发布时间 : 星期六 文章冻干机操作手册更新完毕开始阅读082aa3fbf021dd36a32d7375a417866fb84ac002
2. The condenser drain cooling and aeration are deactivated 冷阱排水、降温没有激活 3. The main door and slot door are closed 大门及小门关闭 4. The main isolation valve FV1 is closed 主隔离阀FV1关闭 5. The evacuation valve FV2 is closed. 抽空阀FV2关闭 After selecting the control button, the main door locking will be activated if the following conditions are satisfied Main door locking 18 大门锁定 当控制按钮选择后，如果以下条件满足，大门锁定将被激活 1. The main door is closed 大门关闭 2. The main door unlocking is deactivated 大门解锁没有激活 After selecting the control button, the main door unlocking will be activated if the following conditions are satisfied 19 Main door unlocking 大门解锁 当控制按钮选择后，如果以下条件满足，大门解锁将被激活 1. The main door is closed. 大门关闭 2. The main door locking is deactivated 大门锁定没有激活 The slave panel is activated after selecting the control button. The ram shelf retraction, door locking/unlocking, and chamber lighting can be operated in the slave panel. 当控制按钮选择后，使能控制面板激活。使能控制面板激活后，可以在机器房控制面板上操作板层上升、板层下降、大门锁定、大门解锁和箱体照明。 20 Slave panel 使能控制面板 4.3
Automatic Control自动控制
The automatic control of the lyophilizer contains freeze drying cycle, condenser defrost cycle, CIP cycle, SIP cycle, vacuum leakage test, shelfbellow test.Before the automatic operation, the utilities shall be checked, including compressed air, cooling water, steam (if SIP is needed), pure water, or injection water (if CIP is needed)
冻干机自动控制包含冻干周期、冷阱除霜周期、在线清洗周期、在线灭菌周期、真空泄漏测试、板层波纹管测试、主阀波纹管测试。启动自动控制前，需检查公用设施供应是否正常，包括压缩空气、冷却水、蒸汽(如需SIP)、纯水或注射水(如需CIP)。
Following the steps below to start the automatic operation:
请按以下步骤，启动自动控制：
? Go to the console mimic by clicking the operation button in the menu bar
点击菜单条上”操作”按钮，进入操作台画面；
? Setup the reasonable general parameters with reference to table 3.4
设定合理的通用参数，请参考表3.4控制台界面功能说明；
? Check the equipment to satisfy all start-up conditions, if not, manually operate to
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satisfy them
检查设备全部满足以下自动周期控制启动条件，如果不满足，进行手动操作，使之满足：
1. close the main door
大门关闭
2. stop the manual mode
停止手动模式
? Activate the automatic mode
激活自动模式
After activating the automatic mode, the following operations can be acted, including freeze drying cycle, condenser defrost, CIP, SIP, vacuum leakage test, shelfbellow test. The detailed descriptions are as follows.
激活自动模式后，可以进行冻干周期、冷阱除霜、在线清洗、在线灭菌、真空泄漏测试、板层波纹管测试、主阀波纹管测试。详细操作说明如下。
4.3.1 Freeze Drying Cycle冻干周期
In the automatic mode, the freeze drying cycle can execute automatically based on the selected recipe. After the cycle runs, the authorized user can skip (only in loading phase and sampling phase) and change the parameters online except this step. Now take a complete clean cycle for instance:
自动模式下，冻干周期按选定的配方自动执行。周期运行后，有权限的用户可进行跳步，并可对步骤参数进行在线修改。现在以一个完整的冻干周期为例进行操作说明：
? Recipe edit: if there is recipe, then skip this step and start cycle directly. The recipe editing mimic will be entered by clicking the recipe button in the menu bar to edit a complete automatic clean cycle recipe as in diagram4.1 which can be saved and downloaded to the PLC. For the detailed operation, refers to the section 3.2.10.
配方编辑：如果已有配方，则跳过该步，直接启动周期。点击菜单条上”配方”按钮进入配方编辑界面，编辑一个完整的自动清洗周期配方，如下图4.1所示，保存并下载至PLC。详细操作请参考第3节3.2.10上位机配方编辑操作说明。
Diagram 4.1 the freeze drying cycle recipe冻干周期配方
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? To confirm the successful download of the recipe: after download, click the operation button in the menu bar, it will switch to the recipe operation mimic, then confirm the data have all been downloaded to the PLC. Note: there are 200 data go into the PLC at the same time, so the speed will shortly slow down, please wait with patience.
确认配方下载成功：下载完毕后，点击菜单条上”运行”按钮，切换至配方运行画面，确认数据是否全部下载至PLC。注意，因为同时有200个数据写入PLC，所以此时读写速度将短暂变慢，请耐心等待。
? Enable the freeze drying cycle
启动冻干周期
Diagram 4.2 Enablefreeze drying cycle启动冻干周期
Switch to the console mimic by clicking the operation button in the menu bar, click ―start freeze drying cycle‖ button to start the cycle (details in table 3.4). When the cycle starts, it goes to the first step pre-freezing.
