CN101799348B - Application of double-layer vacuum time-delay leak detection technique in large capacity injection - Google Patents
Application of double-layer vacuum time-delay leak detection technique in large capacity injection Download PDFInfo
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- CN101799348B CN101799348B CN2010101147202A CN201010114720A CN101799348B CN 101799348 B CN101799348 B CN 101799348B CN 2010101147202 A CN2010101147202 A CN 2010101147202A CN 201010114720 A CN201010114720 A CN 201010114720A CN 101799348 B CN101799348 B CN 101799348B
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- capacity injection
- leakage
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- leak detection
- injection
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- 238000002347 injection Methods 0.000 title claims abstract description 47
- 239000007924 injection Substances 0.000 title claims abstract description 47
- 238000001514 detection method Methods 0.000 title claims abstract description 21
- 238000000034 method Methods 0.000 claims abstract description 15
- 238000007689 inspection Methods 0.000 claims abstract description 14
- 239000007788 liquid Substances 0.000 claims abstract description 10
- 239000003814 drug Substances 0.000 claims abstract description 6
- 238000000605 extraction Methods 0.000 claims abstract description 4
- 238000005286 illumination Methods 0.000 claims description 11
- 238000012856 packing Methods 0.000 claims description 10
- 230000007306 turnover Effects 0.000 claims description 10
- 238000007789 sealing Methods 0.000 claims description 7
- 238000000151 deposition Methods 0.000 claims description 4
- 238000004806 packaging method and process Methods 0.000 claims description 4
- 239000002131 composite material Substances 0.000 claims description 3
- 239000012528 membrane Substances 0.000 claims description 3
- 230000002262 irrigation Effects 0.000 claims description 2
- 238000003973 irrigation Methods 0.000 claims description 2
- 238000004659 sterilization and disinfection Methods 0.000 claims description 2
- 210000000056 organ Anatomy 0.000 claims 1
- 238000001802 infusion Methods 0.000 abstract description 20
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract description 6
- 235000014347 soups Nutrition 0.000 description 10
- 238000005516 engineering process Methods 0.000 description 8
- 238000004519 manufacturing process Methods 0.000 description 7
- 238000006243 chemical reaction Methods 0.000 description 4
- 239000000463 material Substances 0.000 description 4
- 239000000779 smoke Substances 0.000 description 4
- 238000003466 welding Methods 0.000 description 4
- 230000015572 biosynthetic process Effects 0.000 description 2
- 230000000284 resting effect Effects 0.000 description 2
- 241000894006 Bacteria Species 0.000 description 1
- ZAMOUSCENKQFHK-UHFFFAOYSA-N Chlorine atom Chemical compound [Cl] ZAMOUSCENKQFHK-UHFFFAOYSA-N 0.000 description 1
- 241000233866 Fungi Species 0.000 description 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
- 241000700605 Viruses Species 0.000 description 1
- 238000000071 blow moulding Methods 0.000 description 1
- 239000000460 chlorine Substances 0.000 description 1
- 229910052801 chlorine Inorganic materials 0.000 description 1
- 238000005520 cutting process Methods 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 230000003203 everyday effect Effects 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 230000002503 metabolic effect Effects 0.000 description 1
- 244000000010 microbial pathogen Species 0.000 description 1
- 239000002510 pyrogen Substances 0.000 description 1
- 238000012797 qualification Methods 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 210000003462 vein Anatomy 0.000 description 1
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Abstract
The invention relates to application of a double-layer vacuum time-delay leak detection technique in a large capacity injection. The large capacity injection mainly comprises an interior package, a liquid medicine and a protection outer bag outside the interior package. The process for detecting the leakage of the interior package comprises the following steps of: performing vacuum extraction between the protection outer bag and the interior package; putting the large capacity injection in a temporary storeroom for 13 to 15 days; and turning out the large capacity injection to perform inspection, wherein when an infusion soft bag with obvious water fog or water droplets is formed between the interior package and the protection outer bag, a micro-leakage large capacity injection is generated and is winkled out. The double-layer vacuum time-delay leak detection technique puts off the leakage detection time to 15 days (not the day when a product is offline) and then performs liquid leakage inspection on the large capacity injection, so the large capacity injection generating micro-leakage or has potential micro-leakage shows out and is removed. Through a technical skill of the invention, the ex-factory micro-leakage rate is reduced to 0.003 to 0.005 percent. Thus, medical accidents are reduced and the excellent health of people is ensured.
