CN113511352A - A continuous multi-batch aseptic filling system for biological drugs - Google Patents
A continuous multi-batch aseptic filling system for biological drugs Download PDFInfo
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- CN113511352A CN113511352A CN202110933885.0A CN202110933885A CN113511352A CN 113511352 A CN113511352 A CN 113511352A CN 202110933885 A CN202110933885 A CN 202110933885A CN 113511352 A CN113511352 A CN 113511352A
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
- B65B3/003—Filling medical containers such as ampoules, vials, syringes or the like
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
- B65B3/04—Methods of, or means for, filling the material into the containers or receptacles
- B65B3/10—Methods of, or means for, filling the material into the containers or receptacles by application of pressure to material
- B65B3/12—Methods of, or means for, filling the material into the containers or receptacles by application of pressure to material mechanically, e.g. by pistons or pumps
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
- B65B3/26—Methods or devices for controlling the quantity of the material fed or filled
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
- B65B3/26—Methods or devices for controlling the quantity of the material fed or filled
- B65B3/28—Methods or devices for controlling the quantity of the material fed or filled by weighing
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
- B65B55/02—Sterilising, e.g. of complete packages
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B7/00—Closing containers or receptacles after filling
- B65B7/16—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons
- B65B7/28—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons by applying separate preformed closures, e.g. lids, covers
- B65B7/2842—Securing closures on containers
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- Engineering & Computer Science (AREA)
- Mechanical Engineering (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Abstract
本发明涉及药品灌装技术领域，尤其为一种生物药品连续多批次无菌灌装系统，包括耗材上料单元舱体、存储单元舱体、灌装/分装操作单元舱体和产品传出/产品外包单元舱体，所述耗材上料单元舱体的正面中间处安装有上料操作舱门，所述耗材上料单元舱体内部的右侧中间处安装有操作机器人，所述耗材上料单元舱体的内部并且位于操作机器人的左侧安装有上料滚筒，所述耗材上料单元舱体的内部并且位于上料滚筒的表面安装有暂存滚筒，本系统整体步骤均在密封系统内完成，同时配备在线灭菌与环控功能，保障全流程操作的无菌安全性；各个单元独立运行，并配备多通道泵液通路，倍数级提高系统通量。
The invention relates to the technical field of medicine filling, in particular to a continuous multi-batch aseptic filling system for biological medicines, comprising a consumable material feeding unit cabin, a storage unit cabin, a filling/subpackaging operation unit cabin and a product transfer unit cabin. Out/product outsourcing unit cabin, a feeding operation hatch is installed in the middle of the front of the consumables feeding unit cabin, and an operation robot is installed in the middle of the right side inside the consumables feeding unit cabin, the consumables Inside the feeding unit cabin and located on the left side of the operating robot is a feeding drum, and a temporary storage drum is installed inside the consumables feeding unit cabin and located on the surface of the feeding drum, and the overall steps of the system are all sealed. It is completed in the system, and is equipped with online sterilization and environmental control functions to ensure the aseptic safety of the whole process operation; each unit operates independently, and is equipped with multi-channel pump fluid passages, which improves the system throughput by multiples.
Description
Technical Field
The invention relates to the technical field of medicine filling, in particular to a continuous multi-batch aseptic filling system for biological medicines.
Background
Biological medicines, such as various antibodies, biological vaccines, cell products, gene virus products and the like, are rapidly enlarged in batch production scale in the high-speed development process, after the batch production is completed, the products need to be filled into product containers for distribution and clinical use, and compared with traditional medicines (chemical medicines and the like), the biological medicines are mostly characterized by bioactivity, and can not be subjected to final product sterilization operations such as irradiation, high temperature and the like, the traditional medicine filling system is operated in a non-sealed system, filling consumables are generally uncapped, the strict aseptic safety of the biological products in the large-scale filling process is difficult to guarantee, the microbial pollution of non-inactivated products in the large-scale production process is easy to generate, and the traditional filling system needs to perform sterilization and cleaning operations on the internal open environment and perform complicated verification before each batch of secondary production, the conventional filling system needs to ensure aseptic safety, needs to be deployed in an A-level (hundred-level) environment, needs to be matched with a large plant-level environment control system, is high in fixed asset input cost, high in operating cost (electric power) cost (tens of millions of inputs per year), complex in batch operation verification, long in batch preparation time, and not suitable for copying in different production facility layouts, is lack of standardization in the conventional filling line, basically serves for customer customization, pays high design and deployment cost, greatly prolongs the construction and use period, and is customized for special products, high in flexibility, and high in cost and repeated investment when different products are switched.
