RU2780008C1 - Method for continuous production of water for injections and set for implementation thereof - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: invention relates to the production of pharmacopoeia-grade water and can be used in medicine. Source water is preliminarily purified in reverse osmosis and electrodeionisation apparatuses 1 and 2, respectively. The pre-purified water is supplied to a unit for producing water for injections (WFI), containing a storage container 3, a circulation pump 4, a heat exchanger, and an ultrafiltration module, connected in series via pipelines. The water from the storage container 3 is continuously supplied into the heat exchanger by means of the circulation pump 4. Tangential ultrafiltration is then performed in the ultrafiltration module equipped with a ceramic membrane, while providing an 0.1 to 0.7 MPa pressure drop, resulting in the target product — WFI, sent to the consumer, and the unutilised WFI is returned to the storage container. The ultrafiltration module periodically undergoes chemical and thermal cleaning by introducing a detergent agent into the water, followed by passing the water through the heat exchanger to heat to 60–80°C, supplying into the ultrafiltration module, holding therein for 30–120 minutes, and discharging the spent water. In order to produce hot WFI, the pre-purified water can be heated in the heat exchanger to the required temperature.

EFFECT: continuous operation of the set for 3 months and consistently high quality of water without losses thereof or stagnant and uncleanable sections.

4 cl, 2 dwg, 1 tbl, 3 ex

Description

The invention relates to a method and device for producing water that meets the pharmacopoeial requirements for the category of water for pharmaceutical use, and can be used in medicine to obtain water for injection (WFI) by ultrafiltration.

During ultrafiltration, water is purified by passing through a semi-permeable membrane with a pore size of 0.002 ... 0.1 microns (nanosized pores). In the production of water for injection, ultrafiltration allows you to purify water from pyrogens, bacterial endotoxins, microorganisms and other microbial pollutants and macromolecules. The main difficulty lies in the fact that ultrafiltration membranes are prone to contamination, silting, so ultrafiltration is used as an intermediate or final stage of water purification.

A known method of water purification using ultrafiltration (see, patent RU 2606610 C2, class IPC C02F 1/04, C02F 1/08, C02F 1/42, C02F 1/56, publ. 10.01.2017). According to the description of the invention, water (effluent from the production of polyvinyl chloride) can be treated with a purification step, including microfiltration or ultrafiltration. Microfiltration and ultrafiltration are carried out, in particular, to remove very fine particles from wastewater. The filter element is preferably a membrane. The material of the filter element can be a ceramic filter, cermet, metal fibers or polymer membranes. This may be filtration, known as "countercurrent (CW) filtration" with the tangential introduction of filtered wastewater. Filtration is combined with wastewater treatment by evaporation and condensation. The treated, evaporated wastewater, in some cases recompressed as above, can provide the heat needed to evaporate the contaminated wastewater by re-condensing through heat exchange in the appropriate parts of the evaporator. Appropriate measurements with respect to dry sewage sludge and concentrates separated after treatment show that the content of contamination in the latter can be even 300 times greater than in wastewater.

The known method provides only the production of process water from wastewater suitable for use in the production of polymers, in cooling towers, for washing and cleaning, as well as wastewater of environmentally acceptable quality and does not provide water for injection of pharmacopoeial quality.

Known installation for the production of water for injection "Vladistart", attached to the device for distillation, and representing a closed system with replaceable membrane filters. It consists directly of a filtration unit (pre-filtration and ultrafiltration), a pressure pump and a container with a device for sterile "breathing" (air filter-separator), connected by a pipeline with shut-off valves. The two installation options are designed for capacities up to 100 l/h and up to 800 l/h for pyrogen-free water. Membrane module - a rectangular cassette with a package of 1 to 7 mechanically and thermally strong ultrafiltration membranes made of cellulose triacetate, installed in the filter holder. Before the filter, a pre-filter is installed to remove random suspensions and extend the life of the module. Upon completion of filtration, the hose supplying water from the filtration unit is turned off, and the bottle remains tightly closed for subsequent transportation (see http://medprom.ru/medprom/mpp_0004502).

The installation allows to obtain water from purified water that meets the requirements of the FS "Water for injections".

