CN101603031A - Quality management system for stem cell production - Google Patents
Quality management system for stem cell production Download PDFInfo
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- CN101603031A CN101603031A CNA2009101580408A CN200910158040A CN101603031A CN 101603031 A CN101603031 A CN 101603031A CN A2009101580408 A CNA2009101580408 A CN A2009101580408A CN 200910158040 A CN200910158040 A CN 200910158040A CN 101603031 A CN101603031 A CN 101603031A
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Abstract
The invention discloses a kind of quality management system for stem cell production, it includes following link: (1) environment control and management; (2) tissue sampling management; (3) blood sample collection; (4) tissue handing-over management; (5) separate tissue management; (6) cell cultures, frozen management; (7) archive office and database system management.The present invention is provided with each separate Function detection unit with the various kinds of cell detection means innovatively, combination detects, both guaranteed the comprehensive of detection, incident careless omission of single detection and personal errors have also been avoided, and introduced the external quality assurance means, guarantee respectively to detect the standard of department's quality examination; Simultaneously, each link with the stem cell storage is divided into several independent unit innovatively, carries out independent workflow management and quality monitoring, helps the interference of stablizing and avoid human factor of stem cell storage quality; The present invention also can make constituent parts information interrelated, concentrates and uses the common database information.
Description
Technical field:
The present invention relates to the stem cell production technical field, especially relate to quality management system for stem cell production.
Background technology:
The purposes of stem cell is very extensive, relates to the every field of medical science.At present, scientist can be at external discriminating, separation, purifying, amplification and cultivation human stem cell, and is seed with such stem cell, cultivates some histoorgans.The extensive clinical application of stem cell and derived tissues organ thereof, a kind of brand-new medical skill will be produced, just reproduce the normal even young histoorgan of human body, thereby make the people can use oneself or other people stem cell or by the new histoorgan that stem cell derived, replace self pathology or old and feeble histoorgan.U.S.'s " science " magazine was classified stem-cell research the first of the world's ten big sciences achievement as in 1999, came before human genome order-checking and the clone technology.
In recent years, along with the development of stem cells technology, it is more prevalent that its clinical application is just becoming, and so far, except that navel blood stem cell, Shang Weiyou relates to the quality control system that extracts stem cell in the tissue.
Summary of the invention:
The object of the present invention is to provide a kind of quality management system for stem cell production, store to obtain stem cell in the solution tissue, and be applied to the problem of clinical treatment.
For reaching above goal of the invention, quality management system for stem cell production of the present invention includes following link:
(1) environment control and management: tissue is answered the strict pollution that prevent pathogenic micro-organism with blood collection, requires the place in cleaning;
(2) tissue sampling is managed: after (a) tissue being put into aseptic disposable collecting bottle, should fill in donor name, date, time on collecting bottle, reach hospital; (b) collecting bottle is packed into seal in the sealed bag; (c) fill in the tissue sampling registry form, registry form contains donor health and fitness information and collection situation;
(3) blood sample collection: (a) donor venous blood 5ml; (b) mark donor name on the blood test tube; (c) with collecting bottle, collection registry form, the unified sign of blood test-tube, and the sample sack of packing into, 4 ℃ of preservations, and fill in the transportation list;
(4) tissue handing-over management: (a) traffic unit should contain the sample sack transfer stem cell bank reception chamber of collecting bottle, collection registry form, blood test-tube, and after transferring to reception chamber personnel check, signs on transportation is single; (b) the reception chamber personnel should in time fill in the collection registry form, situation when record receives, and unification is numbered in computer typing mode collecting bottle, collection registry form, blood sample, traffic unit need be signed, and gathers registry form and contains information such as haulage time, sample situation, collection hospital, collection people; (c) reception chamber is transferred immunity and microorganism department with blood preparation, and collecting bottle is transferred in the cellular segregation laboratory, will gather registry form and transfer archive office;
