CN101493695B - Sterilizing data acquiring and processing method for sterilizing cabinet for producing medicine - Google Patents
Sterilizing data acquiring and processing method for sterilizing cabinet for producing medicine Download PDFInfo
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- CN101493695B CN101493695B CN2009100142247A CN200910014224A CN101493695B CN 101493695 B CN101493695 B CN 101493695B CN 2009100142247 A CN2009100142247 A CN 2009100142247A CN 200910014224 A CN200910014224 A CN 200910014224A CN 101493695 B CN101493695 B CN 101493695B
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- 230000001954 sterilising effect Effects 0.000 title claims abstract description 112
- 239000003814 drug Substances 0.000 title claims abstract description 14
- 238000003672 processing method Methods 0.000 title 1
- 238000004659 sterilization and disinfection Methods 0.000 claims abstract description 99
- 238000000034 method Methods 0.000 claims abstract description 67
- 238000004519 manufacturing process Methods 0.000 claims abstract description 23
- 238000009434 installation Methods 0.000 claims abstract description 7
- 238000004891 communication Methods 0.000 claims abstract description 4
- 230000005540 biological transmission Effects 0.000 claims description 9
- 230000005855 radiation Effects 0.000 claims description 5
- 238000012806 monitoring device Methods 0.000 claims description 2
- 229940079593 drug Drugs 0.000 abstract description 6
- 238000012545 processing Methods 0.000 abstract description 5
- 238000013480 data collection Methods 0.000 description 6
- 238000004458 analytical method Methods 0.000 description 4
- 230000033228 biological regulation Effects 0.000 description 2
- 238000005538 encapsulation Methods 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 230000006698 induction Effects 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 238000012544 monitoring process Methods 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 1
- 238000007405 data analysis Methods 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000004744 fabric Substances 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 231100000572 poisoning Toxicity 0.000 description 1
- 230000000607 poisoning effect Effects 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 238000012546 transfer Methods 0.000 description 1
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- Apparatus For Disinfection Or Sterilisation (AREA)
Abstract
The invention provides a method for collecting and processing sterilization data of a sterilization cabinet used for drug production. The method comprises installation sterilization process and a result data collecting equipment; wherein, the equipment comprises a sterilization control monitor with a communication function and an online data collecting terminal; the online data collecting terminal processes the sterilization data collected by the sterilization control monitor of the sterilization cabinet, encapsulates the collected data according to the given logics and safely transmits the data to a data center; the data center receives the relevant data of the sterilization process and the result and carries out the processing according to the sterilization requirement, analyzes whether the sterilization process and the result have problem or not and whether the sterilization process and the result meet the requirement or not by contrasting with the GMP requirement; and if not, the data center automatically and immediately sends a reform notice or pre-alarm to the enterprise. The invention can effectively monitor the problems possibly to occur during the product sterilization link of all production enterprises, improves the production quality of the drug of the enterprises, improves the supervising efficiency of the supervising department, and effectively reduces the generation of drug-harm events.
Description
Technical field
When pharmaceutical producing enterprise produces, air pressure difference for some workshop condition has strict demand, the pressure difference data that this invention is intended to solve relevant place is gathered, and the data of gathering are handled, timely early warning information is sent in related personnel's hand, make things convenient for enterprise and Bureau of Drugs Supervision the monitoring of production environment air pressure difference and the processing of relevant potential problem.
Background technology
In pharmaceutical industry, for sterilization process between some workshop and result strict requirement is arranged, the production of medicine must be carried out in strict accordance with regulation.Phenomenons such as because pharmaceutical producing enterprise management and GMP executive level are uneven, strictness organizes the production behavior to happen occasionally by the GMP regulation, still exists part enterprise not have correctly to handle the relation of business economic benefit and social benefit, and responsibility consciousness is thin.
Pharmaceutical producing enterprise is more at present, the branch cloth cover is big, and supervision strength is limited, the supervision coverage rate is little, can't strictness hold problems such as drug quality, is the difficult problem of each supervision department's supervision of puzzlement always.
Primary monitor infrastructure and technical supervision condition relatively lag behind, and the supervisor is few, supervision information is not smooth etc., also is the bottleneck that restricts supervisory efficiency and quality at present.So the pharmaceutical production supervision is long-term, complicated, a large order, should put forth effort to solve current distinct issues, tries to explore some permanent mechanisms again, and the drug safety supervision is not only taken stopgap measures but also effect a permanent cure.The non-at-scene supervision information data center of pharmaceutical production is exactly effective assistant that a supervision department carries out routine monitoring work.