Description
Technical field
The present invention relates to a kind of medical high-capacity injection and make the field.
Background technology
High-capacity injection promptly is used for the transfusion of vein, but comprises vial transfusion, plastic bottle transfusion, soft bag infusion and vertical type infusion bag vertical packaging infusion bag.
High-capacity injection is in soup production, the process of packing, dispatch from the factory, and utmost point individual packages is known from experience because accidental factor causes micropore or slit, and produces the seepage of soup:
Like the vial transfusion, in production, packing or transportation, produce slit or micropore because of colliding each other between the vial; Plastic bottle may produce on the local bottle factors such as became uneven in its blow molding process, produce crack or small opening; Soft bag infusion or vertical type infusion bag, can vertical infusion bag, in the heat seal welding process because of edge sealing process around its bag and bag body and fluid-delivery valve, the welding position is because of the uncertain reason formation of technology slit.Owing to comprise above reason deposit, and produce the seepage of soup.
This seepage can not find that we are called " little leakage " to this trickle seepage usually through naked eyes because very trickle.The infusion medicine that produces little leakage can contact and contaminated with the external world, and the pyrogen material (comprises microbiology class various work or dead, various microbial pathogens and metabolic product thereof; Like bacterium, virus, fungi and bacteriotoxin or the like) may enter in the infusion medicine.
Contaminated transfusion uses on one's body the patient, has brought body & mind painful to the patient to some extent, and severe patient causes death; Medically be infusion reaction to this badness reaction, in the medical care process, the annual infusion reaction that is produced in the whole nation is quite surprising; In hospital, happen occasionally, many people's health and lives has perhaps been robbed in infringement, the Chinese safety injection of certificate alliance statistics; China causes dead number more than 390,000 because of dangerous injection every year; Just there were 326 routine infusion reactions in 6 medical institutions, wherein dead 7 examples among 1 year.The malpractice of more than enumerating comprises that certainly some is because the reason that the transfusion leakage is polluted.On the other hand: extraneous other factors (like harmful gas, air) also can influence the stability of soup, and biological characteristics possibly make soup rotten or work the mischief to patient body.
Aspect little leakage of control large capacity transfusion; Each manufacturer's major part of infusing can only be utilized from the artificial control of quality of production link and pick up; Prevent little leakage product export, but little leakage product is difficult to control effectively artificially because of the diversity of its reason formation and the not clear dominance of state.After transfusion was transported to the medical space, partly the transfusion of little leakage still can not be found through medical personnel's naked eyes, is finally used on the patient body.
The whole nation only soft bag large capacity transfusion product export quantity just was more than 1,000,000,000 bags in 2009.At present, in the domestic like product that dispatches from the factory, the transfusion flexible bag that produces little leakage just accounts for tool dispatch from the factory (0.5 ‰) of quantity.
Therefore, consider from the people's life, health, be badly in need of to want a kind of effectively, can accurately control the production technology of the transfusion flexible bag quality of finished product.
Summary of the invention
In order to overcome the deficiency of existing high-capacity injection production technology; Reject the high-capacity injection of leakage; Do not allow the soup that produces seepage to use on one's body the patient, the present invention provides a kind of double-layer vacuum high-capacity injection time-delay (prolonging the resting period) leak hunting technology and application process thereof.
