CN202263549U - Sterile mixing machine - Google Patents

Sterile mixing machine Download PDF

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Publication number
CN202263549U
CN202263549U CN201120394807XU CN201120394807U CN202263549U CN 202263549 U CN202263549 U CN 202263549U CN 201120394807X U CN201120394807X U CN 201120394807XU CN 201120394807 U CN201120394807 U CN 201120394807U CN 202263549 U CN202263549 U CN 202263549U
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CN
China
Prior art keywords
mixing
valve
cylindrical shell
materials
inlet pipe
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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.)
Expired - Fee Related
Application number
CN201120394807XU
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Chinese (zh)
Inventor
易志斌
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Chongqing Kerui Pharmaceutical Group Co Ltd
Original Assignee
Chongqing Kerui Pharmaceutical Group Co Ltd
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Filing date
Publication date
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Priority to CN201120394807XU priority Critical patent/CN202263549U/en
Application granted granted Critical
Publication of CN202263549U publication Critical patent/CN202263549U/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Abstract

The utility model relates to pharmaceutical machinery, in particular to a sterile mixing machine, which comprises a frame, power equipment and a material mixing device, wherein the power equipment is disposed on the frame, and the material mixing device is connected with a power output spindle of the power equipment and capable of rotating along the spindle. The material mixing device comprises a material mixing barrel and a material access port which is arranged at the bottom of the material mixing barrel, a connecting device which is connected with a material barrel and can be sealed with the material barrel is arranged at the material access port, a feeding-discharging butterfly valve is further arranged on the material mixing barrel above the connecting device, and an air breather and a cleaning device are disposed on the material mixing barrel. The sterile mixing machine has the advantages that the risk of material contamination is lowered, online cleaning, sterilizing and drying are realized, labor intensity is relieved for workers, medicine yield and pharmaceutical efficiency are improved, and the sterile mixing machine meets the requirements of national GMP (good manufacturing practice) 2010 .

