CN112190740A

CN112190740A - Sterile isolator

Info

Publication number: CN112190740A
Application number: CN202011189168.3A
Authority: CN
Inventors: 陈磊; 刘冰; 刘科学; 赵岩
Original assignee: Hangzhou Kingineer Pharmaceutical Technology Co ltd
Current assignee: Hangzhou Kingineer Pharmaceutical Technology Co ltd
Priority date: 2020-10-30
Filing date: 2020-10-30
Publication date: 2021-01-08

Abstract

The invention provides an aseptic isolator which comprises a cabin body, a visual operating part, a sterilization system and a wind circulating system, wherein the cabin body is of a horizontal cylindrical structure, a detachable operating platform is arranged in the cabin body, the visual operating part comprises a visual window and an operating opening, the visual window is arranged on the annular surface of the cabin body and is detachably and hermetically connected with the cabin body, the operating opening is formed in the visual window, detachable gloves are hermetically arranged in the operating opening, the wind circulating system provides one-way wind flow from top to bottom for the cabin body, and a sterilization object generated by the sterilization system sterilizes the cabin body along with the one-way wind flow. The sterile isolator is in a horizontal cylindrical structure, the capability of resisting positive pressure and negative pressure is effectively improved, the cabin body has no dead angle, the sterilization effect is good, the possibility of bacterial contamination is greatly reduced, and a closed effective partition is formed inside and outside the cabin body.

Description

Sterile isolator

Technical Field

The invention relates to the technical field of biological medicines, in particular to an aseptic isolator.

Background

The isolation technology is used as an advanced biological technology and is more and more commonly applied to the biomedical industry. On one hand, the isolation technology is adopted, so that the operation environment can be better prevented from being polluted; on the other hand, in the production and experiment processes of biological products with high activity, high sensitization, high toxicity and the like, the biological products can better protect operators and prevent the health of the operators from being damaged. The most common application of the isolation technology is the aseptic isolator, which can provide the most reliable environment for biological experiment operation, better prevent microbial pollution, and is widely applied in the global biological medicine industry.

The current sterile isolator mostly adopts the square cabin body (being the cuboid cabin body), and cabin body edge adopts the mode of full weld then coping fillet to handle, and the square cabin body of this kind of processing has still had great fungus contamination hidden danger although having reduced the dead angle as far as, in addition, more welding seam and corner are handled and must be increased sterile isolator's quality risk, and resistant positive negative pressure degree is more weak. In view of the above, there is a need for a new type of aseptic isolator with a more rational design.

Disclosure of Invention

In view of the above, there is a need for a sterile isolator with simple structure and reasonable design to overcome the deficiencies of the prior art.

The invention provides an aseptic isolator which comprises a cabin body, a visual operating part, a sterilization system and a wind circulating system, wherein the cabin body is of a horizontal cylindrical structure, a detachable operating platform is arranged in the cabin body, the visual operating part comprises a visual window and an operating opening, the visual window is arranged on the annular surface of the cabin body and is detachably and hermetically connected with the cabin body, the operating opening is formed in the visual window, detachable gloves are hermetically arranged in the operating opening, the wind circulating system provides one-way wind flow from top to bottom for the cabin body, and a sterilization object generated by the sterilization system sterilizes the cabin body along with the one-way wind flow.

Further, the sterilization system includes a VHP generator that generates vaporized hydrogen peroxide to sterilize the enclosure.

Further, the wind circulation system includes and mixes wind cabin, air inlet portion, the portion of flow equalizing, return air pipeline and exhaust portion, mix the wind cabin set up in cabin body top and with cabin body intercommunication, the air inlet portion set up in mix the wind cabin top with mix the wind cabin intercommunication, exhaust portion with mix the wind cabin intercommunication, the portion of flow equalizing set up in the inside top in cabin body, the return air pipeline will the cabin body with mix the wind cabin intercommunication.

Further, the portion of flow equalizing includes flow equalizing membrane and laminar flow fan, flow equalizing membrane horizontally set up in the internal top of cabin just is higher than the visual window, laminar flow fan set up in flow equalizing membrane top.

Further, the glove and the operation opening are detachably connected in a sealing mode through a glove ring.