Gather air sterilization process and result, analyze it and whether meet the crucial supervision point that the GMP standard is the medicine supervision.
Sterilization process and result's equipment is not gathered by general pharmaceutical producing enterprise.
Realize workshop sterilization process and result's collection, just must install and have the sterilization process of communication function and sensor as a result in detected workshop, then to the sterilization process gathered with result data is analyzed and encapsulate according to promptly deciding logic, adopt secured fashion to be transferred to the non-at-scene supervision information data center of pharmaceutical production then by public network, this data center just can handle these data, treatment measures comprise early warning and on-the-spot rectification etc., thereby reach the purpose of non-at-scene supervision.It is reported that at present domestic also do not have the second tame enterprise to use this method to carry out the real-time collection and the analyzing and processing of sterilization process and result data except that tide company.
Summary of the invention
Technical matters to be solved by this invention provides a kind of pharmaceutical producing enterprise workshop sterilization process and result's collection and disposal route, the problem that influences drug quality that the sterilization process of analytic product production environment and the possibility of result occur.
Method of the present invention realizes in the following manner, sterilization process and result data collecting device are installed, equipment comprises sterilization control monitor and the on-line data acquisition terminal with communication function, the on-line data acquisition terminal is handled the sterilization data of sterilization cabinet sterilization control monitor collection, be transferred to data center safely after according to set logic institute's image data being encapsulated, data center receives sterilization process and requires to handle according to sterilization after the related data as a result, by requiring to contrast with GMP, whether analyze sterilization process and result has problems, whether sterilization process and result meet the requirements, undesirable then data center can automatic immediate send rectification notice or early warning to enterprise, and concrete steps are as follows:
(1) sterilization process and resultant induction equipment are installed
Sterilization process and result's equipment is not gathered by general pharmaceutical producing enterprise, needs to install the collecting device of corresponding band transfer function.Sterilization process and sensor as a result are installed between two monitored workshops.
(2) set up being connected of sensing apparatus and on-line data acquisition terminal by signal wire
Sterilization process and result data generally are the RS484 signals, are connected with the serial ports of on-line data acquisition terminal by special signal bundle of lines collecting device.
(3) gather, store, encapsulate, transmit sterilization process and result data
Data acquisition equipment is stored earlier after gathering sterilization process and result data, then data is carried out analyzing and processing, and handle the back data are encapsulated according to certain form, and to the transmission of the data encryption after the encapsulation, with the assurance safety of data transmission.
(4) receive sterilization process and result data and handle
The non-at-scene supervision information data center of pharmaceutical production at first receives sterilization process and result data, then data is put into data center's database.
(5) handle according to analysis result
After the non-at-scene supervision information data center of pharmaceutical production is analyzed sterilization process and result data, judge whether to meet the storage request of pharmaceutical production, undesirable data are taken measures on customs clearance handle with material according to analysis result.
Beneficial effect of the present invention is as follows:
(1) sterilization process between the workshop and result are gathered in real time, can in time be found the problem of the air pressure difference existence of workshop.Avoid not influencing quality of material because of air pressure difference does not meet the demands.
(2) from the generation of beginning of production control poisoning incident, improve the pharmaceutical production quality, improve competition among enterprises and managerial ability.
(3) innovation supervision department regulatory format improves supervision usefulness.
(4) finally reach " manufacturing enterprise use on, the living of supervision department's pipe " purpose.
Description of drawings
Accompanying drawing is the device structure synoptic diagram.
Embodiment
With reference to accompanying drawing technical scheme of the present invention is done following detailed explanation:
Sterilization process and result data collecting device are installed
Sterilization process and result's equipment is not gathered by general pharmaceutical producing enterprise, needs to install corresponding sterilization process result data collecting device.
Equipment comprises: data center, on-line data acquisition terminal, sterilization control monitor and be provided with sterilization process and the sterilization cabinet of sensor as a result.Wherein, sterilization process is connected with sterilization control monitor with the result data sensor, and some sterilization control monitors are connected with the on-line data acquisition terminal, and some on-line data acquisition terminals are connected with data center by network.
By signal wire data center, data collection station, sterilization cabinet control monitor are connected with the sterilization cabinet that is provided with video heads, the good radiation sensor of temperature sensor, the sterilization process and the result data of the collection of sterilization control monitor are shown, make things convenient for the workshop management personnel of enterprise to observe sterilization process and result, can the information transmission of gathering be beaten on the data collection station by instrument again.Be connected by signal wire and data collection station are online then, sterilization process and result data generally are the RS484 signals, are connected with the serial ports of result data with the on-line data acquisition terminal by special signal bundle of lines sterilization process.