During personalized precision treatment (such as personalized immune cell therapy), a large amount of medicaments such as cytokines and viruses are used, and the medicaments need to be subjected to sterile small-dose subpackaging for independent use of a single patient before personalized production. The traditional manual subpackaging mode has small flux and easy pollution caused by open operation in the process, and brings extremely high risk for subsequent expensive production. And the problem of unstable dosage is easily caused in the manual operation process, so that a continuous multi-batch sterile filling system for biological medicines is needed to improve the problem.
Disclosure of Invention
The present invention is directed to a system for continuously and aseptically filling biopharmaceuticals in multiple batches, so as to solve the above problems in the background art.
In order to achieve the purpose, the invention provides the following technical scheme:
the utility model provides a many continuous batch aseptic filling systems of biological medicine, spreads/the product outsourcing unit cabin body including the consumptive material loading unit cabin body, the storage unit cabin body, the filling/partial shipment operation unit cabin body and product, the department installs the material loading operation hatch door in the middle of the front of the consumptive material loading unit cabin body, department installs the operation robot in the middle of the right side of the internal portion of consumptive material loading unit cabin, the material loading cylinder is installed in the inside of the consumptive material loading unit cabin body and the left side that is located the operation robot, the surface mounting that the internal portion of the consumptive material loading unit cabin body and be located the material loading cylinder has the cylinder of keeping in, the internally mounted of the consumptive material loading unit cabin body has H2O2The top lets in the pipeline, the environment admission line is installed to the upside middle department in the consumptive material loading unit cabin body, the environmental control return air pipeline is installed to the bottom middle department in the consumptive material loading unit cabin body, airtight transmission hatch door is installed to the right side middle department in the consumptive material loading unit cabin body, the right side in the consumptive material loading unit cabin body is provided with the storage unit cabin body, the storage maintenance operation hatch door is installed to the positive middle department in the storage unit cabin body, the right side in the storage unit cabin body is provided with the filling/partial shipment operation unit cabin body, the operation hatch door is installed to the positive left and right sides symmetry of the filling/partial shipment operation unit cabin body, the back in the filling/partial shipment operation unit cabin body is provided with the pumping unit, the liquid bag storage unit is installed to the back in the filling/partial shipment operation unit cabin body and the downside that lies in the pumping unit, department installs the pump liquid unit in the middle of the inside upside of filling/partial shipment operating unit cabin body, the calibration weighing unit is installed in the inside left side of filling/partial shipment operating unit cabin body, the product weighing unit is installed on the inside right side of filling/partial shipment operating unit cabin body, the right side of the filling/partial shipment operating unit cabin body is provided with the product and spreads/the product outsourcing unit cabin body, the product is spread/the product outsourcing unit cabin body is installed to the positive middle department and is maintained/operate the hatch door, the product is spread/the product outsourcing unit cabin body is provided with ejection of compact interface in the middle of the right side, the product spreads/the productThe inside of outsourcing unit cabin body and the one side that is close to product maintenance/operation hatch door are provided with the inner packing unit, the inside of product transmission/product outsourcing unit cabin body and the rear side that is located the inner packing unit are provided with the extranal packing unit, the inside of product transmission/product outsourcing unit cabin body and the rear side that is located the extranal packing unit are provided with and transmit temporary storage unit.
