CN101804869A - Application of double-layer aseptic vacuum technique in external package of large volume injection - Google Patents
Application of double-layer aseptic vacuum technique in external package of large volume injection Download PDFInfo
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- CN101804869A CN101804869A CN 201010114711 CN201010114711A CN101804869A CN 101804869 A CN101804869 A CN 101804869A CN 201010114711 CN201010114711 CN 201010114711 CN 201010114711 A CN201010114711 A CN 201010114711A CN 101804869 A CN101804869 A CN 101804869A
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- 238000002347 injection Methods 0.000 title claims abstract description 41
- 239000007924 injection Substances 0.000 title claims abstract description 41
- 238000000034 method Methods 0.000 title claims abstract description 22
- 239000000463 material Substances 0.000 claims abstract description 14
- 230000001954 sterilising effect Effects 0.000 claims abstract description 14
- 239000007788 liquid Substances 0.000 claims abstract description 7
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 5
- 238000012856 packing Methods 0.000 claims description 54
- 239000003814 drug Substances 0.000 claims description 7
- 229940079593 drug Drugs 0.000 claims description 5
- 239000000779 smoke Substances 0.000 claims description 4
- 230000000844 anti-bacterial effect Effects 0.000 claims description 3
- 241000894006 Bacteria Species 0.000 abstract description 4
- 230000001681 protective effect Effects 0.000 abstract description 3
- 238000004806 packaging method and process Methods 0.000 abstract description 2
- 238000001035 drying Methods 0.000 abstract 1
- 239000003595 mist Substances 0.000 abstract 1
- 238000007789 sealing Methods 0.000 abstract 1
- 239000004743 Polypropylene Substances 0.000 description 8
- 238000001802 infusion Methods 0.000 description 7
- 235000014347 soups Nutrition 0.000 description 7
- 238000004659 sterilization and disinfection Methods 0.000 description 7
- 238000004519 manufacturing process Methods 0.000 description 5
- -1 polypropylene Polymers 0.000 description 4
- 229920001155 polypropylene Polymers 0.000 description 4
- 239000004952 Polyamide Substances 0.000 description 3
- 239000011229 interlayer Substances 0.000 description 3
- 229920002647 polyamide Polymers 0.000 description 3
- 208000028399 Critical Illness Diseases 0.000 description 2
- 239000010410 layer Substances 0.000 description 2
- 229920000573 polyethylene Polymers 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 210000003462 vein Anatomy 0.000 description 2
- 241000233866 Fungi Species 0.000 description 1
- 241000700605 Viruses Species 0.000 description 1
- 238000009455 aseptic packaging Methods 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 238000004140 cleaning Methods 0.000 description 1
- 239000002131 composite material Substances 0.000 description 1
- 238000005520 cutting process Methods 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 239000013536 elastomeric material Substances 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 230000036512 infertility Effects 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 230000002503 metabolic effect Effects 0.000 description 1
- 244000000010 microbial pathogen Species 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- 239000002510 pyrogen Substances 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 229920001935 styrene-ethylene-butadiene-styrene Polymers 0.000 description 1
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Abstract
The invention relates to application of a double-layer aseptic vacuum technique in the external package of large volume injection. The invention adopts a technical scheme comprising the following steps of: 1, filling medicinal liquid; 2, packaging the large volume injection into the external protective package and sealing; 3, vacuumizing a space between the internal package and the external package; 4, placing the package in a sterilizing device to sterilize; 5, drying; and 6, checking micro-leakage and removing the large volume injection which forms obvious water mist or droplet between the internal package and the external package. The external protective package can be PVC and non-PVC materials. Through the application, the large volume injection which forms micro-package in the internal package can be removed conveniently and effectively. At the same time, the application ensures that the internal package is under an aseptic condition and is not polluted from the sterilizing process to the use in medicinal places; and when used in the medicinal places with strict hygiene level requirement (such as a surgical operating room, an intensive care unit and the like), the internal package does not pollute the environments and does not carry bacteria into the medicinal places.
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, comprises glass bottle transfusion, plastic bottle transfusion, soft bag infusion and vertical type infusion bag, but the vertical packaging infusion bag.
High-capacity injection directly applies to human vein, and the safety of soup own is self-evident for the life and health influence of human body, needn't discuss at this.In order to guarantee the high-capacity injection drug safety, at each production link, high-capacity injection all strives accomplishing sterile production.At present greatly most: protective bag liquid drug is sterilized, encapsulated to inner packing, to the good high-capacity injection of can outside, case and dispatch from the factory for the production process of high-capacity injection.In the medical space, take the outer bag of protection apart and promptly use.
Its advantage of above technological process is: add bag outside the protection outside inner packing, can effectively protect inner packing in the processes such as transportation of injection; Can guarantee the aseptic requirement of the packing inside bag of injection.
