技术领域technical field
本实用新型涉及一种双面层流操作的无菌检查工艺隔离器，该装置为制药企业质量无菌检查的操作环节提供稳定的、低污染风险的、低耗能、完全隔离的A级无菌区域。The utility model relates to a double-sided laminar flow operation aseptic inspection process isolator. The device provides a stable, low pollution risk, low energy consumption, and completely isolated Class A sterile bacteria area.
背景技术Background technique
无菌药品根据药品的性质的不同，制作工艺也不尽相同，从无菌冻干制剂到无菌原料药，从无菌大输液到无菌滴眼液，都离不开无菌。那么保证无菌性的要求除了需要对其生产环境、生产工序、操作等要严格控制外，那么更为关键的就是对成品进行无菌性检查，来证明其最终产品符合无菌的要求。Sterile drugs have different production processes depending on the nature of the drug. From sterile freeze-dried preparations to sterile raw materials, from sterile infusions to sterile eye drops, they are all inseparable from sterility. In addition to the strict control of the production environment, production process, and operation, the requirement to ensure sterility is more critical to carry out sterility inspection on the finished product to prove that the final product meets the sterility requirements.
无菌检查过程是按照生产产品的一定比例进行抽样，并提取抽检的样品经稀释，通过集菌仪将液体泵送通过集菌器滤膜，然后注入培养基进行菌落培养，并判定抽检样品是否染菌，通过测试结果来判定整批生产药品的质量。The process of sterility inspection is to take samples according to a certain proportion of the production products, and extract the samples for sampling and dilute them, pump the liquid through the filter membrane of the bacteria collector through the bacteria collection device, and then inject the culture medium for colony cultivation, and determine whether the samples for sampling inspection are Infection, the quality of the entire batch of produced drugs is judged by the test results.
目前，在无菌药品生产中，无菌检查操作工艺存在下列缺陷：At present, in the production of sterile drugs, the sterility inspection process has the following defects:
1、传统无菌药品的无菌检测操作，目前还停留在简单的百级层流罩、百级垂帘结构或百级超净台，但无法做到真正与外界的环境及操作者隔离开，无法使内部生产环境参数完全可控，更不能保证无料及操作工具的无菌传递，如何能减少无菌检测过程中假阳性的发生几率及阴性对照结果的真实性成为了需要解决的难题；1. The aseptic testing operation of traditional sterile drugs is still stuck in the simple 100-level laminar flow hood, 100-level vertical curtain structure or 100-level ultra-clean bench, but it cannot be truly isolated from the external environment and operators. It is impossible to completely control the internal production environment parameters, and it is impossible to ensure the aseptic delivery of materials and operating tools. How to reduce the probability of false positives during the aseptic testing process and the authenticity of negative control results has become a difficult problem to be solved;
2、无菌药品的无菌检测操作过程中，采用层流罩或超净台进行非封闭式隔离弊端很多。首先，不能满足“强效药品必须尽可能避免与操作人员接触”的要求；其次，对于生产区域环境参数要求严格的，无法达到参数完全可控，并且无法达到可验证的要求；最后，生产区域内部无法做到CIP（Cleaninplace在线清洗）及SIP（SterilizeinPlace在线灭菌）很容易发生交叉污染影响检测结果；2. In the process of aseptic testing of sterile drugs, there are many disadvantages in using laminar flow hoods or ultra-clean benches for non-closed isolation. First of all, it cannot meet the requirement that "powerful drugs must avoid contact with operators as much as possible"; secondly, if the environmental parameters of the production area are strictly required, the parameters cannot be completely controllable and cannot meet the verifiable requirements; finally, the production area CIP (Clean in place) and SIP (Sterilize in Place) cannot be achieved internally, and cross-contamination may easily occur and affect the test results;
3、传统的无菌检测区域要求背景操作环境等级较高，导致无菌工作区的造价昂贵，身着无菌工作服的操作人员不仅降低生产效率，而且需要增加处理操作人员带来的污染成本。3. The traditional aseptic testing area requires a higher level of background operating environment, resulting in high cost of the aseptic work area. Operators wearing sterile work clothes not only reduce production efficiency, but also need to increase the pollution cost brought by the processing operators.
4、虽然现在也有厂家用隔离器做无菌检查，但是用的隔离器大多材质是PVC软墙的，无法保证内部的压差，容易破损，灭菌时对隔离器本身材料的腐蚀性大，无法达到层流的效果。4. Although some manufacturers now use isolators for sterility inspection, most of the isolators used are made of PVC soft walls, which cannot guarantee the internal pressure difference and are easily damaged. The material of the isolator itself is highly corrosive during sterilization. The effect of laminar flow cannot be achieved.
