CN217138695U - On-site sterilization tank - Google Patents

On-site sterilization tank Download PDF

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Publication number
CN217138695U
CN217138695U CN202220623754.2U CN202220623754U CN217138695U CN 217138695 U CN217138695 U CN 217138695U CN 202220623754 U CN202220623754 U CN 202220623754U CN 217138695 U CN217138695 U CN 217138695U
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China
Prior art keywords
liquid medicine
pipeline
tank
sterilization
steam
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CN202220623754.2U
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Chinese (zh)
Inventor
阳发
石明凤
张林春
莫乙凯
吴四清
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Hunan Jiujian Pharmaceutical Technology Co ltd
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Hunan Jiujian Pharmaceutical Technology Co ltd
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Abstract

The utility model discloses an on-site sterilization tank, locate including the jar body that is used for holding the liquid medicine with sealed cover on the jar body, be equipped with the jacket layer on the external wall of jar, be connected with on the jacket layer be used for to it is right with the heat source is provided in the jacket layer the steam conduit of the internal liquid medicine sterilization of jar with be used for to it is right with the cooling water pipeline of the internal liquid medicine cooling of jar to press from both sides the jacket in situ. The tank body and the tank cover can be locked and sealed through a sealing ring and a screw. The utility model discloses a sterilization jar on throne sets up the jacket layer on jar external wall, connects steam line and cooling water pipeline on the jacket layer, can realize the preparation of aseptic liquid preparation, can solve unable aseptic liquid preparation sterilization demand that realizes aseptic characteristic through final sterilization, aseptic material or aseptic filtration technology of throwing.

