CN103693791B - Sterile injection water production technique - Google Patents
Sterile injection water production technique Download PDFInfo
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- CN103693791B CN103693791B CN201310669224.7A CN201310669224A CN103693791B CN 103693791 B CN103693791 B CN 103693791B CN 201310669224 A CN201310669224 A CN 201310669224A CN 103693791 B CN103693791 B CN 103693791B
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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 technology
.
Background technology
Current water for injection adopts glass ampoule bottles and polypropylene (PP) plastic ampoule bottle packaging usually, ensures aseptic by final sterilization technique.
At present, glass ampoule bottles then also exists the problem that cannot clean safely, and glass ampule needs use water to rinse the inside and outside surface of ampoule, but cannot clean safely.Especially washed glass ampoule bottles is entering in drying machine drying process, also easily produces ampoule bottle inwall flake, forms glass granules.And after glass ampoule bottles fill when sealing with flame high temperature, combustion particle can be produced and fall in ampoule bottle.Glass ampoule bottles also has a problem, exactly when needs injection is opened in the process of glass ampoule bottles, a large amount of tiny glass bits can fall into (Tianjin City Medicine Inspection Inst.'s test report display: when particulate determination value is 10um in medicinal liquid, plastic ampoule is 10, glass ampule is 300), cannot eliminate after these chipss of glass are injected into human body, and can health hazard be brought.
In addition, the machine packet size long (about 8 meters) of whole glass ampoule bottles cleaning, dehydrator, rotation process risk is large, cannot protect during wash bottle under A level laminar flow hood.
In order to solve the problem of glass chip, occur that polypropylene (PP) plastic ampoule bottle is packed afterwards.But when carrying out high temperature sterilize to plastic ampoule bottle, additive (additive of PP, metallic element: about magnesium≤0.2% that the plastic bottle of polypropylene (PP) material contains, about aluminum≤0.03%, the additive of PE, metallic element: magnesium≤0.0002%, substantially can't check, aluminum≤0.00002%, substantially can't check) and antioxidant (antioxidant of PP is about≤0.3%, the antioxidant of PE is≤0.00001%, substantially can't check), high temperature can produce migration, in water for injection, enter human body, there is health hazard by injection.
In traditional handicraft, water for injection microbial contamination level before filling the container higher (see Affiliated Hospital of Zhejiang University chemical data), carrying out being filled to after in glass ampoule bottles or polypropylene ampoule bottle, when 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 particularity of thermal source, it is high temperature resistant, water-soluble, and small volume, entering human body cannot effectively remove, and according to the individual variation of people, can make the raw heat source response of Crinis Carbonisatus.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 heating of animal allergy, can block the blood capillary tip of human body, produce granuloma, develop into angiomatous potential hazard.Larger potential safety hazard is brought to Clinical practice.
Summary of the invention
The invention provides sterile water for injection production technology; the three-in-one aseptic filler BFS of embedding is blown in utilization; drench at wind and complete bottle blowing, fill, sealing under the protection of A level laminar flow hood; overall process is under sterility protection; because bottle blowing, fill and sealing complete on a station; there is not position transmission and collision in its process, do not produce microgranule.And whole equipment size only has 2 meters, be entirely under the protection of A level laminar flow hood.This technique controls the thermal source content of water for injection effectively, and the terminal sterilization technique that sterility barrier level is more traditional has had a larger raising, provides strong guarantee to the safety of its Clinical practice.
For achieving the above object, technical scheme of the present invention is:
Sterile water for injection production technology, comprises the steps:
1): with distilled water or steam, on-line cleaning CIP and online sterilizing SIP is carried out to all pipelines of sterile water for injection production, preparing tank and storage tank; With aseptic compressed air, all pipelines of sterile water for injection production, preparing tank and storage tank are dried up online again;
2): by raw material distilled water under aseptic compressed air promotes, by the sterilizing filter of 0.22um, send into sterilized preparing tank; Preparing tank is provided with heating jacket, uses Steam Heating sterilizing;
3) storage tank sent into by the distilled water after the sterilizing: after sterilizing completes, step 2 obtained; The outer chuck of storage tank passes into cooling water, and the distilled water that its inside is stored is cooled to the room temperature scope of 25 DEG C-30 DEG C;
4): with aseptic compressed air, cooled distilled water is carried out aseptic filtration by the degerming level filter of the dual 0.22um of redundant filtration system;
5): the sterile distilled water after filtration blows embedding three-in-one aseptic filler BFS by aseptic pipe-line system injection and carries out aseptic embedding; the other end blowing the three-in-one aseptic filler of embedding adds plastic pellet; pass into filtrated air after adopting hot melt to be melted by plastic pellet to blow parison and make sky ampoule bottle; aseptic embedding is carried out under the protection of A level laminar flow hood; namely obtain sterile water for injection, finally carry out lamp inspection, labeling successively 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; The distilled water of 300kg temperature more than 80 DEG C is used to carry out flushing sterilizing storage tank more than 15 minutes after prewashing; Then use 80 DEG C of distilled water, more than 0.25MP pressure, carry out online drip washing more than 15 minutes, finally utilize aseptic compressed air carry out under 0.15MP pressure 15 minutes dry up operation.
