CN114510000A - Integrated control system for auxiliary process materials in clean room - Google Patents
Integrated control system for auxiliary process materials in clean room Download PDFInfo
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- CN114510000A CN114510000A CN202210139004.2A CN202210139004A CN114510000A CN 114510000 A CN114510000 A CN 114510000A CN 202210139004 A CN202210139004 A CN 202210139004A CN 114510000 A CN114510000 A CN 114510000A
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- 239000000463 material Substances 0.000 title claims abstract description 32
- 238000000034 method Methods 0.000 title claims abstract description 31
- 230000008569 process Effects 0.000 title claims abstract description 30
- 239000007788 liquid Substances 0.000 claims abstract description 34
- 238000003756 stirring Methods 0.000 claims abstract description 12
- 238000012545 processing Methods 0.000 claims abstract description 9
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 claims abstract description 5
- 238000001728 nano-filtration Methods 0.000 claims abstract description 5
- 239000001301 oxygen Substances 0.000 claims abstract description 5
- 229910052760 oxygen Inorganic materials 0.000 claims abstract description 5
- 238000004945 emulsification Methods 0.000 claims abstract description 4
- 238000012546 transfer Methods 0.000 claims abstract description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 15
- 238000004140 cleaning Methods 0.000 claims description 14
- 238000004659 sterilization and disinfection Methods 0.000 claims description 9
- 230000029058 respiratory gaseous exchange Effects 0.000 claims description 7
- 239000002351 wastewater Substances 0.000 claims description 6
- 238000011049 filling Methods 0.000 claims description 5
- 238000005070 sampling Methods 0.000 claims description 5
- 238000009833 condensation Methods 0.000 claims description 4
- 230000005494 condensation Effects 0.000 claims description 4
- 239000000498 cooling water Substances 0.000 claims description 4
- 238000009413 insulation Methods 0.000 claims description 4
- 229920002635 polyurethane Polymers 0.000 claims description 4
- 239000004814 polyurethane Substances 0.000 claims description 4
- 239000000523 sample Substances 0.000 claims description 4
- 239000012774 insulation material Substances 0.000 claims description 3
- 238000002360 preparation method Methods 0.000 description 23
- 238000004519 manufacturing process Methods 0.000 description 19
- 239000003814 drug Substances 0.000 description 16
- 238000002347 injection Methods 0.000 description 8
- 239000007924 injection Substances 0.000 description 8
- 238000005498 polishing Methods 0.000 description 6
- 230000001954 sterilising effect Effects 0.000 description 5
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- 238000009825 accumulation Methods 0.000 description 2
- 238000013019 agitation Methods 0.000 description 2
- 230000007547 defect Effects 0.000 description 2
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- 241000588724 Escherichia coli Species 0.000 description 1
- 206010063385 Intellectualisation Diseases 0.000 description 1
- 241000186781 Listeria Species 0.000 description 1
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- 238000012864 cross contamination Methods 0.000 description 1
- 238000005261 decarburization Methods 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 229910001873 dinitrogen Inorganic materials 0.000 description 1
- 239000003651 drinking water Substances 0.000 description 1
- 235000020188 drinking water Nutrition 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 230000001804 emulsifying effect Effects 0.000 description 1
- 239000003344 environmental pollutant Substances 0.000 description 1
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- 238000010438 heat treatment Methods 0.000 description 1
- 238000012376 hot air sterilization Methods 0.000 description 1
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- 230000002195 synergetic effect Effects 0.000 description 1
- 238000000108 ultra-filtration Methods 0.000 description 1
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Classifications
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- G—PHYSICS
- G05—CONTROLLING; REGULATING
- G05B—CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS
- G05B19/00—Programme-control systems
- G05B19/02—Programme-control systems electric
- G05B19/418—Total factory control, i.e. centrally controlling a plurality of machines, e.g. direct or distributed numerical control [DNC], flexible manufacturing systems [FMS], integrated manufacturing systems [IMS] or computer integrated manufacturing [CIM]
- G05B19/41865—Total factory control, i.e. centrally controlling a plurality of machines, e.g. direct or distributed numerical control [DNC], flexible manufacturing systems [FMS], integrated manufacturing systems [IMS] or computer integrated manufacturing [CIM] characterised by job scheduling, process planning, material flow
-
- G—PHYSICS
- G05—CONTROLLING; REGULATING
- G05B—CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS
- G05B2219/00—Program-control systems
- G05B2219/30—Nc systems
- G05B2219/32—Operator till task planning
- G05B2219/32252—Scheduling production, machining, job shop
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02P—CLIMATE CHANGE MITIGATION TECHNOLOGIES IN THE PRODUCTION OR PROCESSING OF GOODS
