CN204699077U - A kind of RTP container and online sterilizing and online dry device - Google Patents

Abstract

The utility model discloses an RTP container and an on-line sterilization and on-line drying device comprising the RTP container. The current RTP container must be placed in a sterilizer for off-line sterilization. It is difficult to achieve complete drying through the drying system of the sterilizer, which cannot meet the process requirements for strict control of the dryness of the item. The utility model RTP container is characterized in that an air inlet is opened on the cavity close to the passive door and is connected with an air inlet diaphragm valve, and an exhaust port is opened at the bottom of the cavity and is connected with an exhaust port diaphragm valve; The outer wall of the cavity is covered with a detachable insulation layer, and the passive door is covered with a pressure protection cover resistant to high pressure steam sterilization pressure. The RTP container of the utility model is suitable for on-line sterilization and on-line drying.

Description

A kind of RTP container and its on-line sterilization and on-line drying device

technical field

The utility model relates to the technical field of pharmaceutical machinery steam sterilization, in particular to an RTP container used in pharmaceutical, biological, food and other industries for transferring aseptic items and an on-line sterilization and on-line drying device containing the RTP container.

Background technique

In the production process of pharmaceutical, biological, food and other industries, it is often necessary to transfer sterilized items from one sterile space to another in a non-sterile production environment. Maintain the sterility of items, such as transferring sterile items from a sterilizer to an aseptic filling isolator.

At present, the most widely used is RTP (Rapid Transfer Port) fast transfer door technology. A complete set of RTP doors consists of alpha doors (also called active doors) and beta doors (also called passive doors), where alpha doors are generally installed on the walls of isolators, RABS or biological safety cabinets, and beta doors are installed on On the outlet of the container containing the items, the container is therefore also called an RTP container.

A hydrophobic sterile-grade filter is installed at the bottom of the RTP container, which allows saturated steam to pass through, so the entire RTP container can be sterilized in a sterilizer.

The current sterilization process of RTP containers is as follows: First, put the items that need to be delivered aseptically (including production tools, glassware, packaging materials and other items that can be sterilized by steam) into the RTP container, and close the beta door;

Second, put the entire RTP container into a sterilizer for steam sterilization;

Then, take out the sterilized RTP container, connect the beta door of the outlet to the alpha door of the isolator (the isolator has been sterilized in advance and is ready for use), and lock it;

Finally, through the gloves on the isolator, open the entire set of RTP doors inside the isolator, thereby connecting the two sterile spaces, and quickly transfer the sterilized items from the RTP container to the isolator.

Although the above method has been widely used, its disadvantage is that the entire RTP container must be placed in the sterilizer for off-line sterilization, which is necessary for some items that need to be thoroughly dried after sterilization (such as rubber stoppers and glass bottles, etc.) ), it is difficult to achieve complete drying through the drying system that comes with the sterilizer, which cannot meet the process requirements for strict control of the dryness of the items.

Utility model content

The technical problem to be solved by the utility model is to overcome the above-mentioned defects in the prior art and provide an RTP container with improved structure, so that the RTP container can be suitable for on-line sterilization and on-line drying.

For this reason, the utility model adopts the following technical scheme: an RTP container, including a cavity resistant to high pressure steam sterilization pressure and a passive door installed at the discharge port of the cavity, characterized in that the cavity close to the passive door An air inlet is opened on the top and connected to an air inlet diaphragm valve, and an exhaust port is opened on the bottom of the cavity and connected to an exhaust port diaphragm valve;

The outer wall of the cavity is covered with a detachable insulation layer, and the passive door is covered with a pressure protection cover resistant to high pressure steam sterilization pressure.

The utility model removes the filter installed at the bottom of the RTP container in the existing RTP container structure, and the exhaust and drainage are all performed through the diaphragm valve at the exhaust port. The cavity and the pressure protection cover of the utility model need to withstand the sterilization pressure of saturated steam above 0.1 MPa.

