able to distinguish inorganic carbon(Carbon dioxide produced by the decomposition of dissolved carbon dioxide and bicarbonate in water)Compared to organic carbon(Carbon dioxide produced by the oxidation of organic matter)And it can eliminate the interference of inorganic carbon on the determination of organic carbon.

2It should meet the requirements of system suitability testing.

3It should have sufficient detection sensitivity(The minimum detection limit is carbon content equal to or less than per liter0.05mg/L).

3、 Process flow

1.primarywater tank→Raw water booster pump→Multi-media filter→Activated carbon filter→water softener→Security has passedfilter→First level reverse osmosis→PHadjust→Intermediate water tank→Second level reverse osmosis→Purified water tank→Sterilization system→Purified water transfer pump→Ultraviolet→Microporous filter→Water point

2.Raw water tank→Raw water booster pump→Multi-media filter→Activated carbon filter→water softener→Security filter→First level reverse osmosis→PHadjust→Intermediate water tank→Second level reverse osmosis→Pure water tank→Intermediate water pump→EDIsystem→Purified water tank→Sterilization system→Purified water transfer pump→Ultraviolet→Microporous filter→Water point

3.Raw water tank→Raw water booster pump→Multi-media filter→Activated carbon filter→water softener→Security filter→Primary reverse osmosis machine→Intermediate water tank→Intermediate water pump→EDIsystem→Purified water tank→Sterilization system→Purified water transfer pump→Ultraviolet→Microporous filter→Water point

4 GMPRelated requirements

1The structural design should be simple, reliable, and easy to disassemble.

2In order to facilitate disassembly, replacement, and cleaning of parts, the design of the actuator should use standardized, universal, and systematic components as much as possible.

3The inner and outer wall surfaces of the equipment should be smooth, flat, without dead corners, and easy to clean and sterilize. The surface of the parts should be treated with chrome plating or other surface treatments to resist corrosion and prevent rusting. Avoid using paint on the outside of the equipment to prevent peeling.

4The preparation of purified water equipment should use low-carbon stainless steel or other materials that have been verified to not pollute water quality. The equipment for preparing purified water should be regularly cleaned and the cleaning effect should be verified.

5The material in contact with injection water must be high-quality low-carbon stainless steel or other materials that have been verified not to pollute the water quality. The equipment for preparing injection water should be regularly cleaned and the cleaning effect should be verified.

6The storage period of purified water should not exceed24The storage tank should be made of stainless steel material or other materials that have been verified to be non-toxic, corrosion-resistant, and do not leak out pollutant ions. A hydrophobic sterilization filter with non shedding fibers should be installed to protect its ventilation port. The inner wall of the storage tank should be smooth, and there should be no dead corners or sand holes in the connecting pipes and welds. Sensors that do not cause stagnant water pollution and display parameters such as liquid level, temperature, and pressure should be used. Regularly clean, disinfect and sterilize storage tanks, and verify the effectiveness of cleaning and sterilization.

7Transportation of pharmaceutical water

1）Purified water and pharmaceutical water should be transported using stainless steel pumps that are easy to disassemble, clean, and disinfect. In situations where purified water and injection water require compressed air or nitrogen pressure delivery, the compressed air and nitrogen must be purified.

2）Purified water should be transported through a circulating pipeline. The pipeline design should be concise and avoid blind pipes and dead corners. The pipeline should be made of stainless steel pipes or other pipes that have been verified to be non-toxic, corrosion-resistant, and do not leak pollutants. Valves should be sanitary grade valves without dead corners, and the flow direction of purified water should be indicated.

3）The pipelines and pumps used for transporting purified water and injection water should be regularly cleaned, disinfected, and sterilized before being put into use.

8The design of pressure vessels must be undertaken by licensed units and qualified personnel, in accordance with the national standard of the People's Republic of China "Steel Pressure Vessels"（GB150-80）And"Supervision Regulations for Safety Technology of Pressure Vessels"The relevant regulations for handling.

5、 Equipment advantages

(1)The entire system adopts fully automatic control, with simple and convenient operation;

(2)The entire equipment is made of stainless steel material, and the water tank is made of stainless steel specifically for medical use;

(3)Equipped with a water softener to ensureROSystem andEDIThe system operates stably due to the influence of hardness;

(4)Adopting imported Dow ultra-low pressure reverse osmosis, with high desalination rate, long service life, stable operation, and low energy consumption reduction20%;

(5)The reverse osmosis system adopts fully automatic control, with imported components as the main components, high stability, and simple and convenient operation;

(6)EDIThe system adopts a constant pressure regulation system to ensure stable water quality;

(7)Using authentic imported membrane stack, stable performance, long service life, and professional technology to ensureEDIThe water quality remains stable during short-term or long-term system shutdown;

(8)EDIThe flow meter adopts an imported flow meter, which can prevent damage to the membrane stack caused by the lack of concentrated water due to blockage of the concentrated water channel or other equipment failures;

(9)EDIThe system is equipped with ultraviolet sterilization and membrane filters,ensureEDIStable water quality of the produced water;

(10)It has multiple safety functions such as waterless protection and high/low pressure protection;

(11)All water tanks use purified water and dedicated water tanks, and are equipped with pressure type liquid level gauges, rotating spray cleaning, and air breathing devices;

(12)Equipped with ozone sterilization to ensure quality and quantity, and designed according to the optimal configuration.

The effluent quality of the equipment meets the requirements2015National Pharmacopoeia, United StatesfdaPurified water standard, compliant withGMPCertification requirements: Due to the high efficiency and energy-saving advantages of the equipment, long-term use can save users a lot of investment.

6、 Application Fields

Biotechnology, pharmaceutical industry, medical research institutions, etc.
-----------Our company can provide 250L/H~100T/H pharmaceutical pure water equipment-----------For more parameter information, please consult our online customer service-----------