CN115594135A - Full-automatic robot filling system of GMP compliance - Google Patents

Abstract

The invention relates to the technical field of medicine preparation filling, in particular to a GMP (good manufacturing practice) compliant full-automatic robot filling system which comprises a loading frame, wherein a top laminar flow component is arranged on the upper side of the loading frame, a feeding cabin is arranged on the right side of the loading frame, a discharging cabin is arranged on the left side of the loading frame, a filling cabin is arranged on the loading frame and between the feeding cabin and the discharging cabin, a raw liquid cabin is arranged on the loading frame and on the right front side of the filling cabin, and a buffer cabin is arranged on the front side of the raw liquid cabin; the full process flow realizes full-automatic operation, including automatic material transfer, automatic consumable transfer, automatic detection, automatic liquid operation, automatic sterilization and residue discharge, automatic storage and processing of production data, and guarantees the continuity, repeatability and stability of the operation flow.

Description

Full-automatic robot filling system of GMP compliance

Technical Field

The invention relates to the technical field of medicine preparation filling, in particular to a full-automatic robot filling system with GMP (good manufacturing practice) compliance.

Background

The GMP-compliant filling ensures that various types of pharmaceutical preparations can be safely and effectively delivered to end users, and plays a vital role in ensuring the quality, efficiency and safety of the preparations. The filling operation is widely applied to the production processes of products such as biological vaccines, antibody preparations, protein preparations, blood products, micromolecular medicines, chemoradiotherapy preparations and the like. The filling process flow comprises the steps of feeding, consumable material transferring, preparation filling weighing (weighing and waste removing), bottle body glue pressing plug sealing, cover rolling, finished product boxing, product blanking and the like. The new regulations of the regulatory agency supervise the filling equipment and the filling process more strictly, and the traditional filling equipment and the traditional filling process are easy to have risks under the background, so that the products are scrapped, and the loss in various aspects such as manpower, material resources, products, production period and the like is brought. The rapid development of various types of preparation products, CM0/CDMO enterprises need to switch between different products rapidly, new requirements are brought to the rapid switching of production systems between different products, and new high-flexibility production modes are needed.

In the conventional filling system, the external operation of personnel occupies a very important position. Personnel are the largest source of contamination in filling, and it is therefore becoming imperative to minimize personnel involvement in the filling process, and it is in this context that fully automated isolator-type filling equipment is being introduced.

The traditional filling system operation process needs a lot of manual operations to completely execute the whole process steps, and the operation state of the equipment needs to be monitored at any time by arranging hands to stand on a fixed station at any time to supplement materials, so that a production party needs to store a batch of technical personnel trained professionally, the capital and the manpower are consumed, and the cost of a final product is increased invisibly. The variation of the operator brings a great risk to the quality of the product.

Traditional filling system is under the mode of operation, and the most consumptive material that need carry out the filling all is direct and outside air contact, or utilizes the vibration dish or the material loading mode of carousel to supply the material, and the artifical material that supplies that needs during, the in-process brings the suspended particles into, greatly increased like this the pollution probability of consumptive material, the material loading mode also produces microbial contamination easily.

The general operating accuracy of traditional filling system is not high, and the error can't effective control in less scope, like this to the preparation that the high requirement of filling accuracy, can't realize the functional requirement.

In the aseptic filling process of the traditional filling system, cleaning, disinfection and sterilization are carried out at intervals. Many container assemblies all are external parts, need disassemble respectively and wash, disinfect, assemble together again, and there is the risk of pollution in each link.

Most of the traditional filling systems are specially designed for fixed products, and when the products are changed, the whole system can be abandoned, so that a large amount of fixed asset investment is wasted. Part filling system can switch between limited product type, and nevertheless spare part changes the flow complicacy loaded down with trivial details, changes the cycle length, needs special verification and aassessment work after changing, consequently needs a full-automatic robot filling system of GMP compliance to make improvement to above-mentioned problem.

Disclosure of Invention

The invention aims to provide a full-automatic robot filling system in GMP compliance to solve the problems in the background art.