Another object of the present utility model is to provide an on-line sterilization and on-line drying device comprising the above-mentioned RTP container, so that it can carry out on-line sterilization and on-line drying to the RTP container, which can thoroughly dry the sterilized articles, To meet the technical requirements of strictly controlling the dryness of the sterilized items.

For this reason, the technical scheme that another purpose of the present utility model adopts is as follows: RTP container on-line sterilization and on-line drying device, comprise above-mentioned RTP container, it is characterized in that, it also comprises conveying pipeline, clean steam system, clean compressed air system, Vacuum system, air heating system, air sterile filtration system, safety pressure relief device and drainage, drainage and exhaust system, and the drainage, drainage and exhaust system include discharge pipes;

The diaphragm valve at the exhaust port of the RTP container is connected to the discharge pipeline through a silicone hose and a quick-connect clamp;

The input end of the delivery pipeline is provided with the vacuum system and the clean compressed air system, the output end of the delivery pipeline is connected to the diaphragm valve of the air inlet of the RTP container through a silicone hose and a quick-connect clamp, and the input end of the delivery pipeline is connected to the The air heating system, air sterile filtration system, clean steam system and safety pressure relief device are sequentially arranged between the output ends;

The clean compressed air system is used to provide clean compressed air to the RTP container, the air heating system heats the clean compressed air, and the sterile air filter system sterilizes and filters the heated clean compressed air. The clean steam system is used to provide clean steam to the RTP container and the sterile air filtration system, and the hydrophobic, drainage and exhaust systems are used to sterilize the condensed water generated during the sterilization of the sterile air filtration system and the sterile air in the RTP container The condensed water produced and the clean compressed air passed into the RTP container during drying are discharged. The vacuum system is used to control the vacuum degree in the RTP container for vacuum drying; the safety pressure relief device is used for relief when overpressure Pressure, to ensure the safety of the RTP container in-line sterilization and in-line drying device when used. the

Further, the clean compressed air system includes a clean compressed air delivery pipeline, a pressure reducing valve and a first diaphragm valve installed on the clean compressed air delivery pipeline.

Further, the vacuum system includes a vacuum delivery pipeline, a vacuum pump installed on the vacuum delivery pipeline, a check valve and a second diaphragm valve.

Further, the air sterile filtration system includes a stainless steel filter housing, a sterilizing grade hydrophobic filter element placed in the housing, and a pressure gauge installed on the housing.

Further, the clean steam system includes a clean steam delivery pipeline and a steam proportional regulating valve installed on the clean steam delivery pipeline.

Further, the drainage, drainage and exhaust system also includes a condensate drainage pipeline, a first steam trap and a third diaphragm valve installed on the condensate drainage pipeline, and a discharge valve and a second steam trap installed on the discharge pipeline , the air sterile filtration system is connected to the discharge pipeline through the condensed water drainage pipeline.

Further, the on-line sterilization and on-line drying device also includes a control cabinet with PLC, man-machine interface and control software, the conveying pipeline is provided with a pressure probe and a pressure sensor, and the discharge Temperature probes and sensors are installed on the pipes and condensate drain pipes, and the entire operation of the RTP container on-line sterilization and on-line drying device is automatically controlled by PLC (all diaphragm valves, discharge valves, regulating valves and other valves are pneumatic).

The beneficial effects of the utility model are as follows: the on-line sterilization and on-line drying of the RTP container are realized, and the sterilization effect is better; the sterilization heating and cooling process is shortened, and the sterilization speed is faster; vacuum drying and hot air purge drying can Alternately, the drying is more thorough, which is suitable for the process with strict requirements on the dryness of the items; the whole operation process can be automatically controlled by PLC, which is more in line with the automation requirements of pharmaceutical equipment.

Description of drawings

Fig. 1 is a structural schematic diagram of the utility model RTP container.

