CN204086931U - For the centralized monitoring system of aseptic medicine lyophilized formulations production line - Google Patents
For the centralized monitoring system of aseptic medicine lyophilized formulations production line Download PDFInfo
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- CN204086931U CN204086931U CN201420088791.3U CN201420088791U CN204086931U CN 204086931 U CN204086931 U CN 204086931U CN 201420088791 U CN201420088791 U CN 201420088791U CN 204086931 U CN204086931 U CN 204086931U
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- 238000004519 manufacturing process Methods 0.000 title claims abstract description 50
- 238000012544 monitoring process Methods 0.000 title claims abstract description 37
- 239000000203 mixture Substances 0.000 title claims abstract description 28
- 238000009472 formulation Methods 0.000 title claims abstract description 27
- 239000003814 drug Substances 0.000 title claims abstract description 21
- 238000004891 communication Methods 0.000 claims abstract description 7
- 238000005096 rolling process Methods 0.000 claims description 12
- 238000005406 washing Methods 0.000 claims description 12
- 239000000463 material Substances 0.000 claims description 8
- 230000008901 benefit Effects 0.000 abstract description 2
- 230000007613 environmental effect Effects 0.000 description 8
- 238000011958 production data acquisition Methods 0.000 description 8
- 230000006872 improvement Effects 0.000 description 7
- 238000000034 method Methods 0.000 description 6
- 238000007405 data analysis Methods 0.000 description 5
- 230000008569 process Effects 0.000 description 4
- 238000012545 processing Methods 0.000 description 3
- 230000001954 sterilising effect Effects 0.000 description 3
- 238000004659 sterilization and disinfection Methods 0.000 description 3
- 238000007599 discharging Methods 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 230000007246 mechanism Effects 0.000 description 2
- 241001269238 Data Species 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 230000003115 biocidal effect Effects 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 238000004140 cleaning Methods 0.000 description 1
- 238000013480 data collection Methods 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 239000006185 dispersion Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 230000002708 enhancing effect Effects 0.000 description 1
- 238000009432 framing Methods 0.000 description 1
- 230000036512 infertility Effects 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 238000003908 quality control method Methods 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 230000009897 systematic effect Effects 0.000 description 1
- 230000007306 turnover Effects 0.000 description 1
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- Y02P90/18—
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- Y02P90/22—
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Abstract
The utility model discloses a kind of centralized monitoring system for aseptic medicine lyophilized formulations production line, comprise Centralized Monitoring terminal and plural host computer, each described host computer all connects by a unit monitor component is corresponding with the wherein unit on lyophilized formulations production line, and all described host computers to be connected with Centralized Monitoring terminal by communication network and the unit status data collected by unit monitor component sends to Centralized Monitoring terminal.The utility model has that structure is simple, easy and simple to handle, automaticity is high, can production efficiency, ensure the advantages such as product quality.
Description
Technical field
The utility model is mainly concerned with medical production equipment field, refers in particular to a kind of centralized monitoring system being applicable to aseptic medicine lyophilized formulations production line.
Background technology
At present, the main lyophilized formulations production equipment forming lyophilized formulations production line comprises antibiotic bottle washing, drying and pouring linkage line, one or multiple stage freeze dryer, automatic feed/discharge system, Cover-rolling machine, rubber plug cleaning machine and liquid mixing system.The enhancing realized drug safety along with people and the enforcement of new edition GMP standard will be more and more higher to the robotization of pharmaceutical producing enterprise's equipment, integrated level requirement.But the lyophilized formulations production line in existing most pharmaceutical factory all adopts different unit to be assembled into, every platform unit all has independently control system, the lot number of all production datas and medicine is all kept on unit, obviously, and the quality management of this more and more higher pharmaceutical production that cannot meet the demands.
As from the foregoing, existing lyophilized formulations production line mainly has the following disadvantages:
1, be made up of the unit of several dispersions, each unit is because being placed on the room (coming in and going out in the room of different sterilization grade needs to change different aseptic clothes) of different sterilization grade respectively, cause when producing, because easily there is the cross pollution of the stream of people and logistics when passing in and out on-the-spot workshop in slip-stick artist and Production Supervisor, destroy production environment, cause pharmaceutical production quality control cost too high.