- Y02P90/00—Enabling technologies with a potential contribution to greenhouse gas [GHG] emissions mitigation
- Y02P90/02—Total factory control, e.g. smart factories, flexible manufacturing systems [FMS] or integrated manufacturing systems [IMS]
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- Engineering & Computer Science (AREA)
- General Engineering & Computer Science (AREA)
- Manufacturing & Machinery (AREA)
- Quality & Reliability (AREA)
- Physics & Mathematics (AREA)
- General Physics & Mathematics (AREA)
- Automation & Control Theory (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
Abstract
The invention provides a process auxiliary material integrated control system for a clean room, which comprises a reaction tank, a control system and a processing system, wherein the control system and the processing system are arranged on the reaction tank; the control system comprises at least one of: the device comprises a stirring control unit, a CIP/SIP control unit, a temperature control unit, a liquid level control unit, a flow control unit, a PH control unit, a dissolved oxygen control unit, a material transfer control unit and an emulsification control unit; the processing system comprises at least one of: homogenizer, centrifuge, ultrafilter, chromatographic column, nanofiltration machine.
Description
Technical Field
The invention relates to the technical field of process auxiliary material integrated control, in particular to a clean room process auxiliary material integrated control system.
Background
In the production of medicines, the pollution of production environment and production conditions generally comprises microorganisms, dust, particles, corrosion, errors, cross-contamination and the like. The prevention and control of the pharmaceutical equipment on pollution in production comprise two meanings, and the first equipment does not pollute the medicine and does not pollute the environment; the second should have effective means of controlling contamination. For this reason, GMP has made several instructive regulations on pharmaceutical equipment directly involved in drug production, and its essential points are to ensure drug quality, prevent various pollutions to drugs during production, and prevent factors that may affect environment and human health. Therefore, the design of pharmaceutical equipment is required to meet the requirements of GMP, reduce pollution factors and have good prevention and control on pollution.
The liquid preparation system for pharmacy is mainly applied to liquid medicine preparation and filtration and the cleaning and sterilization processes of various solid and liquid preparation equipment, is mutually linked with the traditional solid preparation equipment products in the pharmacy process, and participates in the whole pharmacy process, thereby having vital influence on the medicine quality.
The existing automatic liquid preparation device has a plurality of defects. One of the problems is that the overall structure and the shape are not simplified enough, the whole equipment and parts (including some parts which are visible intuitively) which need to be exposed are too complex, and the concave-convex part, the groove and the platform in the conventional design of the equipment are not flat and simple enough, so that dust and dirt can be hidden to some extent, and the equipment is not easy to clean. The existing liquid preparation device has the defect that a small part of liquid medicine remains on the inner side wall of a pipeline after the concentrated solution of a medicament is added, so that the liquid preparation structure is unqualified.
The production and assembly automation degree of the existing traditional pharmaceutical liquid preparation system product is not high, the production equipment is not advanced enough, the assembly link is mainly manual, and the labor production cost is high. At present, many links in the production process are manually completed, so that microorganisms are easily mixed, the whole batch of finished injection is scrapped, and in addition, the injection preparation is not uniform, and the quality uniformity of each production batch of the injection is poor.
Disclosure of Invention
The invention aims to provide a clean room process auxiliary material integrated control system. So as to solve the technical problems existing in the background technology.
In order to achieve the purpose, the invention adopts the following technical scheme:
the utility model provides a toilet's technology auxiliary material integrated control system, includes retort and installs control system, the processing system on the retort, includes following at least one: the device comprises a stirring control unit, a CIP/SIP control unit, a temperature control unit, a liquid level control unit, a flow control unit, a PH control unit, a dissolved oxygen control unit, a material transfer control unit and an emulsification control unit; the processing system comprises at least one of: homogenizer, centrifuge, ultrafilter, chromatographic column, nanofiltration machine.
In some embodiments, a plurality of parallel common pipelines are arranged above the reaction tank, and each pipeline is provided with an electromagnetic valve.
In some embodiments, the tank bodies of the reaction tank are of a vertical double-layer structure, and the reaction tank comprises an outer tank body and an inner tank body.