In order to achieve the purpose, the invention provides the following technical scheme:

a GMP (good manufacturing practice) compliant full-automatic robot filling system comprises a loading frame, wherein a top laminar flow assembly is arranged on the upper side of the loading frame, a feeding cabin is arranged on the right side of the loading frame, a discharging cabin is arranged on the left side of the loading frame, a filling cabin is arranged on the loading frame and between the feeding cabin and the discharging cabin, a raw liquid cabin is arranged on the right front side of the loading frame and on the filling cabin, and a cache cabin is arranged on the front side of the raw liquid cabin;

the front side and the rear side of the loading frame are provided with air return pipelines corresponding to the feeding cabin, the discharging cabin and the filling cabin;

a distribution board is arranged on the loading frame and on the lower left side of the filling cabin, a waste collection box is arranged on the loading frame and on the lower right side of the filling cabin, a static pressure cabin is arranged on the upper side of the filling cabin, a cabin sealing automatic door is arranged on the left side of the filling cabin, an empty box buffer position is arranged on the front right side of the inside of the filling cabin, a rubber plug buffer position is arranged on the left side of the empty box buffer position inside the filling cabin, a first manipulator is arranged on the rear side of the empty box buffer position inside the filling cabin, a heating assembly is arranged behind the first manipulator, a water washing water inlet is arranged on the left rear side of the inside of the filling cabin and behind the rubber plug buffer position, a rubber plug pressing seat is arranged on the left rear side of the inside of the filling cabin and on the left rear side of the rubber plug buffer position, a second manipulator is arranged on the right side of the rubber plug pressing seat, a folding manipulator is arranged behind the second manipulator, a third manipulator is arranged on the right side of the folding conveyor line, an environment monitor is arranged on the right side of the third manipulator, and a water washing conveyor line is arranged in front of the folding conveyor line;

the bottom plate of the filling cabin is provided with a CIP drainage slope, the bottom plate of the filling cabin is correspondingly provided with a CIP main drainage port on the left and the right, a drainage pipe is arranged on the bottom plate of the filling cabin through the CIP main drainage port, an electric butterfly valve is arranged on the drainage pipe on the left side, a check valve is arranged on the drainage pipe on the right side, a spring water pipe is arranged on the bottom plate of the filling cabin corresponding to the drainage pipe, a water inlet pipe is arranged on the side surface, located on the drainage pipe, of the bottom plate of the filling cabin, and a water pipe sealing cover is arranged at the upper end of the drainage pipe;

a waste recovery box is arranged on the lower left side of the feeding cabin, a fourth manipulator is arranged inside the feeding cabin and positioned in the front right of the waste recovery box, a cutter assembly is arranged on the right side inside the feeding cabin, a first conveying line is arranged on the rear side inside the feeding cabin, a lifting assembly is arranged at the rear end of the cutter assembly, and packaging consumables are arranged on the first conveying line;

a discharging cabin discharging door is arranged on the left side face of the discharging cabin, a second conveying line is arranged inside the discharging cabin, aluminum cover consumables are arranged on the second conveying line, an aluminum cover tray cache position is arranged on the right rear side inside the discharging cabin, a fifth manipulator is arranged inside the discharging cabin and on the front side of the second conveying line, a capping component is arranged on the left front side inside the discharging cabin, an aluminum cover box cache position is arranged on the right front side inside the discharging cabin, and an air velocity sensor is arranged on the rear upper side inside the discharging cabin;

the side surface of the cache cabin is provided with two side doors of the cache cabin, the front side surface of the cache cabin is provided with a stock solution cabin connecting door, the stock solution cabin connecting door is provided with a consumable material passage door, the two side doors of the cache cabin are provided with glove boxes, the lower right side of the cache cabin is provided with a peristaltic pump, a filling pump is arranged inside the cache cabin, the left side of the cache cabin is provided with filling needle consumable materials, and the upper rear side of the cache cabin is provided with filling bag consumable materials;

the top of the stock solution cabin is provided with a fan, and a stock solution barrel is arranged inside the stock solution cabin;

as a preferable scheme of the invention, isolation sealing door bodies among cabins are arranged on two sides of the feeding cabin, the discharging cabin and the filling cabin, and isolation sealing door bodies among cabins are also arranged between the front side of the filling cabin and the cache cabin.

As the preferable scheme of the invention, the cabins of the feeding cabin, the discharging cabin, the filling cabin and the cache cabin all adopt a frame-type isolator structure, and the cabins are provided with independent environment control laminar flow and sterilization units.

As the preferable scheme of the invention, the cabin body of the stock solution cabin adopts an RABS structure, and the preparation stock solution used in filling production is placed.

As a preferable scheme of the invention, static pressure cabins are arranged on the upper sides of the feeding cabin, the discharging cabin and the buffer cabin.

Compared with the prior art, the invention has the beneficial effects that:

1. in the invention, the full process flow realizes full-automatic operation, including automatic material transfer, automatic consumable material transfer, automatic detection, automatic liquid operation, automatic sterilization and residue discharge, automatic storage and processing of production data, and guarantees the continuity, repeatability and stability of the operation flow.