According to the preferable scheme, a consumable clamping unit, a consumable bracket and a matched high-freedom-degree robot are arranged inside the consumable feeding unit cabin, a full-automatic feeding mechanism is arranged on one side of the consumable feeding unit cabin and is in sealing connection with the connection part of the consumable feeding unit cabin, the pressure inside the consumable feeding unit cabin is I pressure grade, and H pressure is H pressure grade2O2Evenly distributed contact points are arranged on the top inlet pipeline, and the H2O2The top part is communicated with the pipeline and is provided with H in the middle of the contact point2O2A top channel.
As a preferable scheme of the invention, the left side and the right side of the storage unit cabin are respectively communicated with the consumable material loading unit cabin and the filling/subpackaging operation unit cabin, and the pressure inside the storage unit cabin is of a pressure grade II.
As a preferred scheme of the present invention, an environmental gas control system is arranged inside the filling/dispensing operation unit cabin, a high-freedom aseptic operation robot is arranged inside the filling/dispensing operation unit cabin and at a position corresponding to the operation cabin door, an inner packaging waste temporary storage region is arranged on the left side inside the filling/dispensing operation unit cabin, an inner packaging stripping and clamping unit is arranged inside the filling/dispensing operation unit cabin and behind the inner packaging waste temporary storage region, a product filling/dispensing unit is arranged inside the filling/dispensing operation unit cabin and between the high-freedom aseptic operation robots, a liquid volume calibration unit is arranged inside the filling/dispensing operation unit cabin and behind the product filling/dispensing unit, a first temporary storage support is arranged in the filling/subpackaging operation unit cabin body and on the front side of the product filling/subpackaging unit, a product transfer support is arranged in the middle of the right side of the inner part of the filling/subpackaging operation unit cabin body, a gland/sealing unit is arranged in the inner part of the filling/subpackaging operation unit cabin body and on the rear side of the product transfer support and has a component with a two-dimensional detection function for realizing the monitoring of the position of a pressing plate and the processing and detection of the pressing plate, the specific arrangement of the components of the gland/sealing unit can be based on actual matching consumables and process configuration, a second temporary storage support is arranged in the inner part of the filling/subpackaging operation unit cabin body and on the front side of the product transfer support, and a freeze dryer (or other types of process equipment) is installed on one side of the filling/subpackaging operation unit cabin body, and the freeze dryer (or other types of process equipment) is hermetically connected with the connection part of the filling/subpackaging operation unit cabin, and the pressure inside the filling/subpackaging operation unit cabin is in a III pressure level.
As a preferable scheme of the present invention, the pumping unit is a non-contact pump, the non-contact pump may be a peristaltic pump, a centrifugal negative pressure pump, or the like, the number of the pumping units may be configured according to the number of channels in the pump industry, a disposable liquid storage bag or a solution stored in other similar consumables is disposed inside the liquid storage bag storage unit pair, the liquid storage bag storage unit and the pumping unit are connected by a disposable pipeline, a pipeline sealing structure is installed at a connection of the disposable pipeline and the pumping unit, the pumping unit includes a sterile operation bracket, a non-contact liquid amount sensor, and a disposable needle, and the product weighing unit is provided with a product bracket.
As a preferable scheme of the present invention, a high-freedom sterile operation robot is disposed inside the product delivery/outsourcing unit cabin, and the delivery temporary storage unit is a temporary storage rack.
In a preferred embodiment of the present invention, the storage unit chamber, the filling/dispensing operation unit chamber, and the product delivery/product wrapping unit chamber are all provided with H inside2O2The top is communicated with a pipeline.
As a preferable scheme of the present invention, the storage unit cabin, the filling/sub-packaging operation unit cabin and the product delivery/product outsourcing unit cabin are all provided with an environment air inlet pipeline and an environment control air return pipeline, and the joints between the storage unit cabin, the filling/sub-packaging operation unit cabin and the product delivery/product outsourcing unit cabin are all provided with airtight delivery doors.