Description

Aseptic mixer
Technical field
The utility model relates to the aseptic mixing apparatus of producing in the medicine process, specifically is a kind ofly can reduce the contaminated risk of medicine, meets 2010 editions GMP requirements of country, can also be to aseptic mixing apparatus on-line cleaning, sterilization, dry aseptic mixer.
Background technology
Manual work or vacuum dual mode are adopted in the material loading and the discharging of the aseptic mixing apparatus in the domestic production medicine process at present mostly; And in this dual mode operating process; It is more when the people contacts with material; Aggravated material by the risk of particulate or microbial contamination, made that the medicine percent defective of producing is high; And existing aseptic mixing apparatus is in cleaning, sterilization, dry run; Usually adopt artificial cleaning on the throne or off-line to clean; Water for cleaning and draining during on the throne the cleaning all need man-handling of materials, and sterilization then uses disinfectant to carry out wiping, and these two kinds of methods make that not only working strength of workers is big; Also all can increase environment or mixer by particulate or microbial contamination risk, thereby make that the medicine percent defective is high and pollute surrounding environment.
According to 2010 editions GMP requirements of country, aseptic medicine should reduce human intervention in process of production as far as possible, reduces contaminated risk.Yet the aseptic mixing apparatus of prior art can't satisfy 2010 editions GMP requirements of country at all; The aseptic mixing apparatus of prior art is more time of contact with the people in production, cleaning, sterilization, dry run simultaneously; Material and aseptic mixing apparatus are high by the risk of particulate or microbial contamination, and then make that the medicine percent defective of producing is high.
Therefore; This invention main purpose is in order to solve aseptic mixer in material loading, discharging, cleaning, sterilization, dry run; The position that material, cleansing medium and mixer contact with material does not come in contact with the people basically, reduces the microbial contamination risk to greatest extent.According to 2010 editions GMP requirements of country, aseptic medicine should reduce human intervention in process of production as far as possible, reduces contaminated risk.Therefore, the utility model is mainly considered to solve material and is contacted in mixer, how reducing with the people; After mixer is accomplished mixing, how mixer is carried out online cleaning, sterilization, drying, and in this process, reduce human intervention, can control automatically.
Summary of the invention
The purpose of the utility model is in order to overcome the above-mentioned deficiency that prior art exists, to provide a kind of and can reduce the contaminated risk of medicine, meet 2010 editions GMP requirements of country, can also be to aseptic mixing apparatus on-line cleaning, sterilization, dry aseptic mixer.
The utility model is realized through following technical scheme, and a kind of aseptic mixer comprises frame and is arranged on the power-equipment on the frame, is connected with the main shaft of power-equipment power output and along the mixing of materials device of main axis rotation; Wherein: said mixing of materials device comprises mixing of materials cylindrical shell and the material import and export that is arranged on mixing of materials cylindrical shell bottom; Be provided with at the material import and export place attachment barrel and can with the jockey of material tube sealing, on the mixing of materials cylindrical shell above the jockey, also be provided with the input and output material butterfly valve; Said power-equipment is connected with the PLC controller of external control system, and PLC controller control mixing of materials device is along main axis rotation.Said jockey comprises the upper flange plate on the mixing of materials cylindrical shell that is arranged on the material import and export place, and upper flange plate is provided with gathering sill; Be provided with the guide finger that cooperates with gathering sill with the clamping hoop type lower flange of upper flange plate pairing, the guide finger top is provided with the locking pin that passes guide finger, and the guide finger bottom is connected with handle; The centre bore of lower flange and/or upper flange plate is provided with sealing ring.Said mixing of materials cylindrical shell top is provided with cleaning device.Said cleaning device comprises the cleaning control pipeline and sterilization control piper that is connected with the PLC controller of external control system; The connection pipeline of cleaning device is communicated with water inlet pipe, outlet pipe and steam inlet pipe, is communicated with through pipeline and the drain valve II that is arranged on the pipeline between steam inlet pipe and the outlet pipe; On water inlet pipe and steam inlet pipe, be connected with filter core I and filter core II respectively; On water inlet pipe, also be connected with water intaking valve, injection water valve and be arranged on the control valve II of the filter core II port of export; On steam inlet pipe, be connected with intake valve and the control valve III that is arranged on the filter core I port of export, the uphole end of steam inlet pipe is provided with inlet valve; On outlet pipe, be connected with preparatory drain valve, main drain valve and near the drain valve I of main drain valve end, with the pneumatic angle pedestal valve I of drain valve I polyphone, with drain valve I and pneumatic angle pedestal valve I and be connected in the pneumatic angle pedestal valve II by their; Connect pipeline and be provided with pressure transmitter and control valve I.Said mixing of materials cylindrical shell top is provided with air respiratorresuscitator.This structure also is connected with PRN device with the PLC controller of external control system.
