CN106944365B - The online quality inspection device and quality control method of freeze-drying powder-injection - Google Patents

The online quality inspection device and quality control method of freeze-drying powder-injection Download PDF

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Publication number
CN106944365B
CN106944365B CN201710154926.XA CN201710154926A CN106944365B CN 106944365 B CN106944365 B CN 106944365B CN 201710154926 A CN201710154926 A CN 201710154926A CN 106944365 B CN106944365 B CN 106944365B
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cillin bottle
bottle
cillin
camera
freeze
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CN106944365A (en
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李玉红
何玉祥
胡军
邵建超
王鑫
王瑞杰
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CHENGDU TIANTAISHAN PHARMACEUTICAL CO LTD
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CHENGDU TIANTAISHAN PHARMACEUTICAL Co Ltd
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B07—SEPARATING SOLIDS FROM SOLIDS; SORTING
    • B07C—POSTAL SORTING; SORTING INDIVIDUAL ARTICLES, OR BULK MATERIAL FIT TO BE SORTED PIECE-MEAL, e.g. BY PICKING
    • B07C5/00—Sorting according to a characteristic or feature of the articles or material being sorted, e.g. by control effected by devices which detect or measure such characteristic or feature; Sorting by manually actuated devices, e.g. switches
    • B07C5/34—Sorting according to other particular properties
    • B07C5/342—Sorting according to other particular properties according to optical properties, e.g. colour
    • B07C5/3422—Sorting according to other particular properties according to optical properties, e.g. colour using video scanning devices, e.g. TV-cameras
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/84—Systems specially adapted for particular applications
    • G01N21/88—Investigating the presence of flaws or contamination
    • G01N21/90—Investigating the presence of flaws or contamination in a container or its contents

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  • Engineering & Computer Science (AREA)
  • Multimedia (AREA)
  • Physics & Mathematics (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Investigating Materials By The Use Of Optical Means Adapted For Particular Applications (AREA)

Abstract

The present invention relates to the online quality inspection devices and quality control method of freeze-drying powder-injection.The online quality inspection device is for checking the visible foreign matters of freeze-drying powder-injection, device is set on linkage production line of the freeze-drying powder-injection before liquid drug and after liquid drug, comprising: cillin bottle transmission belt, drencher, first camera, second camera, backlight, computer, rejecting mechanism.Wherein first camera images empty cillin bottle, second camera images the cillin bottle of liquid drug, backlight provides the light source of camera shooting, computer acquisition and analysis camera image data for cillin bottle and rejects signal to feeding back there are the cillin bottle of visible foreign matters.The method for further relating to check the visible foreign matters of freeze-drying powder-injection using above-mentioned online quality inspection device.Apparatus of the present invention and method can the very effective visible foreign matters inspection item to freeze-drying powder-injection carry out in advance, online, the quality monitoring of bulk sample sheet.

Description

The online quality inspection device and quality control method of freeze-drying powder-injection
Technical field
The invention belongs to pharmaceutical technology field, it is related to a kind of online quality inspection device of preparation in process of production, with And the method for using this device to carry out online quality monitoring to medicine preparation.In particular, the present invention relates to a kind of freeze dried powders The online quality inspection device of injection, and the method that online quality monitoring is carried out to freeze-drying powder-injection using this system. Particularly relate to in freeze-drying powder-injection there may be or introduce visible foreign matters detected and reject in time with The method for monitoring product quality.
Background technique
All previous " Chinese Pharmacopoeias ", such as detection project of " Chinese Pharmacopoeia " version in 2015 in its rules of preparations about injection In, it requires to carry out visible foreign matters inspection, and define the inspection method of visible foreign matters.Such as " Chinese Pharmacopoeia " version in 2015 In " the 0904 visible foreign matters inspection technique " that four general rules are recorded, manual " lamp test " is provided, and by using instrument " light scattering method ".Such as wherein to Injectable sterile preparation (including Injectable sterile freeze-drying powder-injection of the present invention) When being checked, " lamp test " is handled sample using following operation: " test sample 5 (bottle) unless otherwise specified, are taken, After being completely dissolved medicinal powder with suitable solvent and method appropriate, check according to the above method.With the injection for having dedicated solvent With sterile preparation, after the regulation that should first dedicated solvent be checked and be met injection by injection requirement, then is dissolved and injected with it Use sterile preparation.Such as vacuum-treated test sample, its vacuum is broken using method appropriate when necessary, in order to drug dissolution. The kind of deepfreeze should first be put to room temperature, then dissolved and checked." " light scattering method " also using similar as follows Operation handles sample: " unless otherwise specified injection sterile powder, takes test sample 5 (bottle), with suitable solvent and It after method appropriate makes complete drug dissolution, checks according to the above method ".As it can be seen that existing pharmacopeia to the visible of freeze drying powder injection The method that the method that foreign matter carries out quality testing and evaluation is all subsequent detection and is evaluated, i.e., detect finished product and evaluated, This method is substantially to take representative sample to be detected, but above-mentioned so-called " 5 (bottle) " is used as representative sample, generation Table is up to ten thousand bottles of every batch of of finished product, this representative in fact its risk pole for needing to inject endovascular drug Greatly, such as because a variety of causes falls into visible foreign matters in cillin bottle such as vitroclastic, hair, fiber etc., these foreign matters are not every Bottle has, so this using " 5 (bottle) " as up to ten thousand bottles of every batch of of representative samples, can not to freeze drying powder injection at Product carry out effective quality monitoring.And this detection method is method that is destructive, cannot using large area sample detection To judge that this batch of product is qualified or not.
In addition, the preparation process of freeze drying powder injection is also to be different from some other solution type preparation such as injection completely 's.The preparation process of freeze drying powder injection generally includes: by drug and auxiliaries at solution, by the solution through (this that is sterile filtered Filtering can remove the impurity such as visible foreign matters in medical fluid), filtered medical fluid is through pipeline to filling process, by medical fluid It is filled in cillin bottle cleaned in advance, cillin bottle is partly jumped a queue, and freeze-drying obtains finished product after tamponade.As it can be seen that freeze drying powder injection In most of process before filling the container, there is a possibility that introducing visible foreign matters.It is molten in vial after freeze-drying Liquid becomes the solid matter of pie or powder or chunky shape, is that can not carry out can in the case where not destroying finished product at this time See inspection of foreign substance, this situation and solution type medicine are entirely different, such as finished product, injection quilt is being made in solution-type injection After being sealed in vial, it still is able to by way of not destroying finished product carry out visible foreign matters inspection to it, and check sample This quantity is unrestricted.
Therefore, just the visible foreign matters of product are monitored in freeze drying powder injection preparation process, are that there is greatly industry Value, this scheme can be realized the monitoring in advance of bulk sample sheet, overcomes in above-mentioned official method and only carries out thing to Minimum Sample After the shortcomings that detecting.However, the prior art there is not yet this scheme come solve freeze drying powder injection bulk sample sheet, monitor it in advance can See the introduction of foreign matter.Although some documents mention the method for carrying out inspection of foreign substance to powder needle, these methods not can solve The above problem.
For example, CN204028015U (201420487088.X) discloses a kind of lamp inspection device of powder-injection cillin bottle, belong to In candling apparatus technical field.The lamp inspection device includes chain clip-type conveying belt, spacer and sunpender, and the spacer is equipped with Boom hole, spacer are fixed on sunpender by boom hole, it is characterised in that: are additionally provided with lamp inspection on the chain clip-type conveying belt Bracket is provided with the lampshade of lamp source, one section of isolation blade saw between lampshade lower boom hole on the lamp inspection bracket At hollow form, it is welded with steel wire on the spacer of hollow form, is equipped with one side lamp inspection mirror, the lamp inspection behind the steel wire Mirror is mounted on the rear side of conveyer belt.The utility model structure is simple, only needs one can front to cillin bottle and back simultaneously It is detected in face.