5、现在有的厂家提供无菌检查，但大都是单面层流或者紊流操作的，也有双面紊流操作的无菌检查工艺隔离器，单面层流或者紊流的工艺隔离器，批量小，而双面的紊流的工艺的隔离器，自净时间长，灭菌、排残时间长，同样达不到快速、大批量的无菌检测要求，对于大批量的无菌检查，传统的单面层流或者紊流操作的无菌检查隔离器，只能采用多批次的检查方法，不仅费时、费力，同时也会增加操作人员的疲劳强度。对于有大批量无菌检查要求的企业远远不能满足，双面层流操作的无菌检查工艺隔离器就可以解决这方面的问题。5. At present, some manufacturers provide aseptic inspection, but most of them are operated by single-sided laminar flow or turbulent flow. There are also aseptic inspection process isolators with double-sided turbulent flow operation, and single-sided laminar or turbulent flow. The batch is small, and the isolator with double-sided turbulent flow process takes a long time for self-cleaning, sterilization, and residue removal. It also fails to meet the requirements of rapid and large-scale sterility testing. For large-scale sterility testing, traditional The single-sided laminar flow or turbulent flow operation of the sterile inspection isolator can only use multi-batch inspection methods, which is not only time-consuming and laborious, but also increases the fatigue strength of the operators. It is far from being able to meet the requirements of large-volume sterility inspection enterprises, and the aseptic inspection process isolator with double-sided laminar flow operation can solve this problem.
目前还没有一种设备能解决上述问题。Also do not have a kind of equipment to solve the above-mentioned problem at present.
发明内容Contents of the invention
本实用新型所要解决的问题是为制药企业质量无菌检查的操作环节提供稳定的、降低样品受污染的风险、环境级别较低的无菌检查环境。The problem to be solved by the utility model is to provide a stable aseptic inspection environment for the operation link of quality aseptic inspection in pharmaceutical enterprises, reduce the risk of sample contamination, and have a lower environmental level.
为了解决上述问题，本实用新型的技术方案是提供了一种双面层流操作的无菌检查工艺隔离器，其特征在于，包括顶部设有空气处理系统的手套仓系统及电气柜系统，所述手套仓系统包括仓体，仓体上设有手套操作组件，所述手套操作组件包括操作窗密封玻璃，手套通过手套连接组件与操作窗密封玻璃连接。In order to solve the above problems, the technical solution of the utility model is to provide a double-sided laminar flow operation aseptic inspection process isolator, which is characterized in that it includes a glove compartment system and an electrical cabinet system with an air treatment system on the top. The glove compartment system includes a compartment body, on which a glove operating assembly is provided, and the glove operating assembly includes an operation window sealing glass, and the gloves are connected to the operation window sealing glass through a glove connecting assembly.
优选地，所述电气柜系统底部设有真空泵及阀体安装箱及集成式过氧化氢蒸汽灭菌系统，与集成式过氧化氢蒸汽灭菌系统连接的泵体设于真空泵及阀体安装箱内，集成式过氧化氢蒸汽灭菌系统通过管道与空气处理系统、传递仓组件连通。Preferably, the bottom of the electrical cabinet system is provided with a vacuum pump, a valve body installation box and an integrated hydrogen peroxide steam sterilization system, and the pump body connected to the integrated hydrogen peroxide steam sterilization system is arranged in the vacuum pump and valve body installation box Inside, the integrated hydrogen peroxide steam sterilization system communicates with the air handling system and transfer chamber components through pipelines.
优选地，所述电气柜系统上设有手套仓工作状态指示灯、传递舱工作状态指示灯、消除警报按钮、触摸屏系统以及打印机。Preferably, the electrical cabinet system is provided with a working status indicator light for the glove compartment, a working status indicator light for the transfer compartment, an alarm cancel button, a touch screen system and a printer.
优选地，还包括与手套仓系统的仓体底部连通的袋出系统。Preferably, a bag out system communicating with the bottom of the glove bin system is also included.
优选地，所述空气处理系统包括设于空气处理系统壳体内的带新风阀的新风组件，空气处理系统壳体内的左右两侧分别设有一组排风循环装置，所述排风循环装置包括从上至下分布的带排风蝶阀一的排风组件、循环风机组件一、液槽密封过滤器。Preferably, the air treatment system includes a fresh air assembly with a fresh air valve in the air treatment system casing, and a set of exhaust air circulation devices are respectively provided on the left and right sides of the air treatment system casing, and the exhaust air circulation devices include The exhaust assembly with the exhaust butterfly valve 1, the circulation fan assembly 1, and the liquid tank sealing filter are distributed from top to bottom.