2, in the room (turnover of personnel is restricted) that sterilization grade is high, in the whole production run of medicine, main production management personnel, cannot the production run of complete monitoring medicine and equipment state because not entering workshop at any time.Meanwhile, also cannot monitor in real time for key parameters such as important device procedures data and environment.
3, after pharmaceutical production completes, the data of individual equipment (each unit) can only be deposited separately, cannot whole batch reports of automatic analysis single batch of medicine, after the data of each unit collection can only be artificially collected, carry out artificial treatment again, this will cause the batch report handling cost of medicine high, and the condition of production of simultaneously afterwards inquiring about medicine is very difficult.
Utility model content
The technical problems to be solved in the utility model is just: the technical matters existed for prior art, the utility model provides that a kind of structure is simple, easy and simple to handle, automaticity is high, can production efficiency, ensure the centralized monitoring system for aseptic medicine lyophilized formulations production line of product quality.
For solving the problems of the technologies described above, the utility model by the following technical solutions:
A kind of centralized monitoring system for aseptic medicine lyophilized formulations production line, comprise Centralized Monitoring terminal and plural host computer, each described host computer all connects by a unit monitor component is corresponding with the wherein unit on lyophilized formulations production line, and all described host computers are connected with Centralized Monitoring terminal by communication network.
As further improvement of the utility model: each described unit monitor component includes unit controller, several sensors for data acquisition and secondary instrument, and sensor described in several and secondary instrument are all connected with described unit controller.
As further improvement of the utility model: be provided with monitoring module in each described unit controller, each monitoring module includes data analysis and batch administration module and device data acquisition module, Operation Log acquisition module, environmental parameter acquisition module, technological parameter acquisition module, production data acquisition module.
As further improvement of the utility model: be integrated with data analysis and batch administration module and device data acquisition module, Operation Log acquisition module, environmental parameter acquisition module, technological parameter acquisition module, production data acquisition module in described Centralized Monitoring terminal.
As further improvement of the utility model: corresponding with the unit on described lyophilized formulations production line, described host computer is respectively bottle washing machine host computer, baking oven host computer, bottle placer host computer, input and output material host computer, freeze dryer host computer and Cover-rolling machine host computer.
As further improvement of the utility model: corresponding with the unit on described lyophilized formulations production line, described unit controller is respectively bottle washing machine controller, baking oven controller, bottle placer controller, input and output material controller, freeze dryer controller and Cover-rolling machine controller.
As further improvement of the utility model: described communication network adopts the network architecture of Ethernet and switch.
Compared with prior art, the utility model has the advantage of: the centralized monitoring system for aseptic medicine lyophilized formulations production line of the present utility model, structure is simple, easy and simple to handle, automaticity is high, based on robotization and information-based correlation technique, achieve the automatic collection of the key parameter such as process data and environment to apparatus for production line, Storage and Processing, simultaneously can batch management process data, convenience is carried out to the record that history is produced, inquire about fast, decrease staff in process of production to come in and go out the number of times of sterile workshop, improve the sterility assurance level of pharmaceutical production, reduce the quality of production to control risk, effective guarantee produces line administration measure, contribute to maintaining good GMP quality system and improving production efficiency.
Accompanying drawing explanation
Fig. 1 is structural framing principle schematic of the present utility model.
Fig. 2 is the module theory of constitution schematic diagram in the utility model in Centralized Monitoring terminal and unit controller.
Marginal data:
1, Centralized Monitoring terminal; 201, bottle washing machine host computer; 202, baking oven host computer; 203, bottle placer host computer; 204, input and output material host computer; 205, freeze dryer host computer; 206, Cover-rolling machine host computer; 3, Ethernet; 4, switch; 601, bottle washing machine controller; 602, baking oven controller; 603, bottle placer controller; 604, input and output material controller; 605, freeze dryer controller; 606, Cover-rolling machine controller.
Embodiment
Below with reference to Figure of description and specific embodiment, the utility model is described in further details.