However, the known installation is not suitable for continuous production of water for injection, but works intermittently.

Known method and device for continuous production of water for injection (see patent RU 2258045 C1, class IPC C02F 9/08, C02F 9/08, C02F 1/28, C02F 1/42, C02F 1/44, C02F 1/ 58, C02F 103/04, published 8/10/2005). In the method for obtaining water for injection from waters of natural sources, including coarse filtering and sterilization, water from open reservoirs is first subjected to purification on a preliminary filter, after purification on a coarse filter, ultrafiltration is carried out, additional processing to drinking quality is carried out by means of reverse osmosis, and after sorption on coal materials, drinking water is sequentially subjected to cation and anion exchange, after which it is sterilized, while water quality control is carried out in a continuous mode according to the electrical resistivity value. The installation for implementing the method includes a coarse filter and a sterilizing device and additionally a pre-filter, a pressure pump, a supply line, an ultrafilter, a high pressure pump, a reverse osmosis filter, electrical resistivity meters, a carbon filter, a sorption filter, a cation exchange filter, an anion exchange filter, a filter - cartridge for sterilization, moreover, the reverse osmosis filter is additionally connected to the discharge line, the anion exchanger filter has an additional outlet to the purified water collector, and the filter cartridge for sterilization - to the collector of water for injection, the installation provides for the possibility of recirculating treated water. The ultrafilter is implemented on porous fibers, with the help of which purification from high-molecular organic compounds and suspended colloidal particles is achieved (for example, in VKU cartridges (selectivity 60%)) with a pore size of 0.01 μm. After water treatment at the reverse osmosis stage - an indicator of electrical resistivity equal to at least 0.1 MΩ cm (at a temperature of (20.0 ± 1.0) ° C), after treatment of water at the stages of ion exchange - an indicator of electrical resistivity within from 0.5 to 2.5 MΩ⋅m (at a temperature of (20.0 ± 1.0) ° C), which corresponds to a specific electrical conductivity of 0.4-2.0 μS/cm.

The installation makes it possible to obtain water from natural sources that fully complies with the requirements of FS 42-2620-97 "Water for injections". The productivity of the unit in the conditions of the North-West region is from 30 to 35 l/h in the spring-summer period, from 25 to 30 l/h in the autumn-winter period.

The disadvantage of the method and installation is low productivity. The resulting water complies with the requirements of FS 42-2620-97 "Water for injection", which has become invalid, but does not meet modern requirements for water for injection. In addition, the known installation can only be used near natural sources from which water must be transported, and the use of ion-exchange resins is associated with water pollution with organic compounds released from the ion-exchange resins themselves, as well as acids and alkalis used for their regeneration.

A method and apparatus for producing non-pyrogenic water for injection is known (patent RU 2094393 C1, class IPC C02F 9/00, C02F 1/46, C02F 1/78, publ. 27.10.1997). The method includes filtration, sorption, staged water treatment in diaphragm electrolyzers with insoluble electrodes, in which the anolyte is sent to feed the water flow before sorption, and the catholyte after each electrolysis stage enters the next one with the flow diverted from the last stage to feed the source water, the selection of treated water by the consumer, and drinking and / or distilled water is subjected to treatment with additional exposure to ultraviolet irradiation and ozonation during the stages of ozonation, sorption and electrolysis by three-stage processing in a parallel-sequential mode, in which drinking water after filtering by three parallel streams is first served for ozonation by mixing water at each stage with an ozone-air mixture generated from air, and then to sorption and electrolysis, to which distilled water is also independently supplied in three parallel streams with the addition of sodium chloride to it, while the rest The distilled water flow is directed to ultraviolet irradiation, three-stage micro- and ultrafiltration with water withdrawal to the pyrogen-free water collector and then to the I ozonation stage, and the flow after the I sorption stage is fed to the I stage of electrolysis and / or to the II stage of ozonation, the water flow after The second stage of sorption is sent to the second stage of electrolysis and / or to the third stage of ozonation, and the flow after the third stage of sorption is fed to the third stage of electrolysis and / or diverted to the ozonized water collector, and / or to the non-pyrogenic water collector, the anolyte is fed after each electrolysis stage for water make-up before the corresponding sorption stage or is sent to the anolyte collector, the catholyte after the III stage of electrolysis is mixed with the catholyte of the I and II stages and sent to the catholyte collector or mixed with the water flow from the non-pyrogenic water collector and fed to distilled water before ultraviolet irradiation and further return to the I stage of ozonation for re-treatment, and the selection of treated water by the consumer is carried out from the collector of non-pyrogenic water after a repeated cycle of treatment in the form of non-pyrogenic ionized water, from the collectors of pyrogen-free and ozonized water, as well as from the collectors of anolyte and catholyte.

