阅读说明：本技术 一种交替式药品凝胶体配制方法与系统 (Method and system for preparing alternating medicine gel ) 是由 田耀华 赵海峰 陈龙 黄海芳 石永胜 马亦蓉 于 2019-09-24 设计创作，主要内容包括：本发明提供了一种交替式药品凝胶剂配制系统,其特征在于:包括凝胶体配置单元、分隔单元、凝胶体罐装单元、清洗灭菌单元和压力输送单元；其中,清洗灭菌单元,分别向凝胶体配置单元、分隔单元和凝胶体罐装单元独立地输送清洗灭菌的物质；压力输送单元,分别向凝胶体配置单元、分隔单元和凝胶体罐装单元独立地提供压力；凝胶体配置单元与凝胶体罐装单元之间,具有物料运输线；分隔单元,设置于凝胶体配置单元与凝胶体罐装单元之间,分隔凝胶体配置单元与凝胶体罐装单元使其能彼此独立运行,同时阻断或开放物料运输线。该交替式药品凝胶剂配制方法与系统,可利用有限配制间面积,增加合规的批次凝胶体配制量,达到提高生产率的目的。(The invention provides an alternating type medicine gel preparation system which is characterized by comprising a gel preparation unit, a separation unit, a gel canning unit, a cleaning and sterilizing unit and a pressure conveying unit, wherein the gel preparation unit is used for preparing a gel; wherein, the cleaning and sterilizing unit is used for independently conveying cleaning and sterilizing substances to the gel configuration unit, the separation unit and the gel canning unit respectively; a pressure delivery unit for independently providing pressure to the gel configuration unit, the partition unit and the gel canning unit; a material conveying line is arranged between the gel configuration unit and the gel canning unit; and the separation unit is arranged between the gel configuration unit and the gel canning unit, and separates the gel configuration unit and the gel canning unit to enable the gel configuration unit and the gel canning unit to operate independently and simultaneously block or open a material conveying line. The alternating medicine gel preparation method and system can increase the preparation amount of gel in batches in compliance by using the limited preparation room area, thereby achieving the purpose of improving the productivity.)

1. An alternating type medicine gel preparation system is characterized by comprising a gel preparation unit, a separation unit, a gel canning unit, a cleaning and sterilizing unit and a pressure conveying unit;

wherein, the cleaning and sterilizing unit independently conveys cleaning and sterilizing substances to the gel configuration unit, the separation unit and the gel canning unit respectively;

the pressure conveying unit is used for independently providing pressure to the gel configuration unit, the separation unit and the gel canning unit respectively;

a material conveying line is arranged between the gel configuration unit and the gel canning unit;

the separation unit is arranged between the gel configuration unit and the gel canning unit, and separates the gel configuration unit and the gel canning unit to enable the gel configuration unit and the gel canning unit to operate independently and simultaneously block or open a material transportation line.

2. The alternating drug gel formulation system of claim 1, wherein:

the gel configuration unit comprises at least two pre-mixing tanks and a main tank;

the gel canning unit comprises a buffer tank;

the separation unit comprises a separation middle pipe;

each pre-mixing tank is communicated with the main material tank;

the main material tank is communicated with the buffer tank through a finished product feeding pipe;

the separation middle pipe is communicated with the finished product feeding pipe and is a branch.

3. The alternating pharmaceutical gel formulation system of claim 2, wherein:

the cleaning and sterilizing unit comprises at least one liquid conveying pipe and at least one steam conveying pipe;

the pressure conveying unit comprises at least one compressed gas conveying pipe;

the liquid conveying pipe is provided with a plurality of liquid output ends;

the steam conveying pipe is provided with a plurality of steam output ends;

the compressed gas conveying pipe is provided with a plurality of compressed gas output ends;

the liquid output end, the steam output end and the compressed gas output end are the same in number and are the sum of the number of the pre-mixing tank, the number of the main material tank, the number of the buffer tank and the number of the separation middle pipes.

