CN103693791A - Sterile injection water production technique and sterile compressed air preparation method - Google Patents
Sterile injection water production technique and sterile compressed air preparation method Download PDFInfo
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- CN103693791A CN103693791A CN201310669224.7A CN201310669224A CN103693791A CN 103693791 A CN103693791 A CN 103693791A CN 201310669224 A CN201310669224 A CN 201310669224A CN 103693791 A CN103693791 A CN 103693791A
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Abstract
The invention discloses a sterile injection water production technique and a sterile compressed air preparation method. The sterile injection water production technique comprises the following steps: firstly, performing online cleaning CIP (Cleaning in Place) and online SIP (Sterilization in Place) and online drying to all pipelines, a preparation tank and a storage tank used in the production of sterile injection water through distilled water or pure steam, and delivering distilled water into the preparation tank; heating and sterilizing the distilled water, and leading into the storage tank and cooling; and finally, performing sterile filtration to the distilled water through a redundant filtration system, and injecting in a blowing-pouring-sealing three-in-one pouring machine through a sterile pipeline system for sterile pouring and sealing, thus obtaining the product. Through the production technique, the injection water is strictly sterilized before pouring and sealing, heat source content can be effectively controlled, an additive and an antioxidant of a plastic bottle can be prevented from diffusing into the injection water and no impurities of scraps and the like do not exist when terminal high-temperature sterilizing is carried out, therefore, the sterile injection water can provide powerful guarantee for the clinical use safety.
Description
Technical field
The present invention relates to pharmaceutical production field, be specifically related to sterile water for injection production technique
andaseptic compressed air preparation method.
Background technology
Water for injection adopts glass ampoule bottles and polypropylene (PP) plastic ampoule bottle packing conventionally at present, by final sterilization technique, ensures aseptic.
At present, glass ampoule bottles exists problem that cannot be clean safely, and glass ampoule needs water to rinse the inside and outside surface of ampoule, but cannot clean safely.Especially the glass ampoule bottles of washing, in entering drying machine drying process, also easily produces ampoule inwall flake, forms glass granules.And glass ampoule bottles filling after when with the sealing of flame high temperature, can produce combustion particle and fall in ampoule.Glass ampoule bottles also has a problem, exactly when needing injection to open in the process of glass ampoule bottles, a large amount of small cullet can fall into (Tianjin City Medicine Inspection Inst.'s test report demonstration: when particulate determination value is 10um in liquid, plastic ampoule is 10, glass ampoule is 300), these cullet cannot be eliminated after being injected into human body, can bring Health hazard.
In addition, whole glass ampoule bottles cleans, the machine packet size of dryer long (8 meters of left and right), and rotation process risk is large, during wash bottle, cannot under A level laminar flow hood, protect.
In order to solve the problem of glass chip, there is afterwards polypropylene (PP) plastic ampoule bottle packing.But when plastic ampoule bottle is carried out to high-temperature sterilization, additive (additive of PP, metallic element: magnesium≤0.2% left and right that the Plastic Bottle of polypropylene (PP) material contains, aluminium≤0.03% left and right, the additive of PE, metallic element: magnesium≤0.0002%, substantially can't check, aluminium≤0.00002%, substantially can't check) and oxidation inhibitor (oxidation inhibitor of PP is for≤0.3% left and right, the oxidation inhibitor of PE is≤0.00001%, substantially can't check), high temperature can produce migration, in water for injection, by injection, enter human body, there is Health hazard.
In traditional technology, the microbial contamination level of water for injection before filling higher (seeing affiliated hospital of Zhejiang University chemical data), after in being filled to glass ampoule bottles or polypropylene ampoule, while carrying out final sterilization again, in it, the content of bacterial endotoxin (thermal source) increases, bacterial endotoxin is higher, for 0.20EU/ml(national standard is <0.25EU/ml).And due to the singularity of thermal source, it is high temperature resistant, water-soluble, and small volume, enter human body cannot effectively remove, according to people's individual difference, can make the raw heat source response of human hair.According to the description of thermal source in U.S. FDA pharmacopeia, thermal source is the variant protein of 5000 molecular weight, can make the irritated heating of animal, can block the capillary vessel tip of human body, produces granuloma, develops into angiomatous potential hazard.Brought larger potential safety hazard to clinical use.
Summary of the invention
The invention provides sterile water for injection production technique; the three-in-one aseptic filler BFS of embedding is blown in utilization; under wind pouring and the protection of A level laminar flow hood, complete bottle blowing, filling, sealing; whole process is under aseptic conservation; because bottle blowing, filling and sealing are to complete on a station; in its process, not occurrence positions transmission and collision, does not produce particulate.And whole equipment size only has 2 meters, entirely under the protection of A level laminar flow hood.This technique has been controlled the thermal source content of water for injection effectively, and the more traditional terminal sterilization technique of aseptic safeguard level has had a larger raising, strong guarantee is provided to the security of its clinical use.