The installation for multi-stage water treatment contains a source water supply unit, a filtering unit, a sorption purification unit, a water electrolysis treatment unit in diaphragm electrolyzers with insoluble electrodes, in which the anode space of the first electrolyzer is connected to the sorption purification unit, the cathode spaces of all electrolyzers are connected in series with each other, and the outlet of the cathode space of the last electrolyzer is connected to the source water supply, the treated water withdrawal unit to the consumer, pumps, valves, while the installation is equipped with an ultraviolet irradiator and three micro- and ultrafilters connected to it, a three-stage ozonizer, three ozone generators connected in series with three ozonizer stages and connected in parallel to the atmospheric air supply line containing an air filter, a compressor, a refrigerator and a drying chamber, while the sorption purification unit contains three filters loaded with activated carbon The filters connected in series at the inlet with the outputs of the three stages of the ozonizer, the electrolysis water treatment unit contains three electrolyzers, the water supply unit includes a means for supplying drinking water connected through a valve to the filter unit, the output of which is connected in parallel to the three stages of the ozonator, as well as a means for supplying distilled water. water, connected in parallel to the tank for sodium chloride and through a valve, a collection of distilled water, a pump and a check valve with an ultraviolet irradiator, three micro- and ultrafilters installed in series and through a valve with a collection of pyrogen-free water, and the output of the second filter is connected through a valve to a collection of distilled water. water, the outlet of the pyrogen-free water collector through a pump and a valve is connected to the inlet of the 1st stage of the ozonator, and the outlet of the tank for sodium chloride is connected to the inlets of three electrolyzers, which are also connected through valves to the outlets of three sorption filters, while the outlet of the first filter through the veins The style is connected to the inlet of the 2nd stage of the ozonator, the outlet of the second filter is connected through the valve to the inlet of the 3rd stage of the ozonator, and the outlet of the third filter through the valves is connected in parallel with the collectors of ozonized and non-pyrogenic water, the outlets from the anode space of the three electrolyzers are connected through the valves to the inlets of the three sorption filters and through valves with an anolyte collector, the outlet from the cathode space of the third electrolyzer through a valve and a pump is connected to the outlet of the non-pyrogenic water collector and the inlet of the ultraviolet irradiator, the treated water selection unit by the consumer contains water sampling means connected through valves to the non-pyrogenic water, ozonized and pyrogen-free water collectors, as well as anolyte and catholyte.

The known method of multi-stage water treatment and installation for its implementation can increase the degree of purification of distilled water from pyrogenic substances (microorganisms) of bacterial and animal origin due to the complex (simultaneous and repeated) exposure to ultraviolet irradiation, compressed three-stage ozonation with an ozone-air mixture and electrolytic ionization of water, get biologically active, ionized water (catholyte with a pH of at least 11), which stimulates the healing of wounds, burns and the treatment of other diseases, get bactericidal, sterilizing, ionized water (anolyte with a pH of no more than 3), get toxic substances, pathogenic microorganisms and carcinogenic trace elements - disinfected, discolored and odorless water (in different operating modes of the installation)

The disadvantage of this method is its complexity, multi-stage, high capital and operating costs for obtaining water for injection.