优选地，所述空气处理系统与手套仓系统之间设有均流膜一。Preferably, a flow equalizing film 1 is provided between the air handling system and the glove compartment system.
进一步地，所述空气处理系统壳体内左右两侧设有照明灯一。Further, lighting lamps 1 are provided on the left and right sides of the housing of the air handling system.
优选地，所述操作窗密封玻璃的上侧或下侧与仓体活动连接，下侧或上侧与仓体之间设有门锁组件。Preferably, the upper or lower side of the sealing glass of the operation window is movably connected with the warehouse body, and a door lock assembly is arranged between the lower side or the upper side and the warehouse body.
进一步地，所述门锁组件上设有门开启状态信号装置。Further, the door lock assembly is provided with a door opening state signal device.
优选地，所述操作窗密封玻璃内侧设有内部回风玻璃，操作窗密封玻璃与内部回风玻璃之间形成回风通道，该回风通道用于将仓体中的垂直的层流风返回到顶部空气处理系统；两者之间通过手套连接组件、连接部件连接。Preferably, an internal air return glass is provided inside the sealing glass of the operation window, and a return air passage is formed between the sealing glass of the operation window and the internal return air glass, and the return air passage is used to return the vertical laminar flow wind in the warehouse body to Top air handling system; the two are connected through glove connecting components and connecting parts.
进一步地，所述操作窗密封玻璃的左右两侧分别设有氮气弹簧，氮气弹簧的上端通过氮气弹簧上安装支座与操作窗密封玻璃固定连接，下端通过氮气弹簧安装底座与仓体固定连接。Further, the left and right sides of the sealing glass of the operation window are respectively provided with nitrogen springs, the upper end of the nitrogen spring is fixedly connected with the sealing glass of the operation window through the nitrogen spring mounting support, and the lower end is fixedly connected with the bin body through the nitrogen spring mounting base.
优选地，所述手套操作组件与仓体之间设有密封圈。Preferably, a sealing ring is provided between the glove operating component and the bin body.
优选地，所述手套仓系统底部设有框架支撑组件。Preferably, a frame support assembly is provided at the bottom of the glove storage system.
优选地，还包括传递仓组件，所述传递仓组件包括传递仓壳体，传递仓壳体上段为进风段，下段为回风段，底部设有气动元器件箱；传递仓壳体进风段前侧设有栅孔，顶部设有排风过滤分解系统，排风过滤分解系统与带排风蝶阀二的排风风机连接，排风过滤分解系统的下方设有带新风蝶阀的循环风机组件二；传递仓壳体回风段的两侧分别设有带门锁系统的门，其中一侧的门与手套仓系统的仓体一侧的门框相配合，该门打开后与仓体内部连通；回风段的后侧设有回风板，回风板与传递仓壳体后侧形成回风通道；气流从栅孔中进入传递仓壳体内，依次经过新风蝶阀、循环风机组件二至回风段底部后，经回风板与传递仓壳体之间的回风通道回风至排风蝶阀二，经排风风机进入排风过滤分解系统。Preferably, it also includes a transfer bin assembly, the transfer bin assembly includes a transfer bin housing, the upper section of the transfer bin housing is an air inlet section, the lower section is an air return section, and the bottom is provided with a pneumatic component box; There are grid holes on the front side of the section, and an exhaust air filtration and decomposition system on the top. The exhaust air filtration and decomposition system is connected to the exhaust fan with exhaust butterfly valve 2, and the circulation fan assembly with fresh air butterfly valve is installed under the exhaust air filtration and decomposition system. 2. The two sides of the return air section of the transfer chamber shell are respectively equipped with doors with door lock system, and the door on one side is matched with the door frame on the side of the glove bin system. After opening, the door communicates with the interior of the bin body. ;The rear side of the return air section is provided with a return air plate, and the return air plate forms a return air passage with the rear side of the transfer chamber shell; the air flow enters the transfer chamber shell from the grid hole, and passes through the fresh air butterfly valve, the circulating fan assembly two to the return air After the bottom of the air section, the air returns to the exhaust butterfly valve 2 through the return air channel between the return air plate and the transfer chamber shell, and enters the exhaust air filtration and decomposition system through the exhaust fan.
