CN114570100A - Aseptic raw materials production line - Google Patents
Aseptic raw materials production line Download PDFInfo
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- CN114570100A CN114570100A CN202210191631.0A CN202210191631A CN114570100A CN 114570100 A CN114570100 A CN 114570100A CN 202210191631 A CN202210191631 A CN 202210191631A CN 114570100 A CN114570100 A CN 114570100A
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- aseptic
- clean room
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D36/00—Filter circuits or combinations of filters with other separating devices
- B01D36/003—Filters in combination with devices for the removal of liquids
- B01D36/008—Means to filter or treat the separated liquid
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- Chemical Kinetics & Catalysis (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
Abstract
The invention discloses an aseptic raw material production line, which relates to the technical field of medicine preparation and production and comprises an aseptic workshop, wherein a raw material temporary storage chamber, a first clean room, a second clean room, a third clean room and a fourth clean room are arranged in the aseptic workshop side by side, and a dissolving and decoloring tank, an organic solvent storage tank, an aseptic processing device, a crystallization processing tank, a filtering, washing and drying machine, a pulverizer, an aseptic subpackaging system and a capping and sealing machine are arranged in the aseptic workshop; the dissolving and decoloring tank and the organic solvent storage tank are arranged in a first clean room; the sterile treatment device and the crystallization treatment tank are arranged in a second clean room, the filtering, washing and drying machine and the grinder are arranged in a third clean room, and the temporary storage bin, the sterile subpackaging system and the capping and sealing machine are arranged in a fourth clean room, so that the pollution risk caused by artificial transfer is eliminated, and the product quality is ensured; meanwhile, the operation difficulty is reduced, the operation flow is simplified, and the labor intensity of workers is reduced.
Description
Technical Field
The invention relates to the technical field of related production of medicine preparation, in particular to the technical field of sterile production lines.
Background
The raw material medicaments refer to raw material medicaments for producing various preparations, are effective components in the preparations, are various medicinal powders, crystals, extracts and the like prepared by chemical synthesis, plant extraction or biotechnology, but cannot be directly taken by patients. The aseptic bulk drugs must be prevented from being polluted by microorganisms as much as possible in the operation processes of filtering, drying, crushing, subpackaging and the like. Factors influencing whether the product is sterile are quite many, such as the design of production and the equipment layout thereof, the production environment condition, the pollution conditions of all equipment and materials related to production, the personnel operation and the sanitation condition, and the like, and each link plays a great role in the quality of the final product. In order to ensure the reliability and adaptability of the sterility of the aseptic production process system, a set of aseptic production process and process equipment will be required to ensure the sterility of the product.
The current medicine production line has the following problems: 1. every process of production line all needs the manual work to shift, and is higher as aseptic raw materials quality requirement, has certain aseptic risk, and 2, former production line staff intensity of labour is big, and all valves and material shift all have staff's manual completion, move and lift and sweat stream down the back of the body, and degree of automation is lower, and former production line production efficiency is lower, and the transfer process takes time and takes trouble.
Disclosure of Invention
The embodiment of the application solves the technical problems in the prior art by providing the sterile raw material production line, avoids the pollution risk caused by artificial transfer, and ensures the product quality; meanwhile, the operation difficulty is reduced, the operation flow is simplified, and the labor intensity of workers is reduced.
In order to achieve the purpose, the invention adopts the following technical scheme:
an aseptic raw material production line comprises an aseptic workshop, wherein a raw material temporary storage chamber, a first clean room, a second clean room, a third clean room and a fourth clean room are arranged in the aseptic workshop side by side, and a dissolving and decoloring tank, an organic solvent storage tank, an aseptic processing device, a crystallization processing tank, a filtering, washing and drying machine, a pulverizer, an aseptic subpackaging system and a capping and sealing machine are arranged in the aseptic workshop;
the dissolving and decoloring tank and the organic solvent storage tank are connected with the crystallization treatment tank through an aseptic treatment device, the discharge end of the crystallization treatment tank is connected with the filtering, washing and drying machine through a connecting pipeline, the discharge port of the filtering, washing and drying machine is connected with the crusher through a connecting pipeline, and the discharge end of the crusher is sequentially connected with an aseptic subpackaging system and a capping and sealing machine;
the dissolving and decoloring tank and the organic solvent storage tank are arranged in a first clean room; the sterile treatment device and the crystallization treatment tank are arranged in a second clean room, the filtering, washing and drying machine and the pulverizer are arranged in a third clean room, and the temporary storage bin, the sterile subpackaging system and the rolling cover sealing machine are arranged in a fourth clean room.