A method is known for producing water for injection using a combination of reverse osmosis and subsequent ultrafiltration, and it is noted that after the reverse osmosis stage, it is advisable to use electrodeionization. Ultrafiltration membranes are operated in cross flow (tangential flow) so that dirt does not accumulate on the membranes - there is always a flow along the membrane surface, which carries away the separated material, due to which, along with the filtrate (permeate), a concentrate is formed. Electrodeionization is carried out in an ion exchange apparatus, reverse osmosis in a reverse osmosis unit, ultrafiltration in an ultrafiltration membrane unit (membrane module) (Prikhodko A.E., Valevko S.A. Methods of preliminary preparation and production of water for pharmaceutical purposes // Chemical and Pharmaceutical Journal, 2002, vol. 36, no. 10, pp. 31-40).

The main disadvantage of this method of obtaining water for injection is the need to ensure further storage of the resulting water.

Known method and installation for producing water for injection (application US 2004/079700 A1, class IPC A61K 9/08, B01D 61/02, B01D 61/04, B01D 61/08, B01D 61/10, B01D 65/02, B01D 65/10, C02F 1/02, C02F 1/44, published 04/29/2004).

The method includes pre-treatment of the raw water, which may include a combination of reverse osmosis and deionization, possibly reducing the salt content in the water, and obtaining pre-purified water; directing pre-treated water directly to the high temperature reverse osmosis unit through a heat exchanger and through a pump that provides high pressure water to the membrane; supplying water to the high pressure reverse osmosis membrane side; and collecting and discharging water for injection from the low pressure reverse osmosis membrane side while maintaining self-cleaning conditions. The final membrane filtration of water, as well as pre-treatment of water, in a known method is carried out by reverse osmosis.

The system (installation) for producing water for injection includes an input device, a source water pretreatment device, a continuous high-temperature reverse osmosis device into which pretreated water is supplied, one or more heat exchangers, a water storage device (accumulation tank) and a water outlet device for injections. The raw water pre-treatment device consists of a softener (optional), a second reverse osmosis device and a deionizer connected in series with a pipeline, designed to obtain pre-purified water and connected to a continuous high-temperature reverse osmosis device through a preheater and a heat exchanger. The device for continuous high-temperature reverse osmosis includes a pump for providing high pressure of water supplied to it and a reverse osmosis membrane. The temperature of the reverse osmosis membrane is at least about 60° C. to keep the membrane self-cleaning. Temperature sensors, such as thermocouples, are placed at one or more points in the installation. Other elements of the system are pipes, valves, gaskets.

Thanks to self-purification, the required water quality for endotoxins is ensured, and 98.8-99.99% of salts are removed. The method and installation ensure the production of water for injection in a hot mode with an electrical conductivity corresponding to the required one - less than 1.3 μS/cm.

The disadvantage of the described technical solution is that the performance of the installation is not stable enough - in the first hour of operation of the installation, a productivity of 5.8 l / min (348 l / h) can be provided, and after 60 hours of operation it decreases to 3.725 l / min (223.5 l /h).

The known method according to the set of essential features and the achieved result can be selected as the closest analogue (prototype) for the method of obtaining water for injection.

The objective of the invention is to obtain water for injection in a stream in order to avoid iridescence of the water storage system, with ease of processing, the ability to work both in hot and cold modes, the ability to obtain water for injection of any capacity and the required quality for endotoxins (according to FS.2.2 .0020.19) with stable operation of the unit in all modes and when switching between them in conditions of its continuous operation for a long time.

To solve the problem in the method for producing water for injection (WFI), including preliminary purification of the source water by reverse osmosis and electrodeonization to obtain pre-purified water, its direction through a circulation pump to a heat exchanger and membrane filtration, as well as the subsequent withdrawal of the target product - WFI, at the same time, the pre-purified water is supplied to the storage tank, and from there it is continuously fed by a centrifugal pump to the heat exchanger, as membrane filtration, tangential ultrafiltration is carried out in an ultrafiltration module equipped with a ceramic membrane, while ensuring a pressure drop in the range from 0.1 MPa to 0.7 MPa with the receipt of the VDI sent to the consumer, and the unused VDI is returned to the storage tank.

The ultrafiltration module according to the proposed method is periodically subjected to chemical and thermal cleaning by introducing a washing agent into the water, then passing the water through a heat exchanger to heat it to a temperature of 60-80°C, supplying the resulting hot water containing the washing agent to the ultrafiltration module, keeping it in for 30-120 minutes and discharge of waste water after completion of chemical and thermal treatment.