进一步地，所述新风蝶阀前侧设有新风中效过滤器，气流从栅孔进入传递仓壳体内后经新风中效过滤器过滤后进入循环风机组件二；传递仓壳体进风段下侧的出风口处设有循环高效过滤器。Further, the front side of the fresh air butterfly valve is provided with a fresh air medium-efficiency filter, and the airflow enters the transfer bin housing from the grid hole and then enters the circulating fan assembly 2 after being filtered by the fresh air medium-efficiency filter; the lower side of the air inlet section of the transfer bin housing There is a circulating high-efficiency filter at the air outlet.
进一步地，传递仓壳体内设有照明灯二。Further, the second illuminating lamp is arranged in the housing of the transfer bin.
进一步地，所述传递仓壳体进风段与回风段之间设有均流膜二。Further, a flow equalizing film 2 is provided between the air inlet section and the air return section of the transfer bin housing.
优选地，所述仓体的前后两侧分别设有一组手套操作组件。Preferably, a set of glove operating components are respectively provided on the front and rear sides of the bin body.
本实用新型通过无菌检查隔离器可以实现无菌药品的无菌检查过程中始终处在一个受控的环境下进行，使内部的有毒物质不会危害到操作人员，也阻止了外部环境中的污染物进入操作空间内部污染待测试产品，使测试结果更具有可信度和说服力，同时也降低了生产区域对背景环境的洁净等级的要求。无菌测试工艺隔离器内部任何环境参数的改变，都会得到相对应的调控，从而实现了无菌药品的生产完成后的无菌检查环节的隔离化。The utility model can realize the sterility inspection process of sterile drugs in a controlled environment through the sterility inspection isolator, so that the internal toxic substances will not harm the operators, and also prevent the sterility in the external environment. Pollutants enter the operating space and contaminate the product to be tested, making the test results more credible and convincing, and also reducing the requirements for the cleanliness level of the background environment in the production area. Any changes in the environmental parameters inside the isolator of the aseptic test process will be regulated accordingly, thus realizing the isolation of the aseptic inspection link after the production of sterile drugs is completed.
本实用新型的优点是使内部生产环境与操作者及外部环境完全隔离开，减少了人工污染的风险，同时也减少了产品对操作者和外部环境的污染；并且使生产洁净区域缩小、使生产区域的可控性大大增加，进而降低了运行成本和维护成本，同时带有集成式过氧化氢灭菌系统，可实现在线的SIP，保证了操作环境的无菌性，方便进行大批量的无菌检测。The utility model has the advantages of completely separating the internal production environment from the operator and the external environment, reducing the risk of artificial pollution, and at the same time reducing the pollution of the product to the operator and the external environment; The controllability of the area is greatly increased, thereby reducing the operating cost and maintenance cost. At the same time, it is equipped with an integrated hydrogen peroxide sterilization system, which can realize online SIP, ensure the sterility of the operating environment, and facilitate large-scale aseptic sterilization. Bacteria detection.
附图说明Description of drawings
图1为本实用新型提供的一种双面无菌检查工艺隔离器的结构示意图；Fig. 1 is the structural representation of a kind of double-sided aseptic inspection process isolator provided by the utility model;
图2为图1的后视图；Fig. 2 is the back view of Fig. 1;
图3为电气柜系统组件的主视图；Figure 3 is a front view of the components of the electrical cabinet system;
图4为图3的后视图；Fig. 4 is the back view of Fig. 3;
图5为传递仓组件的主视图；Fig. 5 is the front view of transfer bin assembly;
图6为图5的左视图；Fig. 6 is the left side view of Fig. 5;
图7为手套仓系统的主视图；Figure 7 is a front view of the glove bin system;
图8为图7的侧视图；Fig. 8 is a side view of Fig. 7;
图9为空气处理系统的透视图；Figure 9 is a perspective view of the air handling system;
图10为手套操作组件的主视图；Figure 10 is a front view of the glove operating assembly;
图11为图10中A-A面的剖视图。Fig. 11 is a sectional view of plane A-A in Fig. 10 .
具体实施方式detailed description
为使本实用新型更明显易懂，兹以优选实施例，并配合附图作详细说明如下。In order to make the utility model more comprehensible, preferred embodiments are described in detail below with accompanying drawings.
实施例Example
如图1-2所示，为本实用新型提供的一种双面操作的无菌检查工艺隔离器的总装图，包括顶部设有空气处理系统2的手套仓系统及分别设于手套仓系统两侧的电气柜系统1、传递仓组件。As shown in Figure 1-2, it is an assembly drawing of a double-sided operation aseptic inspection process isolator provided by the utility model, including a glove compartment system with an air treatment system 2 on the top and two Electrical cabinet system on the side 1. Transfer bin components.