As a preferable scheme of the invention, each unit inside the consumable material loading unit cabin, the storage unit cabin, the filling/subpackaging operation unit cabin and the product delivery/product outsourcing unit cabin can work independently and in parallel, each unit is provided with an independent laminar flow air inlet and exhaust channel, a high-efficiency H2O2 sterilization unit, a residue discharge unit and a laminar flow environmental control unit in a standard mode, and the consumable material loading unit cabin, the storage unit cabin, the filling/subpackaging operation unit cabin and the product delivery/product outsourcing unit cabin can be spliced detachably to form a quick and effective combination, and the storage unit and the addition unit can be spliced into different solutions in a latent configuration.
As a preferred embodiment of the present invention, the penetrating structures of the sealing capsule bodies of the consumable material loading unit capsule, the storage unit capsule, the filling/dispensing operation unit capsule and the product delivery/product outsourcing unit capsule may adopt RTP or self-designed pipeline clamping sealing structures, and the installation positions and the number of the high-freedom aseptic operation robots in each unit of the consumable material loading unit capsule, the storage unit capsule, the filling/dispensing operation unit capsule and the product delivery/product outsourcing unit capsule may be adjusted based on process requirements.
Compared with the prior art, the invention has the beneficial effects that:
according to the invention, the whole steps are completed in a sealed system, and the online sterilization and environment control functions are provided, so that the sterile safety of the whole-flow operation is ensured; each unit operates independently and is provided with a multi-channel pump liquid passage, and the flux of the system is improved by multiple levels; the full-flow robot is operated in a humanoid manner, so that the flexibility of matching different processes and different consumables is greatly improved; the calibration is flexible before and during the batch, so that the product filling/subpackaging accuracy in the process is greatly improved; the flexible splicing of the production flow and the scale is convenient, and a system layout which is more ideally matched with the process is formed; the switching period between batches is greatly shortened, and the utilization rate of the system and the flux in the period are improved; the standardization module is convenient for standardization deployment in multiple places and is suitable for distributed production of biological medicines; the design and construction cost of equipment and plants can be reduced in several orders.
Drawings
FIG. 1 is a schematic diagram of the basic structure of the present invention;
FIG. 2 is a schematic diagram of an expanded structure of the basic system of the present invention;
FIG. 3 is an expanded configuration diagram of the present invention;
FIG. 4 is an expanded configuration diagram of the present invention;
FIG. 5 is a flow chart of the operation within a single batch system of the present invention;
FIG. 6 is a schematic diagram of parallel operation within the system of the present invention;
FIG. 7 is a schematic structural view of the cabin of the filling/dispensing operation unit of the present invention;
FIG. 8 is a top view of the internal structure of the cabin of the filling/dispensing operation unit of the present invention;
FIG. 9 is a basic layout of a loading unit according to the present invention;
FIG. 10 is a top flow chart of the loading unit of the present invention;
FIG. 11 is a schematic top feed line of H2O2 according to the present invention;
FIG. 12 is a schematic structural view of the cabin of the filling/dispensing operation unit of the present invention;
FIG. 13 is a view of the seal channel configuration of the present invention;
FIG. 14 is a basic flow diagram of the aseptic filling/dispensing of the present invention;
FIG. 15 is a basic layout of the cabin of the filling/dispensing operation unit of the present invention;
FIG. 16 is a view of a capping/pipe sealing unit of the present invention;
fig. 17 is a basic layout diagram of the cabin of the product delivery/product outsourcing unit according to the present invention.
In the figure: 1. the consumable material loading unit cabin body; 101. a feeding operation cabin door; 102. operating the robot; 103. a feeding roller; 104. a temporary storage roller; 105. h2O2The top is communicated with a pipeline; 2.a storage unit compartment; 201. a storage maintenance/operation bay door; 3. filling/subpackaging the operation unit cabin body; 301. an operating hatch; 302. a pumping unit; 303. a liquid storage bag storage unit; 304. a liquid pumping unit; 305. calibrating the weighing unit; 306. a product weighing unit; 4. a product delivery/product outsourcing unit cabin body; 401. a product maintenance/operation hatch; 402. a discharge port; 403. an inner packaging unit; 404. an outer packaging unit; 405. a transfer-out temporary storage unit; 5. an ambient air intake duct; 6. an environmental control return air line; 7. an airtight transfer hatch door.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to 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, rather than all embodiments, and all other embodiments obtained by a person of ordinary skill in the art without any creative work based on the embodiments of the present invention belong to the protection scope of the present invention.
