CN106726576B - Suspension preparation and conveying system - Google Patents
Suspension preparation and conveying system Download PDFInfo
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- CN106726576B CN106726576B CN201611224499.XA CN201611224499A CN106726576B CN 106726576 B CN106726576 B CN 106726576B CN 201611224499 A CN201611224499 A CN 201611224499A CN 106726576 B CN106726576 B CN 106726576B
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- 238000002360 preparation method Methods 0.000 title claims abstract description 119
- 239000000725 suspension Substances 0.000 title claims abstract description 30
- 239000007788 liquid Substances 0.000 claims abstract description 204
- 238000009826 distribution Methods 0.000 claims abstract description 67
- 238000001914 filtration Methods 0.000 claims abstract description 54
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 47
- 230000001954 sterilising effect Effects 0.000 claims abstract description 45
- 230000003139 buffering effect Effects 0.000 claims abstract description 25
- 239000000498 cooling water Substances 0.000 claims abstract description 21
- 238000002347 injection Methods 0.000 claims abstract description 17
- 239000007924 injection Substances 0.000 claims abstract description 17
- 238000007599 discharging Methods 0.000 claims abstract description 10
- 238000004659 sterilization and disinfection Methods 0.000 claims description 36
- 239000002351 wastewater Substances 0.000 claims description 15
- 239000000203 mixture Substances 0.000 claims description 11
- 238000009472 formulation Methods 0.000 claims description 10
- 238000010438 heat treatment Methods 0.000 claims description 9
- 238000005507 spraying Methods 0.000 claims description 8
- 238000012544 monitoring process Methods 0.000 claims description 5
- 238000012864 cross contamination Methods 0.000 claims description 4
- 239000008213 purified water Substances 0.000 claims description 4
- 238000012360 testing method Methods 0.000 claims description 3
- 230000000903 blocking effect Effects 0.000 claims description 2
- 230000001502 supplementing effect Effects 0.000 claims description 2
- 238000004140 cleaning Methods 0.000 abstract description 18
- 230000000249 desinfective effect Effects 0.000 abstract description 2
- 239000003814 drug Substances 0.000 description 13
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- 238000011194 good manufacturing practice Methods 0.000 description 4
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- SUBDBMMJDZJVOS-UHFFFAOYSA-N 5-methoxy-2-{[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}-1H-benzimidazole Chemical compound N=1C2=CC(OC)=CC=C2NC=1S(=O)CC1=NC=C(C)C(OC)=C1C SUBDBMMJDZJVOS-UHFFFAOYSA-N 0.000 description 3
- 238000004891 communication Methods 0.000 description 3
- 229960000381 omeprazole Drugs 0.000 description 3
- 238000003860 storage Methods 0.000 description 3
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
- A61L2/04—Heat
- A61L2/06—Hot gas
- A61L2/07—Steam
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/26—Accessories or devices or components used for biocidal treatment
- A61L2/28—Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J2200/00—General characteristics or adaptations
- A61J2200/40—Heating or cooling means; Combinations thereof
- A61J2200/42—Heating means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J2200/00—General characteristics or adaptations
- A61J2200/70—Device provided with specific sensor or indicating means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J2200/00—General characteristics or adaptations
- A61J2200/70—Device provided with specific sensor or indicating means
- A61J2200/72—Device provided with specific sensor or indicating means for temperature
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/10—Apparatus features
- A61L2202/14—Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
Abstract
The invention discloses a suspension preparation and delivery system, which comprises: the device comprises a feeding device, a liquid preparation device, a filtering device, a buffering device and a discharging device, wherein the feeding device, the liquid preparation device, the filtering device and the buffering device are sequentially communicated; the feeding device comprises a first compressed air supply device for supplying compressed air to the control cabinet, a steam supply device for supplying steam to the liquid distribution device, the filtering device and the buffering device, a second compressed air supply device for supplying compressed air to the liquid distribution device, an injection water supply device for supplying water to the liquid distribution device, a cooling water supply device for supplying cooling water to the liquid distribution device and an industrial steam supply device for supplying industrial steam to the liquid distribution device. In the invention, steam is provided for the liquid preparation device, the filtering device and the buffering device and is used for cleaning or sterilizing; thereby automatically and thoroughly disinfecting, cleaning and sterilizing the liquid preparation device, the filtering device and the buffering device; the labor intensity is reduced, and the working efficiency is improved.