For achieving the above object, technical scheme of the present invention is:
1. sterile water for injection production technique, comprises the steps:
1): with distilled water or steam, all pipelines, preparing tank and the storage tank of sterile water for injection production use are carried out to on-line cleaning CIP and online sterilizing SIP; With aseptic compressed air, all pipelines, preparing tank and the storage tank of sterile water for injection production use are dried up online again;
2): raw material distilled water, under aseptic compressed air promotes, by the sterilizing filter of 0.22um, is sent into sterilized preparing tank; Preparing tank is provided with heating jacket, uses steam heating sterilizing;
3): after sterilizing completes, the distilled water after the sterilizing that step 2 is obtained is sent into storage tank; The outer chuck of storage tank passes into water coolant, and the distilled water that its inside is stored is cooled to the normal temperature scope of 25 ℃-30 ℃;
4): with aseptic compressed air, by cooled distilled water, the dual 0.22um degerming level strainer by redundancy filtering system carries out Sterile Filtration;
5): the sterile distilled water after filtration blows the three-in-one aseptic filler BFS of embedding by aseptic piping system injection and carries out aseptic embedding; the other end that blows the three-in-one aseptic filler of embedding adds plastic pellet; after adopting hot melt that plastic pellet is melted, passing into sterile air blows parison and makes sky ampoule; under the protection of A level laminar flow hood, carry out aseptic embedding; obtain sterile water for injection, finally carry out successively lamp inspection, labeling and pack to obtain product.
On-line cleaning CIP method described in step 1 is pressurize 15 minutes under 0.15MP aseptic compressed air condition, then carries out prewashing; After prewashing, use 300kg temperature to rinse sterilizing storage tank more than 15 minutes at more than 80 ℃ distilled water; Then use 80 ℃ of distilled water, more than 0.25MP pressure, carry out online drip washing more than 15 minutes, the operation that dries up that finally utilizes aseptic compressed air to carry out 15 minutes under 0.15MP pressure.
Online sterilizing SIP method described in step 1 is for first carrying out pure saturation steam detection, and the steam that detects pure steam generator generation reaches under 130 ℃ of-140 ℃ of conditions of 0.3MP pressure and temperature scope, is aseptic steam; Then under 122 ℃ of-130 ℃ of conditions of 0.15MP pressure and temperature scope, keep carrying out for 30 minutes steam sterilizing, then under 0.15MP pressure condition, carried out aseptic compressed air operation; In temperature, be finally to dry up pressurize below 40 ℃ He under 0.15MP pressure condition.
In step 2, be steam heated to F
0value >12.
The condition of hot melt described in step 5 is 175-230 ℃ and 350bar.
Described aseptic compressed air be use without oil pressure contracting air compressor machine by air compressing to 0.15MP, by obtaining after dry and Sterile Filtration.
Aseptic compressed air preparation method for sterile water for injection production technique claimed in claim 1, comprise the steps: by air being stored at gas-holder without oil pressure contracting air compressor machine, this gas-holder is communicated with tertiary filter successively, and the aseptic compressed air after tertiary filter filters is extremely used gas point by being provided with the Pipeline transport of reducing valve.
It is described that without oil pressure contracting air compressor machine, to be built-in absorption drier revolve tooth air compressor without oil.
Described tertiary filter is respectively the fine filter that filtering accuracy is 1um, superfinishing strainer and the activated charcoal filter that filtering accuracy is 0.01um.
With being also provided with the sterilizing filter of 0.22um on the pipeline before gas point.
Beneficial effect of the present invention:
Production technique of the present invention makes the more traditional terminal sterilization technique of the aseptic safeguard level of water for injection have a larger raising, water for injection is carried out before carrying out filling and sealing to strict sterilizing, under gnotobasis, carry out layer by layer Sterile Filtration simultaneously, therefore effectively controlled thermal source content, and owing to carrying out high-temperature sterilization after packing again, thereby while having avoided terminal high-temperature sterilization, additive, the oxidation inhibitor of PP Plastic Bottle migrate in water for injection.Plastic material ampoule there will not be the impurity such as chip in use, and therefore, the sterile water for injection that the present invention produces provides strong guarantee to the security of its clinical use.
Accompanying drawing explanation
Fig. 1 is sterile water for injection production technological process of the present invention.