While several embodiments of the present invention will be described more fully hereinafter with reference to the accompanying drawings, in order to facilitate an understanding of the invention, the invention may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein, but rather should be construed to provide a more complete disclosure of the invention.
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, that 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, and that the terms "vertical", "horizontal", "left", "right" and the like are used herein for descriptive purposes 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, and the terms used herein in the specification of the present invention are for the purpose of describing particular embodiments only and are not intended to limit the present invention, and the term "and/or" as used herein includes any and all combinations of one or more of the associated listed items.
Referring to fig. 1-15, the present invention provides a technical solution:
the utility model provides a continuous many batches of aseptic filling system of biological medicine, including the consumptive material loading unit cabin body 1, the storage unit cabin body 2, the filling/partial shipment operation unit cabin body 3 and the product spreads/the product outsourcing unit cabin body 4, department installs material loading operation hatch door 101 in the middle of the front of the consumptive material loading unit cabin body 1, department installs operation robot 102 in the middle of the right side of the internal portion of the consumptive material loading unit cabin body 1, the inside of the consumptive material loading unit cabin body 1 and the left side that is located operation robot 102 install material loading cylinder 103, the internal portion of the consumptive material loading unit cabin body 1 and the surface mounting who is located material loading cylinder 103 have roller 104 of keeping in, the internally mounted H of the consumptive material loading unit cabin body 1 has2O2The top of the cabin body is communicated with a pipeline 105, the middle of the upper side of the consumable feeding unit cabin body 1 is provided with an environment air inlet pipeline 5, the middle of the bottom of the consumable feeding unit cabin body 1 is provided with an environment control air return pipeline 6, the middle of the right side of the consumable feeding unit cabin body 1 is provided with an airtight transmission cabin door 7, the right side of the consumable feeding unit cabin body 1 is provided with a storage unit cabin body 2, the middle of the front side of the storage unit cabin body 2 is provided with a storage maintenance/operation cabin door 201, the right side of the storage unit cabin body 2 is provided with a filling/subpackaging operation unit cabin body 3, the left and right sides of the front side of the filling/subpackaging operation unit cabin body 3 are symmetrically provided with operation cabin doors 301, the back side of the filling/subpackaging operation unit cabin body 3 is provided with a pumping unit 302, and the liquid storage bag storage unit 303 is arranged on the back side of the filling/subpackaging operation unit cabin body 3 and is positioned below the pumping unit 302, a pump liquid unit 304 is arranged in the middle of the upper side inside the cabin body 3 of the filling/subpackaging operation unit, a calibration weighing unit 305 is arranged on the left side inside the cabin body 3 of the filling/subpackaging operation unit, a product weighing unit 306 is arranged on the right side inside the cabin body 3 of the filling/subpackaging operation unit, a product delivery/product external packing unit cabin body 4 is arranged on the right side of the cabin body 3 of the filling/subpackaging operation unit, a product maintenance/operation cabin door 401 is arranged in the middle of the front side of the product delivery/product external packing unit cabin body 4, and a product maintenance/operation cabin door 401 is arranged in the middle of the front side of the product delivery/product external packing unit cabin body 4A discharging interface 402 is arranged in the middle of the right side of the product delivery/outsourcing unit cabin 4, an inner packing unit 403 is arranged inside the product delivery/outsourcing unit cabin 4 and on one side close to the product maintenance/operation cabin door 401, an outer packing unit 404 is arranged inside the product delivery/outsourcing unit cabin 4 and on the rear side of the inner packing unit 403, and a delivery temporary storage unit 405 is arranged inside the product delivery/outsourcing unit cabin 4 and on the rear side of the outer packing unit 404.