Description
Technical Field
The invention belongs to the technical field of medicine manufacturing, and particularly relates to a suspension preparation and delivery system.
Background
In biopharmaceutical production systems, for example: the omeprazole dry suspension is prepared, and a liquid preparation tank, a pipeline and other equipment in a conveying system need to be cleaned and disinfected regularly to ensure that the liquid preparation tank, the pipeline and the other equipment in the system meet the requirements of production process regulations.
At present, the cleaning and disinfection of liquid preparation tanks, pipes and other equipment are usually done manually. However, such manual cleaning and sterilization has the following disadvantages: the disinfection, cleaning and sterilization are not thorough, and in the cleaning process, the disassembly and connection of the pipelines can bring the risk of artificial pollution. Meanwhile, the labor intensity of operators is increased, and the interest rate working efficiency is reduced.
Disclosure of Invention
The technical scheme provided by the invention is as follows:
the present invention provides a suspension formulating delivery system comprising: the device comprises a feeding device, a liquid preparation device, a filtering device and a buffering device which are sequentially communicated, and a discharging device which is respectively communicated with the feeding device, the liquid preparation device, the filtering device and the buffering device; the feeding device comprises a first compressed air supply device for supplying compressed air to the control cabinet, a steam supply device for supplying steam to the liquid distribution device, the filtering device and the buffering device, a second compressed air supply device for supplying compressed air to the liquid distribution device, an injection water supply device for supplying water to the liquid distribution device, a cooling water supply device for supplying cooling water to the liquid distribution device and an industrial steam supply device for supplying industrial steam to the liquid distribution device.
Further, the liquid preparation device comprises: each liquid distribution tank is communicated with the first liquid distribution header pipe through a first liquid distribution branch pipe; the first liquid distribution branch pipe is provided with a first liquid distribution pneumatic valve, and the first liquid distribution main pipe is communicated with the steam supply device; each liquid preparation tank is communicated with a second liquid preparation main pipe through a second liquid preparation branch pipe; the second liquid distribution branch pipe is provided with a second liquid distribution pneumatic valve, and the second liquid distribution main pipe is communicated with the injection water supply device.
Furthermore, the tank top of each liquid preparation tank is provided with a first liquid preparation channel and a second liquid preparation channel; the first liquid preparation channel or the second liquid preparation channel is provided with a spraying ball, and the spraying ball is used for sending the injection water and/or the purified water into a liquid sending channel in the liquid preparation tank.
Further, each liquid preparation tank is provided with a liquid preparation respirator communicated with the liquid preparation tank, the liquid preparation respirator is communicated with the steam supply device and the second compressed air supply device, and the liquid preparation respirator is also communicated with the discharge device; and a liquid outlet communicated with the filtering device is formed at the bottom of each liquid distribution tank.
Furthermore, each liquid preparation tank is sleeved with a jacket capable of containing liquid, the jacket is provided with an inlet and an outlet which are communicated with the cooling water supply device, and the jacket is also communicated with the second compressed air supply device and the industrial steam supply device.
Further, the filtering apparatus includes: the two filters are sequentially communicated to form a filtering unit, and each liquid distribution tank is communicated with the filter, close to one side of the liquid distribution tank, in one filtering unit through a conveying pipe; the conveying pipe is provided with a first filtering pneumatic valve and a first filtering pressure sensor; and a second filtering pressure sensor is arranged on the output pipeline of each filter.
Further, an exhaust pipeline communicated with the discharge device is arranged at the top of each filter, and a second filtering pneumatic valve is arranged on the exhaust pipeline.
Further, the buffer device includes: and each buffer tank is communicated with a filter which is arranged in one filtering unit and is close to one side of the buffer tank, and each buffer tank is also communicated with the steam supply device.