CN103645196A (201310410702.2) discloses a kind of foreign matter for penicillin bottle lamp inspection machine to be lyophilized and outer See detection device, which is characterized in that follow acquisition device, mechanical clamping jaw bottle gripper and main driving system including image synchronization System；It includes hollow direct-driven servo motor that the image synchronization, which follows acquisition device, during hollow direct-driven servo motor is fixedly connected Empty direct-driven servo motor output flange, hollow direct-driven servo motor output flange are fixedly connected with one end of pivoted arm, and pivoted arm is fixed to be connected Light source mounting base and camera mounting base are connect, light source mounting base is equipped with light source, and camera mounting base is equipped with camera；The main drive Dynamic system includes main shaft, and main shaft is rotatably arranged in the centre bore of hollow direct-driven servo motor, and main shaft connects speed reducer, is slowed down Machine connects main motor, is equipped with sliding sleeve on the outside of main shaft, sliding sleeve is fixedly connected with lamp inspection disk；The mechanical clamping jaw bottle gripper includes It is rotatably arranged in the clamping jaw of lamp inspection disk periphery, the top of clamping jaw is equipped with synchronous pulley, also is provided on the output shaft of stepper motor The synchronous pulley of synchronous pulley, clamping jaw top is connected with the synchronous pulley on stepper motor output shaft by synchronous belt, stepping electricity Machine is set on stepper motor fixed block, and stepper motor fixed block is fixed on lamp inspection disk, and the upper end connection driving clamping jaw of clamping jaw is opened The lower end of the movable axis of the cylinder of conjunction, the clamping jaw is equipped with cillin bottle collet.It is believed that the invention camera, light source, bottle to be checked three Person's synchronism is high, ensure that camera image acquisition quality, substantially increases the detection accuracy of lamp inspection machine.
CN103512902A (201310410939.0) discloses a kind of for the image synchronization of penicillin bottle lamp inspection machine to be lyophilized Follow acquisition device, it is characterised in that: including main shaft, main shaft is rotatably arranged in the centre bore of hollow direct-driven servo motor, Main shaft one end connects speed reducer, and speed reducer connects main motor, and the other end of main shaft is set to the center of lamp inspection disk and consolidates with lamp inspection disk The periphery of fixed connection, lamp inspection disk is equipped with clamping jaw, cillin bottle to be checked is fixed on clamping jaw, is fixed on hollow direct-driven servo motor Empty direct-driven servo motor output flange, hollow direct-driven servo motor output flange connect pivoted arm, and pivoted arm is fixedly connected with light source installation Plate and industrial camera mounting plate, light source mounting plate are equipped with light source, and industrial camera mounting plate is equipped with industrial camera, industrial camera It is located at the same side of cillin bottle to be checked with light source.It is believed that camera, light source and bottle to be checked keep same during the motion in the invention Step, it is opposing stationary, so that completing Image Acquisition under non-stop-machine state, substantially increase the detection efficiency of lamp inspection machine.
CN103512897A (201310410666.X) disclose it is a kind of for the Baseless light inspection machine of cillin bottle to be lyophilized, Including machine frame system, feed system, cillin bottle head check system, main shaft turret system, follow camera system, discharge system and Control system by control system control cillin bottle head check system, main shaft turret system, follows camera system and discharging system System is detected cillin bottle from bottle inlet system feeding, carries out by head defect of the cillin bottle product head check system to cillin bottle After detection, then it is transferred to main shaft turret system, and by completing one with the cooperation of camera system is followed in main shaft turret system After the detection of serial project, it is respectively outputted in different product trays by going out bottle system, it is characterised in that: feed system, Cillin bottle head check system, main shaft turret system follow camera system and discharge system to be directly installed on the master of machine frame system On bottom plate, camera system is followed to be fixedly connected with main floor, in which: main shaft turret system only includes the master of a hollow structure Axis, main shaft is mounted on main floor by the main shaft device support being arranged outside it with bearing, by main shaft driving device driving spindle It is rotated around own axes, clamping jaw mounting flange is set on main shaft, and driving screw rod is equipped in main shaft, and driving screw rod passes through connector It connect with clamping jaw mounting flange, is positioned clamping jaw mounting flange at various height, on clamping jaw mounting flange by driving screw rod Circumferentially there is mechanical clamping jaw, the cillin bottle clamped by mechanical clamping jaw, clamping jaw driving cylinder pushes mechanical clamping jaw to beat It opens and closes, clamping jaw rotary drive motor is rotated by the mechanical clamping jaw of driving belt Component driver around own axes；Follow bat Lighting system includes the vision system drive motor means being fixed on main floor, and vision system drive motor means use hollow electricity Machine, the hollow motor and main shaft are coaxially arranged, and moveable support is mounted in vision system drive motor means, by vision System drive motor device driving moveable support does and follows wobbling action on opposite main shaft direction of rotation, removable At least provided with vision inspection apparatus and lighting system in support device；Cillin bottle head check system includes being positioned at when detecting Cillin bottle head detection vision system above feed system, the cillin bottle head detection vision system include at least bracket, The middle part of bracket is equipped with top camera, is equipped with annular light source in the lower section of top camera, the camera lens of top camera is saturating when detecting The bottle cap for the cillin bottle that the middle through-hole face of annular light source is disposed below is crossed, at least three side cameras are with annular light source or top Centered on the axis of portion's camera circumferentially, each side camera is fixed on respective Camera fixing seat, and Camera fixing seat is set to On bracket, each Camera fixing seat is moved up and down by the measuring staff driving of respective micrometer head to be accurately positioned corresponding side phase The image-forming range of machine is equipped with a prism below each side camera, is equipped with a backlight on the opposite of each prism Source, the light source that backlight issues are entered by the refraction by prism on the backlight opposite positioned at the prism after being radiated at the head of cillin bottle The sensor devices of the side camera of top are to be imaged.It is believed that the advantages of invention, is: a kind of reduction characterization processes are provided, it is mechanical Structure is simple, and the lamp inspection machine of comprehensive detection can be carried out to cillin bottle.
Therefore, those skilled in the art urgently expect to have the visible foreign matters of a kind of pair of freeze drying powder injection carry out in advance, online, Method and/or device, the equipment of the quality monitoring of bulk sample sheet.
Summary of the invention
It is an object of that present invention to provide a kind of online quality inspection device of freeze-drying powder-injection and use the freezing The method that the online quality inspection device of dry powder-injection carries out online quality monitoring to freeze-drying powder-injection, is especially to provide The visible foreign matters of a kind of pair of freeze-drying powder-injection are carried out the device of online quality monitoring and are done using this device to freezing The method that the visible foreign matters of dry powder-injection carry out online quality monitoring.It has been had now surprisingly been found that, the method for the present invention can be non- Often effectively to the visible foreign matters inspection item of freeze-drying powder-injection carry out in advance, online, the quality monitoring of bulk sample sheet.This hair It is bright to be accomplished based on this discovery.
For this purpose, first aspect present invention provides a kind of online quality inspection device of freeze-drying powder-injection, the device It is checked for the visible foreign matters to freeze-drying powder-injection, which is set to freeze-drying powder-injection before liquid drug On the linkage production line after liquid drug, and include:
Cillin bottle transmission belt, for the cillin bottle cleaned and dried to be transmitted through drencher and is subsequently entered subsequent Cillin bottle is jumped a queue process；
Drencher, liquid drug in each column sky cillin bottle for being continuously transmitted on linkage production line；
First camera is set to before the drencher, and with direction from up to down to connecting on linkage production line The continuous empty cillin bottle passed through is imaged；
Second camera is set to after the drencher, and with direction from up to down to connecting on linkage production line The cillin bottle of the continuous liquid drug passed through is imaged；
Backlight comprising two groups, first group of cillin bottle transmission belt lower section being set under first camera, second group of setting Below cillin bottle transmission belt under second camera, for providing the light source of camera shooting to by the cillin bottle under camera；
Computer, for acquiring and analyzing the image data from first camera and second camera and to there are visible foreign matters Cillin bottle feedback reject signal；
Rejecting mechanism, receives the rejecting signal of computer feedback and the cillin bottle that visible foreign matters will be present is rejected.
The online quality inspection device of the freeze-drying powder-injection of any embodiment according to a first aspect of the present invention, wherein The cillin bottle transmission belt is provided with an aperture in the position being located at below cillin bottle, so that the light from backlight enters XiLin Bottle.Generally cillin bottle transmission belt is to be made either to be process with polyformaldehyde of stainless steel material, can not light transmission, therefore The aperture is arranged to be necessary.