In the figure, 100-cavity, 101-passive door (Beta door), 102-pressure protection cover, 103-inlet diaphragm valve, 104-exhaust diaphragm valve, 105-detachable insulation layer.

Fig. 2 is a schematic diagram of the RTP container on-line sterilization and on-line drying device of the present invention.

In the figure, 200-conveying pipeline, 201-silicone hose, 202-pressure sensor, 203-safety pressure relief device, 204-clean steam pipeline, 205-air sterile filtration system, 206-clean compressed air pipeline, 207 -Vacuum system, 208-air heating system, 209-temperature probe and sensor, 210-drainage, drainage and exhaust system, 211-clean compressed air system, 212-clean steam system, 213-discharge pipe, 214-quick card Hoop, 215-pressure reducing valve, 216-first diaphragm valve, 217-vacuum delivery pipe, 218-vacuum pump, 219-check valve, 220-second diaphragm valve, 221-steam proportional regulating valve, 222-condensate drain Pipeline, 223-first steam trap, 224-third diaphragm valve, 225-discharge valve, 226-second steam trap.

Detailed ways

The utility model will be further described below in conjunction with the accompanying drawings and specific embodiments of the description.

In the RTP container shown in Figure 1, a passive door 101 is installed at the outlet of the cavity 100 resistant to high pressure steam sterilization pressure, and the cavity close to the passive door is provided with an air inlet and connected to an air inlet diaphragm valve 103, The bottom of the cavity is provided with an exhaust port and is connected with the diaphragm valve 104 of the exhaust port. The outer wall of the cavity 100 is covered with a detachable thermal insulation layer 105, and the passive door is covered with a pressure protection cover 102 resistant to autoclave sterilization pressure. Both the cavity 100 and the pressure protection cover 102 can withstand the sterilization pressure of saturated steam above 0.1 MPa. The detachable thermal insulation layer 105 is an ordinary thermal insulation layer or an electric heating thermal insulation layer.

RTP container on-line sterilization and on-line drying device as shown in Figure 2, drainage, drainage and exhaust system 210 are composed of discharge pipeline 213, condensed water drainage pipeline 222, the first steam trap 223 installed on the condensed water drainage pipeline and the second The three-diaphragm valve 224 is composed of a discharge valve 225 and a second steam trap 226 installed on the discharge pipeline.

The exhaust port diaphragm valve 104 is connected to the discharge pipe 213 through a silicone hose 201 and a quick-connect clamp 214 . The input end of the delivery pipeline 200 is provided with a vacuum system 207 and a clean compressed air system 211, and the output end of the delivery pipeline 200 is connected to the inlet diaphragm valve 103 of the RTP container through a silicone hose 201 and a quick-connect clamp 214. The delivery pipeline 200 An air heating system 208 , an air sterile filtration system 205 , a clean steam system 212 and a safety pressure relief device 203 are arranged in sequence between the input end and the output end.

The sterile air filtration system 205 is connected to the discharge pipe 213 through the condensed water drain pipe 222 . The air sterile filtration system 205 is composed of a stainless steel filter housing, a sterilizing grade hydrophobic filter element placed in the housing and a pressure gauge installed on the housing.

The clean compressed air system 211 is used to provide clean compressed air to the RTP container, the air heating system 208 heats the clean compressed air, and the sterile air filter system 205 sterilizes and filters the heated clean compressed air, The clean steam system 212 is used to provide clean steam to the RTP container and the sterile air filtration system, and the hydrophobic, drainage and exhaust system 210 is used to sterilize the sterile air filtration system to produce condensed water, RTP The condensed water generated during the sterilization in the container and the clean compressed air passed into the RTP container during drying are discharged, and the vacuum system 207 is used to control the vacuum degree in the RTP container for vacuum drying; the safety pressure relief device 203 It is used for pressure relief during overpressure to ensure the safety of RTP container in-line sterilization and in-line drying equipment.