Furthermore, each buffer tank is communicated with a buffer respirator, and a first buffer manual valve is arranged between each buffer respirator and the corresponding buffer tank; and the buffer tank is also provided with a buffer liquid level meter and a buffer pressure gauge.
Further, the discharge device includes: the device comprises a waste water discharge channel and a cooling water discharge channel, wherein a centrifugal pump is arranged on the waste water discharge channel, a discharge manual valve and a conductivity meter are arranged on the waste water discharge channel, and the conductivity meter is used for testing the conductivity of the discharged waste water; and the waste water discharge channel and the cooling water discharge channel are respectively provided with a temperature transmitter and a check valve.
Compared with the prior art, the suspension preparation and delivery system provided by the invention has the following beneficial effects:
1) The invention is provided with a feeding device, a liquid preparation device, a filtering device, a buffering device and a discharging device in sequence; the feeding device can provide water for injection to the liquid preparation device for preparing the medicine; steam can be provided for the liquid preparation device, the filtering device and the buffering device and is used for cleaning the liquid preparation device, the filtering device and the buffering device or sterilizing the liquid preparation device, the filtering device and the buffering device; thereby automatically and thoroughly disinfecting, cleaning and sterilizing the liquid preparation device, the filtering device and the buffering device; the labor intensity of operators is reduced, and the working efficiency is improved.
2) Two sets of liquid distribution systems are designed, when one set of liquid distribution system is filled, the other set of liquid distribution system is cleaned or sterilized, a double-valve partition mode (a first liquid distribution pneumatic valve and a second liquid distribution pneumatic valve) is adopted, and double protection is realized, so that cross contamination in the system is avoided.
3) The liquid preparation respirator is arranged on the liquid preparation tank, so that air in the liquid preparation tank can be balanced with external air pressure, and the liquid preparation tank is prevented from being exploded or collapsed due to too large or too small pressure in the liquid preparation tank. And the air entering the liquid preparation tank achieves the purpose of sterilization when passing through the liquid preparation respirator, and does not pollute the liquid medicine.
4) The liquid preparation tank is sleeved with the jacket, and the cooling water supply device and the industrial steam supply device supply cooling water and industrial steam to the jacket, so that the requirements of different liquid medicines at different configuration temperatures in the configuration process are met.
5) According to the invention, a special exhaust pipeline is designed at the top of the filter for sterilization, and pressure sensors (a first pressure sensor and a second pressure sensor) are arranged in front of and behind the filter, so that the pressure difference between the front and the rear of the filter is recorded in real time, and the steam supplement amount is adjusted according to the pressure difference, thereby achieving the effect of sterilizing the filter.
6) The invention adds a conductivity probe and a temperature probe at the discharge port, converts the conductivity value into a 4-20 milliampere analog quantity signal, transmits the signal to a PLC system for data recording and storage, and can monitor the conductivity value and the temperature value on line after the batch production of liquid medicine is finished and pipelines and equipment are cleaned or the system SIP (on-line sterilization) is carried out, thereby achieving the data required in cleaning verification and sterilization verification.
Drawings
The foregoing features, technical characteristics, advantages and modes of realisation of a suspension dispensing delivery system will be further described in the following, in a clearly understandable manner, with reference to the accompanying drawings, which illustrate preferred embodiments.
FIG. 1 is a table of a portion of an identification chart for a suspension dispensing delivery system of the present invention;
FIG. 2 is a table of a further section of a schematic identification chart of a suspension dispensing delivery system of the present invention;
FIG. 3 is a table of yet another portion of an identification chart for a suspension dispensing delivery system of the present invention;
FIG. 4 is a schematic diagram of the structure of a feeding device, a liquid preparation device and a discharge device in a suspension preparation and delivery system according to the present invention;
FIG. 5 is a schematic illustration of the configuration of the dispensing unit of one suspension dispensing delivery system of the present invention;
FIG. 6 is a schematic diagram of the construction of the filtration and buffering devices of a suspension dispensing delivery system of the present invention;
FIG. 7 is a schematic diagram of a control cabinet of a suspension dispensing delivery system of the present invention;
FIG. 8 is a schematic diagram of the filling unit of a suspension dispensing delivery system of the present invention.
