发布时间 : 星期三 文章冻干机操作手册 - 图文更新完毕开始阅读082aa3fbf021dd36a32d7375a417866fb84ac002
Diagram 3.15 Loading and Unloading进出料画面
The screen is divided into three parts: one part is to show communication signal of freeze dryer and loading/unloading system; one part is to set shelf load and unload position; the third part is loading and unloading failure recovery.
本画面分为三个部分：第一部分为冻干机与进出料通讯信号；第二部分为板层进出料位置设定；第三部分为进出料故障恢复。
1. Freeze dryer communication with loading/unloading system
冻干机与进出料通讯信号
Freeze dryer and loading/unloading system need exchange signal when freeze dryer runs in loading and unloading fhase.
present 0,
present 1 as show in the picture
above. 13 signals on the left is sent by freeze dryer, 13 signals on the right side is sent by loading and unloading system. Through exchange the signals, freeze dryer loading and unloading will go smoothly
冻干机在进行进出料阶段需要与进出料系统进行信号交换。从图上可以看出，
代表信号为0，
代
表信号为1。左边的13个信号为冻干机发送的信号，右边的13个信号为自动进出料系统发送的信号，通过的信号的交换使得冻干机的自动进出料能够顺利进行。
2. Loading and unloading shelf position setup板层进出料位置设定
When freeze dryer runs in loading and unloading fhase, it need to set shelf position of each shelf. Shelf position include integer and decimal.
在冻干机的进料阶段，要设定每块板层进料的具体位置，位置设定包括整数部分和小数部分；在冻干机的出料阶段，要设定每块板层出料的具体位置，位置设定包括包括整数部分和小数部分。
3. Loading and unloading failure recovery进出料故障恢复
This eara allow operator to recover loading/unloading failure including: force loading/unloading, slot door home, open slot door, close slot door, shelf reposite, slot door maintenance, slot door servo reset.
在这里可以进行进出料故障恢复的操作，包括强制进出料完成、小门原点模式、打开小门、关闭小门、板
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层重定位、小门维护模式、小门驱动器复位。
3.2.10 Setup Mimic设置画面
Every cycle and general parameters can be set in this mimic. Only the authorized user can modify the parameters, including general parameter setup, condensercooling cycle parameter setup, CIP cycle parameter setup, SIP cycle parameter setup, vacuum leakage test cycle parameter setup, shelfbellow integrity test cycle parameter setup, as shown in diagram 3.15.
设置画面进行各个周期和通用参数的设置，只允许授权的用户才能更改参数，其中包括通用参数设置、冷阱降温周期参数设置、在线清洗周期参数设置、在线灭菌周期参数设置、真空泄漏测试周期参数设置、板层波纹管完整性测试周期参数设置、主阀波纹管完整性测试周期等参数设置。如图3.15所示：
Diagram 3.15 Parameter Setup Mimic参数设置画面
3.2.11 Recipe Edit配方编辑
Only the authorized user can open the recipe edit mimic which is used to edit the freeze drying cycle recipe, save it and download as in diagram 3.16. The mimic contains 4 parts: the first part is the recipe editor area for the detailed editing; second part is the recipe information displaying area for displaying and modifying the relevant information; the third part is operation area for creating, modifying and downloading the recipe; last part is vacuum controlled parameter setup during the freeze drying cycle. Detailed descriptions are as follows:
配方编辑只允许有授权的用户打开，该画面用于编辑冻干周期配方，并执行配方的保存和下载功能，如图3.16所示。该画面主要包含四个部分：第一部分为配方编辑器区域，用于配方的具体步骤编辑；第二部分为配方信息显示区域，用于显示和修改配方相关信息；第三部分为配方操作区域，用于新建、修改和下载配方等；第四部分为冻干周期运行时真空控制参数设置。下面进行详细说明：
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Diagram3.16 Recipe Edit Mimic 1配方编辑画面1
1. Recipe Editor配方编辑器
As in diagram 3.17, the recipe editor provides maximum 40 different control phase editor for each freeze drying cycle. And the phase type displays control phase name which includes 10 different phases: loading, pre-freezing, evacuation, drying, pressure rise, pre-aeration, stoppering, aeration, storage, unloading. In order to satisfy the freeze drying process requirements, the selection comply with the following standards.