To obtain hot WFI, pre-purified water is heated to the required temperature while passing through a heat exchanger.

Also, to solve the problem, a plant for the production of water for injection (WFI) is proposed, equipped with shutoff valves and sensors, reverse osmosis and electrodeionization devices connected in series through pipelines and intended for preliminary purification of the source water, as well as a WFI production unit containing a storage tank and a heat exchanger and a membrane device connected in series through pipelines, in which the storage tank is in communication with the electrodeionization device, and also with the heat exchanger by means of a circulation pump, while the membrane device is an ultrafiltration module with ceramic membranes, made with the possibility of tangential ultrafiltration to obtain WFI sent to the consumer , and communicated with the pipeline for returning the unused WFI to the storage tank, and the specified WFI production unit is configured to provide periodic chemical and thermal cleaning.

The technical result consists in the fact that the installation for obtaining WFI is an ultrafiltration module with piping, integrated into the distribution system of pharmacopoeia-quality water with a quality not lower than purified water (PO) and a specific electrical conductivity lower than 1.1 μS/cm at a temperature 20°C, under conditions of continuous operation of the unit for 3 (three) months, and:

- there are no stagnant and non-washable areas in the system,

- filtration through the membrane module is carried out continuously in a tangential mode, which prevents biofouling of the system and ensures a consistently high quality of the resulting water

- there are no water losses in the production of WFI due to the return of all unused water back to the VO circuit,

- VDI can be produced and consumed at a given temperature and a given volume, depending on the needs of production,

- the use of special membranes and the design of the system makes it possible to carry out thermal (including steam) and chemical sanitation of both the WFI production system separately from the pharmaceutical water distribution circuit, and as part of it.

Water for injection is obtained directly in the ultrafiltration module and is immediately used (consumed) after receipt, in contrast to the prototype. Unused VDI is declassified by pouring into a container of VO. The process is repeated continuously.

On FIG. 1 shows a diagram of the installation for obtaining VDI, where:

1 - reverse osmosis device

2 - electrodeionization device

3 - storage capacity

4 - circulation pump

5 - block receiving VDI

6 - pipeline for returning VDI to the storage tank

7 - pipeline for sending VDI to the consumer

On FIG. 2 shows a schematic diagram of the block for obtaining VDI, where:

5.1.1 - heat exchanger

5.1.2 - membrane device - ultrafiltration module with ceramic membranes

5.1-5.7 - shut-off and control valves

5.8 - flow sensor

5.9 - sensor for measuring electrical conductivity

5.10 - sensor for measuring TOC (total organic carbon).

The unit is permanently installed on a wall or on a frame at the WFI consumption point and connected to the pipeline for WFI return to the storage tank using taps 5.2 and 5.3. To ensure the flow of water through the Installation, a valve 5.1 is installed in the pipeline to return the VDI to the storage tank or a pressure difference is created due to throttling (local narrowing of the flow) between the valves 5.2 and 5.3. Using tap 5.4, a pressure difference is created through the ultrafiltration module with ceramic membranes - 5.1.2 and the permeate flow and the concentrate flow are adjusted. The selection of WFI is carried out by means of a pipeline for sending WFI to the consumer using a valve 5.5. In the absence of withdrawal, unused water is returned back to the pipeline to return the WFI to the storage tank using a valve 5.3.

A heat exchanger (5.1.1) is provided in the system for thermal sanitation and consumption of water at a given temperature.

For chemical cleaning and sanitation, taps 5.6 and 5.7 are provided.

Water quality is controlled using instrumentation:

- flow sensors 5.8 provide control of the speed in the pipeline line to send the WFI to the consumer

- conductivity sensors 5.9 - quality control of produced WFI (electrical conductivity)

- TOC 5.10 sensors - quality control of produced WFI (total organic carbon, optional).

The operation of the installation is automated, carried out using a control panel based on an industrial controller with the possibility of visualization and archiving (optional).

The installation works as follows.

