CN101792028A - Application of double-layer aseptic technique in outer package of large capacity injection - Google Patents
Application of double-layer aseptic technique in outer package of large capacity injection Download PDFInfo
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- CN101792028A CN101792028A CN201010114734A CN201010114734A CN101792028A CN 101792028 A CN101792028 A CN 101792028A CN 201010114734 A CN201010114734 A CN 201010114734A CN 201010114734 A CN201010114734 A CN 201010114734A CN 101792028 A CN101792028 A CN 101792028A
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- capacity injection
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Abstract
The invention relates to application of a double-layer aseptic technique in an outer package of a large capacity injection. The adopted technical scheme comprises the following steps: 1, filling liquor in an inner package to form the large capacity injection; 2, encapsulating the large capacity injection in a protective outer package; 3, completely sealing the protective outer package; 4, placing the large capacity injection with the protective outer package into a sterilization apparatus for sterilizing at a high temperature of 121 DEG C for 20 to 30 minutes; 5, drying the sterilized large capacity injection; and 6, casing a finished product, wherein the protective outer package may be made of a PVC or non-PVC material. The inner package is ensured to be under an aseptic condition without being polluted from the sterilization to use in medical places. When the large capacity injection is used in the medical places (such as a surgical operating room and an intensive care unit and the like) with a strict sanitary level requirement, the large capacity injection does not pollute the environment or carry bacteria into the medical 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: can guarantee the aseptic requirement of the packing inside bag of injection; Outside inner packing, add bag outside the protection, in the processes such as transportation of injection, can effectively protect inner packing.
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.
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 1 in inner packing 2 forms high-capacity injection,
B. high-capacity injection is encapsulated into protection external packing 3,
C. it is complete to protect external packing 3 to seal,
D. will install the high-capacity injection of protection after the external packing 3 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. the finished product of casing.
Protection external packing of the present invention 3 and packing inside bag 2 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 2 is inserted in the sterilization of carrying out again after the protection external packing 3; guaranteed that inner packing 2 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.) time; remove outer packaging bag earlier, only carry the packing inside bag and the soup that are in germ-free condition and enter the medical space, can not produce and pollute environment; and it is easy and simple to handle; save time; save trouble; province takes.Reduce malpractice with this, guaranteed people health.
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 3, and this process is also carried out in sterile workshop.
The 3rd step: it is complete to protect external packing 3 to seal, and 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, as be up to the standards etc.
The 6th step:, dispatch from the factory with up-to-standard high-capacity injection packed products.
If the right and wrong PVC material that inner packing 2 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 aseptic 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. it is complete to protect external packing to seal;
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. the finished product of casing.
2. the application of double-layer aseptic 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 aseptic 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 |
|---|---|---|---|
| CN201010114734A CN101792028A (en) | 2010-02-26 | 2010-02-26 | Application of double-layer aseptic technique in outer package of large capacity injection |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201010114734A CN101792028A (en) | 2010-02-26 | 2010-02-26 | Application of double-layer aseptic technique in outer package of large capacity injection |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN101792028A true CN101792028A (en) | 2010-08-04 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201010114734A Pending CN101792028A (en) | 2010-02-26 | 2010-02-26 | Application of double-layer aseptic technique in outer package of large capacity injection |
Country Status (1)
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| CN (1) | CN101792028A (en) |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101999986A (en) * | 2010-09-29 | 2011-04-06 | 石家庄四药有限公司 | Method for controlling polypropylene bottle infusion particles |
| CN102252848A (en) * | 2011-04-14 | 2011-11-23 | 北京航空航天大学 | Propelling agent supply system for catalytic ignition hydrogen oxygen small-sized rocket thruster test |
| CN103919679A (en) * | 2014-05-06 | 2014-07-16 | 四川太平洋药业有限责任公司 | Negative pressure type soft infusion bag |
| CN103919677A (en) * | 2014-05-06 | 2014-07-16 | 四川太平洋药业有限责任公司 | Negative pressure type double-valve soft infusion bag |
| CN103919678A (en) * | 2014-05-06 | 2014-07-16 | 四川太平洋药业有限责任公司 | Negative pressure type sterile double-valve soft infusion bag |
| CN106742610A (en) * | 2017-03-17 | 2017-05-31 | 山东华鲁制药有限公司 | A kind of plastic ampoule injection double-layer sterile packaging structure and preparation method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1555800A (en) * | 2004-01-05 | 2004-12-22 | 海口龙南医药科技开发有限公司 | Changchun ruibinda transfusion preparation and its preparation method |
| CN1817747A (en) * | 2006-03-03 | 2006-08-16 | 湖南千山制药机械股份有限公司 | Production of multiple chamber-bags for large infusion for preventing from opening pollution at charging after sterilization |
| 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 |
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2010
- 2010-02-26 CN CN201010114734A patent/CN101792028A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1555800A (en) * | 2004-01-05 | 2004-12-22 | 海口龙南医药科技开发有限公司 | Changchun ruibinda transfusion preparation and its preparation method |
| CN1817747A (en) * | 2006-03-03 | 2006-08-16 | 湖南千山制药机械股份有限公司 | Production of multiple chamber-bags for large infusion for preventing from opening pollution at charging after sterilization |
| 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 |
Non-Patent Citations (1)
| Title |
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| 王晓林: "《药物制剂辅料与包装材料》", 31 January 2009, 人民卫生出版社 * |
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101999986A (en) * | 2010-09-29 | 2011-04-06 | 石家庄四药有限公司 | Method for controlling polypropylene bottle infusion particles |
| CN101999986B (en) * | 2010-09-29 | 2013-01-16 | 石家庄四药有限公司 | Method for controlling polypropylene bottle infusion particles |
| CN102252848A (en) * | 2011-04-14 | 2011-11-23 | 北京航空航天大学 | Propelling agent supply system for catalytic ignition hydrogen oxygen small-sized rocket thruster test |
| CN102252848B (en) * | 2011-04-14 | 2012-11-07 | 北京航空航天大学 | Propelling agent supply system for catalytic ignition hydrogen oxygen small-sized rocket thruster test |
| CN103919679A (en) * | 2014-05-06 | 2014-07-16 | 四川太平洋药业有限责任公司 | Negative pressure type soft infusion bag |
| CN103919677A (en) * | 2014-05-06 | 2014-07-16 | 四川太平洋药业有限责任公司 | Negative pressure type double-valve soft infusion bag |
| CN103919678A (en) * | 2014-05-06 | 2014-07-16 | 四川太平洋药业有限责任公司 | Negative pressure type sterile double-valve soft infusion bag |
| CN106742610A (en) * | 2017-03-17 | 2017-05-31 | 山东华鲁制药有限公司 | A kind of plastic ampoule injection double-layer sterile packaging structure and preparation method thereof |
| CN106742610B (en) * | 2017-03-17 | 2020-03-17 | 山东华鲁制药有限公司 | Double-deck aseptic packaging structure of plastics ampoule injection |
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Application publication date: 20100804 |