CN103637976A - Aseptic preparation production process - Google Patents
Aseptic preparation production process Download PDFInfo
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- CN103637976A CN103637976A CN201310564766.8A CN201310564766A CN103637976A CN 103637976 A CN103637976 A CN 103637976A CN 201310564766 A CN201310564766 A CN 201310564766A CN 103637976 A CN103637976 A CN 103637976A
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- Feeding, Discharge, Calcimining, Fusing, And Gas-Generation Devices (AREA)
Abstract
The invention belongs to the medicine field, and relates to an aseptic preparation production process used for medicines, and concretely relates to an improvement of the production process of an aseptic liquid preparation. The production process of the liquid aseptic preparation comprises the following steps: 1)water treatment by completely automatic control; 2) automatic liquid preparation; 3)filling and sealing; and 4)disinfection and packaging.
Description
Technical field
The invention belongs to field of medicaments, relate to the production technology for pharmaceutical preparation, specifically a kind of improvement of production technology of sterile liquid formulations.
Background technology
At present China's medical industry is produced the method for sterile preparation, generally comprises following processing step: container is transported in sterilizing room, capping and export from sterilizing room etc. under the supply cleaning of conveying under aseptic condition of the preparation of the conveying under aseptic condition of cleaning container, sterilizing containers, container, sterile liquid medicine fill, medicinal liquid aseptic filtration, medicinal liquid, lid and sterilizing, aseptic condition.Dosing operation must be water source with fresh distilled water, and generally all adds heating activated carbon, stirring decolouring; Filter operation and often adopt ceramic filter stick, glass filter stick or filter press pre-flock, then filter with sand rod or filter stick, finally use microporous filter membrane fine straining, the medicinal liquid after filtration need be measured the intermediate checks such as PH value and content, clarity.After embedding, must carry out sterilization process again, aseptic to guarantee infusion solutions, and sterilizing great majority are to use hot steam sterilizer.According to the pharmaceutical production management method requirement of China, the production routine use of infusion solutions is complete in changing water manufacturing system (water purification system and the water for injection system) operation in 24 hours of controlling, by the method for physical filtering and distillation, make qualified water for injection (water for injection is product adjuvant), before every batch of production, first by formula requirement, use electronic scale to take raw material, then pass through automatic liquid mixing system, raw material is injected to dilute with water according to a certain percentage, and filtration, fill, sterilizing, outer package get product.
Sterile liquid formulations, owing to directly infusing in afferent veins, as sneaked into antibacterial, thermal source and particulate matter in infusion solution, must threaten patient's life security after input human body.Therefore, sterile liquid formulations must strictly observe sterile working in preparation process, guarantee aseptic, without thermal source and containing capacitive microgranule not., three links are wherein to control the key of quality.The first, the processing of purified water or sterilized water; The second, medicinal liquid configuration, the 3rd link is fill.Above-mentioned three links obtain good control has vital impact to the quality control of sterile liquid formulations.
The conventional fill of sterile liquid formulations adopts vial and polypropylene vial encapsulation conventionally.In recent years, polypropylene plastic bottle infusion products because of its have shock-resistant, not cracky, lightweight, save cost of transportation, reliable product quality, progressively become the main flow direction of novel package infusion vessel.Polypropylene vial also progressively exposes some problems in production and application, for example, occurs some carbonization points in encapsulation process, makes polypropylene vial changeableness after sterilizing, and doleiform is unstable.While how to guarantee to encapsulate, avoid occurring carbonization point, steady quality, doleiform homogeneity is a difficult problem.
Summary of the invention
The present invention is through process modification, invented new method prepared by a kind of sterile liquid formulations, greatly reduced pollution section, assurance sterile liquid formulations is avoided polluting in preparation, especially in pouring process, guarantee polypropylene vial stable uniform, and time cost and the Financial cost of the reasonable production control of energy.
The invention provides a kind of preparation method of liquid asepsis preparation, its processing step comprises:
(1) water treatment of Automatic Control;
(2) automatic liquid matching;
(3) embedding;
(4) sterilizing, packing.
Further, the preparation method of described liquid asepsis preparation,
(1) with the full water manufacturing system from changing control, described water manufacturing system is water purification system and water for injection system, and operation in 24 hours, by the method for physical filtering and distillation, makes qualified water for injection;
(2) before every batch of production, first by formula requirement, use electronic scale to take raw material, then, by automatic liquid mixing system, raw material is injected to dilute with water according to a certain percentage, filter;
(3) fill;
(4) sterilizing, outer package get product.
Further, embedding step comprises system bottle process from injection moulding, cools, blowing changes injection moulding into, stretching, blowing once complete fast, after plastic bottle blowing completes, by astrolabe, pull out wheel, fast plastic bottle is directly delivered to filling machine and sealing machine, reduce transmission time and transmission range, reduced the risk of the dirty bacterium of empty bottle.
Preferably, in described fill step, medicinal liquid embedding temperature is at 10-40 ℃.
Preferably, in described fill step, medicinal liquid embedding temperature is at 20-30 ℃.