The installation provides the following main modes:

Standby mode (no VDI consumption)

Cold WFI production mode (WFI consumption is present, the consumption temperature is equal to the temperature of the source water)

Hot WFI production mode (WFI consumption is present, the consumption temperature is different from the temperature of the source water)

Service maintenance mode (There is no WFI consumption, local chemical / thermal cleaning of the Unit is performed).

1. Standby mode. Pharmacopeial quality water of quality not lower than Purified Water (VO) and electrical conductivity lower than 1.1 μS/cm at a temperature of 20°C is fed to the plant through a pipeline for returning WFI to the storage tank. Tap 5.1 is closed to allow water to flow through tap 5.2 to the ultrafiltration module with ceramic membranes (5.1.2). Valve 5.4 is closed to create a pressure differential across the ultra filtration module with ceramic membranes and allow flow through them. Filtration occurs in tangential mode. At the same time, with the help of a valve 5.4, 5.1 and a flow sensor 5.8, the turbulent flow regime in the pipeline is adjusted and maintained to direct the WFI to the consumer.

In all other pipelines, the systems also maintain a turbulent flow regime and overpressure.

In the absence of WFI consumption (faucet 5.1 is closed), the water is returned back to the pipeline to return the WFI to the storage tank. The quality of the resulting water is controlled by sensors 5.9 (electrical conductivity) and 5.10 (total organic carbon).

2. Mode of production of cold WFI

In this mode, the valve 5.5 is opened, and all produced WFI goes to consumers. The flow is controlled by the flow sensor 5.8.

Thermal sanitation is provided before sampling, similar to the heating and cooling procedure prescribed in the section: “Hot WFI Production Mode” (see below).

3 Hot WFI production mode

In this mode, before opening the valve 5.5 (supplying WDI to the consumer), the heat exchanger (5.1.1) is turned on, and the source water is heated to the desired temperature (60-80°C). Until the desired sanitation temperature is reached, the faucet 5.3 is closed, and the water is discharged through the faucet 5.7 into the sewer. After reaching the temperature mode, the valve 5.7 is closed and the valve 5.5 is opened, and the VDI is selected.

4. Service mode

4.1. Thermal sanitation procedure: In this mode, the heating and cooling procedure is similar to that prescribed in the section: “Hot WFI production mode”, with the exception of water withdrawal (tap 5.5 is closed in this mode).

4.2. Chemical sanitation procedure:

Chemical sanitation of the Units is carried out by connecting the CIP-washer to valves 5.6 and 5.7. The connection is organized in such a way as to form a circulation loop through the CIP-cleaner and the Plant.

The invention is illustrated by the following examples.

Example

In accordance with the scheme (Fig. 2) was designed and launched the proposed plant with a capacity of 500 l/h at a temperature of 18-22°C.

Installation tests are carried out continuously for 3 (three) months.

During the tests were:

- tests were carried out at different initial parameters of the system (pressure, flow, temperature),

- checked the operation of the modes, as well as manual and automatic switching between them,

- the processes of rehabilitation and chemical cleaning of membranes were carried out and worked out.

The system showed stable operation in all modes and when switching between them during continuous operation for 3 (three) months.

Operating parameters Standby settings (example 1):

1. Consumption in the pipeline for the return of VDI to the storage tank of pharmaceutical water - 13-15 m ³ / h.

1. The quality of the source water - corresponds to FS.2.2.0020.18 "Purified water", the specific electrical conductivity of water is 0.3 μS / cm at a temperature of 20 ° C

2. Pressure at the inlet to the Installation - 0.43 MPa

3. Temperature at the inlet to the Unit - 20.6°С

4. Pressure drop across the ultrafiltration module - 0.02 MPa.

5. Pressure drop across ceramic membranes - 0.19 MPa.

6. Productivity of system on VDI - 200 l/h.

7. VDI temperature - 20.7 ° C

8. Electrical conductivity of VDI - 0.3 µS/cm

9. Microbiological purity - 0 CFU/100 ml

10. Bacterial endotoxins - less than 0.25 EU/ml

Operating parameters of the Plant in the cold WFI production mode (example 2):

1. Consumption in the pipeline for the return of VDI to the storage tank of pharmaceutical water (flow rate supplied to the Plant) - 13-15 m ³ / h.