4. The alternating pharmaceutical gel formulation system of claim 3, wherein:

the pre-mixing tank is provided with a premix tank inlet part;

the inlet part of the premix tank is communicated with the corresponding liquid output end, steam output end and compressed gas output end, and each communicated passage is provided with a control valve;

the main material tank is provided with a main material tank inlet part;

the inlet part of the main material tank is communicated with the corresponding liquid output end, the corresponding steam output end and the corresponding compressed gas output end, and each communicated passage is provided with a control valve;

the separation middle pipe is provided with a separation middle pipe inlet part;

the inlet part of the separation middle pipe is communicated with the corresponding liquid output end and the steam output end, and each communicated passage is provided with a control valve;

the buffer tank is provided with a buffer tank inlet part;

the buffer tank inlet part is communicated with the liquid output end, the steam output end and the compressed gas output end which correspond to the buffer tank inlet part, and a control valve is arranged on each communicated passage.

5. The alternating pharmaceutical gel formulation system of claim 2, wherein:

the pre-mixing tank is provided with a pre-mixing tank outlet part;

the main material tank is provided with at least two main material inlet parts;

the material inlet part of each main material tank is communicated with the corresponding outlet part of the premix tank through a premix material conveying pipe;

the premix material conveying pipe is provided with a premix liquid discharge branch pipe;

the premix material conveying pipe is provided with a pipeline switching mechanism at the position of the premix liquid discharge branch pipe;

the main material tank is also provided with a main material tank outlet part;

the buffer tank is provided with a buffer material inlet part;

the main material tank outlet part is communicated with the buffering material inlet part through a finished product feeding pipe;

the finished product feeding pipe is provided with a main material liquid discharging branch pipe;

the finished product feeding pipe is provided with a pipeline switching mechanism at the position of the main material liquid discharge branch pipe;

the buffer tank is also provided with a buffer tank outlet part;

the outlet part of the buffer tank is communicated with a material discharge pipe of the buffer tank;

a control valve is arranged on the material discharge pipe of the buffer tank;

the separation middle pipe is provided with a separation middle pipe outlet part which is provided with a control valve.

6. The alternating pharmaceutical gel formulation system of claim 2, wherein:

a first valve and a second valve are sequentially arranged on the finished product feeding pipe along the direction from the main material tank to the buffer tank;

the partition middle pipe is communicated with a passage between the first valve and the second valve.

7. The alternating pharmaceutical gel formulation system of claim 6, wherein:

the finished product feeding pipe is also provided with a feeding pipe;

and the liquid conveying mechanism is arranged between the second valve and the buffer tank.

8. The alternating drug gel formulation system of any one of claims 1-7 further comprising a central control system;

and the central control system controls the on and off of each equipment component in the alternating type medicine gel preparation system according to a set standard.

9. A method for preparing an alternative pharmaceutical gel, characterized in that it is applied to a system as claimed in any one of claims 1 to 8;

after the gel configuration unit and the gel canning unit are completely isolated by the separation unit,

the gel canning unit is used for cleaning and disinfecting the gel configuration unit while continuing the current canning operation; or

The gel preparation unit is used for cleaning and disinfecting the gel canning unit while preparing the gel.

10. The method of claim 9 for formulating an alternating pharmaceutical gel, wherein:

the gel preparation unit is cleaned and sterilized by the following steps:

s1, respectively inputting cleaning solutions into a premixer and a mixed reaction container in a gel configuration unit for soaking;

s2, after soaking in the step S1, conveying the soaking liquid into a mixed reaction container in the gel configuration unit under the action of pressure, and then discharging the soaking liquid;

s3, isolating the gel canning unit through a separation unit;

s4, repeating S1 and S2, and simultaneously cleaning the separation unit by using the cleaning solution;

s5, performing steam cleaning on the gel configuration unit and the separation unit, and discharging condensed water;

the procedures of cleaning and disinfecting the gel canning unit are as follows:

s1, inputting cleaning fluid into each device in a gel canning unit, soaking and then discharging;

s2, isolating the gel configuration unit through the separation unit;

s3, repeating S1, and cleaning the separation unit by using the cleaning solution;

and S4, discharging condensed water after steam cleaning is carried out on the gel canning unit and the separation unit.