In an embodiment, referring to fig. 1 to 15, a consumable clamping unit, a consumable bracket and a high-degree-of-freedom robot are disposed inside a consumable feeding unit cabin 1, a full-automatic feeding mechanism is disposed on one side of the consumable feeding unit cabin 1, the full-automatic feeding mechanism is hermetically connected with a joint of the consumable feeding unit cabin 1, pressure inside the consumable feeding unit cabin 1 is the lowest pressure in an I-pressure-level system, and H is the lowest pressure in the I-pressure-level system2O2The top inlet line 105 is provided with evenly distributed contact points H2O2The top part is led into the pipeline 105 and is provided with H at the middle part of the contact point2O2A top passage, the left side and the right side of the storage unit cabin body 2 are respectively communicated with the consumable feeding unit cabin body 1 and the filling/subpackaging operation unit cabin body 3, the pressure in the storage unit cabin body 2 is the middle pressure grade in the II pressure grade system, the inside of the filling/subpackaging operation unit cabin body 3 is provided with an environmental gas control system, the inside of the filling/subpackaging operation unit cabin body 3 and the position corresponding to the operation cabin door 301 are provided with a high-freedom-degree sterile operation robot, the left side of the inside of the filling/subpackaging operation unit cabin body 3 is provided with an inner packaging waste temporary storage area, the inside of the filling/subpackaging operation unit cabin body 3 and the rear side positioned in the inner packaging waste temporary storage area are provided with an inner packaging stripping and clamping unit, and the product filling/subpackaging unit is arranged between the inside of the filling/subpackaging operation unit cabin body 3 and the high-freedom-degree sterile operation robot, a liquid amount calibration unit is arranged in the filling/subpackaging operation unit cabin body 3 and at the rear side of the product filling/subpackaging unit, a first temporary storage support is arranged in the filling/subpackaging operation unit cabin body 3 and at the front side of the product filling/subpackaging unit, and the filling/subpackaging operation unit cabin bodyA product transfer support is arranged in the middle of the right side of the interior of the filling/subpackaging operation unit cabin body 3, a gland/gland unit is arranged in the interior of the filling/subpackaging operation unit cabin body 3 and on the rear side of the product transfer support, the gland/gland unit is provided with a component for realizing the double-dimensional detection function of pressure plate position monitoring and pressure plate processing detection, the specific arrangement of each component of the gland/tube sealing unit can be based on actual matching consumables and process configuration, a second temporary storage support is arranged in the interior of the filling/subpackaging operation unit cabin body 3 and on the front side of the product transfer support, a freeze dryer (or other types of process equipment) is installed on one side of the filling/subpackaging operation unit cabin body 3, and the freeze dryer (or other types of process equipment) is in sealing connection with the connection part of the filling/subpackaging operation unit cabin body 3, the pressure in the cabin 3 of the filling/subpackaging operation unit is the highest pressure grade in the III pressure grade system, the pumping unit 302 is a non-contact pump, the non-contact pump can be a peristaltic pump, a centrifugal negative pressure pump and the like, the number of the pumping units 302 can be configured according to the number of pump channels, a disposable liquid storage bag or other solutions stored by similar consumables are arranged in the liquid storage bag storage unit 303, the liquid storage bag storage unit 303 is connected with the pump liquid unit 304 through a disposable pipeline, a pipeline sealing structure is arranged at the joint of the disposable pipeline, the pump liquid unit 304 comprises a sterile operation bracket, a non-contact liquid quantity sensor and a disposable needle, a product bracket is arranged on the product weighing unit 306, a high-freedom sterile operation robot is arranged in the cabin 4 of the product transmission/product external packing unit, and the temporary storage unit 405 is a temporary storage rack, h is arranged inside the storage unit cabin body 2, the filling/subpackaging operation unit cabin body 3 and the product transmitting/product outsourcing unit cabin body 42O2The top part is communicated with a pipeline 105, an environment air inlet pipeline 5 and an environment control air return pipeline 6 are arranged on the storage unit cabin body 2, the filling/subpackaging operation unit cabin body 3 and the product transmission/product outsourcing unit cabin body 4, airtight transmission cabin doors 7 are arranged at the joints between the storage unit cabin body 2, the filling/subpackaging operation unit cabin