The online quality inspection device of the freeze-drying powder-injection of any embodiment according to a first aspect of the present invention, wherein The cillin bottle transmission belt is provided with aperture in the position being located at below cillin bottle, so that the light from backlight enters XiLin Bottle, it is 0.5~0.9:1 that the diameter of the aperture, which is with the diameter of cillin bottle bottle body ratio,.The aperture of setting is unsuitable too small also unsuitable It is excessive, too it is small be not enough to be will affect when too big through enough light cillin bottle it is upright when stability.Unexpected hair Now, anyway, when the diameter of cillin bottle bottle body of the diameter less than 0.3 times of aperture, all observed result can be caused unstable, and When the diameter of aperture be more than or equal to 0.4 times particularly greater than equal to the diameter of 0.5 times of cillin bottle bottle body when never see have it is this Problem.
The online quality inspection device of the freeze-drying powder-injection of any embodiment according to a first aspect of the present invention, wherein The cillin bottle transmission belt is provided with aperture in the position being located at below cillin bottle, so that the light from backlight enters XiLin Bottle, it is 0.6~0.9:1 that the diameter of the aperture, which is with the diameter of cillin bottle bottle body ratio,.
The online quality inspection device of the freeze-drying powder-injection of any embodiment according to a first aspect of the present invention, wherein The cillin bottle transmission belt is provided with aperture in the position being located at below cillin bottle, so that the light from backlight enters XiLin Bottle, it is 0.7~0.9:1 that the diameter of the aperture, which is with the diameter of cillin bottle bottle body ratio,.
The online quality inspection device of the freeze-drying powder-injection of any embodiment according to a first aspect of the present invention, wherein The cillin bottle transmission belt continuously provides a column cillin bottle, and to enter drencher filling and before filling the container afterwards to west to carry out medical fluid Woods bottle carries out visible foreign matters inspection.At this point, as long as a camera is arranged in first camera and second camera respectively.
The online quality inspection device of the freeze-drying powder-injection of any embodiment according to a first aspect of the present invention, wherein The cillin bottle transmission belt continuous synchronization provide two column cillin bottles enter drencher with carry out medical fluid it is filling and before filling the container after Visible foreign matters inspection is carried out to cillin bottle.At this point, first camera and second camera are respectively necessary for two cameras of setting, such as present invention Shown in figure.The setting quantity of columns and camera that cillin bottle transmission belt continuous synchronization provides cillin bottle is analogized with this.
The online quality inspection device of the freeze-drying powder-injection of any embodiment according to a first aspect of the present invention, wherein The cillin bottle transmission belt continuous synchronization provides 2~4 column cillin bottles, and to enter drencher filling and before filling the container to carry out medical fluid Visible foreign matters inspection is carried out to cillin bottle afterwards.In production, cillin bottle transmission belt continuous synchronization provides 2~4 column cillin bottles and enters Drencher is feasible so that it is filling to carry out medical fluid, although generally two column cillin bottles of continuous synchronization offer enter drencher It is preferred.
The online quality inspection device of the freeze-drying powder-injection of any embodiment according to a first aspect of the present invention, wherein The direction of the cillin bottle transmission belt transmission cillin bottle is vertical with the direction that the rejecting mechanism rejects cillin bottle.It rejects in this way It will not influence the normal cillin bottle of forward and backward operation in cillin bottle transmission belt when cillin bottle is rejected by mechanism.Certainly, when cillin bottle passes When two column cillin bottles of defeated band continuous synchronization offer enter drencher position, direction is rejected to reject to the outside of two column cillin bottles To be preferred, another cillin bottle of synchronous transfer thus will not influence.It is the online quality inspection device of the present invention as shown in Figure 2 Part body schematic cross-section, wherein thick black arrow is directed toward behind drawing paper and indicates that cillin bottle transmission belt transmits cillin bottle Direction, and four-headed arrow indicate rejecting mechanism traffic direction, show cillin bottle when needing to be removed to the right side of the figure Direction is rejected, and in the case, enters drencher position when arranging cillin bottle transmission belt continuous synchronization to provide two column cillin bottles When, the left side of another camera camera in Fig. 2 of same running position.This way it is possible to realize when needing to reject some XiLin It will not influence running other cillin bottles when bottle.
The online quality inspection device of the freeze-drying powder-injection of any embodiment according to a first aspect of the present invention, wherein Each column 2~20 empty cillin bottles that the drencher can continuously transmit on linkage production line simultaneously carry out medical fluid filling Dress.Such as each column continuously transmitted simultaneously on linkage production line 5~15 empty cillin bottles progress medical fluids are filling.With XiLin It is filling the same to carry out medical fluid that bottle transmission belt continuous synchronization 2~4 column cillin bottles of offer enter drencher, if this while filling The mode of dry cillin bottle is all design highly developed on current freeze-drying powder-injection production line, and is conducive to improve production Efficiency.In addition, cillin bottle cleaning, dry and arrangement are transferred to first camera station before the online quality inspection device of the present invention I.e. the cillin bottle of liquid drug is transmitting out the second phase after the online quality inspection device of design and the present invention before Design after machine station is all design highly developed on current freeze-drying powder-injection production line.
In the present invention, in the filling forward and backward monitoring for carrying out visible foreign matters of medical fluid, by camera be set to above cillin bottle into Row camera shooting ratio is more favorable in imaging from cillin bottle side, the reason is that, generally, such as vitroclastic, hair, fiber etc. Visible foreign matters would generally fall into the bottom of bottle in the cillin bottle of this station, be conducive to camera and arrest.
Term " visible foreign matters " has a well known meaning in the art, such as " Chinese Pharmacopoeia " version in 2015 four the " 0904 visible foreign matters inspection technique " section defined in, such as comprising: metal fillings, chips of glass, length be more than 2mm fiber, Maximum particle diameter is more than the block of 2mm, these visible foreign matters can be observed in empty bottle, in the filling cillin bottle of medical fluid In, sometimes it can also be observed that standing macroscopic smoke-like particulate deposit, Wu Faji when gently rotating after a certain period of time Several Particle Swarms shakes not scattered precipitating, and the protein floes etc. of more difficult counting at the appointed time.In the present invention, As long as observing that there are above-mentioned visible foreign matters in the cillin bottle of powder charge or non-powder charge, and rejecting signal can be issued by computer and is referred to It enables and is rejected.
Further second aspect of the present invention provides the method for carrying out online quality monitoring to freeze-drying powder-injection, should Method checks that the online quality monitoring is filled using visible foreign matters of the online quality inspection device to freeze-drying powder-injection It installs and is placed on linkage production line of the freeze-drying powder-injection before liquid drug and after liquid drug, and include:
Cillin bottle transmission belt, for the cillin bottle cleaned and dried to be transmitted through drencher and is subsequently entered subsequent Cillin bottle is jumped a queue process；
Drencher, liquid drug in each column sky cillin bottle for being continuously transmitted on linkage production line；
First camera is set to before the drencher, and with direction from up to down to connecting on linkage production line The continuous empty cillin bottle passed through is imaged；
Second camera is set to after the drencher, and with direction from up to down to connecting on linkage production line The cillin bottle of the continuous liquid drug passed through is imaged；
Backlight comprising two groups, first group of cillin bottle transmission belt lower section being set under first camera, second group of setting Below cillin bottle transmission belt under second camera, for providing the light source of camera shooting to by the cillin bottle under camera；
Computer, for acquiring and analyzing the image data from first camera and second camera and to there are visible foreign matters Cillin bottle feedback reject signal；
Rejecting mechanism, receives the rejecting signal of computer feedback and the cillin bottle that visible foreign matters will be present is rejected；
This method comprises the following steps:
(a) it will clean and dry cillin bottle go to drencher to carry out liquid drug and connects through the transmission of cillin bottle transmission belt Jump a queue process into subsequent cillin bottle；
(b) before cillin bottle reaches drencher, by first camera position, the first camera is with side from up to down It is imaged to the empty cillin bottle passed through, computer acquisition and analysis and judge the sky at the image data from first camera It whether there is visible foreign matters in cillin bottle, visible foreign matters if it exists, then computer is fed back to rejecting mechanism rejects signal with should There are the rejecting of the cillin bottle of visible foreign matters, visible foreign matters are then let pass the sky cillin bottle if it does not exist；
(c) drencher station is continued to there is no the empty cillin bottles of visible foreign matters, this station is to transmitting Liquid drug in empty cillin bottle；
(d) cillin bottle of liquid drug continues to progress through second camera position, and the second camera is with side from up to down It is imaged to the cillin bottle of medical fluid that is filling to what is passed through, the image data of computer acquisition and analysis from second camera is simultaneously Judge to whether there is visible foreign matters in the cillin bottle, if it exists visible foreign matters, then computer is fed back to rejecting mechanism rejects letter Number to reject the cillin bottle there are visible foreign matters, visible foreign matters are then let pass the sky cillin bottle if it does not exist；
(e) cillin bottle of filling medical fluid forward and backward is twice monitored simultaneously visible foreign matters therein by medical fluid is filling After display is qualified, into subsequent technique, to complete this online quality monitoring.