如图3.17所示，配方编辑器提供每个冻干周期最多40个不同的控制阶段编辑，步骤类型显示控制阶段名称，包含10个不同的阶段，分别为进料、预冻、抽空、干燥、压升、预放气、压塞、放气、存储、出料。为满足冻干工艺要求，他们的选择遵循以下原则：
1. Loading is an option that is used only once in a recipe. If selected, this must be the
first step.
进料是选项，在配方中只允许有一步。如果选用，必须是第一步。
2. There must be at least one Freezing step. The customer has to decide how many
freezing steps (including the thermal treatment) are required in the recipe.
配方中至少应该有一步预冻，用户在配方中可以配置应包含多步预冻（包括热处理预冻方式）。
3. There must be only one Evacuation step, and it must follow a freezing step and be
immediately before a drying step.
配方中必须有、并且只能有一步抽空，而且必须紧跟在一步预冻步骤之后同时在干燥步骤之前。
4. There must be at least one Drying step, but the customer has to decide how many
drying steps are required in the recipe.
配方中至少应该有一步干燥，用户在配方中可以配置应包含多少步干燥。
5. Pressure rise test is an option that does not have to be used. Multi steps are allowed,
but it must follow a drying step.
压升是选项，在配方中可以包含多步，但必须紧跟在一个干燥步骤之后。
6. Pre-aeration step is an option that is used only once per recipe. It is used to aerate the
chamber to the setpoint of ?Pre-aeration pressure‘ (typically below the atmospheric
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pressure). So that a product that is in vials can be stoppered under a partial vacuum.
预放气是选项，在配方中只能用一步，把箱体压力放到‘预放气压力’的设定值(通常小于大气压)。因此
在小瓶中的产品能够在局部真空下压塞。
7. Stoppering is an option that is used only once per recipe, and is only used after the
product, which is in vial, is dry. Stoppering is never used when bulk product trays are in use.
压塞是选项在配方中只能用一步，只有当产品在小瓶中是干燥的时候使用。当托盘上大量产品使用时从不
使用压塞。
8. Aeration is an option that is used only once per recipe. Its purpose is to aerate the
chamber and condenser, after the product is dry, so the operator can open the chamber door(s).
放气是选项在配方中只能用一步。它在产品干燥后把箱体和冷阱放气，然后可打开小门进行出料。 9. Storage is an option that is used only once per recipe. It is used after the product is dry,
to keep the product at a temperature, before the operator removes the product from the chamber.
存储是选项在配方中只能用一步。它用在产品干燥后，在操作员把产品从箱体移走之前保持产品在一个温
度。
10. Unloading can have only one step in the recipe. If chose, it must be the last step. 出料是选项，在配方中只允许有一步。如果选用，必须是最后一步。
Each step has 3 relevant parameters, but only several parameters configurations are valid based on the different steps. The detailed recipe parameter configurations are as the following table 3.8.
每个阶段对应3个参数，但根据步骤类型的不同，只有若干个参数配置有效。具体配置如下表3.8 配方参数配置表所示。
Table 3.8 Recipe parameter configuration配方参数配置表 No Name Temperature setup 步骤设定温度 Function Description For loading, pre-freezing, drying, storage and unloading steps, the temperature setup step need to be configured. Setup range is -55?C – 80?C. 在进料、预冻、干燥、存储和出料步骤，需要设置―步骤设定温度‖，设定范围是-55?C – 80?C。 1 2 Vacuum setup 步骤设定真空 For evacuation, drying and pressure risesteps, vacuum setup step need to be configured. Setup range is 0 – 1000μBar. 在抽空、干燥和压升步骤，需要设置―步骤设定真空‖，设定范围是0 – 1000ubar. For different steps, there are 3 different ways to setup the time. 对不同步骤，可以有以下3 种不同的时间设定方式： a. 3 Time setup 步骤设定时间 For pre-freezing, drying and storage steps, HH：MM format is adopted. It shows the hour （0-15h）and minute part（0-59 m）. 在预冻、干燥和存储阶段，采用HH：MM格式，分别表示步骤设定时间的小时（0-15小时）及分钟部分（0-59分钟）。 b. For stoppering step, MM：SS format is adopted. It shows the
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