(5) separate tissue management: (a) calculated, check whether sample is overtime, and whether necrotic tissue is arranged, and whether the blood agglutination phenomenon is arranged, above-mentioned situation occurs and fill in the quality advice note and give quality control department with 24 hours; (b) before the separate tissue, extract protection liquid 8-20ml in the collecting bottle, transfer to immunity and microorganism department and carry out bacteriology and detection of mycoplasma; (c) after the cellular segregation, extract centrifugal back cell conditioned medium liquid 8-20ml, transfer to immunity and carry out immunology, bacteriology and detection of mycoplasma with microorganism department; (d) inoculating cell after microscopy is qualified, is transferred culturing room next day, meets the test section gate open and knows except the depleted; (e) fill in separate information sheet after the separation, archive office's microcomputer is transferred in the signature back; (f) above-mentioned transfer form sample need be filled in the transfer table, and receiving department need sign, and need not to import computer;
(6) cell cultures, frozen management: (a) fill in the cultivation observed and recorded, the computer of not importing for future reference; (b) cultivate end, when frozen, need to extract 10
6Individual cell is transferred the fluidic cell chamber and is carried out the cell surface marker detection; (c) cultivate end, when frozen, need to extract 10
6Individual cell is transferred the differentiation authentication room and is carried out the detection of cytodifferentiation ability; (d) cultivate end, when frozen, need to extract 10
6Individual cell is transferred the PCR chamber and is carried out immunology detection; (e) cultivate end, when frozen, need to extract the frozen storing liquid that 10-20ml contains eccentric cell, transfer to immunity and carry out bacteriology and detection of mycoplasma with microorganism department; (f) fill in frozen information slip, archive office's input computer is transferred in selected frozen position; (g) record experimentation, frozen curve is placed by frozen position; (h) above-mentioned transfer form sample need be filled in the transfer table, and receiving department need sign, and need not to import computer;
(7) archive office and database system management: (a) input end station and inquiry terminal, link to each other with database by network, can in time import relevant all departments information and enter database, for future reference; (b) each group data have only the ability typing of the authority of delimitation department, and to avoid various source of same information, link was directly quoted last link input information afterwards, no longer again typing; (c) each data input unit input has sequencing, and previous process procedure is not imported, and a back process procedure must not be imported, to avoid the information misquotation; When (d) detecting sample information and do not import, detected result must not typing; (e) all terminals are equipped with infrared bar code scanner, avoid manually importing the bar code error; (f) database is prevented error management, need data calculated, directly calculate according to related data by database root, and the set up error management, the data that transfinite of input are reported to the police, and the refusal typing; (g) generate quality control table automatically, judge whether automatically to preserve according to logic; (h) be provided with the output report of suitable customer service, stem cell bank, clinical, four patterns of senior executive, can directly require to print according to authority; (i) the main logging data of database is processing parameter and technical data, detection data, output quality information.
The present invention is provided with each separate Function detection unit with the various kinds of cell detection means innovatively, combination detects, both guaranteed the comprehensive of detection, incident careless omission of single detection and personal errors have also been avoided, and introduced the external quality assurance means, guarantee respectively to detect the standard of department's quality examination; Simultaneously, each link with the stem cell storage is divided into several independent unit innovatively, carries out independent workflow management and quality monitoring, helps the interference of stablizing and avoid human factor of stem cell storage quality; In addition, the present invention also is applied to the stem cell quality control with the computer system management messages first, makes constituent parts information interrelated, concentrates and uses the common database information.