The side that online quality monitoring is carried out to freeze-drying powder-injection of any embodiment according to a second aspect of the present invention Method, in the online quality inspection device, the cillin bottle transmission belt is provided with an aperture in the position being located at below cillin bottle, So that the light from backlight enters cillin bottle.Generally cillin bottle transmission belt is made of stainless steel material, can not light transmission, Therefore the aperture is arranged to be necessary.
The side that online quality monitoring is carried out to freeze-drying powder-injection of any embodiment according to a second aspect of the present invention Method, in the online quality inspection device, the cillin bottle transmission belt is provided with aperture in the position being located at below cillin bottle, with The light from backlight is set to enter cillin bottle, it is 0.5~0.9:1 that the diameter of the aperture, which is with the diameter of cillin bottle bottle body ratio,. The aperture of setting too small should not also should not be too large, too small to be not enough to through enough light, will affect when too big cillin bottle it is upright when Stability.
The side that online quality monitoring is carried out to freeze-drying powder-injection of any embodiment according to a second aspect of the present invention Method, in the online quality inspection device, the cillin bottle transmission belt is provided with aperture in the position being located at below cillin bottle, with The light from backlight is set to enter cillin bottle, it is 0.6~0.9:1 that the diameter of the aperture, which is with the diameter of cillin bottle bottle body ratio,.
The side that online quality monitoring is carried out to freeze-drying powder-injection of any embodiment according to a second aspect of the present invention Method, in the online quality inspection device, the cillin bottle transmission belt is provided with aperture in the position being located at below cillin bottle, with The light from backlight is set to enter cillin bottle, it is 0.7~0.9:1 that the diameter of the aperture, which is with the diameter of cillin bottle bottle body ratio,.
The side that online quality monitoring is carried out to freeze-drying powder-injection of any embodiment according to a second aspect of the present invention Method, in the online quality inspection device, the cillin bottle transmission belt continuously provide a column cillin bottle enter drencher with into Row medical fluid is filling and carries out visible foreign matters inspection to cillin bottle afterwards before filling the container.At this point, first camera and second camera difference are only One camera is set.
The side that online quality monitoring is carried out to freeze-drying powder-injection of any embodiment according to a second aspect of the present invention Method, in the online quality inspection device, the cillin bottle transmission belt continuous synchronization provides two column cillin bottles and enters drencher With carry out medical fluid it is filling and before filling the container afterwards to cillin bottle carry out visible foreign matters inspection.At this point, first camera and second camera point Do not need to be arranged two cameras, as shown in Fig. 1 of the present invention.The columns and camera of cillin bottle transmission belt continuous synchronization offer cillin bottle Setting quantity analogize with this.
The side that online quality monitoring is carried out to freeze-drying powder-injection of any embodiment according to a second aspect of the present invention Method, in the online quality inspection device, the cillin bottle transmission belt continuous synchronization provides 2~4 column cillin bottles and enters perfusion dress Set with carry out medical fluid it is filling and before filling the container afterwards to cillin bottle carry out visible foreign matters inspection.In production, cillin bottle transmission belt connects Continuous to simultaneously provide 2~4 column cillin bottles to enter drencher so that it is filling to carry out medical fluid be feasible, although generally continuous synchronization It is preferred for providing two column cillin bottles to enter drencher.
The side that online quality monitoring is carried out to freeze-drying powder-injection of any embodiment according to a second aspect of the present invention Method, in the online quality inspection device, the direction of the cillin bottle transmission belt transmission cillin bottle will be western with the rejecting mechanism The direction that woods bottle is rejected is vertical.It will not influence forward and backward operation in cillin bottle transmission belt when rejecting mechanism rejects cillin bottle in this way Normal cillin bottle.Certainly, it when cillin bottle transmission belt continuous synchronization, which provides two column cillin bottles, enters drencher position, rejects Direction with to the outside of two column cillin bottles reject be it is preferred, thus will not influence another cillin bottle of synchronous transfer.Such as Fig. 2 Shown is online quality inspection device part body schematic cross-section of the invention, wherein thick black arrow is directed toward behind drawing paper And indicate the direction of cillin bottle transmission belt transmission cillin bottle, and four-headed arrow indicates the traffic direction of rejecting mechanism, shows XiLin Bottle is rejected when needing to be removed to the right direction of the figure, in the case, when arrangement cillin bottle transmission belt continuous synchronization mentions When entering drencher position for two column cillin bottles, the left side of another camera camera in Fig. 2 of same running position.In this way, It can realize and will not influence running other cillin bottles when needing to reject some cillin bottle.
The side that online quality monitoring is carried out to freeze-drying powder-injection of any embodiment according to a second aspect of the present invention Method, in the online quality inspection device, the drencher can continuously transmit on linkage production line every simultaneously It is filling that column 2~20 empty cillin bottles carry out medical fluid.Such as each column 5~15 continuously transmitted simultaneously on linkage production line It is filling that empty cillin bottle carries out medical fluid.2~4 column cillin bottles, which are provided, with cillin bottle transmission belt continuous synchronization enters drencher to carry out Medical fluid is filling the same, the mode of this while filling several cillin bottles be all on current freeze-drying powder-injection production line very at Ripe design, and be conducive to improve production efficiency.In addition, cillin bottle cleans, is dry before the online quality inspection device of the present invention Design and the online quality inspection device of the present invention dry and arrange before being transferred to first camera station have filled later Design of the cillin bottle of powder charge liquid after transmitting out second camera station is all non-on current freeze-drying powder-injection production line Often mature design.
Any technical characteristic possessed by any embodiment of the application either side or the either side is equally applicable Any embodiment of other any embodiments or other either sides, as long as they will not be conflicting, certainly mutual Between where applicable, if necessary can individual features be made with appropriate modification.Make to various aspects of the present invention with feature into one below The description of step.
All documents recited in the application, their full content are incorporated herein by reference, and if these are literary Offer expressed meaning and the application it is inconsistent when, be subject to the statement of the application.In addition, various terms used in this application and Phrase has that well known to a person skilled in the art general senses, nonetheless, the application remain desirable at this to these terms and Phrase is described in more detail and explains, the term and phrase referred to is if any inconsistent with common art-recognized meanings, with the application institute table Subject to the meaning stated.
By the method for the invention, can obtain following either side or many aspects the utility model has the advantages that
1, asking for the invisible foreign matter wrapped up in freeze-dried powder can not be detected by effectively preventing artificial lamp inspection, full automatic lamp detecting machine Topic, improves the quality of product, while effectively reducing the complaint of the problems of pharmaceutical producing enterprise, reduces enterprise's spending, mentions Rise goodwill.
2, speed 0-600 bottles/minute of detection is adjustable, matches speed of production, and on-line checking shortens life cycle of the product.
3, can effectively in freeze-drying powder-injection there may be or introduce visible foreign matters detected with monitor The quality of product.
4, can to the visible foreign matters of freeze drying powder injection carry out in advance, online, the quality monitoring of bulk sample sheet.
Detailed description of the invention
Fig. 1 depicts the present invention and one embodiment of online quality inspection device of dry powder-injection is lyophilized in the assembled state Schematic diagram.