2. In the invention, the production and filling of biological medicines can be rapidly carried out only by skillfully operating the system by a small amount of personnel with related professional backgrounds, and the product difference caused by the participation of the personnel in the production process is eliminated; the standardized operation process is convenient for rapid deployment, and the production capacity of preparation products can be rapidly improved under the emergency public health safety state.

3. In the invention, all material transfer, consumable transfer, filling operation, product detection and the like are carried out in the sealed isolator, so that the product can be ensured not to be polluted; compared with the traditional filling equipment, the standard miniaturization equipment has the advantages that the investment and the period of fixed assets of a production plant are reduced by orders of magnitude; by adopting box-type integrated consumables, auxiliary equipment such as a bottle washing machine, a dryer and the like is omitted, and the fixed asset investment of a user is greatly reduced; the box-type integrated consumable material is adopted, modules such as an oscillating pot and the like in the traditional filling equipment are omitted, and the pollution risk of suspended particles in the system is greatly reduced; by adopting box-type integrated consumables, the rapid switching among different product consumables such as penicillin bottles, filling needles, cassette bottles and the like is facilitated.

Drawings

FIG. 1 is a front view of the system of the present invention;

FIG. 2 is a top layout view of the basic structure of the system of the present invention;

FIG. 3 is a front view of the basic structure of the system of the present invention;

FIG. 4 is a left side view of the system of the present invention;

FIG. 5 is an isometric view of the system of the present invention;

FIG. 6 is a basic operation flow of the full-automatic filling of the present invention;

FIG. 7 is a front view of the filling capsule of the present invention;

FIG. 8 is a left side view of the filling pod of the present invention;

FIG. 9 is a top view of the filling capsule of the present invention;

FIG. 10 is an isometric view of the filling capsule of the present invention;

FIG. 11 is a schematic view of the safety of unidirectional flow of material during the production process of the present invention;

FIG. 12 is a schematic diagram of a closed cell CIP cleaning arrangement of the present invention;

FIG. 13 is a CIP cleaning flow diagram of the present invention;

FIG. 14 is a CIP drain line layout of the present invention;

FIG. 15 is a schematic view of a bilge floor structure of the present invention;

FIG. 16 is a flow chart of dynamic filling calibration according to the present invention;

FIG. 17 is a general view of the feeding chamber of the present invention;

FIG. 18 is a top view of the feeding chamber of the present invention;

FIG. 19 is an isometric view of the feed module of the present invention;

FIG. 20 is a general view of the discharge chamber of the present invention;

FIG. 21 is a top view of the discharge chamber of the present invention;

FIG. 22 is an isometric view of the discharge chamber of the present invention;

FIG. 23 is a first view of the cache module of the present invention;

FIG. 24 is a second cache compartment overview of the present invention;

FIG. 25 is a composite view of the dope compartment of the present invention.

In the figure: 1. a loading frame; 101. a return air duct; 2. a top laminar flow assembly; 3. a feeding cabin; 301. a waste recovery box; 302. a fourth manipulator; 303. a cutter assembly; 304. a first conveyor line; 305. a lifting assembly; 306. packaging consumables in a belt; 4. discharging the material cabin; 401. a discharge door of the discharge cabin; 402. a second conveyor line; 403. an aluminum lid consumable; 4031. a fifth manipulator; 404. an aluminum lid disk cache bit; 405. a capping assembly; 406. an aluminum lid box cache bit; 407. a wind speed sensor; 5. filling the cabin; 501. a switchboard; 502. a waste collection box; 503. static pressure cabin; 504. an automatic door for sealing the cabin; 505. an empty box cache bit; 506. a rubber plug buffer position; 507. a first manipulator; 508. a heating assembly; 509. washing a water inlet; 510. a rubber plug pressing seat; 511. a second manipulator; 512. folding the conveying line; 513. a third manipulator; 514. an environmental monitor; 515. filling and weighing devices; 516. washing a water outlet; 517. CIP drainage slope; 518. CIP main drainage port; 519. a drain pipe; 520. an electric butterfly valve; 521. a check valve; 522. a spring water pipe; 523. a water inlet pipe; 524. the water pipe is sealed and covered; 6. a stock solution tank; 601. a fan; 602. a stock solution barrel; 7. a cache compartment; 701. two side doors of the cache cabin; 702. the stock solution cabin is connected with a door; 703. a consumable access door; 704. a glove box; 705. a peristaltic pump; 706. a filling pump; 707. filling needle consumables; 708. and (4) filling bag consumables.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all embodiments, and all other embodiments obtained by a person of ordinary skill in the art without creative efforts based on the embodiments of the present invention belong to the protection scope of the present invention.