The technical solution adopted for the present invention to solve the technical problems is:
It mainly comprises following technological process:
1,, forms high-capacity injection, and pick out the high-capacity injection that obviously has leakage with the medicine liquid irrigation internal layer packaging of packing into; And carry out disinfection;
2, the high-capacity injection after will packing well is inserted in the protection overcoat; Described protection overcoat adopts the PP composite membrane;
3, extracting vacuum between protection overcoat and inner packing, the vacuum drawn value is: the relative vacuum degree for-0.05Pa to-0.1Pa;
4, detect the high-capacity injection that obviously has leakage;
5,, and deposit into transit depot with qualified high-capacity injection vanning;
6, mould turnover inspection, promptly in depositing transit depot 13 to 15 days, 15 day time preferably; Packaged high-capacity injection is routed up once more; Be to carry out the leakage inspection under the light of 2000Lux～3000Lux in illumination, pick out the leakage product, without leakage specification product are packed dispatched from the factory;
7, carry out once more under illumination is the light of 2000Lux～3000Lux, checking in the field of employment of high-capacity injection, pick out the leakage high-capacity injection.
In the process of extracting vacuum, the extraction time be 6.5S to 7.5S, sealing the back is that 1.4S is to 1.6S cool time.When using the lamp inspection, its illumination is preferably 2000Lux.
This The Application of Technology mode does, through the high-capacity injection of double casing and extracting vacuum, wherein between outer bag of protection and inner packing, produced the high-capacity injection globule or that produced water smoke for leakage takes place, and it is picked out.
The present invention quickens the seepage of little leakage product through negative pressure of vacuum, and let little leakage take place and detect through prolonging the resting period simultaneously: any liquid substance all has certain viscosity and surface tension (Fig. 2), comprises transfusion liquid.In the slit of kapillary appearance, when the surface tension that the viscosity of soup forms and the pressure of soup reached relative equilibrium, the soup seepage was just very trickle, slowly also the short time cannot be found by naked eyes; Because soft bag edge sealing or interface have certain width; If kapillary appearance slit is arranged, promptly kapillary has certain-length, under the resistance that the surface tension that the viscosity of liquid produces forms; Within a short period of time, seepage just can not come to light.So; Through extracting vacuum between protection overcoat and transfusion, form negative pressure, can break the balance between the resistance that self-pressure liquid and surface tension bring; Let soup pass through capillary fracture, and between interior dress and outer jointing jacket, form the tangible water smoke or the globule.
The present invention carries out the leakage inspection through the leak detection time being put off after 15 days, (promptly do not roll off the production line at that time at product) to it.
The present invention can let the high-capacity injection that produces little leakage or potential little leakage show, and through being to check under the light of 2000Lux in illumination, gets rid of little leakage high-capacity injection then.Through technology of the present invention, can reduce little leak rate that high-capacity injection dispatches from the factory greatly, the little leak rate with former 0.4 ‰～0.5 ‰ is reduced to 0.03 ‰～0.05 ‰.
Reduce malpractice with this, guaranteed people health.
Description of drawings
Fig. 1 is leakage observation and statistic figure of the present invention;
Fig. 2 is a structural drawing of the present invention;
Fig. 3 is a principle schematic of the present invention.
Embodiment
In the high capacity injecting; Comprise vial transfusion, plastic bottle transfusion, soft bag infusion and vertical type infusion bag; But the vertical packaging infusion bag, what output in domestic was maximum now is the vial transfusion, but because soft bag infusion high capacity injecting can guarantee its safety, health more; The principal market that to occupy the high capacity injecting is so the present embodiment emphasis is set forth from soft bag infusion high capacity injecting.
The production procedure of soft bag infusion is following: cutting film material (wrappage) at first, carry out the three limits heat-sealing envelopes (limit) to the film material, more then at the another side infusion port pipe (liquid drug 1 when being welded) that is welded; In the above process; The welding process of the heat seal process on three limits and welding infusion port pipe, because of the uncertain factor of technology, very likely involution is not tight; Form slit, and then advance into little leakage.