Further, a support frame for supporting the glove is detachably arranged in the hand sleeve ring.

Further, first opening is seted up to the cabin side, the one end of visual window with the first opening periphery the cabin body is articulated to be connected, the visual window can rotate around articulated department and open or the lock first opening, the other end of visual window is provided with the lock body.

Further, a gas spring is arranged between the visual window and the cabin body.

Furthermore, a sealing strip is arranged between the cabin body and the visual window, and the sealing strip is an inflatable sealing strip with a hollow interior; when the sealing strip is inflated, the sealing strip is in close contact with the cabin and the visual window to form a sealing window.

Further, the visual window forms an angle alpha with the vertical direction, and the angle alpha is smaller than 10 degrees.

The technical scheme of the invention has the following beneficial effects: the sterile isolator is in a horizontal cylindrical structure, the capability of resisting positive pressure and negative pressure is effectively improved, the cabin body has no dead angle, the sterilization effect is good, the possibility of bacterial contamination is greatly reduced, and a closed effective partition is formed inside and outside the cabin body.

Drawings

Fig. 1 is a schematic structural view of a sterile isolator according to an embodiment of the present invention.

Fig. 2 is a left side view of fig. 1.

Fig. 3 is a schematic structural diagram of the support frame.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, embodiments of the present invention will be described in detail with reference to the accompanying drawings.

Fig. 1 is a schematic structural view of an aseptic isolator according to an embodiment of the present invention, fig. 2 is a left side view of fig. 1, and fig. 3 is a schematic structural view of a support frame. Referring to fig. 1-3, the sterile isolator 100 includes a frame 11, a cabin 12, a housing 13, a visual operating portion 14, a transmission window 15, a wind circulating system 17, a vacuum pump 18, an illumination lamp 19, and a control system 20.

The support 11 is used to support and mount the cabin 12 and other components such as the enclosure 13, vacuum pump 18, etc. The bracket 11 is made of materials selected and processed according to GMP standard in the pharmaceutical industry, and the material of the bracket 11 is 304 stainless steel.

The cabin 12 is a horizontally arranged cylindrical structure, and the cabin 12 is supported and fixed by the bracket 11. Compared with the existing square cabin body (cuboid cabin body), the cylindrical cabin body has the advantages that the positive and negative pressure tolerance degree of the cylindrical cabin body is far greater than that of the square cabin body under the condition that the material thickness is the same, in addition, no corner exists in the cabin body 12, the arc transition is realized through welding, the welding area at the corner of the cabin body 12 and the area of a polished fillet are greatly reduced, the dead angle is effectively reduced, and the possibility of bacterial contamination is greatly reduced. The cabin body 12 is internally provided with a horizontal detachable operating platform 121, the detachable operating platform 121 is convenient for cleaning the inside of the cabin body 12 and replacing the operating platform 121, the operating platform 121 is uniformly provided with platform through holes (not shown), and the platform through holes can ensure that the air pressure above and below the operating platform 121 in the cabin body 12 is uniform and the air has good fluidity. The cabin body 12 is manufactured and selected according to GMP standard in pharmaceutical industry, and the cabin body 12 is made of 316 stainless steel.

The cabin 12 is provided with a sampling and detection port 127, the sampling and detection port 127 is normally closed when the cabin 12 near the visible operation part 14 is not used, and the sampling and detection port 127 is used for detecting, sampling and purging dust particles, planktonic bacteria, a steam water gun and the like. The lower end of the chamber 12 is provided with a drain 128 having a valve, and the drain 128 is used for draining sewage and the like for cleaning the chamber 12.

The cover 13 is provided to cover unnecessary parts to make the entire sterile isolator 100 more beautiful, and the cover 13 may be provided above the cabin 12 and on a side away from the visible operation portion 14. The housing 13 is manufactured and selected according to GMP standards in the pharmaceutical industry, and the material of the housing 13 is 304 stainless steel.