Detailed Description
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following description will be made with reference to the accompanying drawings. It is obvious that the drawings in the following description are only some examples of the invention, and that for a person skilled in the art, without inventive effort, other drawings and embodiments can be derived from them.
For the sake of simplicity, the drawings only schematically show the parts relevant to the present invention, and they do not represent the actual structure as a product. In addition, in order to make the drawings concise and understandable, components having the same structure or function in some of the drawings are only schematically illustrated or only labeled. In this document, "one" means not only "only one" but also a case of "more than one".
As shown in FIGS. 1-8, according to one embodiment of the present invention, a suspension formulation delivery system includes: the device comprises a feeding device, a liquid preparation device, a filtering device and a buffering device which are sequentially communicated, and a discharging device which is respectively communicated with the feeding device, the liquid preparation device, the filtering device and the buffering device; the feeding device comprises a first compressed air supply device for supplying compressed air to the control cabinet, an electric contact pressure gauge and an air combined element are arranged between the first compressed air supply device and the control cabinet, and the compressed air output by the first compressed air supply device is used for controlling the working state of a starting valve in the control cabinet; the steam supply device supplies steam to the liquid preparation device, the filtering device and the buffer device, and the steam output by the steam supply device (PS supply device) is used for cleaning or sterilizing the liquid preparation device, the filtering device and the buffer device; a second compressed air supply device for supplying compressed air to the liquid distribution device, wherein an output pipeline of the second compressed air supply device is provided with an air combination element; an injection water supply device for supplying water to the liquid preparation device, wherein the injection water output by the injection water supply device is used for preparing the medicine; the injection water supply device and the cooling water supply device are respectively communicated with the heat exchanger; and an industrial steam supply device for supplying industrial steam to the liquid distribution device. An air filter is arranged on an output pipeline of the steam supply device in a communication mode, the air filter is further arranged in a communication mode with the second compressed air supply device, and the air filter is further arranged in a communication mode with the discharge device. The suspension preparation conveying system also comprises a filling device for filling prepared liquid medicine, wherein one filling machine is used for the common use, the time is short, and 3 batches of materials are required to be filled in one day.
In view of the improvement of the above embodiment, in this embodiment, the liquid preparation apparatus includes: each liquid distribution tank is communicated with the first liquid distribution header pipe through a first liquid distribution branch pipe; the first liquid distribution branch pipe is provided with a plurality of first liquid distribution pneumatic valves (for example, 2 or 3), and the first liquid distribution main pipe is communicated with the steam supply device; each liquid preparation tank is communicated with a second liquid preparation main pipe through a second liquid preparation branch pipe; the second liquid distribution branch pipe is provided with a plurality of second liquid distribution pneumatic valves (for example, 2 or 3), and the second liquid distribution main pipe is communicated with the injection water supply device. 300L of liquid preparation tank TK-01 and 300L of liquid preparation tank TK-02 (the volume of the liquid preparation tank can be determined according to the requirements of each different production process), and the materials are passed through compressed air.
The tank top of each liquid preparation tank is provided with a first liquid preparation channel and a second liquid preparation channel; the first liquid distribution channel is communicated with the first liquid distribution branch pipe, and the second liquid distribution channel is communicated with the second liquid distribution branch pipe; the first liquid preparation channel and/or the second liquid preparation channel is/are provided with a spray ball, and the spray ball is used for sending the injection water and/or the purified water into a liquid sending channel in the liquid preparation tank. The bottom of each liquid preparation tank is communicated with a magnetic stirrer, a liquid preparation temperature transmitter and a weighing module, and each liquid preparation tank is also provided with a pressure transmitter, a pressure gauge and a rupture disk.