电气柜系统组件1如图3-4所示，电气柜系统1底部设有真空泵及阀体安装箱8及集成式过氧化氢蒸汽灭菌系统6，与集成式过氧化氢蒸汽灭菌系统6连接的泵体设于真空泵及阀体安装箱8内，集成式过氧化氢蒸汽灭菌系统6通过管道与空气处理系统2、传递仓组件3连通。电气柜系统1上设有手套仓工作状态指示灯10、传递舱工作状态指示灯9、消除警报按钮11、触摸屏系统7以及打印机13。The electrical cabinet system component 1 is shown in Figure 3-4. The bottom of the electrical cabinet system 1 is equipped with a vacuum pump and a valve body installation box 8 and an integrated hydrogen peroxide steam sterilization system 6, and an integrated hydrogen peroxide steam sterilization system 6 The connected pump body is arranged in the vacuum pump and valve body installation box 8, and the integrated hydrogen peroxide steam sterilization system 6 communicates with the air treatment system 2 and the transfer chamber assembly 3 through pipelines. The electrical cabinet system 1 is provided with a glove compartment working status indicator light 10 , a transfer cabin working status indicator light 9 , an alarm cancellation button 11 , a touch screen system 7 and a printer 13 .
手套仓系统如图7-8所示，包括仓体25，仓体25的前后两侧分别设有一组手套操作组件4。手套仓系统固定在设有框架支撑组件26上，仓体25底部设有与之连通的袋出系统5。As shown in Figure 7-8, the glove bin system includes a bin body 25, and a set of glove operating components 4 are respectively arranged on the front and rear sides of the bin body 25. The glove bin system is fixed on a frame support assembly 26, and the bottom of the bin body 25 is provided with a bag out system 5 communicating therewith.
顶部空气处理系统2将处理完成之后形成的垂直向下的层流风灌入仓体25中，通过前后两边的手套操作组件4形成回风的墙，将垂直向下的层流风返回顶部空气处理系统2中，形成循环。底部的框架支撑组件26起到对整个手套仓系统系统的支撑作用，在操作时候，形成的固体废物可以扔在袋出系统5的废物桶中，待操作完成后，将废物桶卸下，将其中的废物清理掉，此废物桶可以循环使用，与仓体25内部一起灭菌使用，其最大的优点是节约耗材，从而减少使用成本的。The top air treatment system 2 pours the vertically downward laminar flow air formed after the treatment into the bin body 25, and forms a return air wall through the glove operation components 4 on the front and rear sides, and returns the vertically downward laminar flow air to the top air treatment system 2, forming a cycle. The frame support assembly 26 at the bottom acts as a support for the entire glove storage system. During operation, the solid waste formed can be thrown into the waste bucket of the bagging system 5. After the operation is completed, the waste bucket is removed and the The waste therein is cleaned up, and this waste bucket can be recycled, and is sterilized together with the inside of the storehouse body 25. Its biggest advantage is to save consumables, thereby reducing the cost of use.
手套操作组件4如图10-11所示，包括操作窗密封玻璃41，手套通过手套连接组件44与操作窗密封玻璃41连接，操作窗密封玻璃41的上侧与仓体25通过不锈钢铰链39活动连接，下侧与仓体25之间设有门锁组件40，门锁组件40上设有门开启状态信号装置。操作窗密封玻璃41内侧设有内部回风玻璃42，操作窗密封玻璃41与内部回风玻璃42之间形成回风通道，该回风通道用于将仓体25中的垂直的层流风返回到顶部空气处理系统2；两者之间通过手套连接组件44、连接部件43连接。操作窗密封玻璃41的左右两侧分别设有氮气弹簧37，氮气弹簧37的上端通过氮气弹簧上安装支座38与操作窗密封玻璃41固定连接，下端通过氮气弹簧安装底座36与仓体25固定连接。手套操作组件4与仓体25之间设有密封圈。The glove operation assembly 4, as shown in Figures 10-11, includes an operation window sealing glass 41, the gloves are connected to the operation window sealing glass 41 through a glove connecting assembly 44, and the upper side of the operation window sealing glass 41 is movable with the bin body 25 through a stainless steel hinge 39 A door lock assembly 40 is provided between the lower side and the warehouse body 25, and the door lock assembly 40 is provided with a door opening state signal device. The inner side of the operation window sealing glass 41 is provided with an internal air return glass 42, and an air return passage is formed between the operation window sealing glass 41 and the internal return air glass 42, and the return air passage is used to return the vertical laminar flow wind in the warehouse body 25 to The top air handling system 2; the two are connected through the glove connecting assembly 44 and the connecting part 43. The left and right sides of the operation window sealing glass 41 are respectively provided with nitrogen springs 37, the upper end of the nitrogen spring 37 is fixedly connected with the operation window sealing glass 41 through the nitrogen spring mounting support 38, and the lower end is fixed with the bin body 25 through the nitrogen spring mounting base 36 connect. A sealing ring is provided between the glove operating assembly 4 and the bin body 25 .
