CN105129706A - Production technology of sterile oxygen humidification bottles - Google Patents
Production technology of sterile oxygen humidification bottles Download PDFInfo
- Publication number
- CN105129706A CN105129706A CN201510485799.2A CN201510485799A CN105129706A CN 105129706 A CN105129706 A CN 105129706A CN 201510485799 A CN201510485799 A CN 201510485799A CN 105129706 A CN105129706 A CN 105129706A
- Authority
- CN
- China
- Prior art keywords
- aseptic
- storage tank
- humidification
- production technology
- tank
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Landscapes
- Vacuum Packaging (AREA)
- Filling Of Jars Or Cans And Processes For Cleaning And Sealing Jars (AREA)
Abstract
The invention provides a production technology of sterile oxygen humidification bottles. The production technology comprises the processes: (1), weighing quantitative raw materials and auxiliary materials according to the formula and adding the raw materials and auxiliary materials into a cleaned mobile tank to prepare humidification liquid; (2), after the humidification liquid is filtered, conveying the humidification liquid into a sterile storage tank through a sterile air source arranged on the gas inlet in the top of the mobile tank; (3), adding filtered injection water into the sterile storage tank and diluting the humidification liquid to a metered volume; (4), guiding industrial steam into a jacket of the sterile storage tank, carrying out heating sterilization, conveying the diluted humidification liquid into a blowing, filling and sealing machine after sterile preparation is completed, carrying sterile filling and then carrying out sealing; (5), carrying out leakage detection and finished product inspection on sealed products; (6), carrying out labeling, box packing and encasement. According to the invention, sterilization is carried out before filling of the humidification liquid, blowing, filling and sealing are completed at one station, the whole production process is carried out under protection of sealing, laminar flow and positive pressure, and therefore sterile production of whole products is achieved, and terminal sterilization is not needed.
Description
Technical field
The present invention relates to a kind of production technology of oxygen humidification bottle, particularly a kind of production technology of aseptic oxygen humidification bottle, belongs to medical instruments field.
Background technology
Oxygen therapy is a kind of nursing technique the most frequently used clinically and rescue means.Oxygen humidifying liquid carries out humidifying to oxygen in process of oxygen therapy, avoids dry oxygen to the stimulation of respiratory mucosa, improves the comfort level of oxygen therapy effect and patient.In China's inside-hospital infection case, respiratory tract infection accounts for first place.Wherein because the infection of the therapeutic device such as humidification fluid, medical treatment device is the factor causing pulmonary complication very important.So, how to control the Carriage of oxygen humidifying liquid, reduce the generation of oxygen therapy patient nosocomial infection and become the problem that hospital infection management person and caregiver more and more pay close attention to.The appearance of disposable oxygen humidification bottle effectively can reduce the conditioned pathogen of nosocomial infection, helpful to control nosocomial infection, eliminate humidification bottle and the daily cleaning and sterilizing of parts thereof, stop secondary pollution, save the consumption such as distilled water, normal saline, reduce medical expense, reduce nurse's operation injury simultaneously.
But, the technique that existing disposable oxygen humidification bottle manufacturer is used in process of production can not ensure humidification fluid not microbiological contamination when producing, in addition the plastics packaging material non-refractory that uses of disposable oxygen humidification bottle, terminal moist heat sterilization cannot be carried out, so the risk that existing disposable oxygen humidification bottle existence itself is carried disease germs, during use, infection may be caused.
Summary of the invention
The invention provides a kind of production technology of aseptic oxygen humidification bottle; sterilizing before humidification fluid is filling; what use sterility barrier ability was strong blows embedding and sterile filling thereof; bottle blowing, filling, sealing is completed at same aseptic station; whole production process carries out under the protection of airtight, laminar flow, malleation; achieve the sterile production of whole product, without the need to terminal sterilization.