Description

On-site sterilization tank
Technical Field
The utility model belongs to the technical field of the sterilization, especially, relate to a sterilization tank.
Background
The existing sterilization tank is mostly a steam sterilizer, is mainly used in a laboratory, and is a device which utilizes an electric heating wire to heat water to generate steam and can maintain certain pressure. When the sterilizing tank is used for sterilization, because steam is introduced into the tank for heating and can be condensed into water, when the sterilizing tank is used for sterilizing the sterile liquid preparation, the concentration of the liquid medicine can be gradually diluted, and the concentration of the sterile liquid preparation cannot meet the requirement finally. Namely, the steam sterilizer can not meet the requirement of in-situ sterilization of the sterile liquid preparation.
Therefore, when preparing the sterile liquid preparation, the aseptic liquid preparation is prepared by adopting a sterile filtration or aseptic feeding process to meet the requirement of the aseptic characteristic of the sterile liquid preparation. Aseptic liquid formulations do not meet aseptic requirements for processes that do not employ sterile filtration or aseptic dosing. The sterilization tank capable of realizing the in-situ sterilization requirement of the sterile liquid preparation has very important practical significance for the preparation of the sterile liquid preparation.
SUMMERY OF THE UTILITY MODEL
The utility model aims to solve the technical problem of overcoming the deficiencies and defects mentioned in the background art and providing an on-site sterilization tank for on-site sterilization of aseptic liquid preparation. In order to solve the technical problem, the utility model provides a technical scheme does:
the utility model provides an in situ sterilization jar, includes the jar body that is used for holding the liquid medicine and sealed locating cover on the jar body, be equipped with the jacket layer on the external wall of jar, be connected with on the jacket layer be used for to it is right to press from both sides the steam conduit of jacket in situ heat source with right the internal liquid medicine sterilization of jar with be used for to it is right to press from both sides the jacket in situ provides the cold source with the cooling water pipeline of the internal liquid medicine cooling of jar. The tank body and the tank cover can be locked and sealed through a sealing ring and a screw.
In the in-situ sterilization tank, preferably, an upper connector and a lower connector are respectively arranged above and below the jacket layer, and the steam pipeline and the cooling water pipeline are arranged between the upper connector and the lower connector.
In the above in-place sterilization tank, preferably, the steam pipeline includes a steam inlet pipeline and a steam condensate outlet pipeline, the steam inlet pipeline is communicated with the upper port, and the steam condensate outlet pipeline is communicated with the lower port. The steam inlet pipeline provides hot steam for heating the tank body for sterilization, and water obtained after steam condensation or uncondensed steam is discharged through the steam condensed water outlet pipeline.
Above-mentioned in situ sterilization jar, preferred, the cooling water pipeline includes refrigerated water inlet line and refrigerated water return line, refrigerated water inlet line with the interface intercommunication down, refrigerated water return line with go up the interface intercommunication. The chilled water inlet pipeline provides cooling water for cooling the liquid medicine in the tank body, and the return water of the cooling water is discharged through the chilled water return pipeline.
In the in-place sterilization tank, preferably, the tank cover is provided with a non-condensable gas discharge line for intermittently discharging non-condensable gas generated during sterilization in the tank body. During sterilization, the non-condensable gas generated in the tank body is intermittently discharged from a non-condensable gas discharge pipeline for a short time (for example, the non-condensable gas is discharged every 60 seconds at the temperature of below 100 ℃ and is discharged every 60 seconds at the temperature of above 100 ℃ for 0.1 second), so that the concentration of the liquid medicine caused by evaporation in the sterilization process is avoided, the evaporation of the liquid medicine is reduced to the maximum extent, and the condition that the liquid medicine is unqualified is avoided. The intermittent discharge is realized by any means, such as a valve with an automatic control function.
In the in-place sterilization tank, preferably, the tank cover is provided with a liquid medicine inlet pipeline, the lower end of the liquid medicine inlet pipeline extends into the tank body, and the end part of the liquid medicine inlet pipeline is provided with a spraying ball; the upper end of the liquid medicine inlet pipeline is connected with an upper station liquid medicine inlet pipeline and a pure steam pipeline. The liquid medicine inlet pipeline on the upper station can be used for adding cleaning water, and on the other hand, the liquid medicine can be added and mixed with the liquid medicine after in-situ sterilization, and the pure steam pipeline is used for introducing steam for sterilization.
In the in-situ sterilization tank, preferably, the lower end of the tank body is an elliptical seal head, and a magnetic stirring device is arranged on the seal head; the bottom of head is equipped with liquid medicine outlet pipe way, liquid medicine outlet pipe way end branch is liquid medicine to lower station pipeline and liquid medicine discharge pipeline. The liquid medicine to lower station pipeline is used for conveying the liquid medicine after in-place sterilization to the next storage tank for constant volume and filling, and the liquid medicine discharge pipeline is used for discharging cleaning water and condensed water during online Sterilization (SIP).