操作窗密封玻璃41与仓体25上的密封圈构成系统的密封结构，将系统内部生产环境与外部环境和操作者完全隔离器开，操作者只允许通操作手套连接组件44来完成系统内部的工艺操作，操作窗密封玻璃41的开关状态可以通过门锁组件40来监控，操作窗密封玻璃41打开时通过氮气弹簧37支撑，保证操作者开关操作窗密封玻璃41的方便性。The sealing glass 41 of the operation window and the sealing ring on the bin body 25 constitute the sealing structure of the system, which completely isolates the internal production environment of the system from the external environment and the operator. Process operation, the switch state of the operating window sealing glass 41 can be monitored by the door lock assembly 40, and the operating window sealing glass 41 is supported by the nitrogen spring 37 when it is opened to ensure the convenience of the operator switching and operating the window sealing glass 41.
空气处理系统2如图9所示，包括设于空气处理系统壳体内的带新风阀33的新风组件32，空气处理系统壳体内的左右两侧分别设有一组排风循环装置，所述排风循环装置包括从上至下分布的带排风蝶阀一30的排风组件29、循环风机组件一34、液槽密封过滤器35。空气处理系统2与手套仓系统之间设有均流膜一28。空气处理系统壳体内左右两侧设有照明灯一27。As shown in Figure 9, the air treatment system 2 includes a fresh air assembly 32 with a fresh air valve 33 located in the air treatment system housing. A group of exhaust air circulation devices are respectively provided on the left and right sides of the air treatment system housing. The circulation device includes an exhaust assembly 29 with an exhaust butterfly valve 1 30 , a circulation fan assembly 1 34 , and a liquid tank sealing filter 35 distributed from top to bottom. A flow equalizing film 1 28 is provided between the air handling system 2 and the glove compartment system. The left and right sides of the housing of the air handling system are provided with lighting lamps 1-27.
无菌检查工艺隔离器的使用环境最低可以是D级，顶部空气处理系统是为了保证内部的A级环境，所有进入隔离器内部的新风必须经过新风组件32处理后进入隔离器，排风组件29的功能是一方面是为处理排除隔离器的气体，保证排出气体的安全性，另一方面防止在突然停机的情况下，外面的脏空气进入隔离器内部造成污染，由于隔离器内部要求层流系统，所有通过循环风机组件一34将空气通过液槽密封过滤器35以及均流膜一28，形成垂直层流的气流保护，内部循环催化分解单元31是为了在过氧化氢蒸汽灭菌的通风阶段能够更快的降低浓度，加快灭菌周期时间，在隔离器内部设置的对过氧化氢蒸汽有催化分解作用的功能模块，照明灯一27可以提供整个隔离器腔体内部照度的要求，保证人员操作的舒适度，新风阀33及排风蝶阀一30能够在泄露测试及灭菌过程保证整个腔体的密闭性。The use environment of the sterility inspection process isolator can be at least grade D, and the top air treatment system is to ensure the internal environment of grade A. All the fresh air entering the isolator must be processed by the fresh air component 32 before entering the isolator, and the exhaust component 29 The function is to process and remove the gas from the isolator on the one hand, to ensure the safety of the exhausted gas, and on the other hand to prevent the dirty air from entering the isolator to cause pollution in the case of sudden shutdown, because the isolator requires laminar flow inside System, all the air is passed through the liquid tank sealing filter 35 and the flow equalizing membrane 28 through the circulating fan assembly 34 to form the airflow protection of vertical laminar flow, and the internal circulation catalytic decomposition unit 31 is for the ventilation of hydrogen peroxide vapor sterilization stage can reduce the concentration faster and speed up the sterilization cycle time. The functional module that can catalyze the decomposition of hydrogen peroxide vapor is set inside the isolator, and the lighting lamp 127 can provide the internal illumination requirements of the entire isolator cavity, ensuring The comfort of personnel operation, the fresh air valve 33 and the exhaust butterfly valve 30 can ensure the airtightness of the entire cavity during the leak test and sterilization process.