Fig. 2 is aseptic compressed air production scheme of the present invention.
specific implementation method
As shown in Figure 1, sterile water for injection production technique of the present invention, is first, with distilled water or pure steam, all pipelines, preparing tank and the storage tank of sterile water for injection production use are carried out to on-line cleaning CIP and online sterilizing SIP.
This on-line cleaning CIP, is by pressurize under 0.15MP aseptic compressed air condition 15 minutes, then carries out prewashing; After prewashing, use 300kg temperature to rinse sterilizing storage tank more than 15 minutes at more than 80 ℃ distilled water; Then use 80 ℃ of distilled water, more than 0.25MP pressure, carry out online drip washing more than 15 minutes, the operation that dries up that finally utilizes aseptic compressed air to carry out 15 minutes under 0.15MP pressure.
This online sterilizing SIP, need to first carry out pure saturation steam detection, detects the steam that pure steam generator occurs, and when steam reaches under 130 ℃ of-140 ℃ of conditions of 0.3MP pressure and temperature scope, is aseptic steam; Then under 122 ℃ of-130 ℃ of conditions of 0.15MP pressure and temperature scope, keep carrying out for 30 minutes steam sterilizing, then under 0.15MP pressure condition, carried out aseptic compressed air operation; In temperature, be finally to dry up pressurize below 40 ℃ He under 0.15MP pressure condition.
After all pipelines, preparing tank and storage tank being completed to on-line cleaning and online sterilizing, use aseptic compressed air to dry up online all pipelines, preparing tank and the storage tank of sterile water for injection production use, remove residual water of condensation in its compounding system.
The aseptic compressed air of the present embodiment be use without oil pressure contracting air compressor machine by air compressing to 0.15MP, by resulting after dry and Sterile Filtration.The preparation flow of this aseptic compressed air comprises the steps: first by air being stored at gas-holder without oil pressure contracting air compressor machine, this gas-holder is communicated with tertiary filter more successively, and the aseptic compressed air after tertiary filter filters is extremely used gas point by being provided with the Pipeline transport of reducing valve.
What without oil pressure contracting air compressor machine, be built-in absorption drier in the present embodiment, revolves tooth air compressor without oil.Tertiary filter is respectively the fine filter that filtering accuracy is 1um, superfinishing strainer and the activated charcoal filter that filtering accuracy is 0.01um.In addition, on the pipeline with before gas point, be also provided with the sterilizing filter of 0.22um.
After pipeline, preparing tank and storage tank dry up, distilled water, under aseptic compressed air promotes, is sent into sterilized preparing tank by the sterilizing filter of 0.22um.Again by being located at steam that the outer chuck of preparing tank injects by distilled water heat sterilization.In the present embodiment, distilled water is to be heated to F
0under the condition of value >12, carry out sterilizing, F
0value is standard sterilization time.
After subject to sterilization completing, the distilled water after sterilizing is passed into storage tank.
Water coolant is passed into the outer chuck of storage tank, the distilled water that its inside is stored is cooled to the normal temperature scope of 25 ℃-30 ℃.
With aseptic compressed air, by cooling good sterile purified water in storage tank, the dual 0.22um degerming level strainer by redundancy filtering system carries out Sterile Filtration again.
Finally, distilled water after filtering is injected and blown the three-in-one aseptic filler BFS of embedding by aseptic piping system, this the other end that blows embedding all-in-one adds plastic pellet, passes into sterile air and blow parison and make sky ampoule after hot melt condition is melted plastic pellet be 175-230 ℃ and 350bar in the situation that.Then continue to carry out aseptic embedding under the protection of A level laminar flow hood, complete sterile water for injection, finally carry out successively lamp inspection, labeling and pack to obtain product.
In the present embodiment, blowing the three-in-one aseptic filler of embedding is and sealed to each other connection of pipeline, preparing tank and storage tank of preparing distilled water, so, when pipeline, preparing tank and storage tank are carried out to on-line cleaning, sterilizing, blow the three-in-one aseptic filler of embedding also while, synchronously on-line cleaning, sterilizing.