点击菜单条上”操作”按钮，切换至操作台画面，点击”启动冻干周期”按钮，启动冻干周期(详细操作及按钮说明参看表3.4控制台界面功能说明)，周期启动，进入第一步进料。
Step1 Pre-freezing
第一步：预冻
The recipe shall have at least one step pre-freezing. The user can configure several pre-freezing steps in the recipe.In this step, the products in the shelfwithin the chamber shall be frozen to the setup limit temperature value (normally -40℃). When the setup time is reached and the shelfinlet temperature is controlled within ±1℃ deviation range, the cycle advances to the next step.
冻干配方中至少应该有一步预冻，用户在配方中可以配置多步预冻。在预冻步骤中，箱体中装载在板层中的产品冻结至设定的极限温度(一般是-40℃)。当步骤设定时间已到，而且系统通过温度控制使板层进口温度控制±1℃偏差范围之内时，周期进入下一个步骤。
Step 2 Evacuation
第二步：抽空
Evacuation is used to evacuate the condenser and the chamber. The recipe must and only have one step for vacuum. And it must go after pre-freezing and before drying. In this step, the condenser cooling will be started firstly. The vacuum pumps will be started when 10 minutes after the condenser temperature is or lower than -40℃. After vacuum pumps have been working for 10 minutes, the main valves will be opened for vacuum control. When the chamber vacuum is or lower than the vacuum setpoint and the shelfinlet temperature is controlled within ±1℃ deviation range, the cycle advances to the next step.
抽空是对冷阱及箱体进行抽空。冻干配方必须有且只能有一步抽空，抽空步骤必须在预冻步骤之后干燥步骤之前。在抽空步骤中，冷阱降温先启动，当冷阱温度达到或低于-40℃后10分钟，真空泵组启动。当真空泵组运行10秒钟后，主阀打开。主阀打开后进行真空控制，当箱体真空达到或小于真空设定值，而且板层入口温
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度被控制在±1℃偏差范围之内时，周期将自动进入下一步。
Step 3 Drying
第三步：干燥
The recipe shall have at least one drying step. The user can configure several drying steps. In this drying step, the cooling and heating systems will work to control the shelfinlet temperature. The refrigeration system cools the condenser, and the vacuum control system controls the vacuum in the chamber and the condenser. When the setup time is reached and the shelfinlet temperature is controlled within ±1℃ deviation range, moreover the chamber vacuum is within the control range, the cycle advances to the next step.
抽空是对冷阱及箱体进行抽空。冻干配方必须有且只能有一步抽空，抽空步骤必须在预冻步骤之后干燥步骤之前。在抽空步骤中，冷阱降温先启动，当冷阱温度达到或低于-40℃后10分钟，真空泵组启动。当真空泵组运行10秒钟后，主阀打开。主阀打开后进行真空控制，当箱体真空达到或小于真空设定值，而且板层入口温度被控制在±1℃偏差范围之内时，周期将自动进入下一步。
Step 4 Pressure Rise
第四步：压升
The pressure rising is an option. It can have many steps in the recipe, but it must go after one drying step. In this step, when the chambervacuum is within the control range, the main isolation valve FV1 will be closed to observe the pressure rise. The vacuum control will be stopped at the moment. In the setup pressure test time period, if vacuum alarm is generated or the chamber pressure rise value is higher than the setpoint, the test fails and it will restart after the test interval. If the pressure rising value is lower than the setpoint, the test passes and the cycle advances to the next step.
压升在冻干配方中是选项，可以包含多步，但必须紧跟在一个干燥步骤之后。在压升步骤中，当箱体真空在有效控制范围之内时，关闭主隔离阀FV1，观察压力升高的情况。此时，真空控制将停止，在设定的压升测试时间内，如果出现真空预警或者箱体压力升高的数值超过设定的压升数值，压升实验失败，并在测试间隔时间后重新开始；如果压升数值小于压升设定值，压升实验通过。当压升实验合格后，周期将自动进入下一步骤。
Step 5Pre-aeration
第五步：预防气
Pre-aeration is an option. It can only have one step in the recipe, and it put the chamber pressure to the set value of the pre-aeration (normally less than atmospheric pressure). In this step, condenser cooling, evacuation and vacuum control will stop, and the shelfinlet temperature is based on the final setpoint in the drying step. When the chamber pressure reaches the set value of the pre-aeration, the relevant valves will be closed and the cycle advances to the next step.
预放气在配方中是选项，在配方中只能用一步，把箱体压力放到”预放气压力”设定值(通常小于大气压)。在预放气步骤中，冷阱降温、抽空和真空控制将停止，同时板层控温以干燥步骤中最后设定的温度控制值为基准控制板层入口温度。当箱体放气到”预放气压力”设定值，关闭相应阀门后周期进入下一步骤。
Step 6Stoppering
第六步：压塞
Stoppering can have only one step in the recipe. In this step, condenser cooling, evacuation and vacuum control will stop, and the shelfinlet temperature is based on the final setpoint in the drying step.Shelves decline completely cap the rubber capper. When the rubber cappers are capped, the hydraulic pressure will reach the setpoint and maintain for some certain time (the setup time). Then the shelves will be raised to the highest position, and the
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