CN102319548B - Isolator for sterile weighing and proportioning process - Google Patents
Isolator for sterile weighing and proportioning process Download PDFInfo
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- CN102319548B CN102319548B CN 201110164229 CN201110164229A CN102319548B CN 102319548 B CN102319548 B CN 102319548B CN 201110164229 CN201110164229 CN 201110164229 CN 201110164229 A CN201110164229 A CN 201110164229A CN 102319548 B CN102319548 B CN 102319548B
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Abstract
The invention provides an isolator for a sterile weighing and burdening process. The isolator is characterized by comprising a glove operation box assembly, wherein the glove operation box assembly is provided with a sterile delivery interface; an air treating system is arranged on the top of the glove operation box assembly; the bottom of the glove operation box assembly is connected with a sterile butt joint valve assembly; and the glove operation box assembly is connected with a drainage system. The invention has the advantages that: the internal production environment is fully isolated from operators and the external environment, the risk of artificial contamination is lowered, the pollution of products on the operators and the external environment is lowered simultaneously, the clean production region is reduced, the controllability of a production region is enhanced greatly, and the running cost and the maintenance cost are reduced.
Description
Technical field
The present invention relates to a kind ofly asepticly weigh, the proportioning process isolator, this device provides A level aseptic area stable, low pollution risk, that isolate fully for weighing in the sterile bulk drug production process, proportioning process link.
Background technology
Sterile bulk drug is according to the difference of the character of medicine, and the technology of making also is not quite similar.In entire making process, weigh and batching is indispensable two processes.
Weighing process be for the content of each composition that makes a kind of medicine can be more accurate operating process; Blending process is the process of each composition of a kind of medicine proportionally being carried out the proportioning mixing.The correctness of operating of weighing and prepare burden is the prerequisite that guarantees medicine effectiveness.
At present, in sterile bulk drug was produced, there was following defective in the operating procedure of weighing and prepare burden:
1, all operations of aseptic raw material before batching can be finished under airtight aseptic environments, but at present production of raw medicine producer or bulk drug use producer to weigh, the blending process protection also rests on simple hundred grades of laminar flow hood or hundred grades of structures of holding court from behind a screen, but can't accomplish real isolation, can't make the internal pair production ambient parameter controlled fully, particularly when producing high sensitization or highly toxic product, how can not only guarantee the aseptic of product but also can guarantee that operating personnel's safety just becomes a difficult problem that needs solution;
2, sterile bulk drug is in weighing, preparing burden operating process, and it is a lot of to adopt laminar flow hood to carry out non-enclosed isolation drawback.At first, can not satisfy the requirement of " potent medicine must be avoided contacting with operating personnel as far as possible "; Secondly, strict for the Production Regional ambient parameter, it is controlled fully to reach parameter, and can't reach the requirement that can verify; At last, CIP(Clean in place on-line cleaning can't be accomplished in Production Regional inside) and the online sterilization of SIP(Sterilize in Place);
3, involving great expense of aseptic workspace, the operating personnel that wear aseptic work clothes not only reduce production efficiency, and need to increase the pollution cost that the processing operating personnel bring.
Also there is not a kind of equipment to address the above problem at present.
Summary of the invention
The objective of the invention is provides A level aseptic area stable, low pollution risk, that isolate fully for weighing in the sterile bulk drug production process, proportioning process link, fundamentally solve the problem of being brought by the artificial contamination, make the operator avoid the harm of high sensitization, highly toxic product.
In order to achieve the above object, technical scheme of the present invention has provided a kind of aseptic weighing and the proportioning process isolator, it is characterized in that: comprise the glove box assembly, be provided with the sterile transfer interface at the glove box assembly, air treatment system places the top of glove box assembly, be connected with aseptic butt joint valve member in the bottom of glove box assembly, the glove box assembly links to each other with drainage system.
The present invention can realize that by aseptic isolator being in a controlled environment all the time in the aseptic poisonous bulk drug weighing and burden process carries out, make inner noxious material can not jeopardize operating personnel, also stop the pollutant in the external environment condition to enter isolator internal contamination sterile bulk drug, also reduced the requirement of Production Regional to the lustration class of background environment simultaneously.Asepticly weigh, the change of the inner any ambient parameter of proportioning process isolator, all can obtain corresponding regulation and control, thereby realize that aseptic raw material is at the isolation of link of weighing and prepare burden.
Advantage of the present invention is that internal pair production environment and operator and external environment condition are kept apart fully, has reduced artificial contamination's risk, has also reduced the pollution of product to operator and external environment condition simultaneously; And make the clean zone of production dwindle, make the controllability of Production Regional to increase greatly, and then reduced operating cost and maintenance cost.