body 3 and the product transmission/product outsourcing unit cabin body 4, and consumable material loading unit cabin bodies 1, the storage unit cabin body 2, the filling/subpackaging operation unit cabin body 3 and the product transmission/product outsourcing unit cabin body 4Each unit in the outer packing unit cabin 4 can work independently and parallelly, each unit is provided with independent laminar flow air inlet and exhaust channel, high-efficiency H2O2 sterilization unit, residue discharge unit and laminar flow environmental control unit, the consumable material loading unit cabin 1, the storage unit cabin 2, the filling/subpackaging operation unit cabin 3 and each cabin of the product transmission/product outer packing unit cabin 4 can be spliced detachably to form quick and effective combination, the latent configuration can eliminate the storage unit and increase the unit splicing into different solutions, the sealing cabin penetrating structures of the consumable material loading unit cabin 1, the storage unit cabin 2, the filling/subpackaging operation unit cabin 3 and the product transmission/product outer packing unit cabin 4 can adopt RTP or self-designed pipeline clamping sealing structures, the consumable material loading unit cabin 1, the storage unit cabin 2, the pipeline clamping structure, the pipeline and the pipeline clamping structure, the pipeline clamping structure and the pipeline clamping structure, the pipeline and the pipeline clamping structure, the pipeline clamping, The installation positions and the number of the high-freedom sterile operation robots in each unit in the filling/subpackaging operation unit cabin body 3 and the product transmission/product outsourcing unit cabin body 4 can be adjusted based on process requirements, the whole steps are all finished in a sealing system, and meanwhile, the online sterilization and environment control functions are provided, so that the sterile safety of the whole-process operation is guaranteed; each unit operates independently and is provided with a multi-channel pump liquid passage, and the flux of the system is improved by multiple levels; the full-flow robot is operated in a humanoid manner, so that the flexibility of matching different processes and different consumables is greatly improved; the calibration is flexible before and during the batch, so that the product filling/subpackaging accuracy in the process is greatly improved; the flexible splicing of the production flow and the scale is convenient, and a system layout which is more ideally matched with the process is formed; the switching period between batches is greatly shortened, and the utilization rate of the system and the flux in the period are improved; the standardization module is convenient for standardization deployment in multiple places and is suitable for distributed production of biological medicines; the design and construction cost of equipment and plants can be reduced in several orders.
The working process of the invention is as follows: feeding flow: open material loading operation hatch door 101, on operating personnel or full automatic feeding mechanism placed the consumptive material cylinder 104 of keeping in, the artifical interface that closes material loading operation hatch door 101 or automatic closing automatic feeding mechanism, later carry out the sterilization of consumptive material loading unit cabin body 1 and inner unit and arrange incomplete operation, carry out the sterilization of consumptive material and demolising (not limited to) of extranal packing through two kinds of modes: hand (W.E.)The worker demolishs the consumable outer package, leaves the consumable inner package, places on the temporary storage roller 104, starts H2O2Sterilizing and removing residue, or placing consumables on the feeding roller 103, and packaging with sealed outer package2O2Sterilization, arrange incomplete back that finishes, what carry out the extranal packing demolish only leaves inside packing, place the consumptive material on the material loading cylinder 103 once more, when taking this type of operation, the chucking unit of under-deck configuration consumptive material, supporting high degree of freedom robot carries out the operation of demolising of extranal packing, keep in the surface of cylinder 104 simultaneously and carry out degree of depth disinfection, operation robot 102 shifts the consumptive material from material loading cylinder 103 to cylinder 104 of keeping in, the sterilization at surperficial dead angle is accomplished to the in-process, accomplish simultaneously and carry out complete sterilization to the surface of material loading cylinder 103, the consumptive material realizes in the consumptive material loading unit cabin body 1 that the consumptive material is before getting into high clean regional operation, realize the isolation of non-sterile environment and sterile environment through the material loading unit, the structure and the H of consumptive material bracket in the consumptive material loading unit cabin body 12O2The top inlet pipe 105 is the same;