Technical Field

The invention relates to a method and a system for preparing an alternative medicine gel/paste, which are suitable for preparing sterile preparation gel in pharmaceutical factories by alternative production and are also suitable for preparing liquid by alternative production.

Background

Generally, when a gel or an ointment in a sterile preparation is produced, the gel or the ointment is usually required to be prepared. The preparation process comprises the following steps: and after the premixing tank A and the premixing tank B are respectively prefabricated, pressing the mixture into a main mixing tank, mixing, defoaming and homogenizing, and then filling into a high-level tank. Typically such a system will be equipped with only one CIP (clean on line)/SIP (sterilize on line) line. Therefore, during each batch of secondary production, the processes of premixing, mixing, defoaming and homogenizing are waited for, and then filling is carried out. However, the cleaning and sterilization are required to be performed after the filling is completed, and the filling process takes a long time during the production. Therefore, the traditional method only comprises one CIP/SIP pipeline, the CIP/SIP can be completed only after filling is completed, 2 times of waiting production conditions (namely filling and other preparation, and the next preparation needs to be finished after filling) occur, a large amount of time is consumed, the production rate is extremely low, and only 1 batch of products can be produced in 1 shift.

In order to improve the productivity of products such as gels, an alternative medicine gel preparation method and system which is simple and convenient to use are greatly needed on the premise of ensuring the CIP/SIP compliance.

Disclosure of Invention

The invention aims to overcome the defects and provides an alternative medicine gel preparation method and system, which are suitable for preparing sterile preparation gel in pharmaceutical factories. The productivity of products such as gels is improved while ensuring CIP/SIP compliance.

The invention provides an alternating type medicine gel preparation system which is characterized by comprising a gel preparation unit, a separation unit, a gel canning unit, a cleaning and sterilizing unit and a pressure conveying unit, wherein the gel preparation unit is used for preparing a gel;

wherein, the cleaning and sterilizing unit independently conveys cleaning and sterilizing substances to the gel configuration unit, the separation unit and the gel canning unit respectively;

the pressure conveying unit is used for independently providing pressure to the gel configuration unit, the separation unit and the gel canning unit respectively;

a material conveying line is arranged between the gel configuration unit and the gel canning unit;

the separation unit is arranged between the gel configuration unit and the gel canning unit, and separates the gel configuration unit and the gel canning unit to enable the gel configuration unit and the gel canning unit to operate independently and simultaneously block or open a material conveying line.

In particular, the alternating drug gel formulation system described above can be used for alternating sequence formulation, CIP/SIP and filling production.

The cleaning and sterilizing unit is used for providing cleaning fluid, mixed liquid, steam and the like for each device;

the pressure conveying unit is used for providing pressure for each device, so that the materials are pressed between tanks among the devices;

the gel preparation unit is used for preparing the gel of the medicine and performing the CIP/SIP subsequently.

The separating unit is a transition connecting the gel configuration unit and the gel canning unit, is also an interface area alternately used by the whole system, and can be alternately used for CIP/SIP of the gel configuration unit and the gel canning unit.

The gel canning unit is used for temporarily storing gel and conveying subsequent canned materials, and subsequent CIP/SIP.

With the separation unit as a boundary, the gel filling unit can independently carry out gel preparation, inter-tank material pressing and CIP/SIP of each pipeline, and at the moment, gel still in the filling is stored in the subsequent gel filling unit, thus the production rate can be improved by alternative production.

Further, the invention provides an alternating type medicine gel preparation system which is characterized in that the gel preparation unit comprises at least two pre-mixing tanks and a main tank;

the gel canning unit comprises a buffer tank;

the separation unit comprises a separation middle pipe;

wherein, each pre-mixing tank is communicated with the main material tank;

the main material tank is communicated with the buffer tank through a finished product feeding pipe;

the separation middle pipe is communicated with the finished product feeding pipe and is a branch.