The technical solution adopted for the present invention to solve the technical problems is:
A kind of production technology of aseptic oxygen humidification bottle, the production technology of described aseptic oxygen humidification bottle comprises following technological process: (1) take quantitative supplementary material according to formula, add in cleaned movable tank by supplementary material from the dog-house of movable tank, preparation forms humidification fluid; (2) after humidification fluid being filtered by the first sterilizing filter, make the temperature of humidification fluid reach 121 DEG C, use the aseptic source of the gas being arranged on movable tank tank deck gas inflow point to deliver in aseptic storage tank, filter the particulate in removal humidification fluid and germ; (3) the water for injection after the second sterilizing filter filters is added in aseptic storage tank, constant volume after dilution humidification fluid; (4) enter industrial steam in logical to the chuck of aseptic storage tank, heat sterilization is carried out to the humidification fluid after dilution, after sterile preparation completes, the humidification fluid after dilution is sent into by the aseptic source of the gas after aseptic filtration and blows embedding machine, carry out sterile filling, seal simultaneously; (5) the product after sealing is stopped leakage in the roof and the inspection of finished product; (6) carry out labeling by through finished product after the assay was approved, labeling terminates rear mounted box, vanning;
Aseptic source of the gas is connected in described movable tank tank deck gas inflow point, described aseptic source of the gas is the pressurized air through aseptic filtration, flexible pipe is provided with at the bottom of described movable tank tank, described flexible pipe is connected with one end of the first humidification fluid delivery pipe, and the other end of the first humidification fluid delivery pipe is connected with the entrance of aseptic storage tank;
Described aseptic storage tank is provided with water for injection pipeline; Be provided with weighing system bottom described aseptic storage tank, be used for controlling the addition of water for injection, diluted by humidification fluid, the bottom of described aseptic storage tank is also provided with the second humidification fluid delivery pipe, and blows embedding machine and is connected;
Enter industrial steam heat sterilization during the described chuck to aseptic storage tank is logical, make the temperature of humidification fluid reach 121 DEG C, time length is 30 minutes; Disconnect industrial steam, in chuck, pass into the cooling water expansion tank of 12 DEG C, the humidification fluid after dilution is cooled between 22-28 DEG C, completes sterile preparation;
Described station place of blowing embedding machine carries A level Airshower chamber, and the aseptic source of the gas of described A level Airshower chamber is the ambient wind after the 3rd sterilizing filter filters, bottle processed, filling, seal three kinds of techniques and all complete blowing the same aseptic station place on embedding machine;
Product after sealing is delivered in the passage carrying out stopping leakage in the roof in ordinary student producing region, is provided with the pressure reduction being not less than 30pa;
Described first sterilizing filter is located on the first humidification fluid delivery pipe; Described second sterilizing filter is located on water for injection pipeline; Especially, in sterile preparation and aseptic filling process, all sterilizing filters before use, use after all to carry out integrity detection timely, detect qualified rear execution next-step operation;
The chuck of described aseptic storage tank is looped around around aseptic storage tank in the shape of a spiral, and described industrial steam thus chuck passes into, and carries out high-temperature sterilization to the humidification fluid after dilution.
The present invention is by above technical scheme, and relative to prior art, the present invention has following beneficial effect:
Each step of the strict Controlling Technology process of the present invention, aseptic filtration is adopted to add the technique of front sterilizing, ensure the reliability of sterile preparation, coordinate and blow the outstanding sterility barrier ability of embedding machine device, by the protection of laminar flow, airtight, malleation, ensure the not microbiological contamination in process of production of sterilized humidification fluid, actv. solves humidification bottle and self to carry disease germs in use caused infection; Further, adopting the disposable sterilized oxygen humidification bottle of this explained hereafter not need terminal sterilization, the other problems that isolated terminal sterilization is brought, is a kind of technique of production aseptic oxygen humidification bottle of very advanced, science, safety.
Accompanying drawing explanation
Below in conjunction with drawings and Examples, the present invention is further described.
Fig. 1 is flow scheme of the present invention.
Detailed description of the invention
As Fig. 1, now in conjunction with production technological process of the present invention, the production technology of the aseptic humidification bottle that the humidification fluid using the present invention to produce is normal saline is illustrated;
Implementation environment of the present invention meets the dust proof workshop that GMP requires, environmental grade is set to C level, blows under embedding machine device is arranged on the A level laminar flow of C level background environment, and all Work tool, clothes contacted with material are all deposited under laminar flow after sterilizing; Before production, personnel change one's clothes on request; The Work tool of production answers sterilizing; Movable tank should clean; Aseptic storage tank, blow embedding machine device and humidification fluid diffuser and perform on-line cleaning, online sterilizing program; The conveying of humidification fluid uses compressed air, and the pressurized air of contact humidification fluid is all through aseptic filtration.