As shown in Figure 1, centralized monitoring system for aseptic medicine lyophilized formulations production line of the present utility model, comprise Centralized Monitoring terminal 1 and plural host computer, each host computer all connects by a unit monitor component is corresponding with the wherein unit on lyophilized formulations production line, and all host computers to be connected with Centralized Monitoring terminal 1 by communication network and the unit status data collected by unit monitor component sends to Centralized Monitoring terminal 1.
Unit monitor component comprises unit controller, several sensors and secondary instrument, and unit controller is used for the data acquisition of receiving sensor and secondary instrument and will drives to corresponding host computer after image data process.Above-mentioned data acquisition comprises device data acquisition, Operation Log collection, environmental parameter collection, technological parameter collection, production data acquisition etc.
Composition graphs 2, the unit (production equipment) on lyophilized formulations production line generally comprises: bottle washing machine, baking oven, bottle placer, feeding-discharging mechanism, freeze dryer and Cover-rolling machine; Corresponding with it, host computer also comprises: bottle washing machine host computer 201, baking oven host computer 202, bottle placer host computer 203, input and output material host computer 204, freeze dryer host computer 205 and Cover-rolling machine host computer 206.Unit controller also comprises accordingly: bottle washing machine controller 601, baking oven controller 602, bottle placer controller 603, input and output material controller 604, freeze dryer controller 605 and Cover-rolling machine controller 606.Be provided with monitoring module in each controller, each monitoring module includes data analysis and batch administration module and device data acquisition module, Operation Log acquisition module, environmental parameter acquisition module, technological parameter acquisition module, production data acquisition module.In like manner, in Centralized Monitoring terminal 1, be integrated with data analysis and batch administration module and device data acquisition module, Operation Log acquisition module, environmental parameter acquisition module, technological parameter acquisition module, production data acquisition module equally.
Wherein, the said equipment data acquisition module is used for production equipment (bottle washing machine, baking oven, bottle placer, automatic feeding and discharging mechanism, freeze dryer, Cover-rolling machine etc.) production process data collection and supervision.Operation Log acquisition module is used for logging in the personnel in production run, publish, operation information complete documentation.Environmental parameter acquisition module is used for production environment parameter monitoring, comprises airborne, flcating germ number, temperature, humidity, pressure reduction, wind speed etc.Technological parameter acquisition module is used for recording the control formulation parameter etc. used in each production run.Production data acquisition module is used for recording lot information (lot number, product, specification, quantity etc.).Systematic collection device data generates a batch form (can temporally, the inquiry such as product, equipment) automatically, meets 21 CFR Part 11 electronical records and electronic signature specification, meets GMP authentication requesting.
In the present embodiment, communication network adopts the network architecture of Ethernet 3 and switch 4, is appreciated that the network architecture of employing other types also should at protection domain of the present utility model.Principle of work of the present utility model is as follows:
1, when starting outfit is produced, the host computer of each unit (bottle washing machine, baking oven, bottle placer, automatic feed/discharge machine, freeze dryer, Cover-rolling machine etc.) starts image data: save the data in the database of each unit by device data acquisition module, Operation Log acquisition module, environmental parameter acquisition module, technological parameter acquisition module, production data acquisition module;
2, the data collected are processed by data processing and a batch administration module by each unit in real time, are organized into the data layout of standard, deposit in the database of each unit;
3, Centralized Monitoring terminal 1 is after device start, the database of each unit is initiatively read by built-in device data acquisition module, Operation Log acquisition module, environmental parameter acquisition module, technological parameter acquisition module, production data acquisition module, and each Data classification read is preserved, real-time being presented in Centralized Monitoring terminal 1 simultaneously.
4, Centralized Monitoring terminal 1 by built-in data processing and batch administration module by collect data analysis, classification, preservation, produce the batch report of medicine, in the database stored in Centralized Monitoring terminal 1.
Below be only preferred implementation of the present utility model, protection domain of the present utility model be not only confined to above-described embodiment, all technical schemes belonged under the utility model thinking all belong to protection domain of the present utility model.It should be pointed out that for those skilled in the art, not departing from the some improvements and modifications under the utility model principle prerequisite, protection domain of the present utility model should be considered as.
