CN201959803U - Purifying and isolating device assorted with aseptic freeze-dried preparation production line - Google Patents
Purifying and isolating device assorted with aseptic freeze-dried preparation production line Download PDFInfo
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- CN201959803U CN201959803U CN 201020682546 CN201020682546U CN201959803U CN 201959803 U CN201959803 U CN 201959803U CN 201020682546 CN201020682546 CN 201020682546 CN 201020682546 U CN201020682546 U CN 201020682546U CN 201959803 U CN201959803 U CN 201959803U
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- spacer assembly
- production line
- air
- casing
- isolating device
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Abstract
The utility model provides a purifying and isolating device assorted with an aseptic freeze-dried preparation production line. The purifying and isolating device is characterized by comprising an isolating device box, wherein the front face of the isolating device box is provided with a double-layer door air return component; a glove system is arranged on the double-layer door air return component; a freeze dryer interface is arranged on the isolating device box; a flow equalizing system component, a one-way laminar flow air supply system and a static-pressure box are arranged in sequence above the isolating device box; the static-pressure box is connected with a fresh air treating unit through a pipeline. In the purifying and isolating device, the feeding hole and discharge hole of a freeze dryer serving as core regions for the production of the freeze-dried preparation are isolated from an operator, and an interface is provided for automatic feeding and discharging devices, so that full enclosing and isolating are realized, the reduction of artificial pollutant sources is ensured, the sterility of a product is better ensured, and therefore the production efficiency is effectively improved.
Description
Technical field
The utility model relates to a kind of and the supporting purification spacer assembly of sterile freeze-drying preparation production line.
Background technology
The sterile freeze-drying preparation production line is behind the washing and sterilizing of packing of product bottle, it is carried out filling liquid, through automatic feed system with can after and the bottle of false add plug be sent to freeze dryer inside and enter freeze drying process, with hydrous matter lower the temperature be frozen into solid-state, under the condition of vacuum, make water vapour directly from solid-state, distil then, send out freeze dryer by the automatic feed/discharge system again after bottle jumped a queue entirely, send the system Cover-rolling machine to roll lid bottle, finish sterile production.
Production environment around the existing sterile preparation production line has following defective:
1, people and product are not kept apart fully.The people is pollution sources maximum in the sterile production environment.Around the sterile preparation production line, still can produce production line at present and intervene by the operating personnel that wear aseptic work clothes, defined A level lustration class in being about to the new edition GMP that puts into effect, any activity of personnel all can cause environment damage.
2, common sterile preparation production line has been hung holding court from behind a screen of plastics usually or has been placed dividing plate as barrier in the key core zone at present, but still utilizes the filtration system of inside, toilet.In this case, the lustration class of whole toilet is necessary for the A level.Large-area A level toilet involves great expense the energy consumption height.After production was finished, whole dust proof workshop all will be unfavorable for energy-saving and emission-reduction with the production equipment sterilization.
3, when producing the aseptic virose or preparation that the property of medicine is stronger, traditional working condition can't guarantee producers' safety and health.Can not satisfy the requirement of FDA " potent medicine must be avoided contacting with operating personnel as far as possible ".
Summary of the invention
The purpose of this utility model provide a kind of can be integrated with sterile freeze-drying preparation production equipments such as bottle placer, automatic feed/discharge system, freeze dryer and Cover-rolling machines; the spacer assembly of a controllable environment purification of crucial Production Regional can be provided; the medicine and the operating personnel that produce are kept apart fully; fundamentally solve the problem that people's pollution brings, protect the people not to be subjected to the influence of toxic medicine again simultaneously.
In order to achieve the above object, the technical solution of the utility model has provided a kind of and the supporting purification spacer assembly of sterile freeze-drying preparation production line, it is characterized in that: comprise the spacer assembly casing, be provided with two storied gate return air assembly in the front of spacer assembly casing, glove system is located on the two storied gate return air assembly, the freeze dryer docking port is located on the spacer assembly casing, be provided with current-equalizing system assembly, unidirectional ply air supply stream system and plenum chamber above the spacer assembly casing successively, the plenum chamber pipeline connects new wind air conditioner unit.
Further, be provided with new wind air intake valve on the pipeline between described plenum chamber and the described new wind air conditioner unit, exhaust valve is connected on the plenum chamber.
Described two storied gate return air assembly comprises outer door and the inner door that the connection backstay links to each other, outer door and inner door are located at the front of described spacer assembly casing by hinge, outer door and described spacer assembly casing carry out dynamic seal (packing) by air inflation sealing device, be provided with the safety door latch switch on outer door, the safety door latch switch links to each other with air inflation sealing device by PLC.
Described glove system comprises the glove port that is arranged on described outer door and the inner door, is connected with the operation gloves on the glove port.