The visual operation unit 14 includes a visual window 141, an operation opening 147, a glove (not shown), a glove ring 149, and a support frame 146. The annular surface (i.e. the cylindrical side surface) of the cabin 12 is provided with a visible window 141, the visible window 141 is detachably and hermetically connected with the cabin 12, specifically, the annular surface of the cabin 12 is provided with a first opening 122, the visible window 141 is buckled in the first opening 122, one end (hinged end) of the visible window 141 is hinged to the cabin 12 at the periphery of the first opening 122, the visible window 141 can rotate around the hinged position to open or close the first opening 122, the other end (locked end) of the visible window 141 is provided with a lock body 143, the lock body 143 can be locked with the visible window 141 and the cabin 12, the locked end of the visible window 141 is provided with a handle 144, and the handle 143 and the lock body 144 can be integrated. A gas spring 145 is further disposed between the visual window 141 and the cabin 12, and the gas spring 145 can help to open the visual window 141 and perform a limiting support on the maximum open state of the visual window 141. In the present embodiment, the viewing window 141 is hinged at the top and locked at the bottom, i.e. gull-wing type. The viewing window 141 is slightly inclined and forms a small angle α with the vertical direction, α <10 °, in this embodiment, the angle α is 5 °, and the arrangement of the angle α conforms to the ergonomic principle and facilitates the visibility of the operation. The visual window 141 with the included angle α can facilitate the operator to observe the interior of the cabin 12 with his head tilted forward, and the visual window 141 can be made of toughened glass (e.g. 15mm thick toughened glass). A sealing strip (not shown) is arranged between the cabin body 12 and the visible window 141, the sealing strip is an inflatable sealing strip with a hollow interior, the sealing strip is communicated with an external air source (not shown), and after the air source inflates the sealing strip, the sealing strip is in close contact with the cabin body 12 and the visible window 141 to form a sealed window.

The viewing window 141 is provided with operation ports 147, the operation ports 147 are usually arranged in pairs, and in this embodiment, two pairs (4) of the operation ports 147 are provided. The gloves are positioned above the operation platform 121 of the cabin body 12, the operation port 147 is detachably connected with the gloves in a sealing way through a hand ring 149, and the operation port 147 and the gloves are installed to pass a conventional integrity (leakage) test. The gloves are made of materials with good elasticity, oxidation resistance and corrosion resistance, such as chlorosulfonated polyethylene (Hypalon). If gloves are damaged during operation, the glove rings 149 can be conveniently detached to ensure safe online glove replacement. The detachable support frame 146 is further arranged in the hand sleeve ring 149, the support frame 146 can support gloves, the surface of the gloves is prevented from being bent and shielded in the disinfection process, in addition, the support frame 146 can also prevent the gloves from being excessively protruded outwards under positive pressure in the cabin body 12, the gloves are not convenient to wear, and the surface of the support frame 146 is smooth. The support frame 146 is manufactured and selected according to GMP standard in pharmaceutical industry, and the material of the support frame 146 is 316 stainless steel.

The cabin 12 may further include a transmission window 15, the side surface (i.e., the bottom surface of the cylinder) of the cabin 12 is provided with the transmission window 15, specifically, the bottom surface (the bottom surface of the cylinder) of the cabin 12 is provided with a second opening 123, the transmission window 15 is fastened in the second opening 123, one end (the hinged end) of the transmission window 15 is hinged to the bottom surface of the cabin 12 at the periphery of the second opening 123, the transmission window 15 can rotate around the hinge shaft to open or close the second opening 123, the other end (the locking end) of the transmission window 15 is provided with a second lock 152, the second lock 152 can be locked with the transmission window 15 and the cabin 12, the locking end of the transmission window 15 is provided with a second handle 153, and the second handle 153 and the second lock 152 can be integrated. An inflatable transfer window sealing strip (not shown) is arranged between the cabin body 12 and the transfer window 15, and the transfer window sealing strip is connected with an air source. The cabin 12 may be provided with the transmission window 15 alone, or may be provided with no transmission window 15 and may realize the function of the transmission window 15 through the visible window 141.

Sterilization system 16 employs Vaporized Hydrogen Peroxide (VHP) sterilization, and sterilization system 16 includes a VHP generator 162 and a VHP valve 164. The VHP generator 162 is disposed outside the cabin 12 and fixedly connected to the cabin 12, the upper portion of the cabin 12 is provided with a VHP inlet 127, and the VHP generator 162 is communicated with the cabin 12 through the VHP inlet 127. A VHP valve 164 is provided between VHP generator 162 and VHP inlet 127.