The clean compressed air system 211 is composed of a clean compressed air delivery pipeline 206, a pressure reducing valve 215 and a first diaphragm valve 216 installed on the clean compressed air delivery pipeline. Clean compressed air can be replaced by clean nitrogen or other clean inert gases.

The vacuum system 207 is composed of a vacuum delivery pipeline 217 , a vacuum pump 218 installed on the vacuum delivery pipeline, a check valve 219 and a second diaphragm valve 220 . The air heating system 208 uses indirect steam heat exchange for heating or direct electric heating.

The clean steam system 212 is composed of a clean steam delivery pipeline 204 and a steam proportional regulating valve 221 installed on the clean steam delivery pipeline. The safety pressure relief device 203 is a safety valve or a rupture disc.

The on-line sterilization and on-line drying device also includes a control cabinet with PLC, man-machine interface and control software, the delivery pipeline 200 is provided with a pressure probe and a pressure sensor 202, and the discharge The pipeline 213 and the condensed water drainage pipeline 222 are respectively provided with a temperature probe and a sensor 209, and the entire operation of the on-line sterilization and on-line drying device is automatically controlled by PLC (all diaphragm valves, discharge valves, regulating valves and other valves are pneumatic).

The method of using the above-mentioned RTP container on-line sterilization and on-line drying device is as follows:

a. Put the items that need to be delivered aseptically (including any items that can be steam sterilized, such as production tools, glassware, packaging materials, etc.) into the cavity 100 of the RTP container, cover the beta door 101, and cover the pressure protection cover 102 , wrap detachable insulation layer 105.

b. Connect clean steam, industrial steam, clean compressed air and instrument gas, and turn on the power supply of the control system;

c. Connect the inlet diaphragm valve 103 and the exhaust port diaphragm valve 104 of the RTP container cavity 100 loaded with articles to be sterilized to the output end of the delivery pipeline 200 and the discharge pipeline 213 respectively through the sanitary silicone hose 201 The access end is fastened with a quick-connect clamp 214;

d. Start the RTP container in-line sterilization and in-line drying program:

d1) Open the clean compressed air system 206 and the corresponding valves, and conduct an air tightness test on the entire device to ensure that it is qualified;

d2) Start the vacuum system 207, and vacuum the RTP container 100 and the sterile air filtration system 205 to a set value;

d3) Open the proportional regulating valve 221 on the clean steam delivery pipeline 204, pressurize the RTP container cavity 100 and the filter 205 to the set value;

d4) Repeat the process of d2)-d3) three times to remove the non-condensable gas in the RTP container 100 and the sterile air filtration system 205;

d5) Open the proportional regulating valve 221 on the clean steam delivery pipeline 204, and feed steam to heat up the RTP container cavity 100 and the sterile air filtration system 205; start the sterilization timing after the temperature rises to 121°C;

d6) After the sterilization timing is over, start the vacuum system 207 to vacuumize and dry the RTP container cavity 100;

d7) Start the clean compressed air system 211 and the air heating system 208, and carry out hot air purging and drying to the RTP container cavity 100;

d8) repeat the process of d6-d7 3 times, thoroughly dry the articles in the cavity 100 of the RTP container;

e. After drying, close all valves, disassemble the quick-connect clamp and disconnect the silicone hose 201, and remove the sterilized RTP container for use.

The above is only a description of the preferred embodiments of the present utility model, but should not be construed as a limitation on the claims. The utility model is not limited to the above embodiments, and its specific structure allows changes. All the various changes made within the scope of protection of the independent claims of the utility model are within the scope of protection of the utility model.