In the in-place sterilization tank, preferably, a hole site is formed in the tank cover and used for arranging the temperature sensor, the pressure sensor and the feeding hopper, and the pressure sensor and the feeding hopper share one hole site; and a lower temperature sensor is arranged below the tank body.
In the in-place sterilization tank, preferably, the in-place sterilization tank further comprises a respirator communicated with the tank body and used for air sterilization, and the respirator is connected with a first compressed air pipeline and a respirator condensate water discharge pipeline. The respirator is used for sterilizing, cooling and filtering air when the normal pressure in the tank is recovered during cooling, and is used for sterilizing air when compressed air is introduced for pressurization, so that the sterile state is ensured. The first compressed air pipeline is used for introducing compressed air into the tank body to pressurize and transfer the liquid medicine in the tank body, and the liquid medicine is sterilized through a respirator when the compressed air is introduced. The condensed water discharge pipeline of the respirator is used for discharging the condensed water in the respirator during the on-line Sterilization (SIP) of the empty tank.
In the in-situ sterilization tank, preferably, the upper connector is connected with a second compressed air pipeline, and the lower connector is connected with a jacket emptying pipe. The cooling water in the jacket layer can be dried through the second compressed air pipeline and then discharged through the jacket emptying pipe.
In the in-situ sterilization tank, preferably, the jacket emptying pipe, the steam condensate water outlet pipeline, the respirator condensate water discharge pipe, the non-condensable gas discharge pipeline and the liquid medicine discharge pipeline are all converged to a water discharge pipe.
In this embodiment, each pipeline can be provided with a valve to open and close the pipeline.
The on-site sterilization tank of the utility model can realize the on-site sterilization requirement of the aseptic liquid preparation. Adding non-sterile raw materials, adjuvants, and solvent into sterilizing tank, stirring, and sealing. Steam is introduced into the jacket layer of the tank body to heat to the sterilization temperature and maintain for a period of time, then cooling water is introduced into the jacket layer to reduce the temperature of the liquid medicine to the required temperature, and the whole process is kept stirring so that the liquid medicine is uniformly heated, thereby realizing the preparation of the sterile liquid preparation.
Compared with the prior art, the utility model has the advantages of:
1. the utility model discloses a sterilization jar sets up the jacket layer on jar external wall on throne, connect steam line and cooling water pipeline on the jacket layer, let in steam heating to sterilization temperature and maintain a period through the jacket layer of the jar body, let in the cooling water to the jacket layer again and fall to required temperature with the liquid medicine temperature, can realize the preparation of aseptic liquid preparation, can solve unable aseptic liquid preparation (including suspension) sterilization demand that realizes aseptic characteristic through final sterilization, aseptic material or aseptic filtration technology. Meanwhile, steam is introduced into the jacket layer to heat the liquid medicine, so that the liquid medicine is prevented from being diluted, and the stability of the liquid medicine can be maintained.
2. The on-site sterilization tank of the utility model has simple structure, convenient operation, short liquid inlet-sterilization-liquid outlet time (with cooling function) and wide market application prospect.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings needed to be used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to these drawings without creative efforts.
Fig. 1 is a schematic structural diagram of an in-place sterilization tank in the embodiment.
Illustration of the drawings:
1. a tank body; 2. a can lid; 11. sealing the end; 12. a magnetic stirring device; 13. a lower temperature sensor; 14. a liquid medicine outlet pipeline; 141. the liquid medicine is delivered to a lower station pipeline; 142. a liquid medicine discharge pipeline; 1421. a drain pipe; 15. a jacket layer; 151. an upper interface; 1511. a steam inlet pipe; 1512. a second compressed air line; 1513. the chilled water returns to the pipeline; 152. a lower interface; 1521. a steam condensate outlet pipe; 1522. a jacket drain pipe; 1523. a chilled water inlet pipe; 21. spraying a ball; 22. an upper temperature sensor; 23. a pressure sensor; 24. a feeding hopper; 25. a liquid medicine inlet pipeline; 251. a liquid medicine inlet pipeline of the upper station; 252. a pure steam line; 26. a respirator; 261. a first compressed air line; 262. a respirator condensed water discharge pipeline; 27. a non-condensable gas discharge pipeline.
Detailed Description
To facilitate understanding of the present invention, the present invention will be described more fully and specifically with reference to the accompanying drawings and preferred embodiments, but the scope of the present invention is not limited to the specific embodiments described below.
Unless otherwise defined, all terms of art used hereinafter have the same meaning as commonly understood by one of ordinary skill in the art. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of the present invention.
Unless otherwise specifically stated, various raw materials, reagents, instruments, equipment and the like used in the present invention are commercially available or can be prepared by an existing method.
Example (b):