In order to facilitate an understanding of the invention, the invention will now be described more fully hereinafter with reference to the accompanying drawings, in which several embodiments of the invention are shown, but which can be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.

It will be understood that when an element is referred to as being "secured to" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "left," "right," and the like are used herein for purposes of illustration only.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

Example (b): please refer to fig. 1-25, which illustrate a GMP compliant full-automatic robot filling system, including a loading frame 1, a top laminar flow component 2 disposed on the upper side of the loading frame 1, a material inlet chamber 3 disposed on the right side of the loading frame 1, a material outlet chamber 4 disposed on the left side of the loading frame 1, a filling chamber 5 disposed on the loading frame 1 and between the material inlet chamber 3 and the material outlet chamber 4, a raw liquid chamber 6 disposed on the loading frame 1 and on the right front side of the filling chamber 5, and a buffer chamber 7 disposed on the front side of the raw liquid chamber 6;

the front side and the rear side of the loading frame 1 are provided with air return pipelines 101 corresponding to the feeding cabin 3, the discharging cabin 4 and the filling cabin 5;

a distribution board 501 is arranged on the loading frame 1 and positioned at the left lower side of the filling cabin 5, a waste collection box 502 is arranged on the loading frame 1 and positioned at the right lower side of the filling cabin 5, a static pressure cabin 503 is arranged at the upper side of the filling cabin 5, a cabin sealing automatic door 504 is arranged at the left side of the filling cabin 5, an empty box buffer position 505 is arranged at the right front side of the inside of the filling cabin 5, a rubber plug buffer position 506 is arranged at the left side of the empty box buffer position 505 and inside the filling cabin 5, a first manipulator 507 is arranged at the rear side of the empty box buffer position 505 and inside the filling cabin 5, a heating assembly 508 is arranged behind the first manipulator 507, a folding water washing conveying line 512 is arranged behind the left rear side of the inside of the filling cabin 5 and behind the rubber plug buffer position 506, a rubber plug pressing seat 510 is arranged at the right of the rubber plug pressing seat 510, a folding water washing conveying line 512 is arranged behind the second manipulator 511, a third manipulator 513 is arranged at the right of the folding conveying line 512, a folding water washing conveying line 513 is arranged at the right of the third manipulator 513, a folding water washing conveying line 516, and a left weighing monitor is arranged at the left side of the folding water washing conveying line 512 and a left side of the folding water washing conveying line 512 is arranged at the left side of the folding water washing conveying line 516;

a bottom plate of the filling cabin 5 is provided with a CIP drainage slope 517, the bottom plate of the filling cabin 5 is correspondingly provided with a CIP main drainage port 518 on the left and the right, the bottom plate of the filling cabin 5 is provided with a drainage pipe 519 through the CIP main drainage port 518, the left drainage pipe 519 is provided with an electric butterfly valve 520, the right drainage pipe 519 is provided with a check valve 521, the bottom plate of the filling cabin 5 is provided with a spring water pipe 522 corresponding to the drainage pipe 519, the bottom plate of the filling cabin 5 is provided with a water inlet pipe 523 on the side surface of the drainage pipe 519, and the upper end of the drainage pipe 519 is provided with a water pipe sealing cover 524;

the cabin of filling cabin 5 adopts frame-type isolator structure, and the independent environmental control laminar flow of cabin configuration and sterilization unit, in the production process, the cabin keeps strict A level sterile condition, and the aseptic security of guarantee operation product carries out interior package in succession in this cabin and tears, snatchs in the filling consumptive material box, the filling, weighs, play useless, the inner cup consumptive material snatchs, the inner cup adds the lid, the operation such as in the filling consumptive material returns the box. Based on the process requirements, 2-4 sterile robots are arranged in the cabin to perform anthropomorphic operation of each link;

a waste recovery box 301 is arranged on the lower left side of the feeding cabin 3, a fourth manipulator 302 is arranged inside the feeding cabin 3 and positioned in the right front of the waste recovery box 301, a cutter assembly 303 is arranged on the right side inside the feeding cabin 3, a first conveying line 304 is arranged on the rear side inside the feeding cabin 3, a lifting assembly 305 is arranged at the rear end of the cutter assembly 303, and a belt packaging consumable 306 is arranged on the first conveying line 304;