Furthermore, the invention provides an alternating type medicine gel preparation system which is characterized in that the cleaning and sterilizing unit comprises at least one liquid conveying pipe and at least one steam conveying pipe;

the pressure delivery unit comprises at least one compressed gas delivery pipe;

the liquid conveying pipe is provided with a plurality of liquid output ends;

the steam conveying pipe is provided with a plurality of steam output ends;

the compressed gas conveying pipe is provided with a plurality of compressed gas output ends;

the liquid output ends, the steam output ends and the compressed gas output ends are the same in number and are the sum of the number of the pre-mixing tank, the number of the main material tank, the number of the buffer tanks and the number of the separating middle pipes.

Furthermore, the alternating type medicine gel preparation system is characterized in that the premix compound tank is provided with a premix compound tank inlet part;

the inlet part of the premix pot is communicated with the corresponding liquid output end, steam output end and compressed gas output end, and each communicated passage is provided with a control valve;

the main material tank is provided with a main material tank inlet part;

the inlet part of the main material tank is communicated with the corresponding liquid output end, the steam output end and the compressed gas output end, and each communicated passage is provided with a control valve;

the separation middle pipe is provided with a separation middle pipe inlet part;

the inlet part of the separation middle pipe is communicated with the corresponding liquid output end and the steam output end, and each communicated passage is provided with a control valve;

the buffer tank is provided with a buffer tank inlet part;

the inlet part of the buffer tank is communicated with the corresponding liquid output end, the corresponding steam output end and the corresponding compressed gas output end, and a control valve is arranged on each communicated passage.

Furthermore, the invention provides an alternate medicine gel preparation system which is characterized in that the premix material tank is provided with an outlet part of the premix material tank;

the main material tank is provided with at least two main material inlet parts;

the material inlet part of each main material tank is communicated with the corresponding outlet part of the premix tank through a premix material conveying pipe;

the premixed material conveying pipe is provided with a premixed liquid discharge branch pipe;

the premix material conveying pipe is provided with a pipeline switching mechanism at the position of the premix liquid discharge branch pipe;

the main material tank is also provided with a main material tank outlet part;

the buffer tank is provided with a buffer material inlet part;

the main material tank outlet part is communicated with the buffering material inlet part through a finished product feeding pipe;

the finished product feeding pipe is provided with a main material liquid discharging branch pipe;

the finished product feeding pipe is provided with a pipeline switching mechanism at the position of the main material liquid discharge branch pipe;

the buffer tank is also provided with a buffer tank outlet part;

the outlet part of the buffer tank is communicated with a material discharge pipe of the buffer tank;

a control valve is arranged on the material discharge pipe of the buffer tank;

the separating middle pipe is provided with an outlet part of the separating middle pipe, and a control valve is arranged on the outlet part of the separating middle pipe.

Further, the alternating type medicine gel preparation system provided by the invention is characterized in that a first valve and a second valve are sequentially arranged on the finished product feeding pipe along the direction from the main material tank to the buffer tank;

the partition middle pipe is communicated with a passage between the first valve and the second valve.

Further, the invention provides an alternate medicine gel preparation system which is characterized in that the finished product feeding pipe is also provided with a gel preparation device;

the liquid delivery mechanism is installed between the second valve and the buffer tank.

Further, the invention provides an alternate drug gel preparation system, which is characterized in that:

the system also comprises a central control system;

the central control system controls the on and off of each equipment component in the alternating type medicine gel preparation system according to a set standard.

In addition, the invention also provides a preparation method of the alternating type medicine gel, which is characterized by being applied to the system;

after the gel configuration unit and the gel canning unit are completely isolated by the separation unit,

the gel canning unit is used for cleaning and disinfecting the gel configuration unit while continuing the current canning operation;

or

The gel preparation unit is used for cleaning and disinfecting the gel canning unit while preparing the gel.