2. The quality of the source water - corresponds to FS.2.2.0020.18 "Purified water", the specific electrical conductivity of water is 0.3 μS / cm at a temperature of 20 ° C

3. Pressure at the inlet to the Installation - 0.45 MPa

4. Temperature at the inlet to the Unit - 20.1°С

5. Pressure drop across the ultrafiltration module - 0.00-0.01 MPa.

6. Pressure drop across ceramic membranes - 0.45 MPa.

7. Productivity of system on VDI - 520 l/h.

8. VDI temperature - 20.1 ° C

9. Electrical conductivity of VDI - 0.3 µS/cm

10. Microbiological purity - 0 CFU/100 ml

11. Bacterial endotoxins - less than 0.25 EU/ml.

Operating parameters of the Plant in the mode of production of hot WFI (example 3):

1. The flow rate in the pipeline for the return of WFI to the storage tank of pharmaceutical water (flow rate supplied to the Unit) - 13-15 m ³ / h.

2. The quality of the source water - corresponds to FS.2.2.0020.18 "Purified water", the specific electrical conductivity of water is 0.3 μS / cm at a temperature of 20 ° C

3. Pressure at the inlet to the Unit - 0.48 MPa.

4. The temperature at the inlet to the Unit is 20.8°С.

5. Pressure drop across the ultrafiltration module - 0.00-0.01 MPa.

6. Pressure drop across ceramic membranes - 0.48 MPa.

7. Productivity of system on VDI - 650 l/h.

8. WFI temperature - 65°С.

9. Electrical conductivity of VDI - 0.7 µS/cm.

10. Microbiological purity - 0 CFU/100 ml.

11. Bacterial endotoxins - less than 0.25 EU/ml.

The operating parameters of the installation are given in the table.

Control of the effectiveness of the proposed method and device is carried out by analyzing the quality indicators of the resulting water for injection. Sampling was carried out every day for 30 days. The system showed stable operation in all modes and when switching between them during continuous operation for 3 (three) months.

Thus, the tests carried out show that the proposed method and device for its implementation provide the quality of WFI samples that meets the requirements of the Pharmacopoeia article FS.2.2.0020.19 "Water for injection" in all respects.

Claims (4)

1. A method for producing water for injection (WFI), including preliminary purification of the source water by reverse osmosis and electrodeonization to obtain pre-purified water, its direction through a circulation pump to a heat exchanger and membrane filtration, as well as the subsequent output of the target product - WFI, characterized in that that the pre-purified water is supplied to the storage tank, and from there continuously by a centrifugal pump to the heat exchanger, as membrane filtration, tangential ultrafiltration is carried out in an ultrafiltration module equipped with a ceramic membrane, while ensuring a pressure drop in the range from 0.1 MPa to 0.7 MPa with receipt of the VDI sent to the consumer, and the unused VDI is returned to the storage tank. 2. The method according to p. 1, characterized in that the ultrafiltration module is periodically subjected to chemical and thermal cleaning by introducing a washing agent into water, then passing water through a heat exchanger to heat it to a temperature of 60-80 ° C, supplying the resulting hot water containing a washing agent , into the ultrafiltration module, keeping in it for 30-120 minutes and discharge of waste water after the completion of chemical and thermal treatment. 3. The method according to p. 1, characterized in that to obtain hot WFI, pre-purified water is heated to the required temperature when passing through a heat exchanger. 4. Installation for the production of water for injection (WFI), equipped with shut-off and control valves and sensors, reverse osmosis and electrodeionization devices connected in series through pipelines and intended for preliminary treatment of source water, as well as a WFI production unit containing a storage tank and connected in series through pipelines, a heat exchanger and a membrane device, characterized in that the storage tank is in communication with the electrodeionization device, and also through the circulation pump - with the heat exchanger, while the membrane device is an ultrafiltration module with ceramic membranes, made with the possibility of tangential ultrafiltration to obtain WFI sent to the consumer , and communicated with the pipeline for returning the unused WFI to the storage tank, and the specified WFI production unit is configured to provide periodic chemical and thermal cleaning.

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