Description of drawings
Fig. 1 is a kind of aseptic weighing and proportioning process spacer structures schematic diagram provided by the invention;
Fig. 2 A is air conditioner unit assembly front view;
Fig. 2 B is air conditioner unit components side view;
Fig. 3 A is glove box assembly front view;
Fig. 3 B is glove box components side view;
Fig. 4 is sterile transfer device assembly structural representation;
Fig. 5 A is aseptic butt joint valve member internal structure schematic diagram;
Fig. 5 B is the outside schematic diagram of aseptic butt joint valve member.
The specific embodiment
Specify the present invention below in conjunction with embodiment.
Embodiment
As shown in Figure 1, be a kind of aseptic weighing and the proportioning process isolator provided by the invention, comprise top air treatment system 1, glove box assembly 2, sterile transfer interface 3 is installed in the aseptic transfer that realizes material on the divider wall of glove box assembly 2, aseptic butt joint valve member 4 is installed in the aseptic butt joint that glove box assembly 2 bottoms are used for realizing proportion container, drainage system 5 is installed in the waste liquid that glove box assembly 2 bottoms are used for collecting isolator CIP, and under(-)chassis assembly 6 is used for supporting on all not isolator assemblies.
Shown in Fig. 2 A and Fig. 2 B, air treatment system 1 comprises casing 14, and air draft blower fan 10 is located on the casing 14, and air draft blower fan 10 pipelines connect exhaust-air filter 12, be provided with continuous prefilter 7 and air intake filter 8 at casing 14, be provided with exhaust outlet 13 at exhaust-air filter 12.Be provided with toilet's tear lamp 11 at casing 14.Be provided with the differential pressure indicator 9 that overhauls cover plate 15 and be used for detecting exhaust-air filter 12 and air intake filter 8 at casing 14.
Since aseptic weigh and the environment for use of proportioning process isolator minimum can be the D level; so need install the new wind that 7 pairs of prefilters enter internal system additional handles; native system is primarily aimed at high sensitization; highly toxic product; air intake filter 8 uses single-stage PUSH-PUSH air intake H14 level high efficiency particulate air filter that new wind is handled; can carry out the safety of filter changes; differential pressure indicator 9 is the resistances of monitoring new wind filter 8 and exhaust-air filter 12; judge whether to need to change filter by Resistance Value; system controls whole system phase pressure to external world by the air quantity of control air draft blower fan 10; the toilet is the clean light fixtures that can be applied under hundred grades of environment with tear lamp 11; can make system's operating surface illumination reach 500-700LUX by tear 11 installation quantity and position; it is the operation that the operator can be more comfortable; the native system inner air is selected two-stage PUSH-PUSH air draft H14 level high efficiency particulate air filter for use by exhaust-air filter 12() be discharged to background environment by exhaust outlet 13; adopt two-stage filter namely environment to be played duplicate protection; also when changing filter, make the operator safer; all air-treatment components and parts all are installed in air treatment system casing 14, and the parts that are installed in box house by 15 pairs of cover plates of maintenance keep in repair and change.
Shown in Fig. 3 A and Fig. 3 B, glove box assembly 2 comprises stainless steel casing 16, be provided with operator running-on 17 at stainless steel casing 16, operation gloves 24 are connected on the operator running-on 17, be provided with the operation window 19 that has handle 20 at stainless steel casing 16, link to each other by nitrogen spring 23 between operation window 19 and the stainless steel casing 16, operation window 19 is by 22 lockings of window locking device, be provided with batching docking port 21 and hydrogen peroxide import and export 25 at stainless steel casing 16, projection electronic weighing scale 18 is located in the stainless steel casing 16.
The fence structure of stainless steel casing 16 and operation window 19 construction systems is opened internal system production environment and external environment condition and the complete isolator of operator, and the operator only allows the logical technological operation that gloves 24 are finished internal system of operating.
As shown in Figure 4, sterile transfer interface 3 comprises material storage silo 36, material storage silo 36 is located at vessel flange 32(BETA vessel flange) on, be respectively equipped with a turning handle 33 in the both sides of vessel flange 32, in vessel flange 32, be provided with the first flange 35(BETA flange), between first flange 35 and the vessel flange 32 by flange seal circle 34(BETA flange seal circle) sealing, first flange 35 links to each other with second flange 28, first flange 35 and the second flange 28(ALPHA flange) between by sealing ring 30(ALPHA sealing ring) sealing, outside vessel flange 32 and second flange 28, be provided with sealing flange 26 and by the locking of sealing snap close 27, handle 29 is located on second flange 28.Can realize spreading out of of material transmission between aseptic isolator and other sterile equipment and the inner discarded object of aseptic isolator by the sterile transfer device assembly.