In some embodiments, an outer insulation board is attached to the surface of the outer tank body.
In some embodiments, a spiral belt is wound on the surface of the inner tank body, steam water or cooling water is injected into the spiral belt, and the inner tank body is attached with a polyurethane thermal insulation material.
In some embodiments, the head of the bottom of the inner tank body is concave-convex, the top of the tank body is provided with a water inlet, a backflow port, a disinfection port, a cleaning ball, a hole-entering filling port and a breathing port, and the bottom of the tank body is provided with a water condensation port, a discharge port, a sewage discharge port, a sampling port, a temperature probe and a liquid level sensor.
In some embodiments, an air respirator, an agitation system is mounted within the breathing port.
In some embodiments, the reaction tank is connected at its bottom with a high temperature wastewater discharge system.
Advantageous effects
Compared with the prior art, the invention has the following remarkable advantages:
the clean room process auxiliary material integrated control system can realize automatic liquid preparation, stirring and mixing, can bear a large amount of repeated work of injection preparation in medicine production by modern intelligent equipment, can relieve the contradiction of shortage of operators at a liquid preparation position in injection production, simultaneously enables liquid preparation to be more accurate and standardized, and ensures the sterile safety requirement of an automatic liquid preparation system by the perfect combination of CIP cleaning and SIP disinfection. The unique tank structure, the combination of the upper elliptical seal head and the lower elliptical seal head with the standard interlayer jacket, has the advantages of large jacket space, large heating area, reduced welding seams, smooth inner container, capability of ensuring that materials are not hung on the wall, attractive appearance, simple structure and durability.
Drawings
FIG. 1 is a schematic view of a clean room process kit integrated control system according to the present embodiment;
FIG. 2 is a schematic view of a control system according to the present embodiment;
FIG. 3 is a schematic view of a processing system according to the present embodiment;
fig. 4 is a schematic view of the cleanroom process kit integrated control system according to the present embodiment.
Detailed Description
In order to make the objects, technical solutions and advantages of the present application more apparent, the present application is described in further detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the present application and are not intended to limit the present application.
On the contrary, this application is intended to cover any alternatives, modifications, equivalents, and alternatives that may be included within the spirit and scope of the application as defined by the appended claims. Furthermore, in the following detailed description of the present application, certain specific details are set forth in order to provide a better understanding of the present application. It will be apparent to one skilled in the art that the present application may be practiced without these specific details.
A cleanroom process kit integrated control system according to an embodiment of the present application will be described in detail with reference to fig. 1 to 4. It is to be noted that the following examples are only for explaining the present application and do not constitute a limitation to the present application.
As shown in fig. 1, a cleanroom process kit integrated control system includes a reaction tank 110, a control system 120, and a processing system 130; the control system comprises at least one of: a stirring control unit 121, a CIP/SIP control unit 122, a temperature control unit 123, a liquid level control unit 124, a flow control unit 125, a PH control unit 126, an oxygen dissolving control unit 127, a material transfer control unit 128 and an emulsification control unit 129; the processing system comprises at least one of: homogenizer 131, centrifuge 132, ultrafilter 133, chromatographic column 134, nanofiltration machine 135.
In some embodiments, the reaction tank is connected at its bottom with a high temperature wastewater discharge system.
In some embodiments, the whole device is divided into functional modules with mutually independent functions according to each constituent function; each module is divided into various standardized components according to different realization modes of functions, specifications and components, each functional module and each component jointly form a module library of an enterprise, various process requirements of users can be met through dynamic combination of each functional module and each component, non-standard products are converted into standardized production, the equipment quality, the stability and the manufacturing efficiency are greatly improved, the stability of the production process is ensured, and the operation and the maintenance are simpler.
In some embodiments, when the clean room process auxiliary material integrated control system works, injection water can be automatically added into a reaction tank through a pipeline, a stirring control unit controls a mechanical stirrer to start, materials are added, then auxiliary materials dissolved in advance are added, stirring is carried out to enable the auxiliary materials to be dissolved completely, a pH control unit realizes pH value adjustment, then the injection water is added to the full amount, stirring is continued, activated carbon for injection is added, stirring adsorption is carried out, and self-circulation decarburization is carried out through filters such as an ultrafiltration machine and a nanofiltration machine of a treatment system.