In the above technological process, sterilization treatment has also been passed through on the surface of inner packing, but in the vanning of dispatching from the factory, the process of transporting, devan, and the inner packing surface still can directly contact with the external world, but install additional protect outside in bag process inner packing surface contaminated equally.By the high-capacity injection that above-mentioned technological process is produced, the safe and sanitary that can reach common medical space is required.But, also just can't guarantee patient's life and health safety fully for the then out of reach levels of sterility requirement of medical space (as Surgical Operating Room, critically ill patient ICU etc.) of some health class requirement strictnesses.Or before entering above-mentioned special medical place, needing disinfection once more, this has just increased medical personnel's work and relevant disinfection cost.
In addition, 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.This seepage is because very trickle, and the impassabitity naked eyes find that we are called " little leakage " to this trickle seepage usually.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; As 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 the body ﹠ mind misery to the patient to some extent, and severe patient causes death.
Summary of the invention
In order to overcome the deficiency of existing high-capacity injection production technology, guarantee that patient's life and health safety the invention provides a kind of high-capacity injection aseptic packaging technology.
The technical solution adopted for the present invention to solve the technical problems comprises following process:
A. liquid drug in inner packing forms high-capacity injection,
B. high-capacity injection is encapsulated into the protection external packing,
C. will protect extracting vacuum between outer bag and the inner packing, form negative pressure, and will protect that external packing is complete seals,
D. will install the high-capacity injection of protection after the external packing additional and insert bactericidal unit and sterilize, sterilising temp is high temperature 121 degree Celsius, time length: 20～30 minutes,
E. the high-capacity injection after will sterilizing dries,
F. get rid of the high-capacity injection that between inside and outside packing, forms the tangible water smoke or the globule.
G. the finished product of casing.
Protection external packing of the present invention and packing inside bag one to, belong to identical material, can be PVC, non-PVC material.
Because of application engineering of the present invention comprises double casing (inner packing and external packing); and be that inner packing is inserted in the sterilization of carrying out again after the protection external packing; guaranteed that inner packing is from the use of back up to the medical space of sterilizing; all be under the aseptic condition; polluted; so; comprise the inner packing surface; be germ-free condition; when the medical space that is used for the strictness of health class requirement (as Surgical Operating Room, critically ill patient ICU etc.); can not pollute, not carry bacterium and carry out the medical space environment.Reduce malpractice with this, guaranteed people health.
(interlayer) extracting vacuum between external packing of the present invention and the inner packing forms the zone of negaive pressure, and this design beneficial effect is:
1, can get rid of the possibility of being detained bacterium in the interlayer.
If a large amount of air is arranged in 2 interlayers, in the process of carrying out high-temperature sterilization, air can produce expansion, and the possibility of the packing destroyed is arranged.Extracting vacuum, can get rid of this may.
3, can get rid of the high-capacity injection that inner packing has formed little leakage easily and effectively.Any liquid substance all has certain viscosity and surface tension, comprises transfusion liquid.In the slit of capillary tub sample, when the surface tension that the viscosity of soup forms and the pressure of soup reached relative equilibrium, the soup seepage cannot be found by naked eyes with regard to very slow, trickle and short time; So, if micropore or slit are arranged on the inner packing,, can allow soup quicken, and between inside and outside packing, form the tangible water smoke or the globule by micropore or slit by extracting vacuum between outer bag of protection and inner packing, and with this type of high-capacity injection eliminating.By present technique, can reduce the leakage rate that infusion bag is dispatched from the factory greatly.
Material and inner packing that external packing of the present invention is adopted are identical material, (non-PVC is often referred to non-PVC composite membrane perhaps can to adopt PVC, non-PVC material, comprise outer as polypropylene PP, polythene PE, polyamide PA and multiple elastomeric material SEBS, co-extruded films under 100 grades of cleaning conditions.Internal layer adopts polypropylene PP, polythene PE usually.The middle level is polypropylene PP, polyamide PA etc., the outer material that adopts has polypropylene PP, polyamide PA etc. usually), these materials have stronger chemical inertness, and stronger heat-resisting ability is arranged, therefore entering the high-temperature sterilization cabinet with packing inside bag through 121 degree Celsius, after reaching 20 to 30 minutes high temperature between continuing into, external packing does not change character, do not break, indeformable, keep the vacuum negative pressure condition between external packing and the inner packing, aseptic in the inner packing table, and can guarantee that the outward appearance of packing is not affected.
Description of drawings
Fig. 1 is a constructional drawing of the present invention.
The specific embodiment
By the non-PVC-soft-bag infusion bag is example, carries out the packing of high-capacity injection by following process:
The first step:, and, form high-capacity injection in liquid drug in inner packing at sterile workshop cutting packing inside bag.
Second step: the high-capacity injection that can is good is encapsulated in the protection external packing, and this process is also carried out in sterile workshop.
The 3rd step: will protect extracting vacuum between outer bag and the inner packing, the formation negative pressure, and will protect that external packing is complete seals, this process is carried out in sterile workshop equally.