In order to further optimize the present invention, the following technical solutions may be preferably adopted:
preferably, a first sterile channel and a second sterile channel are arranged in the sterile workshop, the first sterile channel is communicated to the first clean room and the raw material temporary storage room, and the second sterile channel is communicated to the second clean room, the third clean room and the fourth clean room through a plurality of buffer rooms.
Preferably, the buffer room comprises a first buffer chamber, a sterile outer coating chamber and a second buffer chamber which are sequentially communicated and arranged.
Preferably, the sterile workshop is also provided with an independent inner packing material sterilizing chamber and an independent inner packing material cleaning chamber, and a double-door dry heat sterilizing cabinet is arranged in the inner packing material sterilizing chamber.
Preferably, the dissolving and decoloring tank comprises a dissolving tank and a decoloring tank which are connected with each other, and a pneumatic valve is arranged between the connecting pipelines.
Preferably, a temporary storage bin is further connected between the pulverizer and the sterile subpackaging system.
Preferably, the rubbing crusher includes rubbing crusher body, the crushing cavity has been seted up in the rubbing crusher body, upwards be connected with double-end motor on crushing cavity's the lateral wall, double-end motor's upper and lower both sides fixedly connected with drive pivot, the fixed cover in outside of the drive pivot of double-end motor's upside is equipped with first bevel gear, the inside transverse rotation of rubbing crusher body is connected with the top crushing axle, the top crushing axle runs through crushing cavity and passes through first bevel gear of second bevel gear connection, the fixed cover in outside of top crushing axle is equipped with first helical blade, the first shear blade of a plurality of mutual symmetries of outer wall fixedly connected with of top crushing axle.
Preferably, be provided with the blanking section of thick bamboo under the crushing axle of the internal correspondence top of rubbing crusher, the internal rotation of blanking section of thick bamboo is connected with bottom crushing axle, bottom crushing axle is connected with double-end motor's lower extreme drive pivot transmission, the external fixation cover of bottom crushing axle is equipped with second helical blade, the blade is sheared to the second of a plurality of mutual symmetries of outer wall fixedly connected with of bottom crushing axle, the top of bottom crushing axle extends out the blanking section of thick bamboo and is provided with the charging tray, the internal corresponding blanking section of thick bamboo lateral wall top position of rubbing crusher is provided with the screen cloth, rubbing crusher body bottom is provided with the discharge gate.
Preferably, be provided with on the screen cloth top lateral wall with rubbing crusher inner wall laminating pivoted a plurality of supporting wheels, be provided with on the screen cloth inside wall a plurality of with bottom crushing roller lateral wall fixed connection's gangbar, screen cloth bottom and blanking section of thick bamboo sliding seal are connected.
The invention has the beneficial effects that:
1. this production line mainly by: the device comprises a dissolving and decoloring tank, an aseptic processing device, an organic solvent storage tank, a crystallization processing tank, a filtering, washing and drying machine, a pulverizer, a temporary storage bin, an aseptic subpackaging system, a capping and sealing machine, an online cleaning and sterilizing control system, a heating and cooling system and other units.
2. This production line has avoided the amount of labour that artifical transfer produced, has shortened production cycle more than 5 hours, and the valve more than 95% on the equipment adopts pneumatic control, has realized the function of the automatic operation of equipment online cleaning and online sterilization, has reduced the operation degree of difficulty, has simplified operation procedure, has avoided the loss because of misoperation brings, is favorable to new employee to master operating skill fast. The crushing mechanism in the production line is provided with double crushing, so that the uniformity and the high efficiency of crushing in the drug production process are ensured
Drawings
FIG. 1 is a schematic diagram of the layout of the production line.
FIG. 2 is a schematic view of the internal structure of the pulverizer;
fig. 3 is an enlarged schematic view of a point a.
Wherein, 1-an aseptic workshop, 2-a raw material temporary storage room, 3-a first clean room, 4-a second clean room, 5-a third clean room, 6-a fourth clean room, 7-a dissolving and decoloring tank, 8-an organic solvent storage tank, 9-an aseptic processing device, 10-a crystallization processing tank, 11-a filtering, washing and drying machine, 12-a pulverizer, 13-a temporary storage bin, 14-a capping and sealing machine, 15-a second aseptic passage and 16-a first aseptic passage;
201-a crusher body, 202-a feed inlet, 203-a discharge outlet, 204-a driving rotating shaft, 205-a double-head motor, 206-a first bevel gear, 207-a top crushing shaft, 208-a first spiral blade, 209-a material homogenizing disc, 210-a linkage rod, 211-a screen, 212-a supporting wheel, 213-a bottom crushing shaft, 214-a second spiral blade and 215-a blanking barrel.