After the self-circulation solution is clarified and qualified through sampling detection, nitrogen gas is introduced into the reaction tank through sterilization and filtration, and the liquid medicine is filtered to an aseptic storage tank through a relevant filter of the series treatment system or directly enters the emulsifying tank to start the next process.
After the liquid preparation of a batch is finished, the reaction tank starts to clean the tank body, namely CIP (cleaning in place) on-line cleaning is firstly carried out, wherein non-biological pollutants are mainly removed, then SIP (steam in place) steam damp and hot air sterilization is carried out, and the produced production wastewater and steam condensate water are connected into a high-temperature wastewater discharge system through a pipeline at the bottom of the tank body.
In some embodiments, liquid preparation, CIP cleaning, SIP disinfection, medicament storage and production wastewater discharge of the whole liquid preparation system are automatically carried out through a PLC control program, and a series of parameters are printed out through a set printer; through parameter analysis, whether the liquid preparation system is correct in liquid preparation, whether CIP cleaning and SIP disinfection are qualified or not is judged, and therefore whether the whole liquid preparation system is sterile and safe or not is determined.
In some embodiments, the entire dispensing system may have more than one tank, and may be based on each tank, with a control sub-module, with multiple tanks having multiple parallel sub-modules, and with a main module controlling the multiple sub-modules. A plurality of functional sub-modules, such as an oxygen dissolving module and a centrifugal module, can be matched under the secondary module. And a control interface is reserved between the main modules, so that a standardized control system is provided for multi-process pharmaceutical automation, and a foundation is laid for the establishment of an enterprise module library.
In some embodiments, a plurality of parallel common pipelines are arranged above the reaction tank, and each pipeline is provided with an electromagnetic valve. For example, a plurality of parallel shared pipelines are arranged above the reaction tank and are connected with process materials (containing auxiliary materials), drinking water, circulating chilled water, industrial steam, clean compressed air and pure steam, and the pipelines are provided with electromagnetic valves to realize joint control automatic liquid preparation.
In some embodiments, the tank bodies of the reaction tank are of a vertical double-layer structure, and the reaction tank comprises an outer tank body and an inner tank body. In some embodiments, an outer insulation board is attached to the surface of the outer tank body. In some embodiments, a spiral belt is wound on the surface of the inner tank body, steam water or cooling water is injected into the spiral belt, and the inner tank body is attached with a polyurethane filled heat insulation material.
For example, the tank body adopts a vertical double-layer structure, and the polishing precision of the inner container is RaO.45. The inner cylinder body is wound with a spiral band and is heated by steam or cooled by cooling water, and polyurethane material is filled for heat preservation. The outer layer heat insulation board adopts mirror surface or frosted polishing, and the gloss of the tank body is consistent. The material used for the parts contacting with the liquid medicine is 316L, and the material used for the rest parts is 304.
In some embodiments, the head of the bottom of the inner tank body is concave-convex, the top of the tank body is provided with a water inlet, a backflow port, a disinfection port, a cleaning ball, a hole-entering filling port and a breathing port, and the bottom of the tank body is provided with a water condensation port, a discharge port, a sewage discharge port, a sampling port, a temperature probe and a liquid level sensor. In some embodiments, an air respirator, an agitation system is mounted within the breathing port. For example, the bottom head of the inner tank body is concave-convex, mechanical axial flow stirring is carried out, and the top of the tank body is provided with a water inlet, a backflow port, a disinfection port, a cleaning ball, a hole filling port and a breathing port, and the air respirator and the stirring system are arranged at 0.22 um. The bottom of the tank body is provided with a water condensation port, a discharge port, a drain outlet, a sampling port, a temperature probe and a liquid level sensor. The control cabinet is provided for operation, and the instrument displays the temperature and the liquid level of the liquid medicine and provides the functions of upper limit alarm, lower limit alarm and the like. The tank body can be additionally provided with a nitrogen filling device, a PH meter and the like.
In some embodiments, the parts of the tank, valve, meter, pipe and tube, etc. which are contacted with the process material of each system are made of stainless steel, and ASME BPE or ISO2037 standard, 304 or 316L material can be configured according to requirements, and the surface is subjected to mechanical polishing or electrolytic polishing treatment. The polishing precision reaches Ra0.45, the transition of the container barrel body and the upper and lower end enclosures is formed by adopting a spinning R angle, and the container barrel body is flat and smooth and has no sanitary dead angle; ensuring that the container is always in a sanitary and sterile state. The outer surface adopts various surface treatment modes such as polishing, sand blasting, frosting or cold rolling primary color matte and the like.