Embodiment:
Quality management system for stem cell production of the present invention includes following link:
(1) environment control and management: tissue is answered the strict pollution that prevent pathogenic micro-organism with blood collection, requires the place in cleaning;
(2) tissue sampling is managed: after (a) tissue being put into aseptic disposable collecting bottle, should fill in donor name, date, time on collecting bottle, reach hospital; (b) collecting bottle is packed into seal in the sealed bag; (c) fill in the tissue sampling registry form, registry form contains donor health and fitness information and collection situation;
(3) blood sample collection: (a) donor venous blood 5ml; (b) mark donor name on the blood test tube; (c) with collecting bottle, collection registry form, the unified sign of blood test-tube, and the sample sack of packing into, 4 ℃ of preservations, and fill in the transportation list;
(4) tissue handing-over management: (a) traffic unit should contain the sample sack transfer stem cell bank reception chamber of collecting bottle, collection registry form, blood test-tube, and after transferring to reception chamber personnel check, signs on transportation is single; (b) the reception chamber personnel should in time fill in the collection registry form, situation when record receives, and unification is numbered in computer typing mode collecting bottle, collection registry form, blood sample, traffic unit need be signed, and gathers registry form and contains information such as haulage time, sample situation, collection hospital, collection people; (c) reception chamber is transferred immunity and microorganism department with blood preparation, and collecting bottle is transferred in the cellular segregation laboratory, will gather registry form and transfer archive office;
(5) separate tissue management: (a) calculated, check whether sample is overtime, and whether necrotic tissue is arranged, and whether the blood agglutination phenomenon is arranged, above-mentioned situation occurs and fill in the quality advice note and give quality control department with 24 hours; (b) before the separate tissue, extract protection liquid 8-20ml in the collecting bottle, transfer to immunity and microorganism department and carry out bacteriology and detection of mycoplasma; (c) after the cellular segregation, extract centrifugal back cell conditioned medium liquid 8-20ml, transfer to immunity and carry out immunology, bacteriology and detection of mycoplasma with microorganism department; (d) inoculating cell after microscopy is qualified, is transferred culturing room next day, meets the test section gate open and knows except the depleted; (e) fill in separate information sheet after the separation, archive office's microcomputer is transferred in the signature back; (f) above-mentioned transfer form sample need be filled in the transfer table, and receiving department need sign, and need not to import computer;
(6) cell cultures, frozen management: (a) fill in the cultivation observed and recorded, the computer of not importing for future reference; (b) cultivate end, when frozen, need to extract 10
6Individual cell is transferred the fluidic cell chamber and is carried out the cell surface marker detection; (c) cultivate end, when frozen, need to extract 10
6Individual cell is transferred the differentiation authentication room and is carried out the detection of cytodifferentiation ability; (d) cultivate end, when frozen, need to extract 10
6Individual cell is transferred the PCR chamber and is carried out immunology detection; (e) cultivate end, when frozen, need to extract the frozen storing liquid that 10-20ml contains eccentric cell, transfer to immunity and carry out bacteriology and detection of mycoplasma with microorganism department; (f) fill in frozen information slip, archive office's input computer is transferred in selected frozen position; (g) record experimentation, frozen curve is placed by frozen position; (h) above-mentioned transfer form sample need be filled in the transfer table, and receiving department need sign, and need not to import computer;
(7) archive office and database system management: (a) input end station and inquiry terminal, link to each other with database by network, can in time import relevant all departments information and enter database, for future reference; (b) each group data have only the ability typing of the authority of delimitation department, and to avoid various source of same information, link was directly quoted last link input information afterwards, no longer again typing; (c) each data input unit input has sequencing, and previous process procedure is not imported, and a back process procedure must not be imported, to avoid the information misquotation; When (d) detecting sample information and do not import, detected result must not typing; (e) all terminals are equipped with infrared bar code scanner, avoid manually importing the bar code error; (f) database is prevented error management, need data calculated, directly calculate according to related data by database root, and the set up error management, the data that transfinite of input are reported to the police, and the refusal typing; (g) generate quality control table automatically, judge whether automatically to preserve according to logic; (h) be provided with the output report of suitable customer service, stem cell bank, clinical, four patterns of senior executive, can directly require to print according to authority; (i) the main logging data of database is processing parameter and technical data, detection data, output quality information.
Claims (1)
1, quality management system for stem cell production is characterized in that including following link:
(1) environment control and management: tissue is answered the strict pollution that prevent pathogenic micro-organism with blood collection, requires the place in cleaning;
(2) tissue sampling is managed: after (a) tissue being put into aseptic disposable collecting bottle, should fill in donor name, date, time on collecting bottle, reach hospital; (b) collecting bottle is packed into seal in the sealed bag; (c) fill in the tissue sampling registry form, registry form contains donor health and fitness information and collection situation;
(3) blood sample collection: (a) donor venous blood 5ml; (b) mark donor name on the blood test tube; (c) with collecting bottle, collection registry form, the unified sign of blood test-tube, and the sample sack of packing into, 4 ℃ of preservations, and fill in the transportation list;
(4) tissue handing-over management: (a) traffic unit should contain the sample sack transfer stem cell bank reception chamber of collecting bottle, collection registry form, blood test-tube, and after transferring to reception chamber personnel check, signs on transportation is single; (b) the reception chamber personnel should in time fill in the collection registry form, situation when record receives, and unification is numbered in computer typing mode collecting bottle, collection registry form, blood sample, traffic unit need be signed, and gathers registry form and contains information such as haulage time, sample situation, collection hospital, collection people; (c) reception chamber is transferred immunity and microorganism department with blood preparation, and collecting bottle is transferred in the cellular segregation laboratory, will gather registry form and transfer archive office;
(5) separate tissue management: (a) calculated, check whether sample is overtime, and whether necrotic tissue is arranged, and whether the blood agglutination phenomenon is arranged, above-mentioned situation occurs and fill in the quality advice note and give quality control department with 24 hours; (b) before the separate tissue, extract protection liquid 8～20ml in the collecting bottle, transfer to immunity and microorganism department and carry out bacteriology and detection of mycoplasma; (c) after the cellular segregation, extract centrifugal back cell conditioned medium liquid 8～20ml, transfer to immunity and carry out immunology, bacteriology and detection of mycoplasma with microorganism department; (d) inoculating cell after microscopy is qualified, is transferred culturing room next day, meets the test section gate open and knows except the depleted; (e) fill in separate information sheet after the separation, archive office's microcomputer is transferred in the signature back; (f) above-mentioned transfer form sample need be filled in the transfer table, and receiving department need sign, and need not to import computer;
(6) cell cultures, frozen management: (a) fill in the cultivation observed and recorded, the computer of not importing for future reference; (b) cultivate end, when frozen, need to extract 10
6Individual cell is transferred the fluidic cell chamber and is carried out the cell surface marker detection; (c) cultivate end, when frozen, need to extract 10
6Individual cell is transferred the differentiation authentication room and is carried out the detection of cytodifferentiation ability; (d) cultivate end, when frozen, need to extract 10
6Individual cell is transferred the PCR chamber and is carried out immunology detection; (e) cultivate end, when frozen, need to extract the frozen storing liquid that 10～20ml contains eccentric cell, transfer to immunity and carry out bacteriology and detection of mycoplasma with microorganism department; (f) fill in frozen information slip, archive office's input computer is transferred in selected frozen position; (g) record experimentation, frozen curve is placed by frozen position; (h) above-mentioned transfer form sample need be filled in the transfer table, and receiving department need sign, and need not to import computer;
(7) archive office and database system management: (a) input end station and inquiry terminal, link to each other with database by network, can in time import relevant all departments information and enter database, for future reference; (b) each group data have only the ability typing of the authority of delimitation department, and to avoid various source of same information, link was directly quoted last link input information afterwards, no longer again typing; (c) each data input unit input has sequencing, and previous process procedure is not imported, and a back process procedure must not be imported, to avoid the information misquotation; When (d) detecting sample information and do not import, detected result must not typing; (e) all terminals are equipped with infrared bar code scanner, avoid manually importing the bar code error; (f) database is prevented error management, need data calculated, directly calculate according to related data by database root, and the set up error management, the data that transfinite of input are reported to the police, and the refusal typing; (g) generate quality control table automatically, judge whether automatically to preserve according to logic; (h) be provided with the output report of suitable customer service, stem cell bank, clinical, four patterns of senior executive, can directly require to print according to authority; (i) the main logging data of database is processing parameter and technical data, detection data, output quality information.
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| CNA2009101580408A CN101603031A (en) | 2009-07-17 | 2009-07-17 | Quality management system for stem cell production |
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| CNA2009101580408A CN101603031A (en) | 2009-07-17 | 2009-07-17 | Quality management system for stem cell production |
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Cited By (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102618438A (en) * | 2012-04-11 | 2012-08-01 | 章毅 | System for detecting and screening umbilical cord blood stem cells |
| CN103374760A (en) * | 2012-04-19 | 2013-10-30 | 孙勇 | Construction of human endometrium (menstrual blood) stem cell bank |
| CN104392106A (en) * | 2014-11-03 | 2015-03-04 | 任小宝 | Novel genital system stem cell storage system |
| CN107022648A (en) * | 2017-04-07 | 2017-08-08 | 广东唯泰生物科技有限公司 | A kind of cellular resources store-service method |
| CN107609727A (en) * | 2017-07-25 | 2018-01-19 | 北京呈诺医学科技有限公司 | A kind of Cell Culture Lab total management system and method |
| CN108315299A (en) * | 2018-02-13 | 2018-07-24 | 南京支云松生物科技有限公司 | A kind of instant allosome NK cell banks network storage and transportation application system |
| CN109255411A (en) * | 2018-09-06 | 2019-01-22 | 山东大学齐鲁医院 | The information storage system and method for a kind of portable organ, tissue |
| CN110232546A (en) * | 2019-06-11 | 2019-09-13 | 北京臻溪谷医学研究中心（有限合伙） | A kind of distribution cell Development of intelligent laboratory management system |
| CN110643508A (en) * | 2018-06-26 | 2020-01-03 | 深圳市北科生物科技有限公司 | Modular automatic cell culture system and method |
| CN112686629A (en) * | 2020-12-28 | 2021-04-20 | 浙江中控技术股份有限公司 | Sample inspection data processing method and device, electronic device and storage medium |
| CN114600871A (en) * | 2016-08-04 | 2022-06-10 | 发那科株式会社 | Stem cell cryopreservation equipment |
| CN115440304A (en) * | 2022-08-29 | 2022-12-06 | 新疆碳智干细胞库有限公司 | Cell bank human genetic resource preservation management information system |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101470889A (en) * | 2007-12-26 | 2009-07-01 | 协和干细胞基因工程有限公司 | Cord blood stem cell management system |
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2009
- 2009-07-17 CN CNA2009101580408A patent/CN101603031A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101470889A (en) * | 2007-12-26 | 2009-07-01 | 协和干细胞基因工程有限公司 | Cord blood stem cell management system |
Cited By (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102618438A (en) * | 2012-04-11 | 2012-08-01 | 章毅 | System for detecting and screening umbilical cord blood stem cells |
| CN103374760A (en) * | 2012-04-19 | 2013-10-30 | 孙勇 | Construction of human endometrium (menstrual blood) stem cell bank |
| CN104392106A (en) * | 2014-11-03 | 2015-03-04 | 任小宝 | Novel genital system stem cell storage system |
| CN104392106B (en) * | 2014-11-03 | 2018-12-14 | 任小宝 | A kind of novel germ-line stem cell stocking system |
| CN114600871B (en) * | 2016-08-04 | 2024-04-16 | 发那科株式会社 | Stem cell cryopreservation equipment |
| CN114600871A (en) * | 2016-08-04 | 2022-06-10 | 发那科株式会社 | Stem cell cryopreservation equipment |
| CN107022648A (en) * | 2017-04-07 | 2017-08-08 | 广东唯泰生物科技有限公司 | A kind of cellular resources store-service method |
| CN107609727A (en) * | 2017-07-25 | 2018-01-19 | 北京呈诺医学科技有限公司 | A kind of Cell Culture Lab total management system and method |
| CN108315299A (en) * | 2018-02-13 | 2018-07-24 | 南京支云松生物科技有限公司 | A kind of instant allosome NK cell banks network storage and transportation application system |
| CN110643508A (en) * | 2018-06-26 | 2020-01-03 | 深圳市北科生物科技有限公司 | Modular automatic cell culture system and method |
| CN109255411B (en) * | 2018-09-06 | 2021-08-10 | 山东大学齐鲁医院 | Information storage system and method for transplantable organs and tissues |
| CN109255411A (en) * | 2018-09-06 | 2019-01-22 | 山东大学齐鲁医院 | The information storage system and method for a kind of portable organ, tissue |
| CN110232546B (en) * | 2019-06-11 | 2021-07-02 | 北京臻溪谷医学研究中心（有限合伙） | Distributed cell intelligent laboratory management system |
| CN110232546A (en) * | 2019-06-11 | 2019-09-13 | 北京臻溪谷医学研究中心（有限合伙） | A kind of distribution cell Development of intelligent laboratory management system |
| CN112686629A (en) * | 2020-12-28 | 2021-04-20 | 浙江中控技术股份有限公司 | Sample inspection data processing method and device, electronic device and storage medium |
| CN115440304A (en) * | 2022-08-29 | 2022-12-06 | 新疆碳智干细胞库有限公司 | Cell bank human genetic resource preservation management information system |
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Application publication date: 20091216 |