the cabin of the feeding cabin 3 adopts a frame type isolator structure, the cabin is provided with an independent environment control laminar flow and sterilization unit, and the cabin is kept in a grade A or grade B clean state based on process requirements in the production process. The robot carries out consumptive material packing box body's extranal packing and tears the operation in the cabin, tears the consumptive material box body that removes the extranal packing and can keep in order to satisfy the production beat demand in filling the cabin in this cabin. Based on the process requirements, consumable box bodies can be arranged in the cabin, and VHP surface sterilization and residue removal before external packaging are not torn off;

a discharging cabin discharging door 401 is arranged on the left side face of the discharging cabin 4, a second conveying line 402 is arranged inside the discharging cabin 4, an aluminum cover consumable 403 is arranged on the second conveying line 402, an aluminum cover tray buffer position 404 is arranged on the right rear side inside the discharging cabin 4, a fifth mechanical arm 4031 is arranged inside the discharging cabin 4 and on the front side of the second conveying line 402, a capping assembly 405 is arranged on the left front side inside the discharging cabin 4, an aluminum cover box buffer position 406 is arranged on the right front side inside the discharging cabin 4, and an air velocity sensor 407 is arranged on the rear upper side inside the discharging cabin 4;

the cabin of the discharging cabin 4 adopts a frame type isolator structure, the cabin is provided with an independent environment control laminar flow and sterilization unit, the cabin keeps a B-level clean state based on process requirements in the production process, a robot in the cabin is matched with a special unit to carry out capping operation of filling consumables added with an inner cover and temporarily store products, and VHP sterilization and residue discharge operation in the cabin can be carried out after each batch of products are delivered based on the process requirements;

the side surface of the buffer cabin 7 is provided with a buffer cabin double-side door 701, the front side surface of the buffer cabin 7 is provided with a stock solution cabin connecting door 702, the stock solution cabin connecting door 702 is provided with a consumable passage door 703, the buffer cabin double-side door 701 is provided with a glove box 704, the right lower side of the buffer cabin 7 is provided with a peristaltic pump 705, the interior of the buffer cabin 7 is provided with a filling pump 706, the left side of the buffer cabin 7 is provided with a filling needle consumable 707, and the rear upper side of the buffer cabin 7 is provided with a filling bag consumable 708;

the cabin of the cache cabin 7 adopts a frame type isolator structure, the cabin is provided with an independent environment control laminar flow and sterilization unit, the cabin keeps an A-level sterile state in the production process, consumables are slightly damaged in the filling process, and the high safety of a filling product can still be effectively ensured;

the top of the stock solution tank 6 is provided with a fan 601, and the stock solution tank 6 is internally provided with a stock solution barrel 602; the two sides of the feeding cabin 3, the discharging cabin 4 and the filling cabin 5 are provided with isolation sealing door bodies among the cabins, the isolation sealing door bodies among the cabins are also arranged between the front side of the filling cabin 5 and the buffer cabin 7, the cabins of the feeding cabin 3, the discharging cabin 4, the filling cabin 5 and the buffer cabin 7 all adopt frame type isolator structures, the cabins are provided with independent environment control laminar flow and sterilization units, the cabin body of the stock solution cabin 3 adopts an RABS structure, the stock solution of the preparation used for filling production is placed, and the upper sides of the feeding cabin 3, the discharging cabin 4 and the buffer cabin 7 are provided with static 503 ballast cabins.

The working principle is as follows: when in use, the utility model basically comprises:

1) Filling the cabin: the cabin adopts frame-type isolator structure, and the independent environmental control laminar flow of cabin configuration and sterilization unit, in the production process, the cabin keeps strict A level sterile condition, ensures the aseptic security of operation product. Continuously performing operations of tearing off inner packages, grabbing in a filling consumable box, filling, weighing, waste kicking, grabbing inner cover consumables, capping inner covers, returning filling consumables into the box and the like in the cabin, and configuring 2-4 sterile robots in the cabin based on process requirements to perform personification operation of each link; a full-automatic mechanical arm carries out material transfer, carrying operation and consumable bar code scanning operation; cabin sealing automatic door 504-isolated from other cabins; the heating component 508 is used for coating the upper part of the consumable box body with a film and heating the film, so that the film is conveniently cut off and torn by a manipulator; a waste collection box 502-facilitating the collection of waste material during filling; the folding conveying line 512 is used for conveying a series of consumables such as bottle bodies, needle bodies, rubber plugs and the like; the filling and weighing device 515 can be switched according to the bottle specification, and is used for filling and weighing the bottle and the reagent in the bottle; the rubber plug pressing seat 510 can be switched according to the bottle specification, and is used for sealing the bottle body; a rubber plug buffer level 506, which is used for providing a buffer position for a rubber plug disc used by a rubber plug; empty cassette buffer 505-to facilitate rapid drainage in the event of a bottle fracture or fluid leak; an environment monitor 514 for detecting various environmental data in the filling cabin 5, such as laminar flow wind speed, temperature and humidity, H2O2 solubility and the like; a return air pipeline 101 for connecting the filling cabin module and the laminar flow return air cabin; a static ballast module, which is used for providing a stable and clean laminar flow environment for the filling cabin and is used for sterilizing the filling cabin module VHP; a bay frame-providing mounting and support structure for all other components of the filling bay; automatic drainage device-after the equipment is washed, quickly draining the residual water in the clean cabin; other equipment configured as required;