Utilize this time-delay leak detection technique, carried out 10 times and 10,000 bags " %5 glucose " and " 9% chlorine China sodium injection " have been carried out the preceding leak detection of dispatching from the factory at every turn, the leak detection condition is under the light of illumination 2000Lux.
The leak detection result is by shown in (Fig. 1), and is average:
The leak detection of all transfusion flexible bag mould turnovers was wherein detected 0.32 ‰ and is little leakage transfusion flexible bag in the 5th day, and pick out and have little leakage transfusion flexible bag.
The leak detection of remaining transfusion flexible bag mould turnover was wherein detected 0.09 ‰ and is little leakage transfusion flexible bag in the 7th day, and pick out and have little leakage transfusion flexible bag.
The leak detection of remaining transfusion flexible bag mould turnover was wherein detected 0.02 ‰ and is little leakage transfusion flexible bag in the 9th day, and pick out and have little leakage transfusion flexible bag.
The leak detection of remaining transfusion flexible bag mould turnover was wherein detected 0.02 ‰ and is little leakage transfusion flexible bag in the 11st day, and pick out and have little leakage transfusion flexible bag.
The leak detection of remaining transfusion flexible bag mould turnover was not wherein detected and produces little leakage transfusion flexible bag in the 13rd day, and pick out and have little leakage transfusion flexible bag.
The leak detection of remaining transfusion flexible bag mould turnover was not wherein detected and produces little leakage transfusion flexible bag in the 15th day, and pick out and have little leakage transfusion flexible bag.
The leak detection of remaining transfusion flexible bag mould turnover was not wherein detected and produces little leakage transfusion flexible bag in the 20th day, and pick out and have little leakage transfusion flexible bag.
In the soft bag of detected leakage, all can invent the tangible water smoke or the globule in leakage place, the scope that lamp illuminance can adapt to 3000Lux human body naked eyes from 2000Lux, and can the very convenient effective observation water smoke or the globule.
Because consider the saving human cost, thus can not every day the leakage rate be added up, thus time set the 5th day after going into the stock of hunting leak for the first time, as can beappreciated from fig. 1; The leakage that detected at the 5th day reaches 0.32 ‰, belongs to that to detect the leakage product once maximum, to after the 9th day; Inspection again, the soft bag of leakage has not increased again basically, is merely 0.02 ‰; By the 12nd day, can not detect the leakage transfusion flexible bag more basically, in order further to control the qualification rate of the product that dispatches from the factory; On the 12nd day basis that leakage shown on Fig. 1 stops, postponing three days the final time that dispatches from the factory as leakage inspection again.
Other all did similar check like vial transfusion, plastic bottle transfusion, and was all similar with Fig. 1 about the progress curve of leakage rate, later one to two day of the time to peak of only vial transfusion.
So mould turnover inspection promptly in depositing transit depot 13 to 15 days, preferably 15 day time, is routed up packaged transfusion flexible bag once more, carries out the leakage inspection, picks out the leakage product, without leakage specification product is packed dispatched from the factory.
The vacuum drawn value is: the relative vacuum degree for-0.05Pa to-0.1Pa; Can guarantee under the situation of negative pressure of vacuum, the packing of product not damaged that its vacuum tightness foot is broken surface tension of liquid and viscous force, make potential or just carrying out obvious seepage at the high-capacity injection of little leakage.
In the process of extracting vacuum, according to the material situation of vacuum requirements with protection overcoat 2 and inner packing 3, select the extraction time be 6.5S to 7.5S, sealing back cool time is that 1.4S is to 1.6S.