Data collection station is at first stored after sterilization process and result data are gathered, then data encapsulated according to certain form, and to transmitting after the data encryption after the encapsulation, to guarantee safety of data transmission.
Receive sterilization process and result data and handle and send to the non-at-scene supervision information data center of pharmaceutical production, the database that data center puts into data center to the sterilization process and the result data of reception.Then, data center analyzes sterilization process and result data;
The non-at-scene supervision information data center of pharmaceutical production will be obtained data analysis to putting into data of database according to promptly fixed.
Handle according to analysis result
The non-at-scene supervision information data center of pharmaceutical production judges whether to meet the requirement of pharmaceutical production technology after sterilization process and result data are analyzed according to analysis result.Undesirable data are taken measures on customs clearance handle.
Embodiment
Data acquisition equipment comprises: (1) installs sterilization process and resultant induction equipment; (2) set up sensing apparatus and sterilization process and being connected of Displaying Meter as a result by signal wire; (3) set up sterilization process and Displaying Meter and online data as a result by signal wire
The connection of acquisition terminal; (4) data collection station is responsible for institute's image data is gathered, encapsulated, and data transmission is produced non-at-scene supervision information data center to medicine; (5) the non-at-scene supervision information data center of pharmaceutical production receives sterilization process and result data and analyzes according to set logic; (6) according to operation result relevant issues are handled.
Concrete steps are as follows:
Data collection station according to sterilization process and as a result the logic of Displaying Meter the data of instrument are read;
Sterilization process and result data are encapsulated and encrypted transmission according to set logic, and logical format is as follows:
1) data recording transmits bag, alert data bag;
1) 1 first bag data:
1) 1.1 signs: identification data packet type (char type): on behalf of normal data, 0000 transmit, and 0001 represents alert data;
1) 1.2 packet index char types: 8 bytes, 00000000 represents the first bag data, and FFFFFFFF represents last bag data; The index of reporting to the police and wrapping is that an index is FFFFFFFF, and article one also is the last item;
1) 1.3 data recording
1) 2 middle normal data:
1) 2.1 signs: identification data packet type char type: on behalf of normal data, 0000 transmit, and 0001 represents alert data;
1) 2.2 packet index: 8 bytes, the bar of expression data is counted index and is added up 1;
1) 2.3 data recording
1) 3 last bag data: be not data, just representative transmits and finishes, and the total bag number of " quantity " representative in the data recording does not comprise last bag;
1) 3.1 signs: identification data packet type char type: on behalf of normal data, 0000 transmit, and 0001 represents alert data;
1) 3.2 packet index: 8 bytes, 00000000-FFFFFFFF, FFFFFFFF represent last bag data;
The total bag number of quantity representative in the data recording does not comprise last bag;
2) server acknowledge bag
2) 1 sign: identification data packet type char type: the FFFF representative data transmits successfully, and the FFFE representative data needs to retransmit;
2) 2 packet index: ignore;
2) 3 data recording: ignore.
Sterilization process and result data collecting device comprise: (1) sterilizing installation; (2) be connected with the result data watch-dog with sterilization process by the signal wire sterilizing installation; (3) being connected by signal wire sterilization data monitoring device and on-line data acquisition terminal; (4) the on-line data acquisition terminal is responsible for institute's image data is gathered, encapsulated, and data transmission is produced non-at-scene supervision information data center to medicine; (5) the non-at-scene supervision information data center of pharmaceutical production receives sterilization process and result data and analyzes according to set logic; (6) according to operation result relevant issues are handled.
Sterilizing installation comprises sterilization cabinet and the video heads, radiation sensor, the temperature sensor that are arranged in the sterilization cabinet, and sterilization method comprises high-temperature sterilization, C
60Radiation sterilization and microwave radiation sterilization.
Employed equipment is universal electronic device in the data acquisition equipment.