Further, the preparation method of the alternating type medicine gel is characterized by comprising the following steps:

the gel preparation unit is cleaned and sterilized by the following steps:

s1, respectively inputting cleaning solutions into a premixer and a mixed reaction container in a gel configuration unit for soaking;

s2, after soaking in the step S1, conveying the soaking liquid into a mixed reaction container in the gel configuration unit under the action of pressure, and then discharging the soaking liquid;

s3, isolating the gel canning unit through a separation unit;

s4, repeating S1 and S2, and simultaneously cleaning the separation unit by using the cleaning solution;

and S5, carrying out steam cleaning on the gel configuration unit and the separation unit, and discharging condensed water.

Further, the preparation method of the alternating type medicine gel is characterized by comprising the following steps:

the procedures of cleaning and disinfecting the gel canning unit are as follows:

s1, inputting cleaning fluid into each device in a gel canning unit, soaking and then discharging;

s2, isolating the gel configuration unit through the separation unit;

s3, repeating S1, and cleaning the separation unit by using the cleaning solution;

and S4, discharging condensed water after steam cleaning is carried out on the gel canning unit and the separation unit.

The invention has the following functions and effects:

the invention provides a preparation method and a system of an alternative medicine gel. The alternating pharmaceutical gel formulation system for use in the alternating formulation production (including formulation, CIP/SIP) of sterile pharmaceutical gels in a pharmaceutical factory, comprising: the premixing tank/main material tank form the front end of the preparation system, and are used for preparing gel and subsequent CIP/SIP; the branch pipe (the separation middle pipe) is a transition between the front end of the system and is also an alternately used interface area and can be alternately used for CIP/SIP of the front end of the system and the rear buffer storage section; a rear buffer storage section consisting of a buffer tank and used for filling and storing the gel and subsequent CIP/SIP. The alternating type medicine gel preparation method comprises the gel preparation of the whole system, and CIP/SIP is alternately carried out on the front end and the rear buffer storage section of the system respectively. A method and system for preparing alternative medicine gel features that the branch pipe is used to separate the front end of system from the filling and storing end of gel for CIP/SIP, preparing gel and storing gel, so increasing the preparing amount of gel in batches and increasing productivity.

Drawings

FIG. 1 is a schematic view of an alternate drug gel formulation system of the present invention.

Description of the references in the attached figure 1:

a: a premixing tank; b: a premixing tank; c: a main material tank; d: a buffer tank; WFI: a water line for injection; PS: a pure steam line; PA: a clean compressed air line; DR: a drain pipe; k: a pump; m: a quick-fit hose; a1/a2/a3/a4/a 5: a valve; b1/b2/b3/b4/b 5: a valve; c1/c2/c3/c 4: a valve; d1/d2/d 3: a valve; e1/e 2: a valve; g/f: a valve; l: a branch pipe; h: a hose coupling.

Detailed Description

As shown in figure 1, an alternate medicine gel preparation system for preparing sterile preparation gel in pharmaceutical factory comprises a premixing tank A, a premixing tank B, a main material tank C, a buffer tank D, an injection water pipeline WFI, a pure steam pipeline PS, a clean compressed air pipeline PA, a drain pipe DR, a quick-assembly hose M, a valve a1/a2/a3/a4, a valve B1/B2/B3/B4/B5, a valve C1/C2/C3/C4/C5, a bottom valve D1/D2/D3, a valve e1/e2, a valve g and a branch pipe L.

Wherein: the premixing tank A/B is a conventional gel premixing tank, generally a reaction tank body with a stirring, spraying ball and jacket;

the main material tank C is a conventional gel reaction tank, and is generally a reaction tank with an internal stirring/external scraping plate, emulsification, vacuumizing, spraying balls and a jacket;

the buffer tank D is a conventional gel storage tank/transfer tank, and is generally a storage tank with a spray ball and a jacket;

the water pipeline WFI/pure steam pipeline PS/clean compressed air pipeline PA for injection is mainly a circular straight pipe, is provided with a plurality of branch pipelines, is generally formed by welding and installing a bent pipe, a tee joint and the like in order to be communicated with a premixing tank A/a premixing tank B/a main material tank C/a main material tank D/a branch pipe L;

in this embodiment, the injection water pipeline WFI and the pure steam pipeline PS are merged between the inlet premix tank a/the premix tank B/the main tank C/the main tank D/the branch pipe L, so as to reduce the need for drilling modification of the premix tank a/the premix tank B/the main tank C/the main tank D and improve the sealing degree.