according to the process flow, the filling cabin correspondingly executes the following operations:

1) The consumable materials sent from the feeding cabin 3 run to a designated station on a conveying line and are positioned and clamped;

2) Sealing and laminating the upper part of the heating consumable box body;

3) The first mechanical arm 507 acts to cut off the edge of the box body, tear off the covering film and throw in the waste material box, and simultaneously discard the top sealing cover plate;

4) Taking the rubber plug carrying disc out of the box body, placing a buffer position, and allowing the empty box to flow out;

5) The bottle body flows into a designated station, the second manipulator 511 acts to clamp the bottle body to a filling weighing station for filling, and the bottle body is placed on a high-precision scale for weighing after filling;

6) After weighing is qualified, the second mechanical arm 511 places the bottle body filled with the liquid medicine on the rubber plug pressing position, the first mechanical arm 507 acts at the same time to place a rubber plug strip above the bottle opening, the second mechanical arm 511 performs the action of pressing the rubber plug downwards, after the rubber plug strip is placed above the bottle opening, the empty rubber plug tray is placed into the garbage recycling box by the first mechanical arm 507, and the bottle body clamped and pressed by the second mechanical arm 511 is placed back into the box;

7) The whole box flows out of the central cabin after the rubber plug is fully pressed, and enters the discharging cabin 4;

8) The third manipulator 513 is used for placing environment monitoring components such as planktonic bacteria, settlement bacteria and the like before production, and simultaneously clamping and placing the liquid leakage prevention jig, and can quickly clamp and place the liquid leakage prevention jig in an empty box for discharging in the liquid leakage process;

9) The first mechanical arm 507 and the second mechanical arm 511 are used as manual substitutes during washing, and the clamping water pipe is used for washing all parts in the cabin;

10 Periodically performing VHP sterilization and residue removal operation to ensure the cleanliness of the A-level environment in the filling cabin 5;

the products are transferred to a discharging cabin in the circulation mode until the process is finished;

the feeding cabin correspondingly executes the following operations:

1) A manual or automatic feeding robot puts the sorted materials on a conveying line butted with the outer side of the feeding cabin according to a certain quantity and sequence;

2) The material is scanned and enters a feeding cabin;

3) The outer package in the waste recovery box is manually and periodically removed;

4) The environment monitoring system operates in real time and uploads the data to the system for analysis and storage;

5) The second conveying line 402 conveys the materials to a designated position to stop and adsorb plastic packages at the bottom, and the manipulator presses down the top outer packages of the materials;

6) The lifting assembly 305 is pressed downwards, and the motor drives the roller to straighten the packaging bag;

7) Moving the cutter to cut an opening in the outer packaging bag;

8) The elevator assembly 305 lowers to the same plane as the conveyor line while enlarging the overpack opening;

9) The manipulator pushes the material box to the top surface of the lifting assembly, and the electric cylinder acts to push the box body out of the packaging bag and push the box body into the filling cabin;

10 A manipulator adsorbs the package into a waste recovery box;

11 Periodically executing VHP sterilization and residue discharge operation to ensure the cleanliness of the B-level environment of the transfer discharge cabin;

the cabin of the feeding cabin 3 adopts a frame type isolator structure, the cabin is provided with an independent environment control laminar flow and sterilization unit, the cabin is kept in an A-level or B-level clean state based on process requirements in the production process, a robot in the cabin performs outer package tearing operation on a consumable packaging box body, the consumable box body with the outer package torn off can be temporarily stored in the cabin to meet the production rhythm requirement of a filling cabin, and VHP surface sterilization and residue removal of the consumable box body can be performed in the cabin based on the process requirements;

a discharging cabin: the cabin adopts a frame type isolator structure, the cabin is provided with an independent environment control laminar flow and sterilization unit, the cabin keeps a B-level clean state based on process requirements in the production process, a robot in the cabin is matched with a special unit to perform capping operation of filling consumables subjected to inner cover addition and temporary storage of products, and VHP sterilization and residue removal operation in the cabin can be performed after each batch of products are delivered based on the process requirements;

according to the process flow, the discharging cabin correspondingly executes the following operations:

1) The conveying line is in butt joint with the filling cabin for incoming materials;

2) Stopping the material at a specified position, positioning and clamping, and then grabbing the aluminum cover and the box to an aluminum cover box cache position by the manipulator;

3) The manipulator uniformly grabs the aluminum cover of the aluminum cover cache position to the aluminum cover cache position together with the carrier disc, and an empty box is reserved;

4) After the bottle body is fed, the mechanical arm sucks the aluminum cover and clamps the penicillin bottle;

5) The penicillin bottles are placed on the pre-capping electric cylinder, the aluminum covers are buckled on the rubber plugs at the bottle mouths of the penicillin bottles, the capping electric cylinder is conveyed forwards uniformly, and the penicillin bottles are subdivided below the capping heads uniformly through the rotary disc;

6) When penicillin bottles appear below the four capping heads at the same time, the penicillin bottles descend uniformly to realize capping action;

7) After the capping is finished, the capping head rises, the turntable rotates, and the finished penicillin bottle product flows out to the electric cylinder at the finished product buffer position;

8) Clamping the penicillin bottle with the rolled cover by a mechanical arm, placing the penicillin bottle in the box body, repeatedly sucking the aluminum cover, clamping the penicillin bottle, taking the rolled cover, integrating the action of rolling the cover, and then flowing out;

9) The aluminum cover empty tray is placed in the previously grabbed empty box, and after the whole box is used up, the mechanical arm clamps the empty material of the whole box and flows out;

10 The environment monitoring system operates in real time and uploads data to the system for analysis and storage;

the VHP sterilization and residue discharge operation is performed regularly to ensure the cleanliness of the B-level environment of the discharge cabin

A cache cabin: the cabin adopts frame-type isolator structure, and the cabin configuration is independent environmental control laminar flow and sterilization unit. The cabin keeps A-level sterile state in the production process (consumables are slightly damaged in the filling process, and the high safety of the filled product can be effectively guaranteed). Through this cabin, send into the filling consumptive material external member of installing in the filling cabin, ensure the security of filling consumptive material in full production cycle in-process. In the cabin body, a plurality of passage precision metering grade peristaltic pumps are installed based on process requirements, so that the high precision of independent operation of each filling channel is guaranteed;

according to the process flow, the cache cabin correspondingly executes the following operations:

1) In the filling process, the box-type peristaltic pump is responsible for pumping the stock solution to the cache bag;

2) The filling pump is connected with the cache bag, is communicated with the outlet pipeline and is connected with the consumable filling needle;

3) Controlling the dosage of the filling liquid medicine through a filling pump;

performing VHP sterilization and residue removal operation regularly to ensure the cleanliness of the A-level environment of the cache cabin;

stock solution cabin: the cabin body adopts an RABS structure (B-level clean state), and is filled with preparation stock solution used in production;

according to the process flow, the stock solution cabin correspondingly executes the following operations:

1) In the filling process, the peristaltic pump is responsible for pumping the stock solution to the buffer bag;

2) In the operation process of the equipment, the fan continuously supplies air to the cabin, and the air is communicated with the external environment and is in a C-level environment.

Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that changes, modifications, substitutions and alterations can be made in these embodiments without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.

Claims (5)

1. The utility model provides a full-automatic robot filling system of GMP compliance, includes loading frame (1), its characterized in that: a top laminar flow component (2) is arranged on the upper side of the loading frame (1), a feeding cabin (3) is arranged on the right side of the loading frame (1), a discharging cabin (4) is arranged on the left side of the loading frame (1), a filling cabin (5) is arranged on the loading frame (1) and between the feeding cabin (3) and the discharging cabin (4), a raw liquid cabin (6) is arranged on the right front side of the filling cabin (5) on the loading frame (1), and a buffer cabin (7) is arranged on the front side of the raw liquid cabin (6);

the front side and the rear side of the loading frame (1) are provided with air return pipelines (101) corresponding to the feeding cabin (3), the discharging cabin (4) and the filling cabin (5);