传递仓组件如图5-6所示，包括传递仓壳体12，传递仓壳体12上段为进风段，下段为回风段，底部设有气动元器件箱24。传递仓壳体12进风段前侧设有栅孔45，顶部设有排风过滤分解系统22，排风过滤分解系统22与带排风蝶阀二20的排风风机21连接，排风过滤分解系统22的下方设有带新风蝶阀18的循环风机组件二19；新风蝶阀18前侧设有新风中效过滤器17；传递仓壳体12进风段下侧的出风口处设有循环高效过滤器16。传递仓壳体12回风段的两侧分别设有带门锁系统的门23，其中一侧的门23与手套仓系统的仓体25一侧的门框47相配合，该门23打开后与仓体25内部连通；回风段的后侧设有回风板46，回风板46与传递仓壳体12后侧形成回风通道；传递仓壳体12进风段与回风段之间设有均流膜二14。气流从栅孔45中进入传递仓壳体12内，经新风中效过滤器17过滤后依次经过新风蝶阀18、循环风机组件二19、循环高效过滤器16、均流膜二14至回风段底部后，经回风板46与传递仓壳体12之间的回风通道回风至排风蝶阀二20，经排风风机21进入排风过滤分解系统22。传递仓壳体12内设有照明灯二15。As shown in Figure 5-6, the transfer bin assembly includes a transfer bin housing 12. The upper section of the transfer bin housing 12 is an air inlet section, the lower section is an air return section, and a pneumatic component box 24 is provided at the bottom. The front side of the air intake section of the transfer bin shell 12 is provided with grill holes 45, and the top is provided with an exhaust air filtration and decomposition system 22. The exhaust air filtration and decomposition system 22 is connected with the exhaust fan 21 with the exhaust butterfly valve 22, and the exhaust air filtration and decomposition system Below the system 22, there is a circulating fan assembly 2 19 with a fresh air butterfly valve 18; a fresh air medium-efficiency filter 17 is provided on the front side of the fresh air butterfly valve 18; device 16. Both sides of the air return section of the transfer bin housing 12 are respectively provided with doors 23 with a door lock system, wherein the door 23 on one side is matched with the door frame 47 on the side of the bin body 25 of the glove bin system. The interior of the warehouse body 25 is connected; the rear side of the air return section is provided with a return air plate 46, and the air return plate 46 forms a return air passage with the rear side of the transfer bin housing 12; the air inlet section and the return air section of the transfer bin housing 12 Equilibrium film 2 14 is provided. The air flow enters the transfer bin housing 12 from the grid hole 45, and after being filtered by the fresh air medium-efficiency filter 17, it passes through the fresh air butterfly valve 18, the circulating fan assembly 2 19, the circulating high-efficiency filter 16, the flow equalizing membrane 2 14 to the return air section After the bottom, the air returns to the exhaust butterfly valve 2 20 through the air return channel between the air return plate 46 and the transfer bin housing 12, and enters the exhaust air filtration and decomposition system 22 through the exhaust fan 21. An illuminating lamp 2 15 is provided in the transfer bin housing 12 .
传递仓组件3的主要功能是为手套仓系统提供无菌检测的物品，当手套仓系统正在操作时候，发现原先准备不足，缺少后续检测使用的必需物品时，为了不影响手套仓系统正在进行的操作，此时可以通过传递仓组件来进行，将物品放进传递仓组件进行灭菌，同时不影响后续手套仓系统的操作，待传递仓组件的物品灭菌完成时，可以通过传递仓组件与手套仓系统的中间的对接门23，把传递仓组件的物品传递到手套仓系统，继续进行。另外，传递仓组件还可以作为储备仓使用，当发现手套仓系统东西放不下时候，可以放在传递仓组件。The main function of the transfer bin component 3 is to provide sterile testing items for the glove bin system. When the glove bin system is in operation, if it is found that the original preparations are insufficient and there is a lack of necessary items for subsequent testing, in order not to affect the ongoing glove bin system At this time, the operation can be carried out through the transfer bin assembly, and the items can be put into the transfer bin assembly for sterilization without affecting the operation of the subsequent glove bin system. The docking door 23 in the middle of the glove bin system transfers the items of the transfer bin assembly to the glove bin system and continues. In addition, the transfer bin assembly can also be used as a reserve bin. When it is found that the glove bin system cannot fit, it can be placed in the transfer bin assembly.