The clean compressed air pipeline PA is an independent pipeline and is an air pipe capable of resisting pressure and used for conveying compressed air into the premixing tank A/the premixing tank B/the main charging bucket C/the main charging bucket D/the branch pipe L.

The drain pipe DR has a straight pipe as a main body, and is generally formed by welding and mounting a bent pipe, a tee joint and the like at a joint position in order to communicate with the premixing tank a, the premixing tank B, the main material tank C, the main material tank D and the branch pipe L.

The quick-mounting hose M is a sanitary quick-mounting hose with joints at two ends, and can be connected with equipment such as a canning machine or a drain pipe as required;

the valves a1/a2/a3/a4/a5, b1/b2/b3/b4/b5, c1/c2/c3/c4, the valves e1/e2 and the valves g/f are all sanitary grade diaphragm valves;

the bottom valve d1/d2/d3 is a sanitary three-way diaphragm valve;

the branch pipe L is formed by welding and installing a four-way joint, a three-way joint, a valve piece and the like.

The installation and layout of each device is as follows:

in the present embodiment, the injection water line WFI (cleaning water), the pure steam line PS (steam sterilization), and the clean compressed air line PA (pressure delivery) are respectively disposed above the premixing tank a/premixing tank B/main material tank C, and are connected to the premixing tank a/main material tank C by conventional installation methods such as circular tube, elbow, tee, flange, and valve element (a1/a2/a3, B1/B2/B3, C1/C2/C3). Meanwhile, the lower part of the premixing tank A/the premixing tank B/the main material tank C is connected with a drain pipe DR by a round pipe, a bent pipe, a three-way bottom valve (d1/d2) and other conventional installation methods.

In this embodiment, the injection water line WFI (cleaning water) and the pure steam line PS (steam sterilization) are disposed above the branch line L, and connected to the drain line DR via the valve elements (b5, C5) and the bottom of the branch line L via the bottom valve D3 of the main tank C, the feed line of the buffer tank D, the four-way valve, the three-way valve, the pump K, the valve elements (e1, e2), and the like.

In this embodiment, for the gel filling storage end, the injection water line WFI (cleaning water), the pure steam line PS (steam sterilization), and the clean compressed air line PA (pressure delivery) are respectively disposed above the buffer tank D, and are connected to the buffer tank D through a circular tube, a bent tube, a tee, a flange, and valve members (a4, b4, c 4). Meanwhile, the lower part of the buffer tank D is connected with a filling machine (during filling) or an upper hose connector h of a drain pipe (during CIP/SIP) through a three-way bottom valve f and a quick-assembly hose M.

The specific operation method comprises the following steps:

A. gel formulation

All valves are closed, the medicines are respectively put into the premixing pot A/the premixing pot B, the valve a1/a2 is opened, the water for injection WFI is added according to the process requirement, the valve a1/a2 is closed, and the mixture is stirred. After gel is prefabricated, valve parts C1/C2 are opened respectively, valve parts d1/d2 are reversed to the material pressing direction, the prefabricated gel is pressed into a main material tank C by using clean compressed air PA, and the valve parts C1/C2 and the valve parts d1/d2 are closed.

Then, the valve a3 is opened, the water for injection WFI is added according to the process requirements, the valve a3 is closed, and stirring, homogenizing and vacuum defoaming are carried out. After the uniform gel is prepared, the valve c3 is opened, the valve D3 is switched to the material pressing direction, the valve e1/e2 on the pipeline is opened, the pump K is opened, clean compressed air PA is introduced to press and act with the pump, the uniform gel is pumped into the buffer tank D, and the valve c3, the valve D3, the valve e1/e2 and the pump K are closed. Before the buffer tank D is driven, a valve f of the buffer tank D is opened, and the quick-assembly hose M is connected.