The utility model is owing to the advantage that said structure has is: solved aseptic mixer in material loading, discharging, cleaning, sterilization, dry run; The position that material, cleansing medium and mixer contact with material does not come in contact with the people basically, has reduced material to greatest extent by the risk of microbial contamination; Also realize on-line cleaning, sterilization, drying, reduced working strength of workers, improved medicine yield rate and pharmacy efficient, also met 2010 editions GMP requirements of country.
Description of drawings
The utility model can further specify through the non-limiting embodiment that accompanying drawing provides.
Fig. 1 is the structural representation of the utility model.
Fig. 2 is the input and output material structural representation of the utility model.
Fig. 3 is connected the partial structurtes sketch map that is for the utility model jockey with the material tube with outer cylinder body.
Fig. 4 is the structural representation of the utility model cleaning, sterilization, drying.
Among the figure: 1, inner barrel; 2, outer cylinder body; 3, peep hole; 4, cleaning device; 5, main shaft; 6, input and output material butterfly valve; 7, jockey; 8, electronic scale; 9, frame; 10, material tube; 11, upper flange plate; 12, gathering sill; 13, clamping hoop type lower flange; 14, guide finger; 15, locking pin; 16, handle; 17, sealing ring; 18, soft seal section; 19, connect pipeline; 20, steam inlet pipe; 21, water inlet pipe; 22, outlet pipe; 23, filter core I; 24, water intaking valve; 25, intake valve I; 26, preparatory drain valve; 27, main drain valve; 28, pressure transmitter; 29, control valve I; 30, pneumatic angle pedestal valve II; 31, drain valve I; 32, pneumatic angle pedestal valve I; 33, injection water valve; 34, drain valve II; 35, control valve II; 36, control valve III; 37, filter core II; 38, intake valve II.
The specific embodiment
Below in conjunction with accompanying drawing and embodiment the utility model is described further:
Referring to accompanying drawing 1,2,3 and 4, the aseptic mixer among the figure comprises frame 9 and is arranged on the power-equipment on the frame 9, the mixing of materials device that is connected with the main shaft 5 of power-equipment power output and rotates along main shaft 5; It is characterized in that: said mixing of materials device comprises mixing of materials cylindrical shell and the material import and export that is arranged on mixing of materials cylindrical shell bottom; Be provided with at the material import and export place attachment barrel 10 and can with the jockey 7 of material tube 10 sealings, on the mixing of materials cylindrical shell above the jockey 7, also be provided with input and output material butterfly valve 6; Said power-equipment is connected with the PLC controller of external control system, and PLC controller control mixing of materials device is along main shaft 5 rotations.This structure directly is tightly connected through jockey 7 and material tube 10; Make that materials in the material tube 10 are to get into the mixing of materials cylindrical shell or all avoided contacting with the people from the discharging of mixing of materials cylindrical shell; Avoided material to contact and by particulate or microbial contamination, met 2010 editions GMP requirements of country with the people.
The said jockey 7 of the foregoing description comprises the upper flange plate 11 on the mixing of materials cylindrical shell that is arranged on the material import and export place, and upper flange plate 11 is provided with gathering sill 12; Be provided with the guide finger 14 that cooperates with gathering sill 12 with the clamping hoop type lower flange 13 of upper flange plate 11 pairings, guide finger 14 tops are provided with the locking pin 15 that passes guide finger 14, and guide finger 14 bottoms are connected with handle 16; The centre bore of lower flange 13 and/or upper flange plate 11 is provided with sealing ring 17.The said mixing of materials cylindrical shell of this structure comprises inner barrel 1 and the outer cylinder body 2 that inner barrel 1 is wrapped up.Jockey 7 can also be commercially available AB valve; This jockey 7 mainly is that material tube 10 and mixing of materials cylindrical shell are easier to be tightly connected; Its concrete course of work is---clamping hoop type lower flange 13 is enclosed within material tube 10 material import and export ends, make sealing ring 17 and material tube 10 be tightly connected, then guide finger 14 is inserted in the gathering sill 12 of upper flange plate 11; Through the singlehanded joystick 16 of workman; Make that 11 lockings are one to locking pin 15 with upper flange plate with lower flange 13, realized being tightly connected of material tube 10 and mixing of materials cylindrical shell, the input and output material use is the same.Certainly, material tube 10 can also adopt other plug-ins to be tightly connected with being tightly connected of mixing of materials cylindrical shell, is not limited to aforesaid way and is tightly connected.The use of said structure is through the control button on the control external control system, makes particularly to be operation automation--during-charging; When the mixing of materials cylindrical shell rotates to 45 °; Open input and output material butterfly valve 6, material is closed input and output material butterfly valve 6 because gravity gets in the mixing of materials cylindrical shell; Take off material tube 10, repeat this process and promptly realize charging; During discharging; Make the mixing of materials cylindrical shell rotate to the home position, material tube 10 is connected according to above-mentioned connected mode with the mixing of materials cylindrical shell, open input and output material butterfly valve 6 after connection finishes; Material is because gravity gets into material tube 10; According to the loading amount of electronic scale 8 definite material tubes, after accomplishing, close input and output material butterfly valve 6, repeat this process and promptly accomplish blanking; For further improving sealing effectiveness, the sealing ring 17 that is provided with on said clamping hoop type lower flange 13 centre bores of said structure prevents the soft seal section 18 of dust when having discharging, soft seal section 18 is placed in the material tube 10.