Detailed Description
In order to better understand the technical solution, the technical solution will be described in detail with reference to the drawings and the specific embodiments.
The whole production line mainly comprises: the device comprises a dissolving and decoloring tank, an aseptic processing device, an organic solvent storage tank, a crystallization processing tank, a filtering, washing and drying machine, a crusher, a temporary storage bin, an aseptic subpackaging system, a capping and sealing machine, an online cleaning and sterilizing control system, a heating and cooling system and the like.
In the first embodiment, as shown in fig. 1 to 3, an aseptic raw material production line comprises an aseptic workshop 1, wherein a raw material temporary storage chamber 2, a first clean room 3, a second clean room 4, a third clean room 5 and a fourth clean room 6 are arranged in the aseptic workshop 1 side by side, and a dissolving and decoloring tank 7, an organic solvent storage tank 8, an aseptic processing device 9, a crystallization processing tank 10, a filtering, washing and drying machine 11, a pulverizer 12, an aseptic subpackaging system and a capping and sealing machine are arranged in the aseptic workshop; the dissolving and decoloring tank and the organic solvent storage tank are connected with the crystallization treatment tank through an aseptic treatment device, the discharge end of the crystallization treatment tank is connected with the filtering, washing and drying machine through a connecting pipeline, the discharge port of the filtering, washing and drying machine is connected with the crusher through a connecting pipeline, and the discharge end of the crusher is sequentially connected with the aseptic subpackaging system and the capping and sealing machine; the dissolving and decoloring tank and the organic solvent storage tank are arranged in a first clean room; aseptic processing apparatus, crystallization processing jar are installed in the second toilet, and filtering and washing desiccator, rubbing crusher are installed in the third toilet, and the feed bin of keeping in, aseptic partial shipment system, roll lid sealing machine 14 and install in the fourth toilet, set up independent toilet through every core technology, guarantee the aseptic stability of whole production line.
The pulverizer 12 comprises a pulverizer body 201, a pulverizing chamber is formed in the pulverizer body 201, a feed inlet 202 is formed in the top of the pulverizing chamber, a double-head motor 205 is upwards connected onto the outer side wall of the pulverizing chamber, driving rotating shafts 204 are fixedly connected to the upper side and the lower side of the double-head motor 205, a first bevel gear 206 is fixedly sleeved on the outer portion of the driving rotating shaft on the upper side of the double-head motor, a top pulverizing shaft is transversely and rotatably connected into the pulverizer body, penetrates through the pulverizing chamber and is connected with the first bevel gear through a second bevel gear, a first helical blade 208 is fixedly sleeved on the outer portion of the top pulverizing shaft 207, and a plurality of first shearing blades which are symmetrical to each other are fixedly connected onto the outer wall of the top pulverizing shaft; a blanking barrel 215 is arranged in the crusher body at a position right below the top crushing shaft, a bottom crushing shaft is rotationally connected to the blanking barrel 215, the bottom crushing shaft is in transmission connection with a lower end driving rotating shaft 204 of a double-head motor, a second helical blade 214 is fixedly sleeved outside the bottom crushing shaft, a plurality of second shearing blades which are symmetrical to each other are fixedly connected to the outer wall of the bottom crushing shaft 213, a material equalizing disc 209 is arranged on the blanking barrel extending out of the top of the bottom crushing shaft 213, a screen is arranged in the crusher body at a position corresponding to the top of the outer side wall of the blanking barrel, and a discharge hole 203 is arranged at the bottom of the crusher body; a plurality of supporting wheels 212 which are attached to the inner wall of the pulverizer to rotate are arranged on the outer side wall of the top of the screen, a plurality of linkage rods 210 which are fixedly connected with the outer side wall of the bottom pulverizing shaft are arranged on the inner side wall of the screen, and the bottom of the screen 211 is connected with the blanking barrel in a sliding and sealing manner; the working process of the pulverizer is as follows: the double-head motor is started firstly, the rotation of output shafts on two sides of the double-head motor can drive the rotation of the top crushing shaft, the top crushing shaft can drive the rotation of the first helical blade, the rotation of the top crushing shaft can also drive the rotation of the first shearing blade, meanwhile, the double-head motor can drive the rotation of the bottom crushing shaft, the rotation of the bottom crushing shaft can drive the rotation of the second helical blade, the rotation of the bottom crushing shaft can drive the rotation of the second shearing blade, the rotation of the bottom crushing shaft can drive the rotation of the linkage rod, the rotation of the linkage rod can drive the rotation of the screen mesh, and thus, the screen mesh is prevented from being blocked by crushed objects, the screened objects are crushed twice, the crushing effect is better, the subsequent packaging is more convenient, the screened objects are crushed once, the equipment load is reduced, and finally, the discharge is carried out from a discharge port, and the whole crushing process is finished.