The production technology of a kind of aseptic oxygen humidification bottle provided by the invention, mainly comprises three parts: sterile preparation, sterile filling and packaging of stopping leakage in the roof; Described sterile preparation, comprises following technological process: first take quantitative pharmaceutical grade sodium chloride according to formula, added in cleaned movable tank from the dog-house of movable tank by supplementary material, add quantitative water for injection, stirring and dissolving is complete; For the gas feed of movable tank tank deck connects aseptic source of the gas, described aseptic source of the gas is the pressurized air through aseptic filtration, flexible pipe at the bottom of movable tank tank connects the first humidification fluid delivery pipe, 0.22 μm of first sterilizing filter the first described humidification fluid delivery pipe is equipped with, the other end is connected to the humidification fluid entrance of aseptic storage tank, filters the particulate in removal humidification fluid and germ; Open pressure gas valve, be adjusted to certain pressure, humidification fluid is transported in aseptic storage tank through the first sterilizing filter; Open the water for injection pipeline valve on aseptic storage tank, 0.22 μm of second sterilizing filter described water for injection pipeline is also equipped with, water for injection adds aseptic storage tank after the second sterilizing filter, its addition is controlled by the weighing system bottom aseptic storage tank, humidification fluid is diluted, stir, solution is mixed; After stirring, industrial steam is passed in the chuck of aseptic storage tank, the chuck of aseptic storage tank is looped around around aseptic storage tank in the shape of a spiral, industrial steam thus chuck passes into, high-temperature sterilization is carried out to the humidification fluid after dilution, can ensure that the humidification fluid heating surface area in aseptic storage tank is even, sterilization effect is better.Humidification fluid after heat sterilization dilution, makes the temperature of humidification fluid reach 121 DEG C, continues 30 minutes; Disconnect industrial steam, in the chuck of aseptic storage tank, pass into 12 DEG C of cooling water expansion tanks, humidification fluid is cooled to 22-28 DEG C, and sterile preparation completes, use clean compressed gas to be sent into by the second humidification fluid delivery pipe at the bottom of aseptic storage tank tank by the humidification fluid after dilution and blow embedding machine device, carry out sterile filling;
Described sterile filling, use and blow embedding machine device, the described embedding station that blows carries A level Airshower chamber, and the aseptic source of the gas of described A level Airshower chamber is the ambient wind through aseptic filtration, and bottle processed, filling, the same aseptic station of sealing three kinds of technological processes all under the protection of A level Airshower chamber complete; Product is delivered to ordinary student producing region through transfer passage and carries out packaging of stopping leakage in the roof, and has the pressure reduction being not less than 30pa to protect in passage;
Especially, in sterile preparation and aseptic filling process, all sterilizing filters before use, use after all to carry out integrity detection timely, detect qualified rear execution next-step operation.
Described packaging of stopping leakage in the roof, mainly checks the airtight performance of shaped article, and by acceptable product labeling, mounted box, vanning.
Especially, answer as prescribed to the finished product sampling of producing, line correlation of going forward side by side inspection and sterility test, can let pass after qualified.
Each step of the strict Controlling Technology process of the present invention, aseptic filtration is adopted to add the technique of front sterilizing, ensure the reliability of sterile preparation, coordinate and blow the outstanding sterility barrier ability of embedding machine device, by the protection of laminar flow, airtight, malleation, ensure the not microbiological contamination in process of production of sterilized humidification fluid, actv. solves humidification bottle and self to carry disease germs in use caused infection; Further, adopting the disposable sterilized oxygen humidification bottle of this explained hereafter not need terminal sterilization, the other problems that isolated terminal sterilization is brought, is a kind of technique of production aseptic oxygen humidification bottle of very advanced, science, safety.
With above-mentioned according to desirable embodiment of the present invention for enlightenment, by above-mentioned description, relevant staff in the scope not departing from this invention technological thought, can carry out various change and amendment completely.The technical scope of this invention is not limited to the content on specification sheets, must determine its technical scope according to right.
Claims (8)
1. the production technology of an aseptic oxygen humidification bottle, it is characterized in that: the production technology of described aseptic oxygen humidification bottle comprises following technological process: (1) take quantitative supplementary material according to formula, add in cleaned movable tank by supplementary material from the dog-house of movable tank, preparation forms humidification fluid; By humidification fluid by after the particulate in the first sterilizing filter filtering and wetting liquid and germ, use the aseptic source of the gas being arranged on movable tank tank deck gas inflow point to deliver in aseptic storage tank, the high-temp steam sterilizing process of this aseptic storage tank in its chuck of circulation; (3) the water for injection after the second sterilizing filter filters is added in aseptic storage tank, constant volume after dilution humidification fluid; (4) in the chuck of aseptic storage tank, pass into industrial steam, high-temperature sterilization is carried out to the humidification fluid after dilution, after sterile preparation completes, adopt the aseptic source of the gas after aseptic filtration to be sent into by the humidification fluid after dilution and blow embedding machine, carry out sterile filling, seal simultaneously; (5) the product after sealing is stopped leakage in the roof and the inspection of finished product; (6) carry out labeling by through finished product after the assay was approved, labeling terminates rear mounted box, vanning.