The tank top of the liquid preparation tank TK-01 is provided with an injection water and purified water interface to be connected with a tank top spraying ball together, a pipeline is additionally arranged to directly enter the tank without the tank top spraying ball, and the operation of spraying through the top filling can meet the requirement in the conventional material preparation process. However, in the emerging biopharmaceutical field, the requirements of some special materials on the batching process conditions are extremely strict, and if the conventional method is adopted (i.e. injection water directly enters into the tank by spraying during batching, and an additional inlet is not added directly into the tank), the foaming is easily caused in the batching process, the material transportation is inconvenient, or the material liquid splashes, and for the materials, the material characteristics can be changed. This may be necessary depending on the particular pharmaceutical field.
Each liquid distribution tank is provided with a liquid distribution respirator communicated with the liquid distribution tank, the liquid distribution respirator is communicated with the steam supply device and the second compressed air supply device through a first breathing pneumatic valve, and the liquid distribution respirator is also communicated with the discharge device through a second breathing pneumatic valve; and a liquid outlet communicated with the filtering device is formed at the bottom of each liquid distribution tank.
The liquid preparation respirator can balance the air in the liquid preparation tank with the external air pressure, so that the liquid preparation tank is prevented from being exploded or shriveled due to too large or too small pressure in the liquid preparation tank. And the air entering the liquid preparation tank achieves the purpose of sterilization when passing through the liquid preparation respirator, and does not pollute the liquid medicine. The liquid preparation respirator is additionally provided with the heater, the liquid preparation respirator is additionally provided with a heating function, pure steam is required to be used during online sterilization, the pure steam is easy to generate condensed water, the condensed water can block a filter element in the liquid preparation respirator, and the liquid preparation respirator is heated by adopting a heating mode, so that the condensed water is evaporated, and the blockage of the filter element is avoided.
Each liquid distribution tank is sleeved with a jacket capable of containing liquid, the jacket is provided with an inlet and an outlet which are communicated with the cooling water supply device, cooling water output by the cooling water supply device flows into the jacket through a heat exchanger or directly flows into the jacket from the inlet, then flows out of the jacket from the outlet and returns to the cooling water supply device, and therefore water resources are recycled to cool the liquid distribution tanks; the jacket is also communicated with the second compressed air supply device and the industrial steam supply device; the compressed air output by the second compressed air supply device enters the jacket from the inlet, so that the liquid in the jacket can be discharged to the discharge device; the industrial steam output by the industrial steam supply device flows into the jacket from the inlet, flows out of the jacket from the outlet and is discharged to the discharge device.
In view of the improvement of the above embodiment, in this embodiment, the filtering apparatus includes: the two filters are sequentially communicated to form a filtering unit, and each liquid distribution tank is communicated with the filter, close to one side of the liquid distribution tank, in one filtering unit through a conveying pipe; and a first filtering pneumatic valve and a first filtering pressure sensor are arranged on the conveying pipe. The first filter FL-04 or FL-05 had a filtration precision of 0.45 μm, the second sterilizing filter FL-04 or FL-05 had a filtration precision of 0.22 μm, and fittings on the canister. The fittings include relief valves and diaphragm valves, ball valves, traps, plumbing, etc. of various sizes.
The top of each filter is provided with an exhaust pipeline communicated with the discharging device, when steam is input to the filter by the steam supply device, the steam enters from the bottom of the filter, is discharged from an exhaust pipe at the top of the filter and is discharged to the discharging device, and the filter can be sterilized; the second filtering pressure sensor is arranged at the outlet of the filter and used for detecting a second pressure value; and adjusting the steam supplementing quantity according to the pressure difference between the first pressure value and the second pressure value.
In view of the improvement of the above embodiment, in this embodiment, the buffering device includes: the steam sterilization device comprises two buffer tanks, wherein each buffer tank is communicated with a filter which is arranged on one side of the buffer tank and in one filtering unit, each buffer tank is communicated with a steam supply device, and the buffer tanks are cleaned or sterilized by steam output by the steam supply device. The solution is prepared in the liquid preparation tank T1 or the liquid preparation tank T2, and is conveyed to the buffer tank T3 or the buffer tank T4 through a pipeline after the preparation is finished and a two-stage sterilizing filter for filling, and the control of the whole system is full-automatic control. After cleaning, the process is a pure steam on-line sterilization process (SIP), which includes sterilization of the tank, the tank top breather and the entire system pipeline valve filter. A0.22 mu m sterilizing filter is added in the system to achieve the aim of multi-stage sterilization, thereby better ensuring the quality of the liquid medicine.