In order to further ensure the sterile condition in the production process and prevent the outside from entering personnel to influence the production, a first sterile passage 16 and a second sterile passage 15 are arranged in a sterile workshop, the first sterile passage is communicated to a first clean room and a raw material temporary storage room, the second sterile passage is communicated to a second clean room, a third clean room and a fourth clean room through a plurality of buffer rooms, through independently designed passages, on one hand, the complexity of unnecessary procedures is reduced, and meanwhile, the sterile arrangement of the whole production line is ensured, the buffer rooms comprise a first buffer room, a sterile coat room and a second buffer room which are sequentially communicated and arranged, and the stability of sterile treatment is improved through the first buffer room, the sterile coat room and the second buffer room. In addition, the sterile workshop is also provided with an independent inner packing material sterilization chamber and an independent inner packing material cleaning chamber, a double-door dry heat sterilization cabinet is arranged in the inner packing material sterilization chamber, and the complete independent design can be improved
Furthermore, dissolve the decoloration jar and include interconnect's dissolving tank, decoloration jar, install pneumatic valve between the connecting tube, the valve more than 95% adopts pneumatic control on the equipment, has realized the function of the automatic operation of equipment on-line cleaning and online sterilization, has reduced the operation degree of difficulty, has simplified operation procedure, has avoided the loss because of misoperation brings, is favorable to new employee to master operating skill fast.
Further, still be connected with temporary storage feed bin 13 between rubbing crusher 12, the aseptic partial shipment system, guarantee the continuity of production through temporary storage feed bin, when guaranteeing simultaneously that partial equipment shuts down, can not cause shutting down of whole production line
The working process of the invention is as follows: the raw materials are put into a dissolving and decoloring tank, adsorbed by medicinal carbon and then pumped into a decarburization tank, sterilized and filtered and then fed into a crystallization tank, meanwhile, an organic solvent is sterilized and filtered and then pumped into the crystallization tank, mixed and cooled to crystallize, then a solid-liquid mixture is pressed into a filtering, washing and drying machine through a pipeline, mother liquor is removed after crystal washing, a drying program is carried out, a material valve is opened after drying is finished, a pulverizer is started, the materials are conveyed to a storage bin for temporary storage while being pulverized, the pressure of the storage bin is balanced after the pulverization is finished, a discharge valve is opened, the materials are metered and discharged, the materials are loaded into an aluminum barrel under the protection of A level, a cover is rolled and sealed, and labels are pasted and put into a warehouse.
While preferred embodiments of the present invention have been described, additional variations and modifications in those embodiments may occur to those skilled in the art once they learn of the basic inventive concepts. Therefore, it is intended that the appended claims be interpreted as including preferred embodiments and all such alterations and modifications as fall within the scope of the invention.
It will be apparent to those skilled in the art that various changes and modifications may be made in the present invention without departing from the spirit and scope of the invention. Thus, if such modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include such modifications and variations.
Claims (9)
1. The utility model provides an aseptic raw materials production line, includes aseptic workshop, be provided with raw materials room, first toilet, second toilet, third toilet, fourth toilet of keeping in side by side in the aseptic workshop, its characterized in that: a dissolving and decoloring tank, an organic solvent storage tank, an aseptic processing device, a crystallization processing tank, a filtering, washing and drying machine, a pulverizer, an aseptic subpackaging system and a capping and sealing machine are arranged in the aseptic workshop;
the dissolving and decoloring tank and the organic solvent storage tank are connected with the crystallization treatment tank through an aseptic treatment device, the discharge end of the crystallization treatment tank is connected with the filtering, washing and drying machine through a connecting pipeline, the discharge port of the filtering, washing and drying machine is connected with the crusher through a connecting pipeline, and the discharge end of the crusher is sequentially connected with an aseptic subpackaging system and a capping and sealing machine;
the dissolving and decoloring tank and the organic solvent storage tank are arranged in a first clean room; aseptic processing apparatus, crystallization processing jar set up in the second clean room, filtering, washing and drying machine, rubbing crusher set up in the third clean room, the feed bin of keeping in, aseptic partial shipment system, roll and cover the sealing machine setting in the fourth clean room.
2. An aseptic raw material production line as claimed in claim 1, wherein: a first sterile channel and a second sterile channel are arranged in the sterile workshop, the first sterile channel is communicated to the first clean room and the raw material temporary storage room, and the second sterile channel is communicated to the second clean room, the third clean room and the fourth clean room through a plurality of buffer rooms.