as shown in fig. 1, the in-place sterilization tank of the present embodiment includes a tank body 1 for containing a liquid medicine and a tank cover 2 hermetically disposed on the tank body 1, a jacket layer 15 is disposed on an outer wall of the tank body 1, and a steam pipeline for providing a heat source to the jacket layer 15 to sterilize the liquid medicine in the tank body 1 and a cooling water pipeline for providing a cold source to the jacket layer 15 to cool the liquid medicine in the tank body 1 are connected to the jacket layer 15.
In this embodiment, an upper interface 151 and a lower interface 152 are respectively disposed above and below the jacket layer 15, and the steam pipeline and the cooling water pipeline are disposed between the upper interface 151 and the lower interface 152.
In this embodiment, the steam pipeline includes a steam inlet pipeline 1511 and a steam condensed water outlet pipeline 1521, the steam inlet pipeline 1511 is communicated with the upper interface 151, and the steam condensed water outlet pipeline 1521 is communicated with the lower interface 152.
In this embodiment, the cooling water pipeline includes a chilled water inlet pipe 1523 and a chilled water return pipe 1513, the chilled water inlet pipe 1523 is communicated with the lower interface 152, and the chilled water return pipe 1513 is communicated with the upper interface 151.
In this embodiment, the lid 2 is provided with a non-condensable gas discharge line 27 for intermittently discharging non-condensable gas generated during sterilization in the tank 1.
In the embodiment, the tank cover 2 is provided with a liquid medicine inlet pipeline 25, the lower end of the liquid medicine inlet pipeline 25 extends into the tank body 1, and the end part of the liquid medicine inlet pipeline is provided with a spraying ball 21; the upper end of the liquid medicine inlet pipeline 25 is connected with an upper station liquid medicine inlet pipeline 251 and a pure steam pipeline 252.
In the embodiment, the lower end of the tank body 1 is an elliptical seal head 11, and a magnetic stirring device 12 is arranged on the seal head 11; the bottom of the sealing head 11 is provided with a liquid medicine outlet pipeline 14, and the tail end of the liquid medicine outlet pipeline 14 is branched into a liquid medicine to lower station pipeline 141 and a liquid medicine discharge pipeline 142.
In the embodiment, the tank cover 2 is provided with hole sites for arranging the upper temperature sensor 22, the pressure sensor 23 and the feeding hopper 24, and the pressure sensor 23 and the feeding hopper 24 share one hole site; a lower temperature sensor 13 is arranged below the tank body 1.
In this embodiment, the in-place sterilization tank further comprises a breather 26 communicated with the tank body 1 for air sterilization, and a first compressed air pipeline 261 and a breather condensed water discharge pipeline 262 are connected to the breather 26.
In this embodiment, the upper connector 151 is connected to a second compressed air line 1512, and the lower connector 152 is connected to a jacket emptying tube 1522.
In this embodiment, the jacket evacuation pipe 1522, the steam condensate outlet pipe 1521, the respirator condensate discharge pipe 262, the non-condensable gas discharge pipe 27, and the chemical liquid discharge pipe 142 are all collected in a drain pipe 1421.
In using the in-place sterilization tank of the present embodiment, reference may be made to the following operating modes:
1. before use, injection water enters the in-situ sterilization tank from the upper station liquid medicine inlet pipeline 251, the liquid medicine inlet pipeline 25 and the spray ball 21 to perform online Cleaning (CIP), and cleaning water is discharged from the liquid medicine outlet pipeline 14, the liquid medicine to lower station pipeline 141 and the liquid medicine discharge pipeline 142.
2. Then pure steam enters from the pure steam pipeline 252, the liquid medicine inlet pipeline 25 and the spraying ball 21 to carry out online Sterilization (SIP) at 121 ℃ for 30 min. After that, the valves communicating with the liquid medicine inlet line 25 and the liquid medicine outlet line 14 are closed.
3. The pressure sensor 23 is detached, the feeding hopper 24 is installed, non-sterile raw material medicines, auxiliary materials and solvents which need to be sterilized are added into the in-place sterilization tank and are uniformly stirred, the feeding hopper 24 is detached, and the pressure sensor 23 is installed.
4. Hot steam is introduced into the jacket layer 15 through the steam inlet pipeline 1511 and the upper connector 151, steam condensate is discharged from the steam condensate outlet pipeline 1521, and the liquid medicine in the in-situ sterilization tank is subjected to in-situ sterilization at 121 ℃ for 15 min. Because the temperature of the industrial steam is higher, the pressure in the tank is increased, and the liquid medicine can reach the sterilization temperature. During sterilization, the magnetic stirring device 12 keeps stirring, so that the liquid medicine is heated uniformly. During sterilization, the sterilization temperature is monitored by the upper temperature sensor 22 and the lower temperature sensor 13, the opening and closing of a steam valve in the jacket layer are determined according to the temperature, and the opening and closing of the valve are controlled by a proportional control valve. The non-condensable gas in the tank is intermittently discharged from a non-condensable gas discharge line 27 for a short period of time (1 s per 60s at 100 ℃ or lower, and 0.1s per 60s at 100 ℃ or higher).
5. After the sterilization is finished, the chilled water enters the tank through the chilled water inlet pipe 1523 and the lower interface 152 to cool the liquid medicine in the tank to the required temperature, and the chilled water is discharged from the upper interface 151 and the chilled water return pipe 1513.
6. The qualified sterile liquid medicine after in-situ sterilization is further processed from the liquid medicine outlet pipeline 14 and the liquid medicine to the lower-station pipeline 141 to the lower process.
The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims (10)