The part body that Fig. 2 depicts one embodiment of online quality inspection device that dry powder-injection is lyophilized in the present invention is cut Face schematic diagram.
Fig. 3 is the overhaul flow chart that cillin bottle visible foreign matters are monitored online.
Specific embodiment
The present invention can be further described by the following examples, however, the scope of the present invention and unlimited In following embodiments.One of skill in the art, can be with it is understood that under the premise of without departing substantially from the spirit and scope of the present invention Various change and modification are carried out to the present invention.The present invention carries out the material and test method arrived used in test general And/or specific description.Although to realize the present invention many materials and operating method used in purpose be it is known in the art that But the present invention is still described in this detail as much as possible.
The various embodiments of detailed description of the present invention with reference to the accompanying drawings.
Fig. 1 depicts the present invention and one embodiment of online quality inspection device of dry powder-injection is lyophilized in the assembled state Schematic diagram.Fig. 2 depicts the part body that one embodiment of online quality inspection device of dry powder-injection is lyophilized in the present invention Schematic cross-section.
As shown in Figure 1, the device is for checking the visible foreign matters of freeze-drying powder-injection, which is set to cold It is lyophilized on linkage production line of the dry powder-injection before liquid drug and after liquid drug, and includes:
Cillin bottle transmission belt 1, after the cillin bottle cleaned and dried 7 is transmitted through drencher 3 and is subsequently entered Continuous cillin bottle is jumped a queue process；
Drencher 3, liquid drug in each column sky cillin bottle 7 for being continuously transmitted on linkage production line；
First camera 2 is set to before the drencher 3, and with direction from up to down on linkage production line The empty cillin bottle 7 continued through is imaged；
Second camera 4 is set to after the drencher 3, and with direction from up to down on linkage production line The cillin bottle 7 of the liquid drug continued through is imaged；
Backlight 6 comprising two groups, first group of 1 lower section of cillin bottle transmission belt being set under first camera 2, second group It is set to 1 lower section of cillin bottle transmission belt under second camera 4, for providing the light of camera shooting to by the cillin bottle 7 under camera Source；
Computer 5, for acquiring and analyzing the image data from first camera 2 and second camera 4 and to there are visible The cillin bottle feedback of foreign matter rejects signal；
Rejecting mechanism 8, receives the rejecting signal of the feedback of computer 5 and the cillin bottle that visible foreign matters will be present is rejected.
Above-mentioned various mechanisms or device can be readily on being fixed on column that is original or newly setting up, and example is as shown in figure 1 Column for components such as fixed camera and backlights.
In an embodiment of the online quality inspection device of freeze-drying powder-injection of the present invention, wherein described XiLin Bottle transmission belt 1 is provided with an aperture 10 in the position being located at below cillin bottle 7, so that the light from backlight 6 enters cillin bottle 7.Generally cillin bottle transmission belt 1 is made of stainless steel material, can not light transmission, therefore be arranged the aperture 10 be it is necessary to 's.
In an embodiment of the online quality inspection device of freeze-drying powder-injection of the present invention, wherein described XiLin Bottle transmission belt 1 is provided with aperture 10 in the position being located at below cillin bottle 7, so that the light from backlight 6 enters cillin bottle 7, It is 0.5~0.9:1 that the diameter of the aperture 10, which is with the diameter of cillin bottle bottle body ratio,.The aperture 10 of setting is unsuitable too small also unsuitable It is excessive, too it is small be not enough to be will affect when too big through enough light cillin bottle it is upright when stability.
In an embodiment of the online quality inspection device of freeze-drying powder-injection of the present invention, wherein described XiLin Bottle transmission belt 1 is provided with aperture 10 in the position being located at below cillin bottle 7, so that the light from backlight 6 enters cillin bottle 7, It is 0.6~0.9:1 that the diameter of the aperture 10, which is with the diameter of cillin bottle bottle body ratio,.
In an embodiment of the online quality inspection device of freeze-drying powder-injection of the present invention, wherein described XiLin Bottle transmission belt 1 is provided with aperture 10 in the position being located at below cillin bottle 7, so that the light from backlight 6 enters cillin bottle 7, It is 0.7~0.9:1 that the diameter of the aperture 10, which is with the diameter of cillin bottle bottle body ratio,.
In an embodiment of the online quality inspection device of freeze-drying powder-injection of the present invention, wherein described XiLin Bottle transmission belt 1 continuously provide a column cillin bottle enter drencher 3 with carry out medical fluid it is filling and before filling the container afterwards to cillin bottle into Row visible foreign matters inspection.At this point, as long as a camera is arranged in first camera 2 and second camera 4 respectively.
In an embodiment of the online quality inspection device of freeze-drying powder-injection of the present invention, wherein described XiLin Bottle 1 continuous synchronization of transmission belt provides two column cillin bottles, and to enter drencher 3 filling and before filling the container afterwards to XiLin to carry out medical fluid Bottle carries out visible foreign matters inspection.At this point, first camera 2 and second camera 4 are respectively necessary for two cameras of setting, such as Fig. 1 of the present invention It is shown.The setting quantity of columns and camera that 1 continuous synchronization of cillin bottle transmission belt provides cillin bottle is analogized with this.
In an embodiment of the online quality inspection device of freeze-drying powder-injection of the present invention, wherein described XiLin Bottle 1 continuous synchronization of transmission belt provides 2~4 column cillin bottles, and to enter drencher 3 filling and before filling the container afterwards to west to carry out medical fluid Woods bottle carries out visible foreign matters inspection.In production, 1 continuous synchronization of cillin bottle transmission belt provides 2~4 column cillin bottles and enters perfusion dress It is feasible that 3, which are set, so that it is filling to carry out medical fluid, although it is excellent that generally continuous synchronization, which provides two column cillin bottles to enter drencher, Choosing.
In an embodiment of the online quality inspection device of freeze-drying powder-injection of the present invention, wherein described XiLin The direction that bottle transmission belt 1 transmits cillin bottle 7 is vertical with the direction that the rejecting mechanism 8 rejects cillin bottle 7.Such rejecting mechanism 8 will not influence the normal cillin bottle of forward and backward operation in cillin bottle transmission belt 1 when rejecting cillin bottle 7.Certainly, when cillin bottle passes When defeated 1 continuous synchronization of band provides two column cillin bottles and enters 3 position of drencher, direction is rejected with to picking on the outside of two column cillin bottles Except be preferably, thus will not influence another cillin bottle of synchronous transfer.It is online quality monitoring dress of the invention as shown in Figure 2 Part body schematic cross-section is set, wherein thick black arrow is directed toward behind drawing paper and indicates that cillin bottle transmission belt 1 transmits west The direction of woods bottle 7, and four-headed arrow indicates the traffic direction of rejecting mechanism 8, shows cillin bottle 7 when needing to be removed to the figure Right direction reject, in the case, when arrange 1 continuous synchronization of cillin bottle transmission belt provide two column cillin bottles enter perfusion dress When setting 3 position, the left side of another camera camera in Fig. 2 of same running position.This way it is possible to realize when needing to reject certain It will not influence running other cillin bottles when a cillin bottle.
In an embodiment of the online quality inspection device of freeze-drying powder-injection of the present invention, wherein the perfusion It is filling that each column 2~20 empty cillin bottles 7 that device 3 can continuously transmit on linkage production line simultaneously carry out medical fluid.Example Each column 5~15 empty progress of cillin bottles 7 medical fluids as continuously transmitted simultaneously on linkage production line are filling.It is passed with cillin bottle It is filling the same to carry out medical fluid that 2~4 column cillin bottles of defeated 1 continuous synchronization of band offer enter drencher 3, this while filling several The mode of cillin bottle is all design highly developed on current freeze-drying powder-injection production line, and is conducive to improve production effect Rate.In addition, cillin bottle cleaning, dry and arrangement are transferred to 2 station of first camera before the online quality inspection device of the present invention I.e. the cillin bottle of liquid drug is transmitting out the second phase after the online quality inspection device of design and the present invention before Design after 4 station of machine is all design highly developed on current freeze-drying powder-injection production line.