Described unidirectional ply air supply stream system comprises frequency conversion fan, is provided with high efficiency particle air filter below frequency conversion fan.
In described spacer assembly casing, be provided with cleaning spray gun, be provided with discharge outlet in the bottom of spacer assembly casing.
Be provided with the automatic feeder docking port in the front of described spacer assembly casing, bottom in the spacer assembly casing is provided with isokinetic sampling head, microorganism sampler and humiture transmitter, is connected PLC with the supporting corpuscular counter of isokinetic sampling head, the controller and the humiture transmitter of microorganism sampler.
Top in described spacer assembly casing is provided with the air velocity transducer that is used to measure wind speed below the described high efficiency particle air filter, air velocity transducer links to each other with described frequency conversion fan by PLC, be provided with pressure difference transmitter on described spacer assembly casing, pressure difference transmitter detects the pressure differential at high efficiency particle air filter upstream and downstream two ends in real time.
The utility model by lyophilized formulations is produced nucleus---freeze dryer feed inlet and outlet and operator keep apart, provide the interface of automatic feeding and discharging device to realize the complete closed isolation, thereby guaranteed to reduce the artificial contamination source and provide higher assurance, and then improved productivity ratio effectively the aseptic of product.
Description of drawings
The purification spacer assembly structural representation that a kind of and sterile freeze-drying preparation production line that Fig. 1 provides for the utility model is supporting;
The purification spacer assembly front view that a kind of and sterile freeze-drying preparation production line that Fig. 2 provides for the utility model is supporting;
Fig. 3 is a two storied gate return air assembly schematic diagram;
Fig. 4 is that the utility model cooperates schematic diagram with the automatic feed/discharge system.
The specific embodiment
Specify the utility model below in conjunction with embodiment.
Embodiment
As Fig. 1, Fig. 2 and shown in Figure 4, the supporting purification spacer assembly of a kind of and sterile freeze-drying preparation production line that provides for the utility model, comprise spacer assembly casing 1, be provided with two storied gate return air assembly 4 in the front of spacer assembly casing 1, glove system 2 is located on the two storied gate return air assembly 4, freeze dryer docking port 3 is located on the spacer assembly casing 1, be provided with current-equalizing system assembly 5, unidirectional ply air supply stream system 6 and plenum chamber 7 above spacer assembly casing 1 successively, plenum chamber 7 pipelines connect new wind air conditioner unit 8.Be provided with new wind air intake valve 9 on the pipeline between plenum chamber 7 and the new wind air conditioner unit 8, exhaust valve 10 is connected on the plenum chamber 7.
Described unidirectional ply air supply stream system 6 comprises frequency conversion fan 31, is provided with high efficiency particle air filter 30 below frequency conversion fan 31.In described spacer assembly casing 1, be provided with cleaning spray gun 13, be provided with discharge outlet 17 in the bottom of spacer assembly casing 1.Be provided with automatic feeder docking port 16 in the front of described spacer assembly casing 1, bottom in spacer assembly casing 1 is provided with isokinetic sampling head 26, microorganism sampler 27 and the humiture transmitter that is connected with corpuscular counter, and the corpuscular counter that is connected with isokinetic sampling head 26, microorganism sampler 27 and humiture transmitter connect PLC.Top in described spacer assembly casing 1 is provided with the air velocity transducer 29 that is used to measure wind speed below the described high efficiency particle air filter 30, air velocity transducer 29 links to each other with described frequency conversion fan 31 by PLC, be provided with pressure difference transmitter 11 on described spacer assembly casing 1, pressure difference transmitter 11 detects the pressure differential at high efficiency particle air filter 27 upstream and downstream two ends in real time.
As shown in Figures 2 and 3, described two storied gate return air assembly 4 comprises outer door 15 and the inner door 20 that connection backstay 19 links to each other, outer door 15 and inner door 20 are located at the front of described spacer assembly casing 1 by hinge, outer door 15 is carried out dynamic seal (packing) with described spacer assembly casing 1 by air inflation sealing device 18, be provided with safety door latch switch 12 on outer door 15, safety door latch switch 12 links to each other with air inflation sealing device 18 by PLC.
Described glove system 2 comprises the glove port 21 that is arranged on described outer door 15 and the inner door 20, is connected with operation gloves 22 on the glove port 21.
There is the two storied gate return air assembly 4 that can play the effect of guiding return air in spacer assembly casing 1 front, and this structure below is communicated with isolator casing 1.Cross current-equalizing system assembly 5 by the air communication of unidirectional ply air supply stream system 6 generations and can form more uniform and stable unidirectional laminar flow; this air-flow protection the key area of sterile product, air-flow will be got back in the plenum chamber 7 of blower fan top along two storied gate air return system 4 afterwards.Pressure difference transmitter 11 detects the pressure differential at high efficiency particle air filter 27 upstream and downstream two ends in real time, and whether differentiate high efficiency particle air filter 27 intact.