Shown in Fig. 5 A and Fig. 5 B, aseptic butt joint valve member 4 comprises that upper valve body 37 reaches valve body 46 down, under reaching, upper valve body 37 is embedded with a valve seat 39 respectively in the end of valve body 46, be respectively equipped with valve plate 38 and lower valve plate 47 in the bottom of upper valve body 37 and at the top of following valve body 46, last valve plate 38 docks by the jockey of being located at upper valve body 37 two ends with lower valve plate 47, be provided with sealing gasket 40 at last valve plate 38 with lower valve plate 47 joints, the end of lower valve plate 47 fastens the end of valve plate 38, be respectively equipped with handle cover plate 50 and the second valve plate fixed block 48 at last valve plate 38 and lower valve plate 47, lower valve plate 47 and on be provided with handle cover 49 outside the end of valve plate 38, rotary handle 45 links to each other with handle cover 49.
Jockey comprises the first valve plate fixed block 51, one end of the first valve plate fixed block 51 passes valve plate 38 and is located in the lower valve plate 47, link to each other by spring 52 between outside the other end of the first valve plate fixed block 51, being with end that thimble buckles 53, the first valve plate fixed blocks 51 and thimble buckleing 53.
Use aseptic butt joint valve member 4 and can realize the aseptic aseptic that guarantees in the blending process of docking between material-compound tank and the isolator.
A kind of aseptic weigh and the work of proportioning process isolator the time is kept apart with operating personnel and background environment fully provided by the invention, the endless form of inner totally-enclosed self-loopa can be monitored isolator internal environment parameter in real time, the production asepticize degree that is sterile bulk drug improves greatly, has also reduced poisonous high sensitization medicine to operating personnel's harm simultaneously.
Claims (8)
1. aseptic weighing and the proportioning process isolator, it is characterized in that: comprise glove box assembly (2), be provided with sterile transfer interface (3) at glove box assembly (2), air treatment system (1) places the top of glove box assembly (2), be connected with aseptic butt joint valve member (4) in the bottom of glove box assembly (2), glove box assembly (2) links to each other with drainage system (5);
Described glove box assembly (2) comprises stainless steel casing (16), be provided with operator running-on (17) at stainless steel casing (16), operation gloves (24) are connected on the operator running-on (17), be provided with the operation window (19) that has handle (20) at stainless steel casing (16), link to each other by nitrogen spring (23) between operation window (19) and the stainless steel casing (16), operation window (19) is by window locking device (22) locking, be provided with batching docking port (21) and hydrogen peroxide import and export (25) at stainless steel casing (16), projection electronic weighing scale (18) is located in the stainless steel casing (16).
2. a kind of aseptic weighing and the proportioning process isolator as claimed in claim 1, it is characterized in that: described glove box assembly (2) is located on the frame assembly (6).
3. a kind of aseptic weighing and the proportioning process isolator as claimed in claim 1, it is characterized in that: described air treatment system (1) comprises casing (14), air draft blower fan (10) is located on the casing (14), air draft blower fan (10) pipeline connects exhaust-air filter (12), be provided with continuous prefilter (7) and air intake filter (8) at casing (14), be provided with exhaust outlet (13) at exhaust-air filter (12).
4. a kind of aseptic weighing and the proportioning process isolator as claimed in claim 3 is characterized in that: be provided with toilet's tear lamp (11) at described casing (14).
5. a kind of aseptic weighing and the proportioning process isolator as claimed in claim 3 is characterized in that: be provided with the differential pressure indicator (9) that overhauls cover plate (15) and be used for detecting described exhaust-air filter (12) and described air intake filter (8) at described casing (14).
6. a kind of aseptic weighing and the proportioning process isolator as claimed in claim 1, it is characterized in that: described sterile transfer interface (3) comprises material storage silo (36), material storage silo (36) is located on the vessel flange (32), be respectively equipped with a turning handle (33) in the both sides of vessel flange (32), in vessel flange (32), be provided with first flange (35), seal by flange seal circle (34) between first flange (35) and the vessel flange (32), first flange (35) links to each other with second flange (28), seal by sealing ring (30) between first flange (35) and second flange (28), be provided with sealing flange (26) and by sealing snap close (27) locking, shake hands (29) are located on second flange (28) in that vessel flange (32) and second flange (28) are outer.
7. a kind of aseptic weighing and the proportioning process isolator as claimed in claim 1, it is characterized in that: described aseptic butt joint valve member (4) comprises that upper valve body (37) reaches valve body (46) down, under reaching, upper valve body (37) is embedded with a valve seat (39) respectively in the end of valve body (46), be respectively equipped with valve plate (38) and lower valve plate (47) in the bottom of upper valve body (37) and at the top of following valve body (46), last valve plate (38) docks by the jockey of being located at upper valve body (37) two ends with lower valve plate (47), be provided with sealing gasket (40) at last valve plate (38) and lower valve plate (47) joint, the end of lower valve plate (47) fastens the end of valve plate (38), be respectively equipped with handle cover plate (50) and the second valve plate fixed block (48) at last valve plate (38) and lower valve plate (47), be provided with handle cover (49) outside lower valve plate (47) reaches the end of going up valve plate (38), rotary handle (45) links to each other with handle cover (49).
8. a kind of aseptic weighing and the proportioning process isolator as claimed in claim 7, it is characterized in that: described jockey comprises the first valve plate fixed block (51), one end of the first valve plate fixed block (51) passes valve plate (38) and is located in the lower valve plate (47), be with thimble and buckle (53) outside the other end of the first valve plate fixed block (51), the end of the first valve plate fixed block (51) is buckled with thimble between (53) and is linked to each other by spring (52).
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201110164229 CN102319548B (en) | 2011-06-19 | 2011-06-19 | Isolator for sterile weighing and proportioning process |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201110164229 CN102319548B (en) | 2011-06-19 | 2011-06-19 | Isolator for sterile weighing and proportioning process |
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| Publication Number | Publication Date |
|---|---|
| CN102319548A CN102319548A (en) | 2012-01-18 |
| CN102319548B true CN102319548B (en) | 2013-07-17 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN 201110164229 Active CN102319548B (en) | 2011-06-19 | 2011-06-19 | Isolator for sterile weighing and proportioning process |
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Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104044772B (en) * | 2014-05-22 | 2016-06-29 | 上海拓达机电设备有限公司 | A kind of shielding system with transmission material bucket-tipping device |
| US10029258B2 (en) | 2015-03-31 | 2018-07-24 | Pentair Flow Technologies, Llc | Closed system chemical handling and delivery system and method |
| CN108341089B (en) * | 2017-01-24 | 2021-10-01 | 苏州奥特科然医疗科技有限公司 | Aseptic transmission device and packaging system under clean environment |
| CN109701336A (en) * | 2017-10-25 | 2019-05-03 | 郝占宁 | A kind of aseptic operation box that sterile wind is protected and the aseptic process method based on the aseptic operation box |
| CN111258343B (en) * | 2020-01-17 | 2021-08-03 | 扬子江药业集团有限公司 | Medicine oxygen content control system for medicine production and easily-oxidized medicine production method |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4325193A (en) * | 1980-11-26 | 1982-04-20 | The Virtis Company, Inc. | Shelf arrangement for freeze drying apparatus |
| CN101961294A (en) * | 2010-09-06 | 2011-02-02 | 上海东富龙科技股份有限公司 | Sterile isolator for lyopilization preparation core area |
| CN102032770A (en) * | 2010-12-28 | 2011-04-27 | 上海东富龙科技股份有限公司 | Aseptic isolator for fixed automatic feeding and discharging on vacuum freeze drier |
| CN202169154U (en) * | 2011-06-19 | 2012-03-21 | 上海东富龙科技股份有限公司 | Aseptic weighing and batching process isolator |
-
2011
- 2011-06-19 CN CN 201110164229 patent/CN102319548B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4325193A (en) * | 1980-11-26 | 1982-04-20 | The Virtis Company, Inc. | Shelf arrangement for freeze drying apparatus |
| CN101961294A (en) * | 2010-09-06 | 2011-02-02 | 上海东富龙科技股份有限公司 | Sterile isolator for lyopilization preparation core area |
| CN102032770A (en) * | 2010-12-28 | 2011-04-27 | 上海东富龙科技股份有限公司 | Aseptic isolator for fixed automatic feeding and discharging on vacuum freeze drier |
| CN202169154U (en) * | 2011-06-19 | 2012-03-21 | 上海东富龙科技股份有限公司 | Aseptic weighing and batching process isolator |
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| CN102319548A (en) | 2012-01-18 |
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Owner name: SHANGHAI TOFFLON AIREX TECHNOLOGY CO., LTD. Free format text: FORMER OWNER: SHANGHAI TOFFLON SCIENCE AND TECHNOLOGY CO., LTD. Effective date: 20130710 Owner name: SHANGHAI TOFFLON SCIENCE AND TECHNOLOGY CO., LTD. Effective date: 20130710 |
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Effective date of registration: 20130710 Address after: 201109 Shanghai city Minhang District Fanghe Road No. 2199 building first A zone Patentee after: Shanghai Tofflon Airex Technology Co., Ltd. Patentee after: Shanghai Tofflon Science and Technology Co., Ltd. Address before: 201109 Shanghai city Minhang District Fanghe Road No. 2199 Patentee before: Shanghai Tofflon Science and Technology Co., Ltd. |