2. the production technology of aseptic oxygen humidification bottle according to claim 1, it is characterized in that: connect aseptic source of the gas in described movable tank tank deck gas inflow point, described aseptic source of the gas is the pressurized air through aseptic filtration, flexible pipe is provided with at the bottom of described movable tank tank, described flexible pipe is connected with one end of the first humidification fluid delivery pipe, and the other end of the first humidification fluid delivery pipe is connected with the entrance of aseptic storage tank.
3. the production technology of aseptic oxygen humidification bottle according to claim 2, is characterized in that: described aseptic storage tank is provided with water for injection pipeline; Be provided with weighing system bottom described aseptic storage tank, be used for controlling the addition of water for injection, diluted by humidification fluid, the bottom of described aseptic storage tank is also provided with the second humidification fluid delivery pipe, and blows embedding machine and is connected.
4. the production technology of aseptic oxygen humidification bottle according to claim 3, is characterized in that: describedly in the chuck of aseptic storage tank, pass into industrial steam heat sterilization, and make the temperature of humidification fluid reach 121 DEG C, time length is 30 minutes; Disconnect industrial steam, in chuck, pass into the cooling water expansion tank of 12 DEG C, the humidification fluid after dilution is cooled between 22-28 DEG C, completes sterile preparation.
5. the production technology of aseptic oxygen humidification bottle according to claim 4, it is characterized in that: described in blow embedding machine station place carry A level Airshower chamber, the aseptic source of the gas of described A level Airshower chamber is the ambient wind after the 3rd sterilizing filter filters, bottle processed, filling, seal three kinds of techniques and all complete blowing the same aseptic station place on embedding machine.
6. the production technology of aseptic oxygen humidification bottle according to claim 5, is characterized in that: be delivered in the passage carrying out stopping leakage in the roof in ordinary student producing region by the product after sealing, be provided with the pressure reduction being not less than 30pa.
7. the production technology of aseptic oxygen humidification bottle according to claim 6, is characterized in that: described first sterilizing filter is located on the first humidification fluid delivery pipe; Described second sterilizing filter is located on water for injection pipeline; Described 3rd sterilizing filter is located on the second humidification fluid delivery pipe; Especially, in sterile preparation and aseptic filling process, all sterilizing filters before use, use after all to carry out integrity detection timely, detect qualified rear execution next-step operation.
8. the production technology of aseptic oxygen humidification bottle according to claim 1, is characterized in that: the chuck of described aseptic storage tank is looped around around aseptic storage tank in the shape of a spiral, and described industrial steam thus chuck passes into, and carries out high-temperature sterilization to the humidification fluid after dilution.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510485799.2A CN105129706A (en) | 2015-08-11 | 2015-08-11 | Production technology of sterile oxygen humidification bottles |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510485799.2A CN105129706A (en) | 2015-08-11 | 2015-08-11 | Production technology of sterile oxygen humidification bottles |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN105129706A true CN105129706A (en) | 2015-12-09 |
Family
ID=54715371
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201510485799.2A Pending CN105129706A (en) | 2015-08-11 | 2015-08-11 | Production technology of sterile oxygen humidification bottles |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN105129706A (en) |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN107441522A (en) * | 2017-09-26 | 2017-12-08 | 金宇保灵生物药品有限公司 | A kind of degerming method of aftosa vaccine adjuvant |
| CN108144373A (en) * | 2017-12-19 | 2018-06-12 | 新乡华青药业有限公司 | The aseptic delivery system of sterile ophthalmic ointment agent material |
| CN110745761A (en) * | 2019-11-06 | 2020-02-04 | 无锡生基医药科技有限公司 | Aseptic subpackaging method and subpackaging system for lentiviral vector liquid |