material storage flow: adjusting the pressure between the consumable feeding unit cabin body 1 and the storage unit cabin body 2, preventing dust inside the consumable feeding unit cabin body 1 from entering the storage unit cabin body 2, then opening an airtight transfer cabin door 7 between the consumable feeding unit cabin body 1 and the storage unit cabin body 2, transferring the consumable from the consumable feeding unit cabin body 1 into the storage unit cabin body 2 by an operation robot 102 inside the consumable feeding unit cabin body 1, then selecting whether to perform rapid surface sterilization inside the storage unit cabin body 2 according to process requirements, then enabling the consumable to enter a storage state, realizing mass storage of filling/subpackaging consumables, and guaranteeing continuous operation of process operation;
the operation process comprises the following steps: adjusting the pressure inside the storage unit cabin body 2 and the filling/subpackaging operation unit cabin body 3, preventing dust inside the storage unit cabin body 2 from entering the filling/subpackaging operation unit cabin body, opening an airtight transfer cabin door 7 between the filling/subpackaging operation unit cabin body 3 and the storage unit cabin body 2, transferring consumables from the storage unit cabin body 2 to the filling/subpackaging operation unit cabin body 3 by a robot inside the filling/subpackaging operation unit cabin body 3, dismantling and opening a calibration bottle, and the like for packages inside the consumables, carrying out film tearing operation on the consumables by the cooperation of the two robots, cleaning garbage by the left robot, transferring a disposable transfer tray to the outside of the filling/subpackaging operation unit cabin body 3 through a transfer unit after the wastes are accumulated to a certain amount, and carrying out liquid path titration, the pipeline filling is realized, the robot transfers the pump liquid unit 304 into the adjusting and storing unit cabin body 2, the robot places consumables on the product weighing unit 306 to weigh the initial weight of the consumables, the pump liquid pipelines pump liquid one by one, then the pump liquid unit 304 performs liquid precise filling operation to realize filling or packaging operation, the flow sensor and the weighing sensor are calibrated one by one, the robot transfers the pump liquid unit 304 to a pumping position, then the capping/capping operation is performed through the capping/capping unit, the raw liquid needs to pass through a sealing structure when being replaced at one time, the airtight isolation of the external installation environment of the internal system of the filling/subpackaging operation unit cabin body 3 is ensured, the external part of the disposable consumable hose is sleeved with a hard pipe to ensure the effective compression and sealing of a sealing ring on a system sealing channel, and the effective compression of the sealing ring and the disposable hard pipe is ensured by the compression structure outside the system, the robot puts the product on a temporary storage bracket for temporary storage;
and (3) an outgoing flow: the pressure inside the product transferring/product packaging unit cabin body 4 and the filling/subpackaging operation unit cabin body 3 is adjusted, then the robot inside the product transferring/product packaging unit cabin body 4 can ensure that the products inside the filling/subpackaging operation unit cabin body 3 are transferred into the product transferring/product packaging unit cabin body 4, then inner packaging of the products is carried out, then outer packaging of the products is carried out, and the robot can place the packaged products on a temporary storage frame.
The whole steps are completed in a sealed system, and the online sterilization and environment control functions are simultaneously equipped, so that the sterile safety of the whole-process operation is guaranteed; each unit operates independently and is provided with a multi-channel pump liquid passage, and the flux of the system is improved by multiple levels; the full-flow robot is operated in a humanoid manner, so that the flexibility of matching different processes and different consumables is greatly improved; the calibration is flexible before and during the batch, so that the product filling/subpackaging accuracy in the process is greatly improved; the flexible splicing of the production flow and the scale is convenient, and a system layout which is more ideally matched with the process is formed; the switching period between batches is greatly shortened, and the utilization rate of the system and the flux in the period are improved; the standardization module is convenient for standardization deployment in multiple places and is suitable for distributed production of biological medicines; the design and construction cost of equipment and plants can be reduced in several orders.
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 (10)
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