Claims (4)
1. the application of double-layer vacuum time-delay leak detection technique in high-capacity injection is characterized in that, it mainly comprises following technological process:
1.1, with the medicine liquid irrigation internal layer packaging of packing into, form high-capacity injection, and pick out the high-capacity injection that obviously has leakage; And carry out disinfection;
1.2, the high-capacity injection that will pack after good is inserted in protection overcoat (2); Described protection overcoat adopts the PP composite membrane;
1.3, between protection overcoat and high-capacity injection extracting vacuum; In the process of extracting vacuum, the extraction time be 6.5S to 7.5S, sealing the back is that 1.4S is to 1.6S cool time;
1.4, detect the high-capacity injection that obviously has leakage;
1.5, qualified high-capacity injection is carried out FCL packing, and deposit into transit depot;
1.6, mould turnover inspection, promptly in depositing transit depot 13 to 15 days, packaged high-capacity injection is routed up once more, be to carry out the leakage inspection under the illumination of 2000Lux～3000Lux in illumination, pick out the leakage product, specification product are packed are dispatched from the factory;
1.7, carry out once more under illumination is the illumination of 2000Lux～3000Lux, checking in the field of employment of high-capacity injection, pick out the leakage high-capacity injection.
2. the application of double-layer vacuum time-delay leak detection technique according to claim 1 in high-capacity injection is characterized in that, lamp procuratorial organ formula is adopted in inspection, and its illumination is 2000Lux.
3. the application of double-layer vacuum time-delay leak detection technique according to claim 1 in high-capacity injection; It is characterized in that; Depositing transit depot after 14 days, packaged high-capacity injection is routed up once more, carry out the leakage inspection; Pick out the leakage product, without leakage specification product are packed dispatched from the factory.
4. the application of double-layer vacuum time-delay leak detection technique according to claim 1 in high-capacity injection is characterized in that, checks in the field of employment of high-capacity injection, and its illumination is 2000Lux.
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| CN101799348B true CN101799348B (en) | 2012-11-07 |
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1245217A2 (en) * | 2001-03-27 | 2002-10-02 | Nipro Corporation | Plastic container containing albumin solution |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS63186652A (en) * | 1987-01-29 | 1988-08-02 | 味の素株式会社 | Liquid agent for drug received in bag |
| JPH04295368A (en) * | 1991-03-22 | 1992-10-20 | Green Cross Corp:The | Manufacture of plastic container for transfusion liquid |
| JP3216192B2 (en) * | 1992-01-17 | 2001-10-09 | 凸版印刷株式会社 | Infusion bag and manufacturing method thereof |
| CN2865678Y (en) * | 2006-02-10 | 2007-02-07 | 广州白云山侨光制药有限公司 | Infusion bag |
| CN1961856A (en) * | 2006-11-27 | 2007-05-16 | 四川沱牌药业有限责任公司 | A transfusion soft bag |
| CN201366082Y (en) * | 2009-03-30 | 2009-12-23 | 四川沱牌药业有限责任公司 | Vacuum leakproof soft infusion bag |
-
2010
- 2010-02-26 CN CN2010101147202A patent/CN101799348B/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1245217A2 (en) * | 2001-03-27 | 2002-10-02 | Nipro Corporation | Plastic container containing albumin solution |
Non-Patent Citations (6)
| Title |
|---|
| JP昭63-186652A 1988.08.02 |
| JP特开平4-295368A 1992.10.20 |
| JP特开平5-184643A 1993.07.27 |
| 卞雷.大输液塑料包装方式的对比分析.《机电信息》.2005,(第24期), |
| 大输液塑料包装方式的对比分析;卞雷;《机电信息》;20051220(第24期);第51-53页 * |
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Address after: 629200 Suining City, Sichuan province Shehong County Taihe Town No. 119 North liberation Street No. 602 Building 1 unit Patentee after: Zhang Jie Patentee after: SICHUAN TAIPINGYANG PHARMACEUTICAL CO., LTD. Address before: 629200 Suining City, Sichuan province Shehong County Taihe Town No. 119 North liberation Street No. 602 Building 1 unit Patentee before: Zhang Jie Patentee before: Sichuan Tuopai Pharmaceutical Co., Ltd. |
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