Claims (3)
1. sterilizing cabinet for producing medicine sterilizing data acquiring and disposal route, it is characterized in that, sterilization process and result data collecting device are installed, described equipment comprises sterilization control monitor and the on-line data acquisition terminal with communication function, the on-line data acquisition terminal is handled the sterilization data of the sterilization control monitor collection in the sterilization cabinet, be transferred to data center safely after according to set logic institute's image data being encapsulated, data center receives sterilization process and requires to handle according to sterilization after the related data as a result, by requiring to contrast with GMP, whether analyze sterilization process and result has problems, whether sterilization process and result meet the requirements, undesirable then data center can automatic immediate send rectification notice or early warning to enterprise, and concrete steps are as follows:
The on-line data acquisition terminal reads sterilization cabinet sterilization data according to the sterilization agreement;
Sterilization process and result data are encapsulated and encrypted transmission according to set logic, and logical format is as follows:
[1] data recording transmits bag, alert data bag;
1) the first bag data:
(1) sign: the identification data packet type is the char type: on behalf of normal data, 0000 transmit, and 0001 represents alert data;
(2) packet index char type: 8 bytes, 00000000 represents the first bag data, and FFFFFFFF represents last bag data; The index of reporting to the police and wrapping is that an index is FFFFFFFF, and article one also is the last item;
(3) data recording
2) normal data in the middle of:
(1) sign: identification data packet type char type: on behalf of normal data, 0000 transmit, and 0001 represents alert data;
(2) packet index: 8 bytes, the bar of expression data is counted index and is added up 1;
(3) data recording
3) last bag data: be not data, just representative transmits and finishes, and the total bag number of " quantity " representative in the data recording does not comprise last bag;
(1) sign: identification data packet type char type: on behalf of normal data, 0000 transmit, and 0001 represents alert data;
(2) packet index: 8 bytes, 00000000-FFFFFFFF, FFFFFFFF represent last bag data; The total bag number of quantity representative in the data recording does not comprise last bag;
[2] server acknowledge bag
1) sign: identification data packet type char type: the FFFF representative data transmits successfully, and the FFFE representative data needs to retransmit;
2) packet index;
3) data recording.
2. method according to claim 1 is characterized in that, sterilization process and result data collecting device comprise: (1) sterilizing installation; (2) sterilizing installation is connected with the result data watch-dog with the sterilization process watch-dog by signal wire; (3) be connected with the on-line data acquisition terminal by the signal wire data monitoring device of will sterilizing; (4) the on-line data acquisition terminal is responsible for institute's image data is gathered, encapsulated, and data transmission is produced non-at-scene supervision information data center to medicine; (5) the non-at-scene supervision information data center of pharmaceutical production receives sterilization process and result data and analyzes according to set logic; (6) according to operation result relevant issues are handled.
3. method according to claim 1 is characterized in that, sterilizing installation comprises sterilization cabinet and the video heads that is arranged in the sterilization cabinet, and radiation sensor and temperature sensor, sterilization method comprise high-temperature sterilization, C
60Radiation sterilization or microwave radiation sterilization.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2009100142247A CN101493695B (en) | 2009-02-16 | 2009-02-16 | Sterilizing data acquiring and processing method for sterilizing cabinet for producing medicine |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2009100142247A CN101493695B (en) | 2009-02-16 | 2009-02-16 | Sterilizing data acquiring and processing method for sterilizing cabinet for producing medicine |
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| Publication Number | Publication Date |
|---|---|
| CN101493695A CN101493695A (en) | 2009-07-29 |
| CN101493695B true CN101493695B (en) | 2011-06-08 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN2009100142247A Active CN101493695B (en) | 2009-02-16 | 2009-02-16 | Sterilizing data acquiring and processing method for sterilizing cabinet for producing medicine |
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| Country | Link |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN2340485Y (en) * | 1998-06-25 | 1999-09-29 | 陈仿 | Monitor for crystallization |
| WO2000060449A1 (en) * | 1999-04-05 | 2000-10-12 | Scriptpro Llc | Medicament dispensing control workstation |
| CN101206463A (en) * | 2007-11-30 | 2008-06-25 | 深圳先进技术研究院 | Method and system for on-line monitoring medicaments production mixing process |
-
2009
- 2009-02-16 CN CN2009100142247A patent/CN101493695B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN2340485Y (en) * | 1998-06-25 | 1999-09-29 | 陈仿 | Monitor for crystallization |
| WO2000060449A1 (en) * | 1999-04-05 | 2000-10-12 | Scriptpro Llc | Medicament dispensing control workstation |
| CN101206463A (en) * | 2007-11-30 | 2008-06-25 | 深圳先进技术研究院 | Method and system for on-line monitoring medicaments production mixing process |
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| Publication number | Publication date |
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| CN101493695A (en) | 2009-07-29 |
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