Glove system 2 is fixed by glove port 14 and two storied gate return air assembly, can intervene the abnormal conditions that production line inside occurs by glove system 2 operating personnel.
On the two storied gate return air assembly 4 safety door latch switch 12 is housed, in real time the on off state of detecting gate.Can produce interlocking with the operation of automatic feed or freeze dryer.The safety of gnotobasis when guaranteeing to produce.The outer door 15 of two storied gate return air assembly 4 is carried out dynamic seal (packing) with the casing of spacer assembly by air inflation sealing device 18.Air inflation sealing device 18 is dilatancy by charging into compressed air, and pastes around the outer door 15 and reaches sealing.Two storied gate return air assembly 4 is fixing by being connected backstay 19 with inner door 20 by outer door 15.Be equipped with glove port 21 on the double glazing, and the operation gloves 22 that need for production operation are housed.
The spacer assembly box house is furnished with cleaning spray gun 13, can feed water for injection or special cleaning agent cleans the spacer assembly box house.Waste liquid after the cleaning can be discharged into outside the spacer assembly by discharge outlet 17.
Comprise prefiltration, refrigerating section, bringing-up section, dehumidifying section and middle fillter section in the new wind air conditioner unit 8, except the air that enters spacer assembly to external world carries out primary action, can also mediate to the temperature and humidity of the air that enters spacer assembly, thereby control the effect of isolator casing 1 internal environment humiture.New wind air intake valve 9 can be regulated the size that enters resh air requirement in the isolator, and exhaust valve 10 is enough controlled the exhaust air rate of isolator.
As shown in Figure 4, automatic feeder docking port 16 is in the front of spacer assembly casing 1.Transfer bar mechanism 23 by this interface automatic feed system enters spacer assembly inside.The wicket 24 of freeze dryer 23 is enclosed in the inside of isolator casing 1 by docking port 3, and docking port 3 docks fixing and sealing with the decorative panel 25 of freeze dryer 23.The isokinetic sampling head 26 that corpuscular counter is arranged in spacer assembly inside is monitored the population of spacer assembly casing 1 inside.Microorganism sampler 27 is equipped with in spacer assembly casing 1 inside, can analyze the micro organism quantity in the environment after the sampling.Charging push rod 28 docks with spacer assembly casing 1, promotes bottle and enter freeze drying box 23 under the protection of spacer assembly.The inside of spacer assembly casing 1 is furnished with air velocity transducer 29, can regulate the rotating speed of frequency conversion fan 31 by detecting the wind speed of high efficiency particle air filter 30 belows, makes the flow velocity of inner unidirectional laminar flow reach designing requirement.
After 1 of spacer assembly casing cuts out, send signal to the PLC control system, start casing door sealing system by safety door latch switch 12.The door sealing system utilizes the expansion after the gas-flow closure circle inflation to fit tightly with four limits of cabinet door, with the effect that realizes sealing.
According to the requirement of pharmaceutical production technology, air intake/outtake system can be controlled the pressure differential of spacer assembly temperature inside, humidity and spacer assembly inside and outside toilet.Simultaneously, spacer assembly inside has that air velocity transducer 29, humiture transmitter, pressure differential transmitter 11, the corpuscular counter that is connected with isokinetic sampling head 26 and microorganism sampler 27 are continuous or periodic to be monitored inner clean environment, control, regulate inner humiture by PLC, perhaps send warning, have only as PLC to obtain to produce behind every signal that satisfies working condition.
Claims (8)
- One kind with the supporting purification spacer assembly of sterile freeze-drying preparation production line, it is characterized in that: comprise spacer assembly casing (1), be provided with two storied gate return air assembly (4) in the front of spacer assembly casing (1), glove system (2) is located on the two storied gate return air assembly (4), freeze dryer docking port (3) is located on the spacer assembly casing (1), be provided with current-equalizing system assembly (5), unidirectional ply air supply stream system (6) and plenum chamber (7) successively in the top of spacer assembly casing (1), plenum chamber (7) pipeline connects new wind air conditioner unit (8).
- 2. a kind of and supporting purification spacer assembly of sterile freeze-drying preparation production line as claimed in claim 1, it is characterized in that: be provided with new wind air intake valve (9) on the pipeline between described plenum chamber (7) and the described new wind air conditioner unit (8), exhaust valve (10) is connected on the plenum chamber (7).