Above-mentioned material tube 10 can be that aluminium is listened, and also can be plastic bottle.
After the medicine collection has been adorned, just this system is cleaned, sterilizes and drying.
The said mixing of materials cylindrical shell of the foregoing description top is provided with on-line cleaning and sterilizing and washing device 4.Said cleaning device 4 comprises the cleaning control pipeline and sterilization control piper that is connected with the PLC controller of external control system; The connection pipeline 19 of cleaning device 4 is communicated with water inlet pipe 21, outlet pipe 22 and steam inlet pipe 20, is communicated with through pipeline and the drain valve II 34 that is arranged on the pipeline between steam inlet pipe 20 and the outlet pipe 22; On water inlet pipe 21 and steam inlet pipe 20, be connected with filter core I 23 and filter core II 37 respectively; On water inlet pipe 21, also be connected with water intaking valve 24, injection water valve 33 and be arranged on the control valve II 35 of filter core II 37 ports of export; On steam inlet pipe 20, be connected with intake valve I 25 and the control valve III 36 that is arranged on filter core I 23 ports of export, the uphole end of steam inlet pipe 20 is provided with inlet valve 37; On outlet pipe 22, be connected with preparatory drain valve 26, main drain valve 27 and near the drain valve I 31 of main drain valve 27 ends; With the pneumatic angle pedestal valve I 32 of drain valve I 31 polyphone, with drain valve I 31 and pneumatic angle pedestal valve I 32 and be connected in the pneumatic angle pedestal valve II 30 on their next doors; Connect pipeline 19 and be provided with pressure transmitter 28 and control valve I 29.Specifically referring to accompanying drawing 4, what show among the figure is mixer cleaning, sterilization, dry pipeline sketch map, at first cleans: connect water inlet pipe 21 and outlet pipe 22 and control valve; Form detergent line; Click the drip washing key on the PLC control flow, purified water water intaking valve 24 on the pipeline and preparatory drain valve 26 are opened automatically, and system can drain the surplus water in the former pipeline; Drain valve 26 cuts out in advance; Open main drain valve 27, pneumatic angle pedestal valve II 30 and control valve II 35 then successively, control valve II 35 control filter cores 23 I are carried out drip washing to tank interior; Close main drain valve 27 systems after drip washing finishes and get into the previous cleaning stage automatically, adorn a certain amount of water in jar after, remove detergent line; The mixing of materials cylindrical shell is rotated cleaning automatically; Previous cleaning finishes the back and detergent line is installed once more, opens main drain valve 27 and pneumatic angle pedestal valve II 30, begins to carry out fine purifiation after Yu Shui drains; Injection water valve 33 is opened, and carries out according to first washing procedure.Secondly sterilization: start sterilizing program; Open intake valve II 38; The residual water and the pure steam that connect in the pipeline 19 pass through 34 discharges of drain valve II, open intake valve I 25, control valve III 36 and control valve I 29, and pure steam gets in the jar through filter core II 37, control valve III 36, pressure transmitter 28 and control valve I 29 successively; Open main drain valve 27 and pneumatic angle pedestal valve I 32 simultaneously; The interior steam of mixing of materials cylindrical shell this moment is condensed into water and discharges automatically through drain valve I 31, and the PLC controller is regulated admission and displacement, system's self-clocking automatically through temperature and pressure in the monitoring mixing of materials cylindrical shell; When sterilising temp reaches 121 ℃, also continue 30 minutes, system's sterilization finishes.
Be dry at last: the cylindrical shell of mixing of materials described in said structure top is provided with air respiratorresuscitator.
Open tank body top air respiratorresuscitator, system carries out automatic drying.
Workman for ease of the course of work observes: the said mixing of materials cylindrical shell of said structure top also is provided with peep hole 3.
This structure also is connected with PRN device, and for ease of discharging control accuracy and efficient, when discharging, the corresponding ground of material import and export of mixing of materials cylindrical shell bottom is provided with electronic scale 8.
In sum; The utility model has solved aseptic mixer in material loading, discharging, cleaning, sterilization, dry run; The position that material, cleansing medium and mixer contact with material does not come in contact with the people basically, has reduced material to greatest extent by the risk of microbial contamination; Also realize on-line cleaning, sterilization, drying, reduced working strength of workers, improved medicine yield rate and pharmacy efficient, also met 2010 editions GMP requirements of country.