| CN112512955A (en) * | 2018-08-31 | 2021-03-16 | 大日本印刷株式会社 | Aseptic filling machine and purification method thereof |
| CN113636519A (en) * | 2020-04-27 | 2021-11-12 | 成都一平医药科技发展有限公司 | Aseptic production method of aerosol |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103057759A (en) * | 2013-01-15 | 2013-04-24 | 江苏大红鹰恒顺药业有限公司 | Sterile packaging method for small-volume injection |
| CN103070823A (en) * | 2013-01-15 | 2013-05-01 | 江苏大红鹰恒顺药业有限公司 | Aseptic packaging method of large volume injection |
| CN103693791A (en) * | 2013-12-11 | 2014-04-02 | 江苏大红鹰恒顺药业有限公司 | Sterile injection water production technique and sterile compressed air preparation method |
-
2015
- 2015-08-11 CN CN201510485799.2A patent/CN105129706A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103057759A (en) * | 2013-01-15 | 2013-04-24 | 江苏大红鹰恒顺药业有限公司 | Sterile packaging method for small-volume injection |
| CN103070823A (en) * | 2013-01-15 | 2013-05-01 | 江苏大红鹰恒顺药业有限公司 | Aseptic packaging method of large volume injection |
| CN103693791A (en) * | 2013-12-11 | 2014-04-02 | 江苏大红鹰恒顺药业有限公司 | Sterile injection water production technique and sterile compressed air preparation method |
Non-Patent Citations (5)
| Title |
|---|
| 张洪飞: "吹、灌、封（三合一）设备及其无菌灌装工艺探讨", 《机电信息》 * |
| 张洪飞: "浅谈BFS生产工艺的选择与设计", 《机电信息》 * |
| 张洪飞: "浅谈吹灌封"三合一"工艺与工程", 《机电信息》 * |
| 张诚: "浅议无菌药品配液系统的设备风险及对策", 《机电信息》 * |
| 林茂盛: "无菌全自动化配液系统特点及其设计理念探讨", 《机电信息》 * |
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN107441522A (en) * | 2017-09-26 | 2017-12-08 | 金宇保灵生物药品有限公司 | A kind of degerming method of aftosa vaccine adjuvant |
| CN108144373A (en) * | 2017-12-19 | 2018-06-12 | 新乡华青药业有限公司 | The aseptic delivery system of sterile ophthalmic ointment agent material |
| CN108144373B (en) * | 2017-12-19 | 2020-12-11 | 新乡华青药业有限公司 | Sterile transfer system for sterile ophthalmic ointment materials |
| CN112512955A (en) * | 2018-08-31 | 2021-03-16 | 大日本印刷株式会社 | Aseptic filling machine and purification method thereof |
| CN110745761A (en) * | 2019-11-06 | 2020-02-04 | 无锡生基医药科技有限公司 | Aseptic subpackaging method and subpackaging system for lentiviral vector liquid |
| CN113636519A (en) * | 2020-04-27 | 2021-11-12 | 成都一平医药科技发展有限公司 | Aseptic production method of aerosol |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN105129706A (en) | Production technology of sterile oxygen humidification bottles | |
| CN106829000B (en) | The equipment and its sterilization filling method of sterilization filling facial mask | |
| EP3003404B1 (en) | Automated sterilization process integrated with a blow fill seal machine | |
| CA3042468A1 (en) | System for the production of cells and/or cell products | |
| CN205145190U (en) | Special sterilizing machine of breathing machine | |
| CN106102783B (en) | Sterilization system for a blow/fill/seal machine | |
| CN110587666A (en) | Experimental device | |
| CN102530324A (en) | Purification isolating device of aseptic powder needle split-charging production line | |
| CN206476146U (en) | A kind of sterile facial mask bottle placer | |
| CN207941404U (en) | A kind of sterile liquid mixing system | |
| CN201067487Y (en) | Clean medicine confecting cabinet | |
| CN116688181A (en) | Cleaning and sterilizing equipment for endoscope | |
| CN105434129A (en) | Intravenous medicine preparing cabin | |
| CN102284071B (en) | Transferring cabin with peroxide biological decontamination function | |
| CN204219253U (en) | Intravenous administration allotment cabin | |
| CN202314527U (en) | Delivery cabin with hydrogen peroxide biological decontamination function | |
| CN208065489U (en) | A kind of novel bulk pharmaceutical chemicals sterile processing systems | |
| CN205019501U (en) | Aseptic automation robot that dispenses | |
| CN110006221A (en) | Bulk pharmaceutical chemicals automatic discharge apparatus and its control method with isolator | |
| CN105060228B (en) | A-grade air shower device applied to blowing-filling-packaging integrated machine | |
| CN212651842U (en) | Pharmacy workshop is with contactless operation platform of high-efficient sterilization | |
| CN204600928U (en) | A kind of decontaminating apparatus for ambulance | |
| CN205796190U (en) | disposable humidifying nasal oxygen tube | |
| CN215690187U (en) | Automatic disinfection device for touch screen stylus of robot | |
| CN202414227U (en) | Purification and isolation device for aseptic powder injection sub-packaging production line |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20151209 |