In the present invention, in the filling forward and backward monitoring for carrying out visible foreign matters of medical fluid, by camera be set to above cillin bottle into Row camera shooting ratio is more favorable in imaging from cillin bottle side, the reason is that, generally, such as vitroclastic, hair, fiber etc. Visible foreign matters would generally fall into the bottom of bottle in the cillin bottle of this station, be conducive to camera and arrest.
Term " visible foreign matters " has a well known meaning in the art, such as " Chinese Pharmacopoeia " version in 2015 four the " 0904 visible foreign matters inspection technique " section defined in, such as comprising: metal fillings, chips of glass, length be more than 2mm fiber, Maximum particle diameter is more than the block of 2mm, these visible foreign matters can be observed in empty bottle, in the filling cillin bottle of medical fluid In, sometimes it can also be observed that standing macroscopic smoke-like particulate deposit, Wu Faji when gently rotating after a certain period of time Several Particle Swarms shakes not scattered precipitating, and the protein floes etc. of more difficult counting at the appointed time.In the present invention, As long as observing that there are above-mentioned visible foreign matters in the cillin bottle of powder charge or non-powder charge, and rejecting signal can be issued by computer and is referred to It enables and will reject altogether.
Describe making for the device of the invention that online quality monitoring is carried out to freeze-drying powder-injection below with reference to Fig. 1 and Fig. 2 Use mode.The visible foreign matters of freeze-drying powder-injection are checked using online quality inspection device of the invention, it is described online Quality inspection device is set on linkage production line of the freeze-drying powder-injection before liquid drug and after liquid drug, and is wrapped It includes:
Cillin bottle transmission belt 1, after the cillin bottle cleaned and dried 7 is transmitted through drencher 3 and is subsequently entered Continuous cillin bottle is jumped a queue process；
Drencher 3, liquid drug in each column sky cillin bottle 7 for being continuously transmitted on linkage production line；
First camera 2 is set to before the drencher 3, and with direction from up to down on linkage production line The empty cillin bottle 7 continued through is imaged；
Second camera 4 is set to after the drencher 3, and with direction from up to down on linkage production line The cillin bottle 7 of the liquid drug continued through is imaged；
Backlight 6 comprising two groups, first group of 1 lower section of cillin bottle transmission belt being set under first camera 2, second group It is set to 1 lower section of cillin bottle transmission belt under second camera 4, for providing the light of camera shooting to by the cillin bottle 7 under camera Source；
Computer 5, for acquiring and analyzing the image data from first camera 2 and second camera 4 and to there are visible The cillin bottle feedback of foreign matter rejects signal；
Rejecting mechanism 8, receives the rejecting signal of the feedback of computer 5 and the cillin bottle that visible foreign matters will be present is rejected；
This method comprises the following steps:
(a) it will clean and dry cillin bottle 7 transmits through cillin bottle transmission belt 1 and drencher 3 is gone to carry out liquid drug And it subsequently enters subsequent cillin bottle and jumps a queue process；
(b) before cillin bottle 7 reaches drencher 3, by 2 position of first camera, the first camera 2 is with from up to down Direction the empty cillin bottle 7 passed through is imaged, the acquisition of computer 5 and analysis and are sentenced the image data from first camera 2 Break in the empty cillin bottle 7 with the presence or absence of visible foreign matters, if it exists visible foreign matters, then computer 5 feeds back to rejecting mechanism 8 and rejects Signal is to reject the cillin bottle there are visible foreign matters, and visible foreign matters are then let pass the sky cillin bottle if it does not exist；
(c) there is no the empty cillin bottles 7 of visible foreign matters to continue to 3 station of drencher, this station is to transmitting Empty cillin bottle 7 in liquid drug；
(d) cillin bottle of liquid drug continues to progress through 4 position of second camera, and the second camera 4 is with from up to down The cillin bottle 7 of direction medical fluid filling to what is passed through images, the image of the acquisition of computer 5 and analysis from second camera 4 Data simultaneously judge in the cillin bottle 7 with the presence or absence of visible foreign matters, if it exists visible foreign matters, then computer 5 is anti-to rejecting mechanism 8 Feedback rejects signal to reject the cillin bottle there are visible foreign matters, and visible foreign matters are then let pass the sky cillin bottle if it does not exist；
(e) cillin bottle 7 of filling medical fluid forward and backward is twice monitored simultaneously visible foreign matters therein by medical fluid is filling After display is qualified, into subsequent technique, to complete this online quality monitoring.
In an embodiment for carrying out the method for online quality monitoring to freeze-drying powder-injection in the present invention, it is described In line mass monitoring device, the cillin bottle transmission belt 1 is provided with an aperture 10 in the position being located at below cillin bottle 7, so that Light from backlight 6 enters cillin bottle 7.Generally cillin bottle transmission belt 1 is made of stainless steel material, can not light transmission, Therefore the aperture 10 is arranged to be necessary.
In an embodiment for carrying out the method for online quality monitoring to freeze-drying powder-injection in the present invention, it is described In line mass monitoring device, the cillin bottle transmission belt 1 is provided with aperture 10 in the position being located at below cillin bottle 7, so as to come Enter cillin bottle 7 from the light of backlight 6, it is 0.5~0.9:1 that the diameter of the aperture 10, which is with the diameter of cillin bottle bottle body ratio,. The aperture 10 of setting too small should not also should not be too large, too small to be not enough to that it is upright to will affect cillin bottle when too big through enough light When stability.
In an embodiment for carrying out the method for online quality monitoring to freeze-drying powder-injection in the present invention, it is described In line mass monitoring device, the cillin bottle transmission belt 1 is provided with aperture 10 in the position being located at below cillin bottle 7, so as to come Enter cillin bottle 7 from the light of backlight 6, it is 0.6~0.9:1 that the diameter of the aperture 10, which is with the diameter of cillin bottle bottle body ratio,.
In an embodiment for carrying out the method for online quality monitoring to freeze-drying powder-injection in the present invention, it is described In line mass monitoring device, the cillin bottle transmission belt 1 is provided with aperture 10 in the position being located at below cillin bottle 7, so as to come Enter cillin bottle 7 from the light of backlight 6, it is 0.7~0.9:1 that the diameter of the aperture 10, which is with the diameter of cillin bottle bottle body ratio,.
In an embodiment for carrying out the method for online quality monitoring to freeze-drying powder-injection in the present invention, it is described In line mass monitoring device, the cillin bottle transmission belt 1 continuously provides a column cillin bottle and enters drencher 3 to carry out medical fluid filling It fills and visible foreign matters inspection is carried out to cillin bottle afterwards before filling the container.At this point, as long as first camera 2 and second camera 4 are arranged respectively One camera.
In an embodiment for carrying out the method for online quality monitoring to freeze-drying powder-injection in the present invention, it is described In line mass monitoring device, 1 continuous synchronization of cillin bottle transmission belt provides two column cillin bottles and enters drencher 3 to carry out medicine Liquid is filling and carries out visible foreign matters inspection to cillin bottle afterwards before filling the container.At this point, first camera 2 and second camera 4 are respectively necessary for Two cameras are set, as shown in Fig. 1 of the present invention.1 continuous synchronization of cillin bottle transmission belt provides the columns of cillin bottle and setting for camera Quantity is set to analogize with this.
In an embodiment for carrying out the method for online quality monitoring to freeze-drying powder-injection in the present invention, it is described In line mass monitoring device, 1 continuous synchronization of cillin bottle transmission belt provides 2~4 column cillin bottles and enters drencher 3 to carry out Medical fluid is filling and carries out visible foreign matters inspection to cillin bottle afterwards before filling the container.In production, 1 continuous synchronization of cillin bottle transmission belt is mentioned It is feasible for entering drencher 3 for 2~4 column cillin bottles so that it is filling to carry out medical fluid, although generally continuous synchronization provides two It is preferred that column cillin bottle, which enters drencher,.