Get the sterile water for injection 1000ml after filling, inspection product numbering 13-200431(survey report reference number of a document: SOR-KBQA-066-01), press 2010 editions two checks of < < Chinese Pharmacopoeia > >, after testing, the detection data results of projects is:
| Project name | Standard regulation | Assay |
| Proterties checks | This product is colourless clear liquid; Odorless; Tasteless | Colourless clear liquid; Odorless; Tasteless |
 |
Should be 5.0-7.0 | 5.7 |
| Muriate, vitriol and calcium salt | Should be up to specification | Up to specification |
| Carbonic acid gas | Should be up to specification | Up to specification |
| Readily oxidizable substance | Should be up to specification | Up to specification |
| Nitrate | Must not cross 0.000006% | Do not cross 0.000006% |
| Nitrite | Must not cross 0.000002% | Do not cross 0.000002% |
| Ammonia | Must not cross 0.00002% | Do not cross 0.00002% |
| Specific conductivity | Should be up to specification | Up to specification |
| Total organic carbon | Must not cross 500mg/L | Do not cross 100mg/L |
| Non-volatile matter | Leave over residue and must not cross 1mg | 0.1mg |
| Heavy metal | Must not cross 0.00003% | Do not cross 0.00003% |
| Bacterial endotoxin | Should be less than 0.25EU/ml | Be less than 0.06EU/ml |
| Sterility test | Should be up to specification | Up to specification |
Claims (10)
1. sterile water for injection production technique, is characterized in that comprising the steps:
1): with distilled water or steam, all pipelines, preparing tank and the storage tank of sterile water for injection production use are carried out to on-line cleaning CIP and online sterilizing SIP; With aseptic compressed air, all pipelines, preparing tank and the storage tank of sterile water for injection production use are dried up online again;
2): raw material distilled water, under aseptic compressed air promotes, by the sterilizing filter of 0.22um, is sent into sterilized preparing tank; Preparing tank is provided with heating jacket, uses steam heating sterilizing;
3): after sterilizing completes, the distilled water after the sterilizing that step 2 is obtained is sent into storage tank; The outer chuck of storage tank passes into water coolant, and the distilled water that its inside is stored is cooled to the normal temperature scope of 25 ℃-30 ℃;
4): with aseptic compressed air, by cooled distilled water, the dual 0.22um degerming level strainer by redundancy filtering system carries out Sterile Filtration;
5): the sterile distilled water after filtration blows the three-in-one aseptic filler BFS of embedding by aseptic piping system injection and carries out aseptic embedding; the other end that blows the three-in-one aseptic filler of embedding adds plastic pellet; after adopting hot melt that plastic pellet is melted, passing into sterile air blows parison and makes sky ampoule; under the protection of A level laminar flow hood, carry out aseptic embedding; obtain sterile water for injection, finally carry out successively lamp inspection, labeling and pack to obtain product.
2. sterile water for injection production technique according to claim 1, is characterized in that: the on-line cleaning CIP method described in step 1, for pressurize under 0.15MP aseptic compressed air condition 15 minutes, is then carried out prewashing; After prewashing, use 300kg temperature to rinse sterilizing storage tank more than 15 minutes at more than 80 ℃ distilled water; Then use 80 ℃ of distilled water, more than 0.25MP pressure, carry out online drip washing more than 15 minutes, the operation that dries up that finally utilizes aseptic compressed air to carry out 15 minutes under 0.15MP pressure.
3. sterile water for injection production technique according to claim 1, it is characterized in that: the online sterilizing SIP method described in step 1 is for first carrying out pure saturation steam detection, the steam that detects pure steam generator generation reaches under 130 ℃ of-140 ℃ of conditions of 0.3MP pressure and temperature scope, is aseptic steam; Then under 122 ℃ of-130 ℃ of conditions of 0.15MP pressure and temperature scope, keep carrying out for 30 minutes steam sterilizing, then under 0.15MP pressure condition, carried out aseptic compressed air operation; In temperature, be finally to dry up pressurize below 40 ℃ He under 0.15MP pressure condition.
4. sterile water for injection production technique according to claim 1, is characterized in that: in step 2, be steam heated to F
0value >12.
5. sterile water for injection production technique according to claim 1, is characterized in that: the condition of hot melt described in step 5 is 175-230 ℃ and 350bar.
6. sterile water for injection production technique according to claim 1, is characterized in that: described aseptic compressed air be use without oil pressure contracting air compressor machine by air compressing to 0.15MP, by obtaining after dry and Sterile Filtration.
7. for the aseptic compressed air preparation method of sterile water for injection production technique claimed in claim 1, it is characterized in that comprising the steps: by air being stored at gas-holder without oil pressure contracting air compressor machine, this gas-holder is communicated with tertiary filter successively, and the aseptic compressed air after tertiary filter filters is extremely used gas point by being provided with the Pipeline transport of reducing valve.
8. the preparation method of aseptic compressed air according to claim 7, is characterized in that: described without oil pressure contracting air compressor machine, to be built-in absorption drier revolve tooth air compressor without oil.
9. the preparation method of aseptic compressed air according to claim 7, is characterized in that: described tertiary filter is respectively the fine filter that filtering accuracy is 1um, superfinishing strainer and the activated charcoal filter that filtering accuracy is 0.01um.