Each buffer tank is communicated with a buffer respirator, and a first buffer manual valve is arranged between each buffer respirator and the corresponding buffer tank; the bottom of the buffer tank is communicated with a second buffer manual valve, and a hose is communicated with the second buffer manual valve and used for discharging liquid in the buffer tank; and the buffer tank is also provided with a buffer liquid level meter and a buffer pressure gauge. The buffering respirator can make the air in the buffer tank and external air pressure balance, and the too big or the undersize of pressure in the buffer tank can not lead to the buffer tank to explode or flat. And the air entering the buffer tank achieves the purpose of sterilization when passing through the buffer respirator, and does not pollute the liquid medicine. Be provided with the heating device among the buffering respirator, increased heating function in the buffering respirator, need use pure steam during online sterilization, and pure steam produces the comdenstion water easily, and the comdenstion water can block up the filter core in the buffering respirator, adopts the heating methods this moment, heats buffering respirator, makes the comdenstion water evaporation, is unlikely to lead to the filter core to block up.
In view of the improvement of the above embodiment, in the present embodiment, the discharge device includes: the device comprises a waste water discharge channel and a cooling water discharge channel, wherein a centrifugal pump is arranged on the waste water discharge channel, a discharge manual valve and a conductivity meter are arranged on the waste water discharge channel, and the conductivity meter is used for testing the conductivity of the discharged waste water; and the waste water discharge channel and the cooling water discharge channel are respectively provided with a temperature transmitter and a check valve.
The suspension preparation and conveying system is mainly characterized in that raw material medicines enter a liquid preparation tank through a feeding port, injection water is added for dilution, and the mixture is stirred by a magnetic stirrer; or the liquid medicine is conveyed to the liquid preparation tank through the sanitary water pump, and corresponding injection water is added to complete the accurate liquid preparation process through the weighing module; and then the feed liquid is conveyed to a filling machine through a sterilizing filter for packaging, so that a finished product conveying system is formed.
In the existing omeprazole dry suspension material conveying system, 1 filter with the filtering precision of 0.45 mu m and 2 filters with the filtering precision of 0.22 mu m are generally adopted to be connected in series from a liquid preparation tank to a filling machine, and the material is conveyed to the filling machine after passing through the two filters. Meanwhile, the tank top is also provided with a respirator, and the respirator has the main functions of balancing the air in the tank with the external air pressure in the pharmaceutical industry and carrying out sterile filtration on the external air so as not to cause the tank body to explode or shrink due to too large or too small pressure in the tank; however, pure steam is required to be used in the sterilization or cleaning of the conveying system, and the pure steam is easy to generate condensed water, and the generated condensed water can block a filter element in the respirator, so that the pressure change in the system causes potential safety hazards.
With the development of medical technology today, the validation of material systems in new GMP releases, including the cleaning and sterilization validation of equipment, piping sections, and the filter requirements of material delivery systems, is becoming more stringent. For example: the requirements in the new GMP version are: the sterilization temperature is controlled to be not less than 121 ℃, and the sterilization time is not less than 30min; the traditional conveying system cannot monitor the temperature and the water quality on line, and further the working performance and the working efficiency of the conveying system are influenced.
The two liquid preparation systems of the invention share one filling machine, and the time is short, 3 batches of materials are required to be prepared and filled in one day, so that when one liquid preparation system is used for filling, the other liquid preparation system is used for cleaning or sterilizing, and the systems have the risk of cross contamination; through reasonable design, a double-valve partition mode is adopted, double protection is achieved, and cross contamination is avoided. The traditional online sterilization mode of the sterilization filter is manual exhaust, and the pressure difference is manually recorded; when the sterilization filter in our place is designed for sterilization, a special exhaust pipeline is designed at the top, pressure sensors are arranged in front of and behind the filter, the pressure difference between the front of and behind the filter is recorded in real time, and the steam supplementation amount is adjusted according to the pressure difference, so that the sterilization effect of the filter is achieved.