Claims (8)

1. an aseptic mixer comprises frame (9) and is arranged on the power-equipment on the frame (9), the mixing of materials device that is connected with the main shaft (5) of power-equipment power output and rotates along main shaft (5); It is characterized in that: said mixing of materials device comprises mixing of materials cylindrical shell and the material import and export that is arranged on mixing of materials cylindrical shell bottom; Be provided with at the material import and export place attachment barrel (10) and can with the jockey (7) of material tube (10) sealing, on the mixing of materials cylindrical shell of jockey (7) top, also be provided with input and output material butterfly valve (6); Said power-equipment is connected with the PLC controller of external control system, and PLC controller control mixing of materials device rotates along main shaft (5).
2. aseptic mixer according to claim 1 is characterized in that: said jockey (7) comprises the upper flange plate (11) on the mixing of materials cylindrical shell that is arranged on the material import and export place, and upper flange plate (11) is provided with gathering sill (12); Be provided with the guide finger (14) that cooperates with gathering sill (12) with the clamping hoop type lower flange (13) of upper flange plate (11) pairing; Guide finger (14) top is provided with the locking pin (15) that passes guide finger (14), and guide finger (14) bottom is connected with handle (16); The centre bore of lower flange (13) and/or upper flange plate (11) is provided with sealing ring (17).
3. aseptic mixer according to claim 2 is characterized in that: the sealing ring (17) that is provided with on said clamping hoop type lower flange (13) centre bore prevents the soft seal section (18) of dust when having discharging.
4. aseptic mixer according to claim 1 is characterized in that: said mixing of materials cylindrical shell comprises inner barrel (1) and the outer cylinder body (2) that inner barrel (1) is wrapped up.
5. according to claim 1, one of 2 or 4 described aseptic mixers, it is characterized in that: said mixing of materials cylindrical shell top is provided with the cleaning device (4) that carries out on-line cleaning and sterilization.
6. aseptic mixer according to claim 5 is characterized in that: said cleaning device (4) comprises the cleaning control pipeline and sterilization control piper that is connected with the PLC controller of external control system; The connection pipeline (19) of cleaning device (4) is communicated with water inlet pipe (21), outlet pipe (22) and steam inlet pipe (20), is communicated with through pipeline and the drain valve II (34) that is arranged on the pipeline between steam inlet pipe (20) and the outlet pipe (22); On water inlet pipe (21) and steam inlet pipe (20), be connected with filter core I (23) and filter core II (37) respectively; On water inlet pipe (21), also be connected with water intaking valve (24), injection water valve (33) and be arranged on the control valve II (35) of filter core II (37) port of export; On steam inlet pipe (20), be connected with intake valve (25) and be arranged on the control valve III (36) of filter core I (23) port of export, the uphole end of steam inlet pipe (20) is provided with inlet valve (37); The drain valve I (31) that on outlet pipe (22), is connected with preparatory drain valve (26), main drain valve (27) and holds near main drain valve (27); With the pneumatic angle pedestal valve I (32) of drain valve I (31) polyphone, with drain valve I (31) and pneumatic angle pedestal valve I (32) and be connected in the pneumatic angle pedestal valve II (30) by their; Connect pipeline (19) and be provided with pressure transmitter (28) and control valve I (29).
7. according to claim 1, one of 2 or 4 described aseptic mixers, it is characterized in that: said mixing of materials cylindrical shell top is provided with air respiratorresuscitator.
8. according to claim 1, one of 2 or 4 described aseptic mixers, it is characterized in that: said mixing of materials cylindrical shell top also is provided with peep hole (3).
CN201120394807XU 2011-10-17 2011-10-17 Sterile mixing machine Expired - Fee Related CN202263549U (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201120394807XU CN202263549U (en) 2011-10-17 2011-10-17 Sterile mixing machine

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201120394807XU CN202263549U (en) 2011-10-17 2011-10-17 Sterile mixing machine

Publications (1)

Publication Number Publication Date
CN202263549U true CN202263549U (en) 2012-06-06

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Family Applications (1)

Application Number Title Priority Date Filing Date
CN201120394807XU Expired - Fee Related CN202263549U (en) 2011-10-17 2011-10-17 Sterile mixing machine

Country Status (1)

Country Link
CN (1) CN202263549U (en)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102389736A (en) * 2011-10-17 2012-03-28 重庆科瑞制药(集团)有限公司 Sterilizing mixer
CN105413552A (en) * 2015-11-19 2016-03-23 无锡意凯自动化技术有限公司 Sterile vacuum emulsification system

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102389736A (en) * 2011-10-17 2012-03-28 重庆科瑞制药(集团)有限公司 Sterilizing mixer
CN105413552A (en) * 2015-11-19 2016-03-23 无锡意凯自动化技术有限公司 Sterile vacuum emulsification system

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C14 Grant of patent or utility model
GR01 Patent grant
CF01 Termination of patent right due to non-payment of annual fee

Granted publication date: 20120606

Termination date: 20141017

EXPY Termination of patent right or utility model