In conclusion, the system can realize automation of integrated preparation of process auxiliary materials and intellectualization of operation, improve efficiency and standardization and avoid the risk of product pollution of liquid preparation operators. And the structure of the upper and lower elliptical seal heads or the lower and upper elliptical seal heads with the lower and reverse convex bottoms is adopted, so that the thorough cleaning without residue and dead angles in the liquid medicine conveying process is ensured. The cleaning and sterilizing process is completed by the cleaning and sterilizing combination of IPCIP and SIP in a synergistic way, so that the thorough cleaning and sterilizing of the equipment pipeline can be ensured, and the pollution of harmful microorganisms (such as salmonella, listeria and escherichia coli) can be effectively prevented.
Secondly, the tank body is designed in a sanitary sterile grade, and each pipe orifice is drawn to form smooth transition, so that dead corners caused by direct socket welding are avoided, and the reliability and the stability of the production process are ensured. Meanwhile, the simplification of the whole structure and the shape is emphasized, the whole equipment and the part which needs to be exposed (including some parts which are visible visually) are subjected to shape simplification under the GMP viewpoint, the concave-convex part, the groove and the platform in the conventional design of the equipment can be smooth and concise, the dust accumulation and the dirt accumulation can be reduced to the maximum extent, and the equipment is easy to clean. And the hierarchical control structure of the main module, the secondary module and the sub-modules can accurately and efficiently control and manage the complex and multi-sequence liquid medicine automation program.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents and improvements made within the spirit and principle of the present invention are intended to be included within the scope of the present invention.
Claims (8)
1. A process auxiliary material integrated control system for a clean room is characterized by comprising a reaction tank, a control system and a treatment system, wherein the control system and the treatment system are arranged on the reaction tank;
the control system comprises at least one of: the device comprises a stirring control unit, a CIP/SIP control unit, a temperature control unit, a liquid level control unit, a flow control unit, a PH control unit, a dissolved oxygen control unit, a material transfer control unit and an emulsification control unit;
the processing system comprises at least one of: homogenizer, centrifuge, ultrafilter, chromatographic column, nanofiltration machine.
2. The clean room process auxiliary material integrated control system of claim 1, wherein a plurality of parallel common pipelines are arranged above the reaction tank, and each pipeline is provided with an electromagnetic valve.
3. The integrated control system for the auxiliary materials for the clean room process according to claim 1, wherein the tank bodies of the reaction tanks are all of a vertical double-layer structure, and each reaction tank comprises an outer tank body and an inner tank body.
4. The clean room process auxiliary material integrated control system of claim 3, wherein an outer insulation board is attached to the surface of the outer tank body.
5. The clean room process auxiliary material integrated control system of claim 3, wherein a spiral belt is wound on the surface of the inner tank body, steam water or cooling water is injected into the spiral belt, and polyurethane thermal insulation materials are filled in the inner tank body.
6. The clean room process auxiliary material integrated control system of claim 3, wherein the inner tank bottom end enclosure is concave-convex, the tank top is provided with a water inlet, a backflow port, a disinfection port, a cleaning ball, a hole-entering filling port and a breathing port, and the tank bottom is provided with a water condensation port, a discharge port, a drain outlet, a sampling port, a temperature probe and a liquid level sensor.
7. The integrated control system for clean room process auxiliaries of claim 6, wherein an air respirator and a stirring system are installed in the breathing port.
8. The clean room process auxiliary material integrated control system of claim 1, wherein a high temperature waste water discharge system is connected to the bottom of the reaction tank.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210139004.2A CN114510000A (en) | 2022-02-15 | 2022-02-15 | Integrated control system for auxiliary process materials in clean room |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210139004.2A CN114510000A (en) | 2022-02-15 | 2022-02-15 | Integrated control system for auxiliary process materials in clean room |
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| CN114510000A true CN114510000A (en) | 2022-05-17 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN116440542A (en) * | 2022-06-16 | 2023-07-18 | 华大工程生物学长荡湖研究所 | Continuous flow centrifugal harvesting system and control method |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN116440542A (en) * | 2022-06-16 | 2023-07-18 | 华大工程生物学长荡湖研究所 | Continuous flow centrifugal harvesting system and control method |
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