The invention adds a temperature probe and a conductivity probe at the bottom discharge port of the tank to realize real-time monitoring of temperature and water conductivity, the respirators at the top of the tank respectively adopt electric heating respirators (common respirators are adopted in the traditional conveying system), the main function of the respirators is that in the pharmaceutical industry, the whole system cannot be polluted by bacteria in the outside air due to strict control requirements on the bacteria, so the technical scheme selects and respectively arranges a 0.22 mu m degerming hydrophobic filter at the top end of a proportioning tank as the respirators, the respirators are actually filters, namely hydrophobic filters, namely degerming level filters, and have a heating function, so that gas can pass through but liquid can not pass through, and the main function is to maintain the pressure balance of the outside air in the tank by adopting the electric heating type respirators. Because condensed water is generated in the process of carrying out pure steam online Sterilization (SIP) on the tank body or the pipeline, part of the condensed water is gathered at the top end of the respirator, and the filter element is blocked; in order to prevent this problem, an electric heating function is added to evaporate the condensed water, thereby preventing the condensed water from clogging the filter element. It not only plays the electric heating function, but also plays the role of filtering the atmosphere and maintaining the atmospheric pressure balance inside and outside the tank under the normal condition without sterilization.
Compared with the prior art, the invention also adds a conductivity probe and a temperature probe at the discharge port at the bottom of the tank, converts the conductivity value into a 4-20 milliampere analog signal, transmits the analog signal to the PLC system for data recording and storage, and can monitor the conductivity value and the temperature value on line when cleaning pipelines and equipment and performing SIP (online sterilization) on the system after the batch production of the liquid medicine is finished, thereby achieving the data required in cleaning verification and sterilization verification. In the traditional cleaning verification and sterilization processes, the two online monitoring instruments do not have data required by verification, the cleaned water quality can be monitored due to the conductivity, in GMP (good manufacturing practice) requirements, the sterilization temperature needs to be controlled to be not less than 121 ℃, the sterilization time needs to be not less than 30min, and when a temperature sensor is placed at a discharge port and the position of the lowest temperature point, a relevant node with the lowest temperature point reaching 121 ℃ can be obtained, and timing sterilization is started; whereby the relevant data can be included in the washing and sterilization verification document.
The invention overcomes the defect that the traditional omeprazole dry suspension conveying system cannot monitor the temperature and the water quality on line; and the system can also realize automatic on-line SIP and automatic on-line cleaning process. The system realizes the monitoring of the temperature and the conductivity of the discharged liquid, and prevents the condensed water from blocking a breather at the top of the liquid storage tank through the heating function of the breather so as to prevent the tank body from bursting or collapsing.
It should be noted that the above embodiments can be freely combined as necessary. The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, various modifications and decorations can be made without departing from the principle of the present invention, and these modifications and decorations should also be regarded as the protection scope of the present invention.
Claims (9)
1. A suspension formulation delivery system, comprising:
the device comprises a feeding device, a liquid preparation device, a filtering device and a buffering device which are sequentially communicated, and a discharging device which is respectively communicated with the feeding device, the liquid preparation device, the filtering device and the buffering device;
the feeding device comprises a first compressed air supply device for supplying compressed air to the control cabinet, a steam supply device for supplying steam to the liquid preparation device, the filtering device and the buffering device, a second compressed air supply device for supplying compressed air to the liquid preparation device, an injection water supply device for supplying water to the liquid preparation device, a cooling water supply device for supplying cooling water to the liquid preparation device, and an industrial steam supply device for supplying industrial steam to the liquid preparation device;
the liquid preparation device comprises two liquid preparation tanks, and each liquid preparation tank is communicated with the first liquid preparation main pipe through a first liquid preparation branch pipe; the first liquid distribution branch pipe is provided with a first liquid distribution pneumatic valve, and the first liquid distribution main pipe is communicated with the steam supply device; each liquid preparation tank is communicated with a second liquid preparation main pipe through a second liquid preparation branch pipe; the second liquid distribution branch pipe is provided with a second liquid distribution pneumatic valve, and the second liquid distribution main pipe is communicated with the injection water supply device;
the first liquid distribution pneumatic valve and the second liquid distribution pneumatic valve are respectively provided with at least 2 liquid distribution pneumatic valves, and the liquid distribution pneumatic valves are used for avoiding cross contamination when one liquid distribution tank is filled and the other liquid distribution tank is cleaned or sterilized.