无菌检查工艺隔离器的使用环境最低可以是D级，为了保证内部的A级环境，新风在通过栅孔45进入新风中效过滤器17，新风中效过滤器17的主要作用是对新风进行一个初过滤，过滤较大颗粒的粉尘等，对循环高效过滤器16及排风过滤分解系统22中的排风高效是一个保护作用，特别是对于循环高效过滤器16，能够延长使用寿命；新风在经过新风中效过滤器17后，依次经过新风蝶阀18及循环风机组件二19，此时的循环风机组件二19既可以当做主体循环风机使用，还可以作为新风风机使用，之后，新风经过循环高效过滤器16及均流膜二14后，新风达到层流A级环境，形成垂直向下层流保护，之后通过仓体内的回风板再次进入排风蝶阀二20、排风风机21及排风过滤分解系统22，排风过滤分解系统22保证排出气体的安全性，另一方面防止在突然停机的情况下，外面的脏空气进入隔离器内部造成污染；最后排放到室外。The use environment of the sterility inspection process isolator can be at least Class D. In order to ensure the internal Class A environment, the fresh air enters the fresh air medium-efficiency filter 17 through the grid hole 45. The main function of the fresh air medium-efficiency filter 17 is to carry out fresh air. A preliminary filter, which filters dust of larger particles, etc., is a protective effect on the exhaust air efficiency in the circulating high-efficiency filter 16 and the exhaust air filtration and decomposition system 22, especially for the circulating high-efficiency filter 16, which can prolong the service life; fresh air After passing through the fresh air medium-efficiency filter 17, it passes through the fresh air butterfly valve 18 and the circulating fan assembly 2 19 in turn. At this time, the circulating fan assembly 2 19 can be used as the main circulating fan or as a fresh air fan. After that, the fresh air passes through the circulation After the high-efficiency filter 16 and the flow equalizing membrane 2 14, the fresh air reaches the laminar flow A-level environment, forming a vertical downward laminar flow protection, and then enters the exhaust butterfly valve 2 20, the exhaust fan 21 and the exhaust air again through the return air plate in the warehouse body. Filtration and decomposition system 22, exhaust air filtration and decomposition system 22 ensures the safety of exhaust gas, on the other hand, prevents outside dirty air from entering the isolator and causing pollution in the case of sudden shutdown; finally, it is discharged to the outside.
双面层流操作的无菌检查工艺隔离器工作时完全与操作人员及背景环境隔离开，内部全密闭自循环的循环方式使隔离器内部环境参数能够被实时监控，是无菌药品的生产后检测结果的准确性和可信度大大提高，集成式的的过氧化氢灭菌系统可以使隔离器内部在线灭菌，同时也降低了有毒高致敏性药物对操作人员的危害。The aseptic inspection process isolator with double-sided laminar flow operation is completely isolated from the operator and the background environment when it is working. The internal fully closed self-circulation circulation mode enables the internal environmental parameters of the isolator to be monitored in real time. The accuracy and reliability of the test results are greatly improved. The integrated hydrogen peroxide sterilization system can sterilize the inside of the isolator on-line, and at the same time reduce the hazards of toxic and highly allergenic drugs to operators.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201520798114.5UCN205310303U (en) | 2015-10-15 | 2015-10-15 | Sterility testing technology isolator of two -sided laminar flow operation |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201520798114.5UCN205310303U (en) | 2015-10-15 | 2015-10-15 | Sterility testing technology isolator of two -sided laminar flow operation |
| Publication Number | Publication Date |
|---|---|
| CN205310303Utrue CN205310303U (en) | 2016-06-15 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201520798114.5UExpired - LifetimeCN205310303U (en) | 2015-10-15 | 2015-10-15 | Sterility testing technology isolator of two -sided laminar flow operation |
| Country | Link |
|---|---|
| CN (1) | CN205310303U (en) |
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|---|---|---|---|---|
| CN112728116A (en)* | 2021-03-31 | 2021-04-30 | 创志科技(江苏)股份有限公司 | Sealing structure and double-layer airtight isolating device of granulator using same |
| GB2593277A (en)* | 2020-01-17 | 2021-09-22 | Whitley Don Scient Ltd | Workstation |
| CN115193491A (en)* | 2022-02-22 | 2022-10-18 | 上海东富龙爱瑞思科技有限公司 | System for protecting and aseptically isolating novel COVID-19 virus |
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB2593277A (en)* | 2020-01-17 | 2021-09-22 | Whitley Don Scient Ltd | Workstation |
| GB2593277B (en)* | 2020-01-17 | 2023-11-22 | Whitley Don Scient Ltd | Workstation |
| CN112728116A (en)* | 2021-03-31 | 2021-04-30 | 创志科技(江苏)股份有限公司 | Sealing structure and double-layer airtight isolating device of granulator using same |
| CN115193491A (en)* | 2022-02-22 | 2022-10-18 | 上海东富龙爱瑞思科技有限公司 | System for protecting and aseptically isolating novel COVID-19 virus |
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| Date | Code | Title | Description |
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| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant |