CN1961981A - Method for aseptic production of animal raw serum in full sealing environment by multi-linked blood bag - Google Patents
Method for aseptic production of animal raw serum in full sealing environment by multi-linked blood bag Download PDFInfo
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- CN1961981A CN1961981A CNA2005100963452A CN200510096345A CN1961981A CN 1961981 A CN1961981 A CN 1961981A CN A2005100963452 A CNA2005100963452 A CN A2005100963452A CN 200510096345 A CN200510096345 A CN 200510096345A CN 1961981 A CN1961981 A CN 1961981A
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Abstract
The invention relates to a method for producing animal serum with multiple blood bag sealed germ-free method, wherein it connects the blood taking needle via three-way tube and duct to the blood bag; the needle is inserted into the vessel of cow neck; opens the duct control clamper, the blood will pass the duct into blood bags (12, 13, 14, 15); uses thermal combiner to seal the ducts (8, 9, 10, 11) at A, B, C, and D positions; cuts off the ducts (8, 9, 10, 11); keeping the temperature of bags (12, 13, 14, 15), condensing the blood and evoluting the serum, and decentering the bags (12, 13, 14, 15), to separate the blood and serum; opening the clamper, protruding the serum into bags (16, 17); then uses thermal combiner to seal E, F, G, H positions of ducts (18, 19, 20, 21); cuts off bags (16, 17). The invention can avoid additional device, to realize the production in one sealed system, and avoid pollution.
Description
Technical field
The present invention relates to a kind of full closed aseptic production method of animal raw serum.
Background technology
Animal serum (mainly being new-born calf serum) is main raw and auxiliary material during biological product are produced and the important reagent in the scientific research, require this serum product not have allogenic material (microorganism, phage, endotoxin etc.) and pollute, also will have good promoting growth of cell fertility simultaneously.With the new-born calf serum is example, make finished product serum reach " Chinese biological goods raw and auxiliary material quality control standard ", and its raw material serum must reach quality control standard at items such as antibacterial, endotoxin, phagies at least.And in the existing at home raw material serum production, blood sampling is carried out in different containment system by two sections with separating all.Cause the exposure opportunities for contamination: first section leaves standstill process for blood sampling and constant temperature, and its program is: dissect the cattle neck, expose carotid artery, with blood-letting in blood taking tube or the syringe needle insertion blood vessel, blood is imported in the blood vial, constant temperature, leave standstill blood coagulation; Second section is separation of serum, and its program is: centrifugal---separation of serum.The whole process of this non-sealing blood sampling and separation of serum, blood and serum or container exist opening to expose opportunities for contamination, and the one, connect that blood is uncapped or expose when sealing off; The 2nd, separate and shift serum and exist again and uncap or expose when sealing off.For fear of polluting, can only be ensured by the clean rank of raising operation room and operator's aseptic technique with reducing.In recent years, domestic some manufacturer adopted the blood sampling of blood bag, made this link of blood sampling have certain closure, had reduced to connect that blood is uncapped or expose opportunities for contamination when sealing off, but had still had the exposure opportunities for contamination during separation of serum.That Chinese patent discloses is a kind of " prepare no phage, low endotoxin Ox blood serum with raw material Sanguis Bovis seu Bubali production technology " (application number: 031162290).Its technology is in the toilet that is not more than 10000 grades, locally places the blood taking needle between outer blood sampling to be connected with disposable blood taking bag by conduit for being not more than under 100 grades the environment of laminar flow hood, and blood taking needle penetrates into the cattle body, and Sanguis Bovis seu Bubali flows via a conduit blood taking bag to collecting.The sealing bag mouth gets the Sanguis Bovis seu Bubali product.This technology is finished the collection of Sanguis Bovis seu Bubali under the condition of aseptic sealing, but in same system separation of serum how, this patent does not propose concrete technical scheme.Know from document: the full closed aseptic blood collecting technology is arranged external morning, and its blood sampling and separation of serum also are that branch carries out for two sections, guarantee requisite quality with the GMP condition and the management of strictness only abroad.In a word, do not find also that up to the present one will be taken a blood sample and separation of serum is placed on the technology of finishing in the same closed sterile soft system.
Summary of the invention
Animal blood is gathered and the above-mentioned technical problem of separation of serum in order to solve, purpose of the present invention aims to provide a kind of simple and easy to do a kind of method with the multi-linked blood bag aseptic production of animal raw serum in full sealing environment, finishes the production of animal raw serum in same closed sterile soft system.
The objective of the invention is to be achieved through the following technical solutions:
A kind of method with the multi-linked blood bag aseptic production of animal raw serum in full sealing environment, be that blood taking needle (1) is connected with conduit (2), conduit (2) is connected with tee T (3), tee T (3) is connected with conduit (5) with conduit (4) respectively, conduit (4) and conduit (5) respectively again with tee T (6,7) connect, tee T (6,7) by conduit (8,9,10,11) with blood bag (12,13,14,15) connect, blood bag (16) is by conduit (18,19) respectively with blood bag (12,13) communicate, blood bag (17) is by conduit (20,21) respectively with blood bag (14,15) communicate; Conduit (4,5,8,9,10,11) is equipped with the control folder; Blood taking needle (1) inserts in the blood vessel of cattle cervical region,, open the control folder, Sanguis Bovis seu Bubali flows in the blood bag (12) by conduit (4,8), and is same, opens the control folder, and Sanguis Bovis seu Bubali flows in the blood bag (13,14,15) by conduit (9,10,11) respectively; With heat-sealing machine closes ducts (8,9,10,11) A, B, C, D place, wipe out conduit (8,9,10,11), blood bag (12,13,14,15) is carried out constant temperature, leaves standstill, blood coagulation, separates out serum, and centrifugal blood bag (12,13,14,15) separates serum and clot; Open conduit (18,19,20,21) control folder again, serum is clamp-oned in the blood bag (16,17), use heat-sealing machine closes ducts (18,19,20,21) E, F, G, H place then, cut from blood bag (16,17), a full closed aseptic is finished the production of serum.
The beneficial effect of advantage of the present invention and generation is:
1, the present invention is simple and easy to do, under not additional any appointed condition, has realized the production of full closed aseptic animal raw serum.The invention solves in the prior art owing to blood sampling and separation of serum do not carry out being difficult to get rid of fully raw material serum pollution problems in same closed system, thereby the endotoxin content and the phage that have overcome finished product serum are polluted the problem that two aspects can not be up to standard.Following table is for the present invention adopts with bottle, multi-joint bag is adopted new-born calf serum production method bacterium inspection comparative result:
| Blood-sampling method | The separation of serum method | The separation of serum environment | Bacterium inspection quantity | The positive number | Positive rate (%) |
| Bottle is adopted | Two-step method is separated transfer | 100 grades of purifications | 78 bottles 39000 milliliters | 14 bottles | 18 |
| Multi-joint bag is adopted | Two-step method is separated transfer | 100 grades of purifications | 98 bags 80000 milliliters | 16 bags | 17.8 |
| The present invention | Separate in the same system and shift | Non-purification | 170 bags 80000 milliliters | 4 bags | 2.3 |
As can be seen from the table: 4 bags of pollutions that the present invention detects are all better than bottle blood sampling, multi-joint bag blood sampling effect.4 bags of pollutions of problem may occur in and dissect cattle neck and this link of syringe needle insertion cervical region by analysis.If overcome the problem that this link occurs, positive rate of the present invention is zero.All in a totally-enclosed system, carry out because the present invention adopts new born bovine raw material production environment, do not have the opportunities for contamination of exposure.
2. the present invention is disposable consumption articles for use from blood taking needle, conduit to the whole system of blood bag.The production of blood bag all reaches clean and the designed multi-linked blood bag of aseptic standard, has omitted a plurality of sterile workings link.The capacity of blood bag can be set making according to the blood sampling volume size and the centrifuge amount of capacity of different animals kind.Need the skilled personnel of sterile working with prior art blood sampling and separation of serum, could reduce pollution, and with the designed multi-linked blood bag of the present invention, take a blood sample the worker except that the skilled dissection of need, other operative employees train a little can be on duty, improved blood sampling efficient.
3. widely applicable.The designed multi-linked blood bag of the present invention can be taken a blood sample and separation of serum in the aseptic workshop of strictness, also can carry out at the open-air scene that centrifugal condition is arranged.Accelerated the commercial operations of animal serum.
4. reliable in quality.The serum that the present invention produced all can reach " Chinese biological goods raw and auxiliary material quality control standard ", has fundamentally reversed the difficult quality problem up to standard of using prior art production new-born calf serum.
Description of drawings
Fig. 1 is the sketch map with multi-linked blood bag aseptic production of animal raw serum in full sealing environment method
The specific embodiment
The conduit that the present invention adopts in implementation process is a medical plastic catheter, and the capacity of blood bag is 500ml.
As shown in Figure 1, a kind of method with the multi-linked blood bag aseptic production of animal raw serum in full sealing environment, be that blood taking needle 1 is connected with conduit 2, conduit 2 outlets are connected with tee T 3 imports, tee T 3 outlets are connected with the import of conduit 4 with conduit 5 respectively, conduit 4 is connected with tee T 6,7 imports again respectively with conduit 5, tee T 6,7 outlets are connected with blood bag 12,13,14,15 by conduit 8,9,10,11, blood bag 16 is connected with blood bag 12,13 respectively by conduit 18,19, and blood bag 17 is connected with blood bag 14,15 respectively by conduit 20,21; Conduit 4,5,8,9,10,11 is equipped with the control folder; Blood taking needle 1 inserts in the blood vessel of cattle cervical region, opens the control folder, and Sanguis Bovis seu Bubali flows in the blood bag 12 by conduit 4,8, and is same, opens control folder Sanguis Bovis seu Bubali and flows in the blood bag 13,14,15 by conduit 9,10,11; A, B, C, D place with heat-sealing machine closes ducts 8,9,10,11, wipe out conduit 8,9,10,11, with blood bag 12,13,14,15 carry out constant temperature at 4～8 ℃, leave standstill 4～6 hours, make its blood coagulation, separate out serum, centrifugal blood bag 12,13,14,15 under 4000 rev/mins separates serum and clot; Open conduit 18,19,20,21 control folders again, serum is clamp-oned in the blood bag 16,17, use E, F, G, the H place of heat-sealing machine closes ducts 18,19,20,21 then, cut from blood bag 16,17, a full closed aseptic is finished the production of serum, then the serum finished product is concentrated the vanning warehouse-in with to be used.
Claims (1)
1. method with the multi-linked blood bag aseptic production of animal raw serum in full sealing environment is characterized in that:
(a) blood taking needle (1) is connected with conduit (2), conduit (2) is connected with tee T (3), tee T (3) is connected with conduit (5) with conduit (4) respectively, conduit (4) is connected with tee T (6,7) again respectively with conduit (5), tee T (6,7) is connected with blood bag (12,13,14,15) by conduit (8,9,10,11), blood bag (16) is connected with blood bag (12,13) respectively by conduit (18,19), and blood bag (17) is connected with blood bag (14,15) respectively by conduit (20,21); Conduit (4,5,8,9,10,11) is equipped with the control folder;
(b) blood taking needle (1) inserts in the blood vessel of cattle cervical region, opens the control folder, and Sanguis Bovis seu Bubali flows in the blood bag (12) by conduit (4,8), and is same, opens the control folder according to the order of sequence, and Sanguis Bovis seu Bubali flows in the blood bag (13,14,15) by conduit (9,10,11);
(c) with heat-sealing machine closes ducts (8,9,10,11) A, B, C, D place, wipe out conduit (8,9,10,11), blood bag (12,13,14,15) is carried out constant temperature, leaves standstill, blood coagulation, separates out serum; Centrifugal blood bag (12,13,14,15) separates serum and clot;
(d) open conduit (18,19,20,21) control folder again, serum is clamp-oned in the blood bag (16,17), use heat-sealing machine closes ducts (18,19,20,21) E, F, G, H place then, cut, once finish the production of full closed aseptic serum from blood bag (16,17).
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2005100963452A CN1961981A (en) | 2005-11-08 | 2005-11-08 | Method for aseptic production of animal raw serum in full sealing environment by multi-linked blood bag |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2005100963452A CN1961981A (en) | 2005-11-08 | 2005-11-08 | Method for aseptic production of animal raw serum in full sealing environment by multi-linked blood bag |
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| CN1961981A true CN1961981A (en) | 2007-05-16 |
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| CNA2005100963452A Pending CN1961981A (en) | 2005-11-08 | 2005-11-08 | Method for aseptic production of animal raw serum in full sealing environment by multi-linked blood bag |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107468284A (en) * | 2017-08-21 | 2017-12-15 | 四川大学华西医院 | Special sample bag of thyroid surgery |
| CN107519547A (en) * | 2017-09-29 | 2017-12-29 | 浙江天杭生物科技股份有限公司 | Six blood taking bags |
| CN110694131A (en) * | 2018-07-10 | 2020-01-17 | 亨氏迈泽有限责任公司 | Device for storing and administering eye drops obtained from blood |
| CN113663821A (en) * | 2021-08-20 | 2021-11-19 | 中国人民解放军陆军军医大学第一附属医院 | Separation method of platelet-rich fibrin gel |
-
2005
- 2005-11-08 CN CNA2005100963452A patent/CN1961981A/en active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107468284A (en) * | 2017-08-21 | 2017-12-15 | 四川大学华西医院 | Special sample bag of thyroid surgery |
| CN107468284B (en) * | 2017-08-21 | 2020-05-26 | 四川大学华西医院 | Special sample bag of thyroid surgery |
| CN107519547A (en) * | 2017-09-29 | 2017-12-29 | 浙江天杭生物科技股份有限公司 | Six blood taking bags |
| CN110694131A (en) * | 2018-07-10 | 2020-01-17 | 亨氏迈泽有限责任公司 | Device for storing and administering eye drops obtained from blood |
| CN113663821A (en) * | 2021-08-20 | 2021-11-19 | 中国人民解放军陆军军医大学第一附属医院 | Separation method of platelet-rich fibrin gel |
| CN113663821B (en) * | 2021-08-20 | 2023-08-29 | 中国人民解放军陆军军医大学第一附属医院 | Separation method of platelet-rich fibrin gel |
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