In an embodiment for carrying out the method for online quality monitoring to freeze-drying powder-injection in the present invention, it is described In line mass monitoring device, cillin bottle 7 is picked with the rejecting mechanism 8 in the direction that the cillin bottle transmission belt 1 transmits cillin bottle 7 The direction removed is vertical.It will not influence in cillin bottle transmission belt 1 forward and backward operation when rejecting mechanism 8 rejects cillin bottle 7 so just Normal cillin bottle.Certainly, when 1 continuous synchronization of cillin bottle transmission belt, which provides two column cillin bottles, enters 3 position of drencher, rejecting side To with to the outside of two column cillin bottles reject be it is preferred, thus will not influence another cillin bottle of synchronous transfer.Such as Fig. 2 institute Show it is online quality inspection device part body schematic cross-section of the invention, wherein thick black arrow is directed toward behind drawing paper simultaneously Indicate that cillin bottle transmission belt 1 transmits the direction of cillin bottle 7, and four-headed arrow indicates the traffic direction of rejecting mechanism 8, shows XiLin Bottle 7 is rejected when needing to be removed to the right direction of the figure, in the case, when arrangement 1 continuous synchronization of cillin bottle transmission belt When two column cillin bottles being provided entering 3 position of drencher, the left side of another camera camera in Fig. 2 of same running position.This Sample, so that it may which realization will not influence running other cillin bottles when needing to reject some cillin bottle.
In an embodiment for carrying out the method for online quality monitoring to freeze-drying powder-injection in the present invention, it is described In line mass monitoring device, the drencher 3 can simultaneously continuously transmit on linkage production line each column 2~20 It is filling that empty cillin bottle 7 carries out medical fluid.Such as each column continuously transmitted simultaneously on linkage production line 5~15 empty cillin bottles 7 progress medical fluids are filling.2~4 column cillin bottles, which are provided, with 1 continuous synchronization of cillin bottle transmission belt enters drencher 3 to carry out medical fluid Filling the same, the mode of this while filling several cillin bottles is all highly developed on current freeze-drying powder-injection production line Design, and be conducive to improve production efficiency.In addition, cillin bottle cleaning before the online quality inspection device of the present invention, it is dry with And arrangement be transferred to 2 station of first camera before design and the online quality inspection device of the present invention after it is i.e. filling Design of the cillin bottle of medical fluid after transmitting out 4 station of second camera is all non-on current freeze-drying powder-injection production line Often mature design.
In addition, being imaged to cillin bottle in order to describe in more detail the method for the present invention and analyzing that wherein no there are visible The entire program for whether rejecting judged cillin bottle made in turn for foreign matter, and this application provides Fig. 3 about visible to cillin bottle The overhaul flow chart that foreign matter is monitored online.It is shown in Fig. 3, when cillin bottle reaches below camera, photoelectricity triggering, camera is adopted Scheme, light source stroboscopic, the inspection software analysis picture in computer, and qualification is judged whether to cillin bottle, is picked if unqualified Except the bottle and next bottle is waited, qualified bottle carries out subsequent work stations if qualified, and camera waits next bottle, Camera receives otherwise to continue to detect if so, then stopping to examine about whether the instruction for stopping inspection from computer at any time.The detection Flow chart is suitable for first camera and second camera.Further, in the methods of the invention, first camera is in empty cillin bottle Visible foreign matters can be easy and accurate detection, such as the present inventor carries out visible foreign matters in the cillin bottle to 100,000 or more Detection when do not occurred the result of false positive or false negative.But to second camera for filling colorless and transparent medicine When visible foreign matters in the cillin bottle of liquid carry out visible foreign matters inspection, but often there are false positive results, to 10,000 or more False positive probability is up to 23 or more percent when powder charge cillin bottle carries out visible foreign matters inspection, and false sun is presented to these at this time Property result powder charge cillin bottle taking-up when being detected with official method, find and there is no meet the visible different of pharmacopoeial definitions Object.The present inventor has had now surprisingly been found that, as shown in Fig. 2, being located under cillin bottle transmission belt 1 when in 4 position of second camera One piece of glass plano-convex lens 9 and convex surface are arranged downward between 6 top in side and backlight, and the diameter on convex surface is cillin bottle transmission belt 1 On one. five to two point 5 times of 10 diameter of aperture, and the focal length of the glass plano-convex lens is 15 to 30 centimetres for example burnt When away from being 15 to 25 centimetres, find do not occur when the cillin bottle to 100,000 or more carries out the detection of visible foreign matters The result of false positive or false negative.This phenomenon is that the prior art is never instructed.Therefore, in either side of the present invention In any one embodiment, in 4 position of second camera, above 1 lower section of cillin bottle transmission belt and backlight 6 between be arranged One piece of glass plano-convex lens 9 and convex surface is downward, the diameter on convex surface be 10 diameter of aperture in cillin bottle transmission belt 1 one point five to 2 points 5 times, and it is 15 to 25 centimetres that the focal length of the glass plano-convex lens, which is 15 to 30 centimetres of such as focal lengths,.? It is always the problem for perplexing the producer, manager to the control of visible foreign matters in freeze-dried powder in this field.Powder needle system Common visible foreign matters mainly have vitroclastic, hair, fiber etc. in agent, are the major hidden dangers for influencing product quality.Current detection Method is divided into artificial lamp inspection and large-scale vision automatic lamp-checking machine testing, artificial lamp inspection low efficiency, vulnerable to individual criteria influences not Controllably, cause to detect of poor quality；Automatic lamp-checking machine is limited to powder-injection specifically jelly type, to freeze-drying after wrap it is different Object can not detect, and there is also certain risks.The present invention provides a kind of completely new automatic detection schemes, to detect in vial Visible foreign matters the station detected twice accordingly is increased, to sky on the canning line after wash bottle using machine vision principle Cillin bottle and cillin bottle comprising liquid carry out real-time online detection before freeze-drying, and to the defect sample that detected Automatically kick and remove, so that excluding the later period is lyophilized into the risk for retaining invisible foreign matter after powder, ensure drug quality and medication peace Entirely.
As it can be seen that the present invention uses machine vision principle, automatic rejection defect sample, desin speed up to 600 bottles/minute, And uninterrupted detection, detection efficiency are high.It, can be in real time to bottle under the premise of filling production lines do not influence drug quality simultaneously Interior visible foreign matters are detected, effectively promotion recall rate, after avoiding the later period from being lyophilized into powder caused by foreign matter it is invisible by package Risk.Using the method for the present invention, vitroclastic, hair, fiber defect can all be detected, and detection foreign matter range is wide.Present system knot Structure is compact, using modularized design, is suitable for different canning lines.The present invention is according to machine vision principle, using high-speed industrial Camera is imaged, passes industrial computer back to acquisition sequence image in the vial on canning line, and by image, after testing software Digital Image Processing and analysis are carried out to realtime graphic, judged whether comprising visible foreign matters in current bottle, it can if judging See foreign matter, then by computer control issue kick useless action command, then kick exhaust gas cylinder and take corresponding movement, will test containing The bottle of foreign matter weeds out, and qualified product then passes through transmission and is brought into next process.
Detection scheme of the present invention includes two detection stations: before filling, it is canned after, each detection station configurable one It is a, two, or more the columns of filling vial (quantity depend on) industrial camera be fixed on above bottle, camera is from bottleneck It is shot to bottom of bottle direction, a white light source is respectively configured below bottom of bottle, irradiated from bottom of bottle to camera direction, as shown in Figure 2. It,, can be to chips of glass, fiber, the hair in bottom of bottle after camera collects sequence image without any liquid in bottle body before medical fluid is canned Foreign matter carries out software detection, judges whether qualification；After medical fluid is canned, the quantitative liquid poured into bottle body, fiber, hair are different Object can be swum on liquid level, while the big foreign matter of the chips of glass isodensity for being deposited on bottom of bottle can also take, and soft by detecting Part judges whether qualification.
In the description of the present invention, it is to be understood that, term " center ", " longitudinal direction ", " transverse direction ", " length ", " width ", " thickness ", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom" "inner", "outside", " up time The orientation or positional relationship of the instructions such as needle ", " counterclockwise ", " axial direction ", " radial direction ", " circumferential direction " be orientation based on the figure or Positional relationship is merely for convenience of description of the present invention and simplification of the description, rather than the device or element of indication or suggestion meaning must There must be specific orientation, be constructed and operated in a specific orientation, therefore be not considered as limiting the invention.
In addition, term " first ", " second " are used for descriptive purposes only and cannot be understood as indicating or suggesting relative importance Or implicitly indicate the quantity of indicated technical characteristic.Define " first " as a result, the feature of " second " can be expressed or Implicitly include one or more of the features.In the description of the present invention, the meaning of " plurality " is two or more, Unless otherwise specifically defined.