- 3. a kind of and supporting purification spacer assembly of sterile freeze-drying preparation production line as claimed in claim 1, it is characterized in that: described two storied gate return air assembly (4) comprises outer door (15) and the inner door (20) that connection backstay (19) links to each other, outer door (15) and inner door (20) are located at the front of described spacer assembly casing (1) by hinge, outer door (15) is carried out dynamic seal (packing) with described spacer assembly casing (1) by air inflation sealing device (18), be provided with safety door latch switch (12) on outer door (15), safety door latch switch (12) links to each other with air inflation sealing device (18) by PLC.
- 4. a kind of and supporting purification spacer assembly of sterile freeze-drying preparation production line as claimed in claim 3, it is characterized in that: described glove system (2) comprises the glove port (21) that is arranged on described outer door (15) and the inner door (20), is connected with operation gloves (22) on the glove port (21).
- 5. a kind of and supporting purification spacer assembly of sterile freeze-drying preparation production line as claimed in claim 1, it is characterized in that: described unidirectional ply air supply stream system (6) comprises frequency conversion fan (31), is provided with high efficiency particle air filter (30) in the below of frequency conversion fan (31).
- 6. a kind of and supporting purification spacer assembly of sterile freeze-drying preparation production line as claimed in claim 1, it is characterized in that: in described spacer assembly casing (1), be provided with cleaning spray gun (13), be provided with discharge outlet (17) in the bottom of spacer assembly casing (1).
- 7. a kind of and supporting purification spacer assembly of sterile freeze-drying preparation production line as claimed in claim 1, it is characterized in that: be provided with automatic feeder docking port (16) in the front of described spacer assembly casing (1), bottom in spacer assembly casing (1) is provided with isokinetic sampling head (26), microorganism sampler (27) and humiture transmitter, is connected PLC with the supporting corpuscular counter of isokinetic sampling head (26), the controller and the humiture transmitter of microorganism sampler (27).
- 8. a kind of and supporting purification spacer assembly of sterile freeze-drying preparation production line as claimed in claim 5, it is characterized in that: the top in described spacer assembly casing (1) is provided with the air velocity transducer (29) that is used to measure described high efficiency particle air filter (30) below wind speed, air velocity transducer (29) links to each other with described frequency conversion fan (31) by PLC, be provided with pressure difference transmitter (11) on described spacer assembly casing (1), pressure difference transmitter (11) detects the pressure differential at high efficiency particle air filter (27) upstream and downstream two ends in real time.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201020682546 CN201959803U (en) | 2010-12-28 | 2010-12-28 | Purifying and isolating device assorted with aseptic freeze-dried preparation production line |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201020682546 CN201959803U (en) | 2010-12-28 | 2010-12-28 | Purifying and isolating device assorted with aseptic freeze-dried preparation production line |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN201959803U true CN201959803U (en) | 2011-09-07 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 201020682546 Expired - Lifetime CN201959803U (en) | 2010-12-28 | 2010-12-28 | Purifying and isolating device assorted with aseptic freeze-dried preparation production line |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN201959803U (en) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102090979A (en) * | 2010-12-28 | 2011-06-15 | 上海东富龙科技股份有限公司 | Purification isolation device matched with sterile lyophilized preparation production line |
| CN105999881A (en) * | 2016-07-06 | 2016-10-12 | 山东新华医疗器械股份有限公司 | Static pressure type laminar flow purification system for sterile isolators |
| CN107629943A (en) * | 2017-11-09 | 2018-01-26 | 中国科学院武汉病毒研究所 | A kind of freeze drying plant for carrying out bio-safety operation |
| CN111282944A (en) * | 2018-12-10 | 2020-06-16 | 宝群电子科技(上海)有限公司 | Air flow guiding system of automation equipment |
-
2010
- 2010-12-28 CN CN 201020682546 patent/CN201959803U/en not_active Expired - Lifetime
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102090979A (en) * | 2010-12-28 | 2011-06-15 | 上海东富龙科技股份有限公司 | Purification isolation device matched with sterile lyophilized preparation production line |
| CN102090979B (en) * | 2010-12-28 | 2013-05-08 | 上海东富龙科技股份有限公司 | Purification isolation device matched with sterile lyophilized preparation production line |
| CN105999881A (en) * | 2016-07-06 | 2016-10-12 | 山东新华医疗器械股份有限公司 | Static pressure type laminar flow purification system for sterile isolators |
| CN107629943A (en) * | 2017-11-09 | 2018-01-26 | 中国科学院武汉病毒研究所 | A kind of freeze drying plant for carrying out bio-safety operation |
| CN111282944A (en) * | 2018-12-10 | 2020-06-16 | 宝群电子科技(上海)有限公司 | Air flow guiding system of automation equipment |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| AV01 | Patent right actively abandoned |
Granted publication date: 20110907 Effective date of abandoning: 20130508 |
|
| RGAV | Abandon patent right to avoid regrant |