Claims (8)

1. A kind of RTP container, comprise the cavity body (100) that is resistant to high pressure steam sterilization pressure and be installed in the passive door (101) of cavity discharge port place, it is characterized in that, have an inlet near the cavity body of passive door The air port is connected with an air inlet diaphragm valve (103), and an exhaust port is opened at the bottom of the cavity and connected with an air outlet diaphragm valve (104); The outer wall of the cavity (100) is covered with a detachable thermal insulation layer (105), and the passive door is covered with a pressure protection cover (102) resistant to high pressure steam sterilization pressure. 2. RTP container on-line sterilization and on-line drying device, comprise the RTP container described in claim 1, it is characterized in that, it also comprises conveying pipeline (200), clean steam system (212), clean compressed air system (211), Vacuum system (207), air heating system (208), air sterile filtration system (205), safety pressure relief device (203) and drainage, drainage and exhaust system (210), the drainage, drainage and exhaust The system (210) comprises a discharge conduit (213); The vent diaphragm valve (104) of the RTP container is connected with the discharge pipeline (213) by a silicone hose (201) and a quick-connect clip (214); The input end of the delivery pipeline (200) is provided with the vacuum system (207) and the clean compressed air system (211), and the output end of the delivery pipeline (200) is passed through a silicone hose (201) and a quick-connect clamp (214) ) is connected with the air inlet diaphragm valve (103) of the RTP container, and the air heating system (208), sterile air filtration system (205), clean steam system (212) and safety pressure relief device (203); The clean compressed air system (211) is used to provide clean compressed air to the RTP container, the air heating system (208) heats the clean compressed air, and the sterile air filter system (205) compresses the heated clean compressed air. The air is sterilized and filtered, and the clean steam system (212) is used to provide clean steam to the RTP container and the air sterile filter system (205), and the described hydrophobic, drainage and exhaust system (210) is used to purify the air The condensed water produced during the sterilization of the sterile filtration system (205), the condensed water produced during the sterilization of the RTP container, and the clean compressed air passed into the RTP container during drying are discharged, and the vacuum system (207) is used to control The vacuum degree in the RTP container is used for vacuum drying; the safety pressure relief device (203) is used for pressure relief during overpressure to ensure the safety of the RTP container on-line sterilization and on-line drying device when used. 3. RTP container on-line sterilization and on-line drying device according to claim 2, characterized in that, the clean compressed air system (211) includes a clean compressed air delivery pipeline (206) and a clean compressed air delivery pipeline The pressure reducing valve (215) and the first diaphragm valve (216) on the upper. 4. RTP container on-line sterilization and on-line drying device according to claim 2, characterized in that, said vacuum system (207) comprises a vacuum delivery pipeline (217) and a vacuum pump (218) installed on the vacuum delivery pipeline , check valve (219) and second diaphragm valve (220). 5. RTP container on-line sterilization and on-line drying device according to claim 2, characterized in that, said air sterile filtration system (205) comprises a stainless steel filter housing, a sterilizing grade hydrophobic filter placed in the housing filter element and a pressure gauge mounted on the housing. 6. RTP container on-line sterilization and on-line drying device according to claim 2, characterized in that, the clean steam system (212) comprises a clean steam delivery pipeline (204) and steam installed on the clean steam delivery pipeline Proportional regulating valve (221). 7. RTP container on-line sterilization and on-line drying device according to claim 2, characterized in that, said drainage, drainage and exhaust system (210) also includes condensed water drainage pipes (222), installed in the condensed water The first steam trap (223) and the third diaphragm valve (224) on the drain pipeline and the discharge valve (225) and the second steam trap (226) installed on the discharge pipeline, the air sterile filtration system (205) It is connected with the discharge pipe (213) through the condensed water drain pipe (222). 8. RTP container on-line sterilization and on-line drying device according to claim 2, is characterized in that, it also comprises a control cabinet, and this control cabinet is with PLC, man-machine interface and control software, and described delivery pipeline ( 200) is provided with a pressure probe and a pressure sensor (202), and the discharge pipe (213) and the condensed water drain pipe (222) are respectively provided with a temperature probe and a sensor (209), and the RTP container is sterilized and dried online The whole operation of the device is automatically controlled by PLC.