In the present invention unless specifically defined or limited otherwise, term " installation ", " connected ", " connection ", " fixation " etc. Term shall be understood in a broad sense, for example, it may be being fixedly connected, may be a detachable connection, or integral；It can be mechanical connect It connects, is also possible to be electrically connected；It can be directly connected, can also can be in two elements indirectly connected through an intermediary The interaction relationship of the connection in portion or two elements.It for the ordinary skill in the art, can be according to specific feelings Condition understands the concrete meaning of above-mentioned term in the present invention.
In the present invention unless specifically defined or limited otherwise, fisrt feature in the second feature " on " or " down " can be with It is that the first and second features directly contact or the first and second features pass through intermediary mediate contact.Moreover, fisrt feature exists Second feature " on ", " top " and " above " but fisrt feature be directly above or diagonally above the second feature, or be merely representative of First feature horizontal height is higher than second feature.Fisrt feature can be under the second feature " below ", " below " and " below " One feature is directly under or diagonally below the second feature, or is merely representative of first feature horizontal height less than second feature.
In the description of this specification, reference term " one embodiment ", " some embodiments ", " example ", " specifically show The description of example " or " some examples " etc. means specific features, structure, material or spy described in conjunction with this embodiment or example Point is included at least one embodiment or example of the invention.In the present specification, schematic expression of the above terms are not It must be directed to identical embodiment or example.Moreover, particular features, structures, materials, or characteristics described can be any It can be combined in any suitable manner in a or multiple embodiment or examples.In addition, without conflicting with each other, the technology of this field The feature of different embodiments or examples described in this specification and different embodiments or examples can be combined by personnel And combination.
Embodiment described above is only to absolutely prove preferred embodiment that is of the invention and being lifted, protection model of the invention It encloses without being limited thereto.Those skilled in the art's made equivalent substitute or transformation on the basis of the present invention, in the present invention Protection scope within.Protection scope of the present invention is subject to claims.

Claims (11)

1. the online quality inspection device of freeze-drying powder-injection, the device be used for the visible foreign matters of freeze-drying powder-injection into Row checks that the device is set on linkage production line of the freeze-drying powder-injection before liquid drug and after liquid drug, and Include:
Cillin bottle transmission belt, for the cillin bottle cleaned and dried to be transmitted through drencher and subsequently enters subsequent XiLin Bottle is jumped a queue process；
Drencher, liquid drug in each column sky cillin bottle for being continuously transmitted on linkage production line；
First camera is set to before the drencher, and with direction from up to down to continuously leading on linkage production line The empty cillin bottle crossed is imaged；
Second camera is set to after the drencher, and with direction from up to down to continuously leading on linkage production line The cillin bottle for the liquid drug crossed is imaged；
Backlight comprising two groups, below first group of cillin bottle transmission belt being set under first camera, second group is set to the Below cillin bottle transmission belt under two cameras, for providing the light source of camera shooting to by the cillin bottle under camera；
Computer, for acquiring and analyzing the image data from first camera and second camera and to there are the west of visible foreign matters Woods bottle feedback rejects signal；
Rejecting mechanism, receives the rejecting signal of computer feedback and the cillin bottle that visible foreign matters will be present is rejected,
Wherein,
The cillin bottle transmission belt is provided with aperture in the position being located at below cillin bottle, so that the light from backlight enters west Woods bottle, it is 0.5 ~ 0.9:1 that the diameter of the aperture, which is with the diameter of cillin bottle bottle body ratio,；
In second camera position, be located at below cillin bottle transmission belt and above backlight between be arranged one piece of glass plano-convex lens and Downward, the diameter on convex surface is 1.5 ~ 2.5 times of the hole diameter in cillin bottle transmission belt, and the coke of the glass plano-convex lens on convex surface Away from for 15 ~ 35cm.
2. the online quality inspection device of freeze-drying powder-injection according to claim 1, which is characterized in that the glass The focal length of plano-convex lens is 15 ~ 25cm.
3. the online quality inspection device of freeze-drying powder-injection according to claim 1, which is characterized in that described XiLin Bottle transmission belt is provided with aperture in the position being located at below cillin bottle, so that the light from backlight enters cillin bottle, it is described small It is 0.6 ~ 0.9:1 that the diameter in hole, which is with the diameter of cillin bottle bottle body ratio,.
4. the online quality inspection device of freeze-drying powder-injection according to claim 1, which is characterized in that described XiLin Bottle transmission belt is provided with aperture in the position being located at below cillin bottle, so that the light from backlight enters cillin bottle, it is described small It is 0.7 ~ 0.9:1 that the diameter in hole, which is with the diameter of cillin bottle bottle body ratio,.
5. the online quality inspection device of freeze-drying powder-injection according to claim 1, which is characterized in that described XiLin Bottle transmission belt continuously provide a column cillin bottle enter drencher with carry out medical fluid it is filling and before filling the container afterwards to cillin bottle carry out Visible foreign matters inspection.
6. the online quality inspection device of freeze-drying powder-injection according to claim 1, which is characterized in that described XiLin Bottle transmission belt continuous synchronization provides two column cillin bottles, and to enter drencher filling and before filling the container afterwards to cillin bottle to carry out medical fluid Carry out visible foreign matters inspection.
7. the online quality inspection device of freeze-drying powder-injection according to claim 1, which is characterized in that described XiLin Bottle transmission belt continuous synchronization provides 2 ~ 4 column cillin bottles, and to enter drencher filling and before filling the container afterwards to cillin bottle to carry out medical fluid Carry out visible foreign matters inspection.
8. the online quality inspection device of freeze-drying powder-injection according to claim 1, it is characterised in that: described XiLin The direction of bottle transmission belt transmission cillin bottle is vertical with the direction that the rejecting mechanism rejects cillin bottle.
9. the online quality inspection device of freeze-drying powder-injection according to claim 1, which is characterized in that the perfusion It is filling that each column 2 ~ 20 empty cillin bottles that device can continuously transmit on linkage production line simultaneously carry out medical fluid.
10. the online quality inspection device of freeze-drying powder-injection according to claim 1, which is characterized in that the filling It is filling that each column 5 ~ 15 empty cillin bottles that medicine device can continuously transmit on linkage production line simultaneously carry out medical fluid.
11. the method that pair freeze-drying powder-injection carries out online quality monitoring, this method is using online quality inspection device to cold The visible foreign matters that dry powder-injection is lyophilized are checked that the online quality inspection device is set to freeze-drying powder-injection filling On linkage production line before medical fluid and after liquid drug, and any one of the online quality inspection device such as claim 1 ~ 10 institute It states；This method comprises the following steps:
(a) will clean and dry cillin bottle through the transmission of cillin bottle transmission belt go to drencher carry out liquid drug and then into Enter subsequent cillin bottle to jump a queue process；
(b) before cillin bottle reaches drencher, by first camera position, the first camera is with direction pair from up to down By empty cillin bottle imaged, computer acquisition and image data of the analysis from first camera simultaneously judge described empty XiLin It whether there is visible foreign matters in bottle, visible foreign matters if it exists, then computer is fed back to rejecting mechanism rejects signal with by the presence The cillin bottles of visible foreign matters is rejected, and visible foreign matters are then let pass the sky cillin bottle if it does not exist；
(c) there is no the empty cillin bottles of visible foreign matters to continue to drencher station, this station is western to the sky transmitted Liquid drug in woods bottle；
(d) cillin bottle of liquid drug continues to progress through second camera position, and the second camera is with direction pair from up to down By the cillin bottle of filling medical fluid imaged, computer acquisition and image data of the analysis from second camera and judgement Whether there is visible foreign matters in the cillin bottle, visible foreign matters if it exists, then computer fed back to rejecting mechanism reject signal with The cillin bottle there are visible foreign matters is rejected, visible foreign matters are then let pass the sky cillin bottle if it does not exist；
(e) cillin bottle of filling medical fluid forward and backward be monitored and show to visible foreign matters therein twice by medical fluid is filling After qualification, into subsequent technique, to complete this online quality monitoring.
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