Preferably, in described fill step, the filling speed of medicinal liquid is 10-15 second/time.
Described embedding speed refers to be once one-period, and fill head starts decline-suspend-to have risen computation time.
Further, the sterilising temp in sterilization steps is that the sterilising temp in sterilization steps is 110-130 ℃, preferably 121 ℃.
Sterilization time in sterilization steps is 5-15 minute, preferably 8-12 minute.
During sterilizing in sterilization steps, sterilizing pressure is 3-4 bar, is preferably 3.3-3.5bar.
Sterilization steps adopts air+steam sterilization method.
Accompanying drawing explanation
Fig. 1; Sterile preparation preparation technology flow chart of the present invention
Fig. 2; Fill step schematic diagram
Now the invention will be further described in conjunction with the accompanying drawings and embodiments.
The specific embodiment
The preparation technology of embodiment 1 aseptic injection A
(1) with full water manufacturing system (water purification system and the water for injection system) operation in 24 hours from changing control, by the method for physical filtering and distillation, make qualified water for injection (water for injection is product adjuvant);
(2) before every batch of production, first by formula requirement, use electronic scale to take raw material, then, by automatic liquid mixing system, raw material is injected to dilute with water according to a certain percentage, filter;
(3) by system bottle process from injection moulding, cool, blowing changes injection moulding into, stretching, blowing once complete fast, after plastic bottle blowing completes, by astrolabe, pull out wheel, fast plastic bottle is directly delivered to filling machine fill, medicinal liquid embedding temperature is between 10-20 ℃, and filling speed is 15-17 second/time, is delivered to fast afterwards sealing machine, thereby reduce transmission time and transmission range, reduce the risk of the dirty bacterium of empty bottle.
(4) sterilizing, outer package get product.Adopt air+steam sterilization method, sterilising temp is 110-121 ℃, and sterilization time is 5-12 minute, and sterilizing pressure is 3-3.3 bar.
The preparation technology of embodiment 2 eye drop B
(1) with full water manufacturing system (water purification system and the water for injection system) operation in 24 hours from changing control, by the method for physical filtering and distillation, make qualified water for injection (water for injection is product adjuvant);
(2) before every batch of production, first by formula requirement, use electronic scale to take raw material, then, by automatic liquid mixing system, raw material is injected to dilute with water according to a certain percentage, filter;
(3) by system bottle process from injection moulding, cool, blowing changes injection moulding into, stretching, blowing once complete fast, after plastic bottle blowing completes, by astrolabe, pull out wheel, fast plastic bottle is directly delivered to filling machine fill, medicinal liquid embedding temperature is between 30-40 ℃, and filling speed is 8-10 second/time, is delivered to fast afterwards sealing machine, thereby reduce transmission time and transmission range, reduce the risk of the dirty bacterium of empty bottle.
(4) sterilizing, outer package get product.Adopt air+steam sterilization method, sterilising temp is 121-130 ℃, and sterilization time is 12-15 minute, and sterilizing pressure is 3.5-4bar.
The preparation technology of comparative example 1 aseptic parenteral solution X
(1) with full water manufacturing system (water purification system and the water for injection system) operation in 24 hours from changing control, by the method for physical filtering and distillation, make qualified water for injection (water for injection is product adjuvant);
(2) before every batch of production, first by formula requirement, use electronic scale to take raw material, then, by automatic liquid mixing system, raw material is injected to dilute with water according to a certain percentage, filter;
(3) by system bottle process from injection moulding, cool, blowing changes injection moulding into, stretching, blowing once complete fast, after plastic bottle blowing completes, by astrolabe, pull out wheel, fast plastic bottle is directly delivered to filling machine fill, medicinal liquid embedding temperature is between 5-9 ℃, and filling speed is 5-7 second/time, is delivered to fast afterwards sealing machine, thereby reduce transmission time and transmission range, reduce the risk of the dirty bacterium of empty bottle.
(4) sterilizing, outer package get product.Adopt air+steam sterilization method, sterilising temp is 100-105 ℃, and sterilization time is 20-30 minute, and sterilizing pressure is 4.5-6bar.
The preparation technology of comparative example 2 eye drop Y
(1) with full water manufacturing system (water purification system and the water for injection system) operation in 24 hours from changing control, by the method for physical filtering and distillation, make qualified water for injection (water for injection is product adjuvant);
(2) before every batch of production, first by formula requirement, use electronic scale to take raw material, then, by automatic liquid mixing system, raw material is injected to dilute with water according to a certain percentage, filter;
(3) by system bottle process from injection moulding, cool, blowing changes injection moulding into, stretching, blowing once complete fast, after plastic bottle blowing completes, by astrolabe, pull out wheel, fast plastic bottle is directly delivered to filling machine fill, medicinal liquid embedding temperature is between 35-40 ℃, and filling speed is 17-22 second/time, is delivered to fast afterwards sealing machine, thereby reduce transmission time and transmission range, reduce the risk of the dirty bacterium of empty bottle.