The air circulation system 17 includes an air mixing compartment 171, an air inlet portion 172, a flow equalizing portion 173, a return duct 174, and an air discharge portion 175. The wind circulation system 17 provides a unidirectional wind flow from the top to the bottom to the nacelle 12.

An air inlet (not shown) is formed in the top of the cabin body 12, an air mixing cabin 171 is arranged above the air inlet, and the air mixing cabin 171 is communicated with the air inlet. The air inlet portion 172 comprises an air inlet pipe 1721, an air inlet fan 1722, an air inlet valve 1723 and an air inlet efficient filter 1724, the air inlet pipe 1721 is arranged above the air mixing cabin 171 and communicated with the air mixing cabin, the air inlet fan 1722, the air inlet valve 1723 and the air inlet efficient filter 1724 are sequentially arranged on the air inlet pipe 1721 from top to bottom, and the air inlet efficient filter 1724 is arranged at a lower air position of the air inlet fan 1722. The current equalizing portion 173 includes a current equalizing membrane 1732, a laminar flow fan 1733, a laminar flow high efficiency filter 1734, the inside upper level of the cabin body 12 is provided with a current equalizing membrane 1732, the current equalizing membrane 1732 is higher than the visible window 141, a current equalizing space is formed above the current equalizing membrane 1732 and the cabin body 12, the current equalizing membrane 1732 is provided with pores capable of dispersing wind flow uniformly, the current equalizing membrane 1732 has light transmittance, and the cabin body 12 between the operating platform 121 and the current equalizing membrane 1732 is an operating space. The laminar flow fan 1733 is disposed in the air inlet, and the laminar flow high efficiency filter 175 is disposed below the air outlet of the laminar flow fan 1733. The air return opening 125 is formed in the cabin body 12 below the flow equalizing membrane 1732, and the air return opening 125 (cabin body 12) is communicated with the air mixing cabin 171 through the air return pipe 174. Exhaust portion 175 includes exhaust pipe 1751, the high efficiency filter 1752 of airing exhaust, air exhaust fan 1753, and exhaust valve 1754, and exhaust pipe 1751 and thoughtlessly wind cabin 171 intercommunication are provided with air exhaust fan 1753 on the exhaust pipe 1751, and air exhaust fan 1753 sets up in the leeward position of air exhaust high efficiency filter 1752, and air exhaust high efficiency filter 1752 sets up in exhaust pipe 1751 and thoughtlessly wind cabin 171 intercommunication department. The air inlet valve 1723 and the air outlet valve 1754 are butterfly valves.

A vacuum pumping port 126 is arranged below the chamber body 12, a vacuum pump 18 is arranged below the chamber body 12 and is fixedly connected with the support 11, the vacuum pump 18 is communicated with the vacuum pumping port 126 (chamber body 12), and the vacuum pump 18 can be used for controlling the pressure (differential pressure) in the chamber body 12. The cabin body 12 can maintain micro-positive pressure (40-70 Pa) or negative pressure.

The illuminating lamps 19 are respectively arranged above the flow equalizing films 1732 in the cabin body 12, and the light rays emitted by the illuminating lamps 19 penetrate through the flow equalizing films 1732 to illuminate the operating space below, so that the requirements of the cabin body 12 on the light rays are met. The illumination lamp 19 is electrically connected with an external power supply.

The control system 20 includes an input unit 202, a display unit 203, a control unit 204, a monitoring unit 205, and a warning lamp 206.

The input unit 202 can directly input related control instructions such as automatic sterilization or simple power switch, air source switch, lighting lamp switch, wind circulation switch, VHP switch, etc., and feed the instructions back to the control unit 204, and the display unit 203 displays the executed instructions and the working state. The display unit 203 is used for displaying executed instructions, working states, real-time monitoring parameters and the like, and the input unit 202 and the display unit 203 are of an integrated structure, such as a touch display screen.

The input unit 202 is electrically connected to the control unit 204, the control unit 204 receives an instruction from the input unit 202, the control unit 204 stores a preset program, an index range of monitoring and sampling parameters, and data of each parameter in the monitoring and sampling process, and the control unit 204 can control the air source, the lighting lamp 19, each fan and valve in the air circulation system 17, the VHP generator 162, the VHP valve 164, and the like.

The monitoring unit 205 is disposed in the cabin 12 (operating space), and the monitoring unit 205 includes a sensor and a sampling detector, and the sensor can detect the temperature, humidity, VHP concentration, wind speed, and differential pressure in real time. The monitoring unit 205 is electrically connected to the control unit 204, the monitoring unit 205 monitors data to the control unit 204 in real time, and the control unit 204 performs corresponding adjustment according to the monitored data. The sampling detector comprises an online dust particle counter and a microorganism sampler, the sampling detector is inserted into the sampling and detecting port 127, the online dust particle counter and the microorganism sampler are respectively electrically connected with the control unit 20, and the results are fed back to the control unit 204.

The warning light 206 is disposed outside the cabin 12, and is generally disposed above the display unit 203. Warning light 206 and the control unit 204 electric connection, the real time monitoring data of control unit 205 feedback are judged to the control unit 204, then warning light 206 keeps green lamp at normal scope, then warning light 206 becomes yellow lamp and glimmers at critical scope, exceed critical scope then warning light 206 becomes red lamp and is accompanied scintillation and audible alarm (if dust particle is not up to standard, the sealing door adhesive tape is not sealed pressure and is revealed, the wind speed is too fast etc.).

The sterilization of the sterile isolator 100 can adopt one-key automatic control or step control, and the sterilization operation steps of the sterile isolator 100 are as follows:

a preparation stage: the power supply and the gas source are switched on, the control unit 204 executes a preset program, the gas source is controlled to inflate the sealing strips and the sealing strips of the transfer window, the inflated sealing strips are in close contact with the cabin body 12 and the visual window 141, the inflated sealing strips of the transfer window are in close contact with the cabin body 12 and the transfer window 15 to form a sealing window, the cabin body 12 is sealed, and then the illuminating lamp 19 is turned on.

A wind circulation stage: the control unit 204 controls the air inlet fan 1722 to start and the air inlet valve 1723 to open, the air circulation system 17 starts to inlet air, the inlet air is filtered by the air inlet high-efficiency filter 1724 and then enters the air mixing chamber 171, the laminar flow fan 1733 sucks the inlet air in the air mixing chamber 171 into the cabin body 12 (flow equalizing space), a uniform one-way air flow is formed after passing through the laminar flow high-efficiency filter 1734 and the flow equalizing membrane 1732 and enters the cabin body 12 (operating space) below the flow equalizing membrane 1732, the one-way air flow passes through the operating platform 121 and returns to the air mixing chamber 171 through the air return pipeline 17 to form an air circulation, and the air flow returning to the air mixing chamber 171 and the air supplemented by the air inlet fan 1722 and entering the air mixing chamber 171 together perform a; the sensor of the monitoring unit 205 measures parameters such as temperature and humidity, VHP concentration, wind speed, and pressure difference, and feeds back the parameters to the control unit 204 in real time, and the control unit 204 adjusts and records data according to the monitored data.

And (3) a sterilization stage: the control unit 204 controls the VHP generator 162 and the VHP valve 164 to be opened, the VHP generated by the VHP generator 162 enters the cabin 12 through the VHP valve 164, the VHP sterilizes the cabin 12 along with circulation of wind flow, when the sensor detects that the concentration of the VHP reaches a preset value, the control unit 204 controls the VHP valve 164 to be closed, once the concentration of the VHP is reduced, the VHP valve 164 is controlled to be opened to supplement the VHP, and the control unit 204 controls the VHP valve to be opened and closed to control the change of the concentration of the VHP in the sterilization process; after the sterilization is completed, the control unit 204 controls the VHP generator 162 and the VHP valve 164 to be closed, and controls the exhaust fan 1753 and the exhaust valve 1754 to be opened, and the airflow mixed with the VHP in the cabin 12 is discharged through the exhaust high efficiency filter 1752 and the exhaust pipe 1751.

The experimental operation is completed in the cabin body 12 of the sterile isolator 100, a closed effective partition can be formed between products and operators, complete sterile environment protection is provided for sterile sample detection, the cabin body 12 meets the ISO 5-level environmental requirement, positive pressure (or negative pressure) is maintained on the surrounding environment, and the wind flow in the cabin body is unidirectional flow.

The technical scheme of the invention has the following beneficial effects: the sterile isolator 100 has a horizontal cylindrical structure, effectively improves the capability of resisting positive and negative pressure, has no dead angle in the cabin body 12, has good sterilization effect, greatly reduces the possibility of bacterial contamination, and forms a closed effective partition inside and outside the cabin body 12.

Although the present invention has been described with reference to a preferred embodiment, it should be understood that various changes, substitutions and alterations can be made herein without departing from the spirit and scope of the invention as defined by the appended claims.

Claims

1. An aseptic isolator (100), characterized by: the sterile isolator (100) comprises a cabin body (12), a visible operation part (14), a sterilization system (16) and a wind circulation system (17), the cabin body (12) is a horizontal cylindrical structure, a detachable operating platform (121) is arranged in the cabin body (12), the visual operation part (14) comprises a visual window (141) and an operation opening (147), the visual window (141) is arranged on the annular surface of the cabin body (12), the visual window (141) is detachably connected with the cabin body (12) in a sealing way, the visual window (141) is provided with the operation opening (147), the operation opening (147) is hermetically provided with a detachable glove, the wind circulating system (17) provides unidirectional wind flow from top to bottom for the cabin body (12), the sterilization system (16) generates a sterilant to sterilize the enclosure (12) with a unidirectional flow of wind.

2. The aseptic isolator (100) of claim 1, wherein: the sterilization system (16) includes a VHP generator (162), the VHP generator (162) generating vaporized hydrogen peroxide to sterilize the enclosure (12).

3. The aseptic isolator (100) of claim 1, wherein: wind circulation system (17) is including mixing wind cabin (171), air inlet portion (172), the portion of flow equalizing (173), return air pipeline (174) and exhaust portion (175), mix wind cabin (171) set up in cabin body (12) top and with cabin body (12) intercommunication, air inlet portion (172) set up in mix wind cabin (171) top with mix wind cabin (171) intercommunication, exhaust portion (175) with mix wind cabin (171) intercommunication, the portion of flow equalizing (173) set up in cabin body (12) inside top, return air pipeline (174) will cabin body (12) with mix wind cabin (171) intercommunication.

4. The aseptic isolator (100) of claim 3, wherein: the flow equalizing part (173) comprises a flow equalizing film (1732) and a laminar flow fan (1733), the flow equalizing film (1732) is horizontally arranged above the interior of the cabin body (12) and is higher than the visual window (141), and the laminar flow fan (1733) is arranged above the flow equalizing film (1732).

5. The aseptic isolator (100) of claim 1, wherein: the glove is detachably connected with the operation opening (147) in a sealing way through a hand ring (149).

6. The aseptic isolator (100) of claim 5, wherein: a support frame (146) for supporting the glove is detachably arranged in the hand ring (149).

7. The aseptic isolator (100) of claim 1, wherein: first opening (122) are seted up to cabin body (12) side, the one end of visual window (141) with first opening (122) periphery cabin body (12) are articulated to be connected, visual window (141) can rotate and open or the lock around articulated department first opening (122), the other end of visual window (141) is provided with lock body (143).

8. The aseptic isolator (100) of claim 1, wherein: and a gas spring (145) is also arranged between the visual window (141) and the cabin body (12).

9. The aseptic isolator (100) of claim 1, wherein: a sealing strip is arranged between the cabin body (12) and the visual window (141), and the sealing strip is an inflatable sealing strip with a hollow interior; when the sealing strip is inflated, the sealing strip is in close contact with the cabin body (12) and the visual window (141) to form a sealing window.

10. The aseptic isolator (100) of claim 1, wherein: the viewing window (141) has an angle alpha with the vertical direction, the angle alpha being less than 10 deg.