B. System front end CIP/SIP

Firstly, opening the valve element a1/a2/a3, respectively injecting the water for injection WFI into the premixing tank A/the premixing tank B/the main material tank C, closing the valve element a1/a2/a3 after reaching the liquid level, and respectively soaking the premixing tank A/the premixing tank B/the main material tank C while stirring. After a period of time, the valve element d1/d2 is switched to the material pressing direction, the valve element d3 is communicated with the drain pipe DR, the valve element C1/C2 is opened, the soaking water in the premixing tank A/B is pressed into the main material tank C by using clean compressed air PA, and the valve element C1/C2 is closed. At this time, the immersion water in the main material tank C and the immersion water in the premix tank A/B pressed in are discharged into the drain line DR through the valve element d3, and the valve elements d1/d2/d3 are closed.

Partitioning is performed to open the valve element e1 (closed at e2) below the branch pipe L and open the valve element g.

Then, the valve elements a1/a2/a3/a5 are opened, and the water for injection WFI is injected into the premix tank a/premix tank B/main tank C/branch pipe L, respectively. Meanwhile, the valve element d1/d2 is reversed to the material pressing direction, the valve element d3 is communicated with the drain pipe DR, the valve element C1/C2 is opened, and the clean compressed air PA for pressing the fine bleaching water in the premixing tank A/B into the main material tank C is pressed. At this time, the water in the main material tank C and the finely floated water in the premix tank a/B pressed therein are discharged to the drain line DR through the valve d 3. At the same time, the inside of the branch pipe L (including the lower bypass) is rinsed by injecting water for injection WFI. After the rinsing is finished, the valve element C1/C2 is closed, then the valve element a1/a2/a3/a5 is closed, the valve element d1/d2 is switched to be communicated with the drain pipe DR, water in the premixing tank A/the premixing tank B/the main tank C/the branch pipe L is drained, and the valve element d1/d2/d3 and the valve element g are closed.

In the separated state, namely, when the valve element e1 is opened (closed at e2) below the branch pipe L. Firstly, switching a valve element d1/d2/d3 to a material pressing direction, opening a valve element B1/B2/B3/B5, respectively injecting pure steam PS into the premixing tank A/the premixing tank B/the main charging bucket C/the branch pipe L, and closing the valve element B1/B2/B3/B5 after the pressure maintaining meets the requirements of a sterilization process. Then, the valve element d1/d2/d3 is reversed to be communicated with the drain pipe DR, and the valve element g is opened to drain the condensed water. And finally all valve elements are closed.

C. Gel filling storage end

The quick-fit hose M connected to the filling machine is first removed and connected to the hose connector h on the drain pipe DR.

The valve element a4 is opened, the water for injection WFI is poured into the buffer tank D, and after reaching the liquid level, the valve element a4 is closed, and the buffer tank D is soaked while being stirred. After a period of time, the valve f is opened, the soaking water in the buffer tank D is put into the drain pipe DR through the valve f, and the valve f is closed.

Partitioning is performed to open the valve element e2 (closed at e 1) below the branch pipe L and open the valve element g.

Then, the valves a4/a5 are opened, and the injection water WFI is injected into the buffer tank D and the branch pipe L, respectively. At this time, the finely floated water in the buffer tank D is discharged into the drain pipe DR through the valve member f. At the same time, the branch pipe L (including the lower bypass) is rinsed by injecting water for injection WFI, and the pump K is turned on to pump the water through pipeline into the buffer tank D. After the rinsing is finished, the valve a4/a5 is closed, the water in the buffer tank D/branch pipe L is drained, and the valve f/and the valve g are closed.

In the separated state, namely, when the valve element e2 is opened (closed at e 1) below the branch pipe L. And opening a valve b4/b5, respectively injecting pure steam PS into the D/branch pipe L of the buffer tank, and closing the valve b4/b5 after the pressure maintaining meets the requirement of the sterilization process. Then, the valve f and the valve g are opened to drain the condensed water. And finally all valve elements are closed.