1. The utility model provides an in-place sterilization tank, its characterized in that is located including jar body (1) that is used for holding the liquid medicine and sealed cover (2) on the jar body (1), be equipped with jacket layer (15) on jar body (1) outer wall, be connected with on jacket layer (15) be used for to provide the heat source in jacket layer (15) with right the steam line of the liquid medicine sterilization in jar body (1) and be used for to provide the cold source in jacket layer (15) with right the cooling water pipeline of liquid medicine cooling in jar body (1).
2. A canister as claimed in claim 1, characterised in that said jacket layer (15) is provided above and below with an upper (151) and a lower (152) connection, respectively, said steam and cooling water lines being provided between said upper (151) and lower (152) connections.
3. The in-place sterilization tank of claim 2, wherein said steam line comprises a steam inlet line (1511) and a steam condensate outlet line (1521), said steam inlet line (1511) being in communication with said upper port (151), said steam condensate outlet line (1521) being in communication with said lower port (152).
4. The in-place sterilization tank of claim 2, wherein the chilled water line comprises a chilled water inlet line (1523) and a chilled water return line (1513), the chilled water inlet line (1523) being in communication with the lower port (152), the chilled water return line (1513) being in communication with the upper port (151).
5. A sterilization pot as defined in any of claims 1-4, wherein said pot lid (2) is provided with a non-condensable gas discharge line (27) for intermittently discharging non-condensable gas generated during sterilization inside the pot body (1).
6. An in-place sterilization tank as claimed in any one of claims 1 to 4, wherein a liquid medicine inlet pipeline (25) is arranged on the tank cover (2), the lower end of the liquid medicine inlet pipeline (25) extends into the tank body (1) and the end part is provided with a spraying ball (21); the upper end of the liquid medicine inlet pipeline (25) is connected with an upper station liquid medicine inlet pipeline (251) and a pure steam pipeline (252).
7. An in-place sterilization tank as claimed in any one of claims 1 to 4, wherein the lower end of the tank body (1) is an elliptical head (11), and a magnetic stirring device (12) is arranged on the head (11); the bottom of the end enclosure (11) is provided with a liquid medicine outlet pipeline (14), and the tail end of the liquid medicine outlet pipeline (14) is branched into a liquid medicine to lower station pipeline (141) and a liquid medicine discharge pipeline (142).
8. An in-place sterilization tank as claimed in any one of claims 1 to 4, wherein the tank cover (2) is provided with holes for arranging an upper temperature sensor (22), a pressure sensor (23) and a feeding hopper (24), and the pressure sensor (23) and the feeding hopper (24) share one hole; a lower temperature sensor (13) is arranged below the tank body (1).
9. An in-place sterilization tank according to any of claims 1 to 4, further comprising a breather (26) for air sterilization communicating with the tank body (1), the breather (26) having a first compressed air line (261) and a breather condensate drain line (262) connected thereto.
10. An in-place sterilization tank as defined in any of claims 2-4 wherein a second compressed air line (1512) is connected to said upper port (151) and a jacket drain (1522) is connected to said lower port (152).
CN202220623754.2U 2022-03-21 2022-03-21 On-site sterilization tank Active CN217138695U (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202220623754.2U CN217138695U (en) 2022-03-21 2022-03-21 On-site sterilization tank

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202220623754.2U CN217138695U (en) 2022-03-21 2022-03-21 On-site sterilization tank

Publications (1)

Publication Number Publication Date
CN217138695U true CN217138695U (en) 2022-08-09

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CN202220623754.2U Active CN217138695U (en) 2022-03-21 2022-03-21 On-site sterilization tank

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116650682A (en) * 2023-05-05 2023-08-29 江苏艾克斯医疗设备有限公司 Sterilizer meeting biological requirements and control method thereof

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116650682A (en) * 2023-05-05 2023-08-29 江苏艾克斯医疗设备有限公司 Sterilizer meeting biological requirements and control method thereof
CN116650682B (en) * 2023-05-05 2024-05-17 江苏艾克斯医疗设备有限公司 Sterilizer meeting biological requirements and control method thereof

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Legal Events

Date Code Title Description
GR01 Patent grant
GR01 Patent grant
PE01 Entry into force of the registration of the contract for pledge of patent right

Denomination of utility model: An in place sterilization tank

Granted publication date: 20220809

Pledgee: Hunan Bank Co.,Ltd. Jinshi Branch

Pledgor: Hunan Jiujian Pharmaceutical Technology Co.,Ltd.

Registration number: Y2024980020309