The 4th step: high-capacity injection is inserted bactericidal unit sterilize, sterilising temp is high temperature 121 degree Celsius, time length: 20～30 minutes.
The 5th step: the high-capacity injection after will sterilizing dries, and enters follow-up flow process then.
The 6th step: check little leakage, get rid of and between inside and outside packing, form the high-capacity injection of the tangible water smoke or the globule.
With up-to-standard high-capacity injection packed products, dispatch from the factory at last.
If the right and wrong PVC material that inner packing adopts, then non-PVC material is also adopted in external packing, two kinds of materials one to, can bear in the same time and the high-temperature sterilization under the temperature.
Claims (3)
1. the application of double-layer sterile vacuum technique in outer package of large capacity injection is characterized in that, it comprises following process:
A. liquid drug in inner packing forms high-capacity injection;
B. high-capacity injection is encapsulated into the protection external packing;
C. will protect extracting vacuum between outer bag and the inner packing, form negative pressure, and will protect that external packing is complete seals;
D. high-capacity injection is inserted bactericidal unit and sterilize, sterilising temp is high temperature 121 degree Celsius, time length: 20～30 minutes;
E. the high-capacity injection after will sterilizing dries;
F. check little leakage, get rid of and between inside and outside packing, form the high-capacity injection of the tangible water smoke or the globule.
G. the finished product of casing.
2. the application of double-layer sterile vacuum technique according to claim 1 in outer package of large capacity injection is characterized in that described protection external packing and packing inside bag belong to identical material.
3. the application of double-layer sterile vacuum technique according to claim 1 in outer package of large capacity injection is characterized in that, described protection external packing is PVC, non-PVC material.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201010114711 CN101804869A (en) | 2010-02-26 | 2010-02-26 | Application of double-layer aseptic vacuum technique in external package of large volume injection |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201010114711 CN101804869A (en) | 2010-02-26 | 2010-02-26 | Application of double-layer aseptic vacuum technique in external package of large volume injection |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN101804869A true CN101804869A (en) | 2010-08-18 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 201010114711 Pending CN101804869A (en) | 2010-02-26 | 2010-02-26 | Application of double-layer aseptic vacuum technique in external package of large volume injection |
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| Country | Link |
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| CN (1) | CN101804869A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104434517A (en) * | 2014-10-10 | 2015-03-25 | 西安京西双鹤药业有限公司 | Double-layer aseptic packaging, packaging method and sterility testing method for large-capacity injection |
| CN105125402A (en) * | 2015-08-14 | 2015-12-09 | 石家庄四药有限公司 | Upright-bag infusion double aseptic package system and production method thereof |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1442346A (en) * | 2003-03-27 | 2003-09-17 | 汕头市永安塑胶实业有限公司 | Pesticide packaging bottle and its panufacturing method and special manufacturing equipment |
| US20040040617A1 (en) * | 2000-12-19 | 2004-03-04 | Frederic Dietrich | Method and installation for emptying casks |
| CN1626247A (en) * | 2003-12-12 | 2005-06-15 | 李怀安 | Method for preparing one-off cotton yarn products for medical use |
| CN1943437A (en) * | 2006-10-23 | 2007-04-11 | 葛修来 | Process for producing vacuum cooked crab |
| CN101428698A (en) * | 2008-12-10 | 2009-05-13 | 江西3L医用制品集团有限公司 | Combined packaging bag and sterilizing-drying method |
-
2010
- 2010-02-26 CN CN 201010114711 patent/CN101804869A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20040040617A1 (en) * | 2000-12-19 | 2004-03-04 | Frederic Dietrich | Method and installation for emptying casks |
| CN1442346A (en) * | 2003-03-27 | 2003-09-17 | 汕头市永安塑胶实业有限公司 | Pesticide packaging bottle and its panufacturing method and special manufacturing equipment |
| CN1626247A (en) * | 2003-12-12 | 2005-06-15 | 李怀安 | Method for preparing one-off cotton yarn products for medical use |
| CN1943437A (en) * | 2006-10-23 | 2007-04-11 | 葛修来 | Process for producing vacuum cooked crab |
| CN101428698A (en) * | 2008-12-10 | 2009-05-13 | 江西3L医用制品集团有限公司 | Combined packaging bag and sterilizing-drying method |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104434517A (en) * | 2014-10-10 | 2015-03-25 | 西安京西双鹤药业有限公司 | Double-layer aseptic packaging, packaging method and sterility testing method for large-capacity injection |
| CN105125402A (en) * | 2015-08-14 | 2015-12-09 | 石家庄四药有限公司 | Upright-bag infusion double aseptic package system and production method thereof |
| CN105125402B (en) * | 2015-08-14 | 2018-03-16 | 石家庄四药有限公司 | A kind of butt-ended bag transfusion double-layer sterile packaging system and preparation method thereof |
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| PB01 | Publication | ||
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| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20100818 |