a distribution board (501) is arranged on the loading frame (1) and positioned at the left lower side of the filling cabin (5), a waste collection box (502) is arranged on the loading frame (1) and positioned at the right lower side of the filling cabin (5), a static pressure cabin (503) is arranged at the upper side of the filling cabin (5), a cabin sealing automatic door (504) is arranged on the left side surface of the filling cabin (5), an empty box buffer position (505) is arranged at the right front side inside the filling cabin (5), a rubber plug buffer position (506) is arranged inside the filling cabin (5) and positioned at the left side of the empty box buffer position (505), a first mechanical hand (507) is arranged inside the filling cabin (5) and positioned at the rear side of the empty box buffer position (505), a heating assembly (508) is arranged at the rear side of the first mechanical hand (507), a water inlet (509) is arranged at the left rear side inside the filling cabin (5) and at the rear side of the buffer position (506), a second rubber plug buffer seat (512) is arranged at the rear side of the right side of the pressing mechanical hand (510) and a second rubber plug seat (512) is arranged at the rear side of the right side of the pressing mechanical hand (511), an environment monitor (514) is arranged on the right of the third manipulator (513), a filling weighing device (515) is arranged on the left of the third manipulator (513), and water washing water outlets (516) are correspondingly arranged on the left and right in front of the folding conveying line (512);

a CIP drainage slope (517) is arranged on a bottom plate of the filling cabin (5), CIP main drainage ports (518) are correspondingly arranged on the left and right sides of the bottom plate of the filling cabin (5), a drainage pipe (519) is installed on the bottom plate of the filling cabin (5) through the CIP main drainage ports (518), an electric butterfly valve (520) is installed on the drainage pipe (519) on the left side, a check valve (521) is installed on the drainage pipe (519) on the right side, a spring water pipe (522) is arranged on the bottom plate of the filling cabin (5) and corresponds to the drainage pipe (519), a water inlet pipe (523) is arranged on the side, located on the drainage pipe (519), of the bottom plate of the filling cabin (5), and a water pipe sealing cover (524) is arranged at the upper end of the drainage pipe (519);

a waste recovery box (301) is arranged on the lower left side of the feeding cabin (3), a fourth manipulator (302) is arranged inside the feeding cabin (3) and positioned in the right front of the waste recovery box (301), a cutter assembly (303) is arranged on the right side inside the feeding cabin (3), a first conveying line (304) is arranged on the rear side inside the feeding cabin (3), a lifting assembly (305) is arranged at the rear end of the cutter assembly (303), and a belt packaging consumable material (306) is arranged on the first conveying line (304);

a discharging cabin discharging door (401) is arranged on the left side face of the discharging cabin (4), a second conveying line (402) is arranged inside the discharging cabin (4), an aluminum cover consumable (403) is arranged on the second conveying line (402), an aluminum cover disc buffer position (404) is arranged on the right rear side inside the discharging cabin (4), a fifth manipulator (4031) is arranged inside the discharging cabin (4) and on the front side of the second conveying line (402), a gland component (405) is arranged on the left front side inside the discharging cabin (4), an aluminum cover box buffer position (406) is arranged on the right front side inside the discharging cabin (4), and an air velocity sensor (407) is arranged on the upper rear side inside the discharging cabin (4);

a cache chamber double-side door (701) is arranged on the side face of the cache chamber (7), a raw liquid chamber connecting door (702) is arranged on the front side face of the cache chamber (7), a consumable passage door (703) is arranged on the raw liquid chamber connecting door (702), a glove box (704) is arranged on the cache chamber double-side door (701), a peristaltic pump (705) is arranged on the lower right side of the cache chamber (7), a filling pump (706) is arranged inside the cache chamber (7), filling needle consumables (707) are arranged on the left side of the cache chamber (7), and filling bag consumables (708) are arranged on the upper rear side of the cache chamber (7);

the top of the stock solution tank (6) is provided with a fan (601), and a stock solution barrel (602) is arranged in the stock solution tank (6).

2. The GMP compliant fully automated robotic filling system according to claim 1, wherein: the two sides of the feeding cabin (3), the discharging cabin (4) and the filling cabin (5) are provided with isolation sealing door bodies among the cabins, and isolation sealing door bodies among the cabins are also arranged between the front side of the filling cabin (5) and the cache cabin (7).

3. The GMP-compliant fully automated robotic filling system according to claim 1, wherein: the cabins of the feeding cabin (3), the discharging cabin (4), the filling cabin (5) and the cache cabin (7) all adopt frame-type isolator structures, and are provided with independent environment control layer flow and sterilization units.

4. The GMP compliant fully automated robotic filling system according to claim 1, wherein: the body of the stock solution tank (3) adopts an RABS structure, and the stock solution of the preparation used in filling production is placed.

5. The GMP-compliant fully automated robotic filling system according to claim 1, wherein: the upper sides of the feeding cabin (3), the discharging cabin (4) and the buffer cabin (7) are all provided with static pressure cabins (503).

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