Claims (5)
1. the centralized monitoring system for aseptic medicine lyophilized formulations production line, it is characterized in that, comprise Centralized Monitoring terminal (1) and plural host computer, each described host computer all connects by a unit monitor component is corresponding with the wherein unit on lyophilized formulations production line, and all described host computers are connected with Centralized Monitoring terminal (1) by communication network.
2. the centralized monitoring system for aseptic medicine lyophilized formulations production line according to claim 1, it is characterized in that, each described unit monitor component includes unit controller, several sensors for data acquisition and secondary instrument, and sensor described in several and secondary instrument are all connected with described unit controller.
3. the centralized monitoring system for aseptic medicine lyophilized formulations production line according to claim 1 and 2, it is characterized in that, corresponding with the unit on described lyophilized formulations production line, described host computer is respectively bottle washing machine host computer (201), baking oven host computer (202), bottle placer host computer (203), input and output material host computer (204), freeze dryer host computer (205) and Cover-rolling machine host computer (206).
4. the centralized monitoring system for aseptic medicine lyophilized formulations production line according to claim 2, it is characterized in that, corresponding with the unit on described lyophilized formulations production line, described unit controller is respectively bottle washing machine controller (601), baking oven controller (602), bottle placer controller (603), input and output material controller (604), freeze dryer controller (605) and Cover-rolling machine controller (606).
5. the centralized monitoring system for aseptic medicine lyophilized formulations production line according to claim 1 and 2, is characterized in that, described communication network adopts the network architecture of Ethernet (3) and switch (4).
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201420088791.3U CN204086931U (en) | 2014-02-28 | 2014-02-28 | For the centralized monitoring system of aseptic medicine lyophilized formulations production line |
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| CN201420088791.3U CN204086931U (en) | 2014-02-28 | 2014-02-28 | For the centralized monitoring system of aseptic medicine lyophilized formulations production line |
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| CN204086931U true CN204086931U (en) | 2015-01-07 |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104808631A (en) * | 2015-04-27 | 2015-07-29 | 四川制药制剂有限公司 | Control system based on injection powder injection production process |
| CN104808639A (en) * | 2015-04-29 | 2015-07-29 | 中国石油大学(华东) | Pharmaceutical product manufacturing execution system and method |
| CN104840435A (en) * | 2015-04-27 | 2015-08-19 | 四川制药制剂有限公司 | Preparation method for counting device equipped ceftriaxone sodium for injection |
| CN104840434A (en) * | 2015-04-27 | 2015-08-19 | 四川制药制剂有限公司 | Product qualified rate improving preparation method for cefuroxime sodium for injection |
| CN104887509A (en) * | 2015-04-27 | 2015-09-09 | 四川制药制剂有限公司 | Process for producing powder injections for injection and facilitating monitoring of product quality |
| CN112005069A (en) * | 2018-04-10 | 2020-11-27 | Ima生命北美股份有限公司 | Freeze drying process and equipment health monitoring |
-
2014
- 2014-02-28 CN CN201420088791.3U patent/CN204086931U/en not_active Expired - Lifetime
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104808631A (en) * | 2015-04-27 | 2015-07-29 | 四川制药制剂有限公司 | Control system based on injection powder injection production process |
| CN104840435A (en) * | 2015-04-27 | 2015-08-19 | 四川制药制剂有限公司 | Preparation method for counting device equipped ceftriaxone sodium for injection |
| CN104840434A (en) * | 2015-04-27 | 2015-08-19 | 四川制药制剂有限公司 | Product qualified rate improving preparation method for cefuroxime sodium for injection |
| CN104887509A (en) * | 2015-04-27 | 2015-09-09 | 四川制药制剂有限公司 | Process for producing powder injections for injection and facilitating monitoring of product quality |
| CN104808639A (en) * | 2015-04-29 | 2015-07-29 | 中国石油大学(华东) | Pharmaceutical product manufacturing execution system and method |
| CN112005069A (en) * | 2018-04-10 | 2020-11-27 | Ima生命北美股份有限公司 | Freeze drying process and equipment health monitoring |
| US11359861B2 (en) | 2018-04-10 | 2022-06-14 | Ima Life North America Inc. | Freeze drying process and equipment health monitoring |
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| C14 | Grant of patent or utility model | ||
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| CX01 | Expiry of patent term |
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| CX01 | Expiry of patent term |