Online sterilizing SIP method described in step 1, for first to carry out pure saturated vapor detection, under the steam that namely detection pure steam generator occurs reaches 0.3MP pressure and temperature scope 130 DEG C of-140 DEG C of conditions, is sterile steam; Then under 0.15MP pressure and temperature scope 122 DEG C of-130 DEG C of conditions, keep carrying out steam sterilization in 30 minutes, under 0.15MP pressure condition, then carried out aseptic compressed air operation; Finally temperature be less than 40 DEG C with 0.15MP pressure condition under carry out drying up pressurize.
F is steam heated in step 2
0value >12.
The condition of hot melt described in step 5 is 175-230 DEG C and 350bar.
Described aseptic compressed air uses without oil pressure contracting air compressor machine by after air compressing to 0.15MP, by obtaining after dry and aseptic filtration.
Aseptic compressed air for sterile water for injection production technology according to claim 1 is by storing at air accumulator without oil pressure contracting air compressor machine by air, this air accumulator is communicated with tertiary filter successively, and the aseptic compressed air after tertiary filter filters is by being provided with the Pipeline transport of air relief valve to using gas point.
Described without oil pressure contracting air compressor machine be built-in absorption drier revolve tooth air compressor without oil.
Described tertiary filter is respectively fine filter that filtering accuracy is 1um, filtering accuracy is 0.01um superfinishing filter and active carbon filter.
With the sterilizing filter pipeline before gas point being also provided with 0.22um.
Beneficial effect of the present invention:
Production technology of the present invention makes the more traditional terminal sterilization technique of the sterility barrier level of water for injection have a larger raising, water for injection is carried out stringent sterilization before carrying out filling and sealing, carry out aseptic filtration layer by layer in an aseptic environment simultaneously, therefore thermal source content is effectively controlled, and owing to carrying out high-temperature sterilization after packing again, thus when avoiding terminal high temperature sterilize, additive, the antioxidant of PP plastic bottle migrate in water for injection.Plastic material ampoule bottle 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 safety of its Clinical practice.
Accompanying drawing explanation
Fig. 1 is sterile water for injection production technological process of the present invention.
Fig. 2 is aseptic compressed air flow sheet of the present invention.
specific implementation method
As shown in Figure 1, first sterile water for injection production technology of the present invention is carry out on-line cleaning CIP and online sterilizing SIP with distilled water or pure steam to all pipelines of sterile water for injection production, preparing tank and storage tank.
This on-line cleaning CIP, is by pressurize under 0.15MP aseptic compressed air condition 15 minutes, then carries out prewashing; The distilled water of 300kg temperature more than 80 DEG C is used to carry out flushing sterilizing storage tank more than 15 minutes after prewashing; Then use 80 DEG C of distilled water, more than 0.25MP pressure, carry out online drip washing more than 15 minutes, finally utilize aseptic compressed air carry out under 0.15MP pressure 15 minutes dry up operation.
This online sterilizing SIP, needs first to carry out pure saturated vapor detection, namely detects the steam that pure steam generator occurs, under steam reaches 0.3MP pressure and temperature scope 130 DEG C of-140 DEG C of conditions, is sterile steam; Then under 0.15MP pressure and temperature scope 122 DEG C of-130 DEG C of conditions, keep carrying out steam sterilization in 30 minutes, under 0.15MP pressure condition, then carried out aseptic compressed air operation; Finally temperature be less than 40 DEG C with 0.15MP pressure condition under carry out drying up pressurize.
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 of sterile water for injection production, preparing tank and storage tank, remove condensed water residual in its compounding system.
The aseptic compressed air of the present embodiment uses without oil pressure contracting air compressor machine by after air compressing to 0.15MP, by what obtain after dry and aseptic filtration.The preparation flow of this aseptic compressed air comprises the steps: first by storing at air accumulator without oil pressure contracting air compressor machine by air, this air accumulator is communicated with tertiary filter more successively, and the aseptic compressed air after tertiary filter filters is by being provided with the Pipeline transport of air relief valve to using gas point.
In the present embodiment, without oil pressure contracting air compressor machine be built-in absorption drier revolve tooth air compressor without oil.Tertiary filter is then respectively fine filter that filtering accuracy is 1um, filtering accuracy is 0.01um superfinishing filter and active carbon filter.In addition, with the sterilizing filter pipeline before gas point being also provided with 0.22um.
After pipeline, preparing tank and storage tank dry up, by distilled water under aseptic compressed air promotes, send into sterilized preparing tank by the sterilizing filter of 0.22um.Again by being located at the steam of the outer chuck injection of preparing tank by distilled water heat sterilization.In the present embodiment, distilled water is being heated to F
0sterilizing is carried out, F under the condition of value >12
0value is the normal sterilization time.
Subject to sterilization complete after, the distilled water after sterilizing is passed into storage tank.
Cooling water is passed into the outer chuck of storage tank, the distilled water that its inside is stored is cooled to the room temperature scope of 25 DEG C-30 DEG C.
With aseptic compressed air, the sterile purified water cooled in storage tank is carried out aseptic filtration by the degerming level filter of the dual 0.22um of redundant filtration system again.
Finally, distilled water after filtering is blown the three-in-one aseptic filler BFS of embedding by aseptic pipe-line system injection, this other end blowing encapsulation all-in-one machine adds plastic pellet, when hot melt condition be 175-230 DEG C and 350bar plastic pellet is melted after pass into filtrated air and blow parison and make sky ampoule bottle.Then continue to carry out aseptic embedding under the protection of A level laminar flow hood, namely complete sterile water for injection, finally carry out lamp inspection, labeling successively and pack to obtain product.
In the present embodiment, blowing the three-in-one aseptic filler of embedding is with pipeline, the preparing tank of preparation distilled water and storage tank is sealed to each other is communicated with, so, while on-line cleaning, sterilizing are carried out to pipeline, preparing tank and storage tank, blow the three-in-one aseptic filler of embedding also simultaneously, synchronously on-line cleaning, sterilizing.
Get the sterile water for injection 1000ml after fill, inspection product numbering 13-200431(survey report reference number of a document: SOR-KBQA-066-01), by " Chinese Pharmacopoeia " 2010 editions two inspections, after testing, the detection data result of projects is:
| Project name | Standard specifies | Assay |
| Character checks | This product is colourless clear liquid; Odorless; Tasteless | Colourless clear liquid; Odorless; Tasteless |
| P H-number | Should be 5.0-7.0 | 5.7 |
| Chloride, sulfate and calcium salt | Should conform with the regulations | Conform with the regulations |
| Carbon dioxide | Should conform with the regulations | Conform with the regulations |
| Readily oxidizable substance | Should conform with the regulations | Conform with the regulations |
| Nitrate | Must not 0.000006% be crossed | Do not cross 0.000006% |
| Nitrite | Must not 0.000002% be crossed | Do not cross 0.000002% |
| Ammonia | Must not 0.00002% be crossed | Do not cross 0.00002% |
| Electrical conductivity | Should conform with the regulations | Conform with the regulations |
| Total organic carbon | 500mg/L must not be crossed | Do not cross 100mg/L |
| Non-volatile matter | Remaining residue must not cross 1mg | 0.1mg |
| Heavy metal | Must not 0.00003% be crossed | Do not cross 0.00003% |
| Bacterial endotoxin | 0.25EU/ml should be less than | Be less than 0.06EU/ml |
| Sterility test | Should conform with the regulations | Conform with the regulations |
Claims (10)
1. sterile water for injection production technology, is characterized in that comprising the steps:
1): with distilled water or steam, on-line cleaning CIP and online sterilizing SIP is carried out to all pipelines of sterile water for injection production, preparing tank and storage tank; With aseptic compressed air, all pipelines of sterile water for injection production, preparing tank and storage tank are dried up online again;
2): by raw material distilled water under aseptic compressed air promotes, by the sterilizing filter of 0.22 μm, send into sterilized preparing tank; Preparing tank is provided with heating jacket, uses Steam Heating sterilizing;
3) storage tank sent into by the distilled water after the sterilizing: after sterilizing completes, step 2 obtained; The outer chuck of storage tank passes into cooling water, and the distilled water that its inside is stored is cooled to the room temperature scope of 25 DEG C-30 DEG C;
4): with aseptic compressed air, cooled distilled water is carried out aseptic filtration by dual 0.22 μm of degerming level filter of redundant filtration system;
5): the sterile distilled water after filtration blows embedding three-in-one aseptic filler BFS by aseptic pipe-line system injection and carries out aseptic embedding; the other end blowing the three-in-one aseptic filler of embedding adds plastic pellet; pass into filtrated air after adopting hot melt to be melted by plastic pellet to blow parison and make sky ampoule bottle; aseptic embedding is carried out under the protection of A level laminar flow hood; namely obtain sterile water for injection, finally carry out lamp inspection, labeling successively and pack to obtain product.
2. sterile water for injection production technology according to claim 1, is characterized in that: the on-line cleaning CIP method described in step 1 is pressurize 15 minutes under 0.15MPa aseptic compressed air condition, then carries out prewashing; The distilled water of 300kg temperature more than 80 DEG C is used to carry out flushing sterilizing storage tank more than 15 minutes after prewashing; Then use 80 DEG C of distilled water, more than 0.25MPa pressure, carry out online drip washing more than 15 minutes, finally utilize aseptic compressed air carry out under 0.15MPa pressure 15 minutes dry up operation.
3. sterile water for injection production technology according to claim 1, it is characterized in that: the online sterilizing SIP method described in step 1 is for first to carry out pure saturated vapor detection, namely, under the steam that detection pure steam generator occurs reaches 0.3MPa pressure and temperature scope 130 DEG C of-140 DEG C of conditions, sterile steam is; Then under 0.15MPa pressure and temperature scope 122 DEG C of-130 DEG C of conditions, keep carrying out steam sterilization in 30 minutes, under 0.15MPa pressure condition, then carried out aseptic compressed air operation; Finally temperature be less than 40 DEG C with 0.15MPa pressure condition under carry out drying up pressurize.
4. sterile water for injection production technology according to claim 1, is characterized in that: be steam heated to F in step 2
0value >12.
5. sterile water for injection production technology according to claim 1, is characterized in that: the condition of hot melt described in step 5 is 175-230 DEG C and 350bar.
6. sterile water for injection production technology according to claim 1, is characterized in that: described aseptic compressed air uses without oil pressure contracting air compressor machine by after air compressing to 0.15MPa, by obtaining after dry and aseptic filtration.
7. sterile water for injection production technology according to claim 1, it is characterized in that: described aseptic compressed air is by storing at air accumulator without oil pressure contracting air compressor machine by air, this air accumulator is communicated with tertiary filter successively, and the aseptic compressed air after tertiary filter filters is by being provided with the Pipeline transport of air relief valve to using gas point.
8. sterile water for injection production technology according to claim 7, is characterized in that: described without oil pressure contracting air compressor machine be built-in absorption drier revolve tooth air compressor without oil.
9. sterile water for injection production technology according to claim 7, is characterized in that: described tertiary filter is respectively filtering accuracy to be fine filter, the filtering accuracy of 1 μm be superfinishing filter and the active carbon filter of 0.01 μm.
10. sterile water for injection production technology according to claim 7, is characterized in that: with the sterilizing filter pipeline before gas point being also provided with 0.22 μm.
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| 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 |
| 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 |
| CN109132490B (en) * | 2018-09-10 | 2020-06-30 | 烟台冰轮医药装备有限公司 | Online sterilization system and sterilization method for automatic feeding and discharging mechanism of raw material medicine |
| CN109250505B (en) * | 2018-09-10 | 2020-06-30 | 烟台冰轮医药装备有限公司 | Raw material medicine discharging device and sterilization method thereof |
| 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 |
| CN110005585B (en) * | 2019-04-15 | 2020-07-14 | 英诺维尔智能科技（苏州）有限公司 | Aseptic seal structure of syringe pump |
| JP6897716B2 (en) * | 2019-06-14 | 2021-07-07 | 大日本印刷株式会社 | How to cool the filling valve of an aseptic filling machine |
| CN112617072B (en) * | 2020-11-26 | 2022-06-07 | 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 |
| 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 |
| CN115645561B (en) * | 2022-11-03 | 2023-06-20 | 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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