3. An aseptic raw material production line as defined in claim 2, wherein: the buffer room comprises a first buffer room, a sterile outer coating room and a second buffer room which are sequentially communicated.
4. An aseptic raw material production line as defined in claim 1, wherein: the sterile workshop is also provided with an independent inner packing material sterilization chamber and an independent inner packing material cleaning chamber, and a double-door dry heat sterilization cabinet is arranged in the inner packing material sterilization chamber.
5. An aseptic raw material production line as claimed in claim 1, wherein: the dissolving and decoloring tank comprises a dissolving tank and a decoloring tank which are connected with each other, and a pneumatic valve is arranged between the connecting pipelines.
6. An aseptic raw material production line as defined in claim 1, wherein: a temporary storage bin is also connected between the pulverizer and the sterile subpackaging system.
7. An aseptic raw material production line as defined in claim 1, wherein: the pulverizer comprises a pulverizer body, a pulverizing cavity is formed in the pulverizer body, a double-end motor is upwards connected onto the outer side wall of the pulverizing cavity, the upper and lower two sides of the double-end motor are fixedly connected with driving rotating shafts, a first bevel gear is arranged on the external fixing sleeve of the driving rotating shaft on the upper side of the double-end motor, a top pulverizing shaft is transversely connected to the internal transverse rotation of the pulverizer body, the top pulverizing shaft penetrates through the pulverizing cavity and is connected with the first bevel gear through a second bevel gear, a first helical blade is arranged on the external fixing sleeve of the top pulverizing shaft, and a plurality of mutually symmetrical first shearing blades are fixedly connected to the outer wall of the top pulverizing shaft.
8. An aseptic raw material production line as defined in claim 7, wherein: be provided with blanking barrel under the rubbing crusher internal correspondence top crushing roller, blanking barrel's internal rotation is connected with bottom crushing roller, bottom crushing roller is connected with double-end motor's lower extreme drive pivot transmission, bottom crushing roller's outside fixed cover is equipped with second helical blade, bottom crushing roller's a plurality of mutual symmetrical second of outer wall fixedly connected with shears the blade, bottom crushing roller's top extends out blanking barrel and is provided with the charging tray of equaling, the internal correspondence blanking barrel outside wall top position of rubbing crusher is provided with the screen cloth, rubbing crusher bottom is provided with the discharge gate.
9. An aseptic raw material production line as defined in claim 8, wherein: be provided with on the screen cloth top lateral wall with rubbing crusher inner wall laminating pivoted a plurality of supporting wheels, be provided with a plurality of gangbars with bottom crushing roller lateral wall fixed connection on the screen cloth inside wall, screen cloth bottom and blanking section of thick bamboo sliding seal are connected.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210191631.0A CN114570100A (en) | 2022-02-28 | 2022-02-28 | Aseptic raw materials production line |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210191631.0A CN114570100A (en) | 2022-02-28 | 2022-02-28 | Aseptic raw materials production line |
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| Publication Number | Publication Date |
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| CN114570100A true CN114570100A (en) | 2022-06-03 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202210191631.0A Pending CN114570100A (en) | 2022-02-28 | 2022-02-28 | Aseptic raw materials production line |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107875407A (en) * | 2017-12-15 | 2018-04-06 | 天津梅花生物医药科技有限公司 | A kind of new bulk drug sterile processing systems |
| CN210086919U (en) * | 2019-04-25 | 2020-02-18 | 天俱时工程科技集团有限公司 | GMP workshop with figure flow dual vertical through layout |
| CN212293609U (en) * | 2020-05-15 | 2021-01-05 | 广东华糖实业有限公司 | Redissolved white granulated sugar clarification and decoloration device |
| CN214717293U (en) * | 2021-03-20 | 2021-11-16 | 安徽牧春堂天然药物研究开发有限公司 | Efficient pulverizer for massive objects |
-
2022
- 2022-02-28 CN CN202210191631.0A patent/CN114570100A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107875407A (en) * | 2017-12-15 | 2018-04-06 | 天津梅花生物医药科技有限公司 | A kind of new bulk drug sterile processing systems |
| CN210086919U (en) * | 2019-04-25 | 2020-02-18 | 天俱时工程科技集团有限公司 | GMP workshop with figure flow dual vertical through layout |
| CN212293609U (en) * | 2020-05-15 | 2021-01-05 | 广东华糖实业有限公司 | Redissolved white granulated sugar clarification and decoloration device |
| CN214717293U (en) * | 2021-03-20 | 2021-11-16 | 安徽牧春堂天然药物研究开发有限公司 | Efficient pulverizer for massive objects |
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