(4) sterilizing, outer package get product.Adopt air+steam sterilization method, sterilising temp is 123-125 ℃, and sterilization time is 5-7 minute, and sterilizing pressure is 2.5-3.2bar.
Test example is carried out following inspection with reference to the quality standard of polypropylene transfusion bottle, project and the results are shown in following table:
Note: cost calculation is made as 1 with the cost of embodiment 1; Falling height compares in same sample-loading amount situation; The highest defective percentage rate in the sampling check of substandard product rate.
Above-mentioned detailed description is for the illustrating of one of them possible embodiments of the present invention, and this embodiment is not in order to limit the scope of the claims of the present invention, and the equivalence that all the present invention of disengaging do is implemented or change, all should be contained in the scope of technical solution of the present invention.
Claims (10)
1. a preparation method for liquid asepsis preparation, its processing step comprises:
(1) water treatment of Automatic Control;
(2) automatic liquid matching;
(3) embedding;
(4) sterilizing, packing.
2. the preparation method of liquid asepsis preparation according to claim 1, is characterized in that,
(1) use the full water manufacturing system from changing control, water purification system and water for injection system, move, by the method for physical filtering and distillation, make qualified water for injection for 24 hours;
(2) before every batch of production, first by formula requirement, use electronic scale to take raw material, then, by automatic liquid mixing system, raw material is injected to dilute with water according to a certain percentage, filter;
(3) fill;
(4) sterilizing, outer package get product.
3. the preparation method of liquid asepsis preparation according to claim 1, it is characterized in that, embedding step comprises system bottle process from injection moulding, cools, blowing changes injection moulding into, stretching, blowing once complete fast, after plastic bottle blowing completes, by astrolabe, pull out wheel, fast plastic bottle is directly delivered to filling machine and sealing machine.
4. the preparation method of liquid asepsis preparation according to claim 1, is characterized in that, in described fill step, medicinal liquid embedding temperature is at 10-40 ℃.
5. the preparation method of liquid asepsis preparation according to claim 1, is characterized in that, in described fill step, medicinal liquid embedding temperature is at 20-30 ℃.
6. the preparation method of liquid asepsis preparation according to claim 1, is characterized in that, in described fill step, the filling speed of medicinal liquid is 8-17 second/time, preferably 10-15 second/time.
7. the preparation method of liquid asepsis preparation according to claim 1, is characterized in that, the sterilising temp in sterilization steps is that the sterilising temp in sterilization steps is 110-130 ℃, preferably 121 ℃.
8. the preparation method of liquid asepsis preparation according to claim 1, is characterized in that, the sterilization time in sterilization steps is 5-15 minute, preferably 8-12 minute.
9. the preparation method of liquid asepsis preparation according to claim 1, is characterized in that, the sterilizing pressure in sterilization steps is 3-4 bar, is preferably 3.3-3.5bar.
10. the preparation method of liquid asepsis preparation according to claim 1, is characterized in that, sterilization steps adopts air+steam sterilization method.
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| CN201310564766.8A CN103637976B (en) | 2013-11-14 | 2013-11-14 | Aseptic preparation production process |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN111202855A (en) * | 2020-02-18 | 2020-05-29 | 北京四环科宝制药有限公司 | Damp-heat sterilization method for citicoline and sodium salt injection thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101007003A (en) * | 2007-02-01 | 2007-08-01 | 扬子江药业集团南京海陵药业有限公司 | A stable torasemide injection and its preparation method |
| CN101467987A (en) * | 2007-12-26 | 2009-07-01 | 上海复星医药（集团）股份有限公司 | Method for preparing lidocaine carbonate injection |
-
2013
- 2013-11-14 CN CN201310564766.8A patent/CN103637976B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101007003A (en) * | 2007-02-01 | 2007-08-01 | 扬子江药业集团南京海陵药业有限公司 | A stable torasemide injection and its preparation method |
| CN101467987A (en) * | 2007-12-26 | 2009-07-01 | 上海复星医药（集团）股份有限公司 | Method for preparing lidocaine carbonate injection |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN111202855A (en) * | 2020-02-18 | 2020-05-29 | 北京四环科宝制药有限公司 | Damp-heat sterilization method for citicoline and sodium salt injection thereof |
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| CN103637976B (en) | 2015-01-21 |
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Address after: 515000, Shantou bonded area, Guangdong, Germany square, block B Patentee after: Guangdong loest Pharmaceutical Co. Ltd. Address before: Guangdong province Shantou city Haojiang District 515011 Shantou bonded area Chengde Plaza B block, Shantou free trade zone loest Pharmaceutical Co. Ltd. Patentee before: SHANTOU FREE TRADE ZONE LUSTRE PHARMACEUTICAL CO., LTD. |
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Address after: 515000 one of the second floor of building 0001, block e08-4, Shantou Free Trade Zone, Shantou City, Guangdong Province Patentee after: Guangdong loest Pharmaceutical Co.,Ltd. Address before: 515000 block B, Chengde Plaza, Shantou Free Trade Zone, Guangdong Province Patentee before: Guangdong loest Pharmaceutical Co.,Ltd. |