2. The suspension formulation delivery system of claim 1, wherein:
the tank top of each liquid preparation tank is provided with a first liquid preparation channel and a second liquid preparation channel; the first liquid preparation channel or the second liquid preparation channel is provided with a spraying ball, and the spraying ball is used for sending the injection water and/or the purified water into a liquid sending channel in the liquid preparation tank.
3. The suspension formulation delivery system of claim 1, wherein:
each liquid preparation tank is provided with a liquid preparation respirator communicated with the liquid preparation tank, the liquid preparation respirator is communicated with the steam supply device and the second compressed air supply device, and the liquid preparation respirator is also communicated with the discharge device; the bottom of each liquid preparation tank is provided with a liquid outlet communicated with the filtering device;
the liquid distribution respirator has a heating function and is used for preventing condensed water generated by steam from blocking the filter element in a heating mode.
4. The suspension formulation delivery system of claim 1, wherein:
each liquid preparation tank is sleeved with a jacket capable of containing liquid, the jacket is provided with an inlet and an outlet which are communicated with the cooling water supply device, and the jacket is also communicated with the second compressed air supply device and the industrial steam supply device.
5. The suspension formulation delivery system of claim 1, wherein the filtration device comprises:
the two filters are sequentially communicated to form a filtering unit, and each liquid distribution tank is communicated with the filter, close to one side of the liquid distribution tank, in one filtering unit through a conveying pipe; the conveying pipe is provided with a first filtering pneumatic valve and a first filtering pressure sensor; a second filtering pressure sensor is arranged on an output pipeline of each filter;
each filter is provided with an exhaust pipeline communicated with the discharging device, when the steam supplying device inputs steam to the filter for sterilization, the exhaust pipeline discharges the steam to the discharging device, the first filtering pressure sensor is used for detecting a first pressure value, the second filtering pressure sensor is used for detecting a second pressure value, and the steam supplementing quantity is adjusted according to the pressure difference between the first pressure value and the second pressure value.
6. The suspension formulation delivery system of claim 5, wherein:
and a second filtering pneumatic valve is arranged on the exhaust pipeline.
7. The suspension formulation delivery system of claim 5, wherein the buffer device comprises:
and each buffer tank is communicated with a filter which is arranged on one side of the buffer tank and close to one filtering unit, and each buffer tank is also communicated with the steam supply device.
8. The suspension formulation delivery system of claim 7, wherein:
each buffer tank is communicated with a buffer respirator, and a first buffer manual valve is arranged between each buffer respirator and the corresponding buffer tank; and the buffer tank is also provided with a buffer liquid level meter and a buffer pressure gauge.
9. The suspension formulation delivery system of any one of claims 1-8, wherein the discharge device comprises:
the device comprises a waste water discharge channel and a cooling water discharge channel, wherein a centrifugal pump is arranged on the waste water discharge channel, a discharge manual valve and a conductivity meter are arranged on the waste water discharge channel, and the conductivity meter is used for testing the conductivity of the discharged waste water; the waste water discharge channel and the cooling water discharge channel are respectively provided with a temperature transmitter and a check valve;
the conductivity meter is used for monitoring the cleaned water quality, and the temperature transmitter is used for monitoring the sterilization temperature of the lowest temperature point.
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