10. the preparation method of aseptic compressed air according to claim 7, is characterized in that: with being also provided with the sterilizing filter of 0.22um on the pipeline before gas point.
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105129706A (en) * | 2015-08-11 | 2015-12-09 | 江苏大红鹰恒顺药业有限公司 | Production technology of sterile oxygen humidification bottles |
| CN107198657A (en) * | 2016-03-17 | 2017-09-26 | 江苏大红鹰恒顺药业有限公司 | Collect sterile preparation and blow the three-in-one plastic ampoule sterile preparation technique of embedding and system |
| CN109132490A (en) * | 2018-09-10 | 2019-01-04 | 烟台冰轮医药装备有限公司北京分公司 | A kind of online disinfection system and sterilizing methods of bulk pharmaceutical chemicals automatic feeding and discharging mechanism |
| CN109250505A (en) * | 2018-09-10 | 2019-01-22 | 烟台冰轮医药装备有限公司北京分公司 | Bulk pharmaceutical chemicals discharging device and its sterilizing methods |
| CN109364279A (en) * | 2018-09-06 | 2019-02-22 | 丽珠集团利民制药厂 | It is a kind of can online CIP/SIP thimerosal filtration sterilization and cleaning system |
| CN109550297A (en) * | 2018-12-25 | 2019-04-02 | 山东泰邦生物制品有限公司 | A kind of aseptic medicine filtration sterilization device and technique |
| CN110005585A (en) * | 2019-04-15 | 2019-07-12 | 英诺维尔智能科技（苏州）有限公司 | A kind of sterile sealing structure of syringe pump |
| CN112617072A (en) * | 2020-11-26 | 2021-04-09 | 长春豪邦健康科技有限公司 | Aseptic preparation process based on aseptic liquid beverage |
| CN113522073A (en) * | 2021-07-01 | 2021-10-22 | 褚培忠 | Production process of sterile disinfectant |
| CN113825705A (en) * | 2019-06-14 | 2021-12-21 | 大日本印刷株式会社 | Aseptic filling machine and method for cooling filling valve of aseptic filling machine |
| CN114955031A (en) * | 2022-05-27 | 2022-08-30 | 山东希尔康泰药业有限公司 | Diclofenac sodium lidocaine hydrochloride injection aseptic preparation system |
| CN115645561A (en) * | 2022-11-03 | 2023-01-31 | 长春豪邦健康科技有限公司 | Preparation method and device of sterile ginseng secondary polishing essence |
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Cited By (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105129706A (en) * | 2015-08-11 | 2015-12-09 | 江苏大红鹰恒顺药业有限公司 | Production technology of sterile oxygen humidification bottles |
| CN107198657A (en) * | 2016-03-17 | 2017-09-26 | 江苏大红鹰恒顺药业有限公司 | Collect sterile preparation and blow the three-in-one plastic ampoule sterile preparation technique of embedding and system |
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| CN109250505A (en) * | 2018-09-10 | 2019-01-22 | 烟台冰轮医药装备有限公司北京分公司 | Bulk pharmaceutical chemicals discharging device and its sterilizing methods |
| CN109550297A (en) * | 2018-12-25 | 2019-04-02 | 山东泰邦生物制品有限公司 | A kind of aseptic medicine filtration sterilization device and technique |
| CN110005585A (en) * | 2019-04-15 | 2019-07-12 | 英诺维尔智能科技（苏州）有限公司 | A kind of sterile sealing structure of syringe pump |
| CN113825705A (en) * | 2019-06-14 | 2021-12-21 | 大日本印刷株式会社 | Aseptic filling machine and method for cooling filling valve of aseptic filling machine |
| CN112617072A (en) * | 2020-11-26 | 2021-04-09 | 长春豪邦健康科技有限公司 | Aseptic preparation process based on aseptic liquid beverage |
| CN113522073A (en) * | 2021-07-01 | 2021-10-22 | 褚培忠 | Production process of sterile disinfectant |
| CN114955031A (en) * | 2022-05-27 | 2022-08-30 | 山东希尔康泰药业有限公司 | Diclofenac sodium lidocaine hydrochloride injection aseptic preparation system |
| CN114955031B (en) * | 2022-05-27 | 2023-09-22 | 山东希尔康泰药业有限公司 | Sterile preparation system for diclofenac sodium lidocaine hydrochloride injection |
| CN115645561A (en) * | 2022-11-03 | 2023-01-31 | 长春豪邦健康科技有限公司 | Preparation method and device of sterile ginseng secondary polishing essence |
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| CN103693791B (en) | 2015-04-15 |
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