冻干机操作手册.doc

1、DG16064-DG01-OM-R0.0 Page 1 of 113LYOTK15OPERATION MANUAL 操作手册Equipment Name: Automatic Vacuum Lyophilizer设备名称: 真空冷冻干燥机Equipment model: LYOTK15设备型号： LYOTK15Please hand the manual to the end user for keeping.请将该操作手册交至最终用户，并妥善保存DG16064-DG01-OM-R0.0 Page 2 of 113PREFACE 前 言Thank you for purchasing Truk

2、ing Lyophilizer. This operation manual introduces how to correctly operate LYOTK15 Lyophilizer. Please read this manual carefully and understand safety notice before operation. 感谢您购买楚天科技冻干机。本操作手册介绍了如何正确使用 LYOTK15 系列冻干机。在使用该产品前，请务必认真阅读本操作手册，并在理解产品的安全注意事项后再使用该产品General cautions一般注意事项This manual includ

3、es: safety, introduction, PC operation description, lyophilizer operation description, alarm and failure analysis, terminology and abbreviations.For better introduction of the product details, the diagrams in the manual are the status without the covers. When operating the products, please make sure

4、 the covers are installed and operate according to the manual description. The diagrams in this manual are only examples, which may have differences from your purchased products. For improving the convenience of the manual, the contents in the manual may be timely updated when the products and speci

5、fication updates. If you need to order the operation manual due to damage and losing, please contact our company or the office sitting nearest to you in the back cover and tell us the reference number in the cover. If the writings on the nameplate installed in the products blurs, please order from o

6、ur company or the office sitting nearest to you in the back cover.本手册包含：安全、简介、上位机操作说明、冻干机机操作说明、常见报警及故障分析、术语和缩写六个部分。为了说明产品的细节部分，本说明书中的图解有时为卸下外罩或安全遮盖物的状态。运行本产品时，请务必按规定装好外壳或遮挡物，并按使用说明书的内容进行运行。本操作手册中的图示仅为代表例，可能会与您订购的产品有所不同。由于产品改良或规格变更，以及为了提高操作手册的便利性，本操作手册的内容会及时变更。由于损坏或遗失而需要订购操作手册时，请向本公司或者封底上记载的离您最近的本公司营

7、业所联系，并告知封面上的资料编号。安装在产品上的铭牌如果已经字迹模糊或发生破损时，请向本公司或封底上记载的离您最近的本公司营业所订购。DG16064-DG01-OM-R0.0 Page 3 of 113Table of contentsTable of contents .31 Safety Related Marks 与安全 有关的标记说明 .51.1 Safety notice 安全注意事项 .61.1.1 Before Power-on 上电前 .61.1.2 Mechanical Safety 机械安全 .71.1.3 Emergency Stop 紧急停止 .71.1.4 Maint

8、enance and Inspection 维护与检查 .82 Lyophilizer Introduction 冻干机简介 .92.1 Purpose 冻干机用途 .92.2 Configuration 冻干机配置 .92.3 Control System 冻干机控制系统 .103 HMI Operation Description 上位机操作说明 .113.1 System Introduction 上位机系统简介 .113.2 Operation instruction .113.2.1 Menu Bar 菜单条 .123.2.2 Login 登陆 .133.2.3 Log out 登出

9、 .143.2.4 Flow Chart 流程图 .143.2.5 Console 操作台 .163.2.6 PID Control Mimic PID 控制画面 .303.2.7 Alarm mimics 报警画面 .313.2.8 Trend Mimic 曲线画面 .333.2.9 Loading and Unloading 进出料画面 .363.2.10 Setup Mimic 设置画面 .383.2.11 Recipe Edit 配方编辑 .383.2.12 Recipe running 配方运行 .443.2.13 PLC Input Status PLC 输入状态 .453.2.1

10、4 PLC Output Status 输出状态 .453.2.15 Recorder 记录仪画面 .463.2.16 Application 应用画面 .463.2.17 Report 报表查询 .483.2.18 Maintenance 维护 .493.2.19 System Configuration 系统配置 .493.2.20 Exit 退出 .503.2.21 Status Bar 状态条 .504 Operation Instruction 冻干机操作说明 .524.1 Power on 上电 .524.2 Manual Control 手动控制 .574.3 Automatic

11、 Control 自动控制 .614.3.1 Freeze Drying Cycle 冻干周期 .624.3.2 Condenser Defrosting 冷阱除霜 .65DG16064-DG01-OM-R0.0 Page 4 of 1134.3.3 CIP 在线清洗 .674.3.4 SIP 在线灭菌 .714.3.5 Vacuum Leakage Test 真空泄漏测试 .754.3.6 Shelf Bellow Test 板层波纹管测试 .774.3.7 Main Valve Bellows Iitegrity Test 主阀波纹管测试 .784.3.8 Unloading Pusher

12、 Bellows Test 后推波纹管测试 .794.3.9 Filter1 integrity test 过滤器 1 完整性测试 .814.3.10 Filter2 integrity test 过滤器 2 完整性测试 .825 Operation Instruction of HMI .855.1 Manual operation interface.865.2 State monitoring interface .876 Alarms and Failures Analysis 常见报警及故障分析 .896.1 PC Failures PC 故障 .906.2 Utility Fail

13、ures 工艺故障 .906.3 Instrumentation Failures 仪器仪表故障 .916.4 Device Failure 部件故障 .946.4.1 Device State Failure 部件状态故障 .946.4.2 Device IO Failure 元件 IO 故障 .976.5 Process Failure 过程故障 .1027 Terminology and Abbreviation 术语和缩写 .111DG16064-DG01-OM-R0.0 Page 5 of 1131 Safety Related Marks 与安全有关的标记说明This manual

14、 uses the following marks based on the safety contents. 本手册根据与安全有关的内容，使用了下列标记。The safety related marks are extremely important to follow. 有安全标记的说明，表示重要内容，请务必遵守。However, even the attention items may cause major accident based on the actual situation.但是，即使是 事项，根据具体情况，有时也可能导致重大事故。Incorrect usage may ca

15、use injuries or death.表示错误使用时，将会引发危险情况，导致人身伤亡。Incorrect usage may cause mild or moderate personal injury. Moreover the equipment will be damaged. 表示错误使用时，将会引起危险情况，导致轻度或中度人身伤害，损坏设备。Even items do not belong to “danger” or “attention”, we also mark in the relevant places.即使不属于“危险”或“注意”，但需要用户遵守的事项，也在相关的

16、地方同时进行了标记。DG16064-DG01-OM-R0.0 Page 6 of 1131.1 Safety notice 安全注意事项1.1.1 Before Power-on 上电前Attention 注意Please confirm whether the voltage of the external main circuit power supply is the same with the rated voltage of the cabinet transformer, otherwise it will result in injury and fire. 请确认外接交流主回路

17、电源的电压与电控柜变压器额定电压是否一致；否则会有引起人员受伤和火灾的危险。Do not perform pressure test with the cabinet components, otherwise the components will be damaged. 请勿对电控柜各元件进行耐压试验；否则会造成电器元件的损坏。The control circuits, test circuits and other circuits have been connected and tested, so non-staffs cannot change the circuits. Othe

18、rwise it may cause fire and the damage of the frequency transformer, transformer, motor, and other units. 控制回路和检测回路等线路已接好并测试出厂，非工作人员切忌修改线路；否则会有引发火灾的危险。另外，还有可能造成变频器、变压器、电动机以及其他单元的损坏。Please fasten the terminal screw based on the specified torque; otherwise the fire will be caused. 请按指定的力矩来紧固端子螺丝；否则会有引

19、发火灾的危险。Please pay great attention to the safety instructions on the cabinet and cleaning machine; otherwise it will result in injury and fire. 请重视电控柜及清洗机本体上的安全指示；否则会有引起人员受伤和火灾的危险。Please make sure the site temperature is between -1545，and relative humidity between 40%-70%RH. Or it will result in casu

20、alties and fire.请确保现场环境在-1545，相对湿度在 40%-70%RH；否则会有引发火灾及造成人员伤亡的危险。Danger 危险Please make sure all testing components (flow switch, temperature switch, thermal resistor, gauge) are undamaged and reliably connected; otherwise the operating equipment will be seriously damaged and result in personal casual

21、ties.请确保所有检测元件（流量开关、温度开关、热电阻、压力表等）连接可靠、未损坏；否则会引起运行中的设备严重损坏并造成人员伤亡。Please make sure the power supply and the motor switch are off; otherwise electric shock and fire will be caused. 上电前，请确认输入电源和马达开关是否处于OFF 状态；否则会有引发触电和火灾的危险。The wiring operation shall be performed by the professional electrician; other

22、wise electric shock and fire will be caused.接线作业请由专业的电工人员进行；否则会有引发触电和火灾的危险。DG16064-DG01-OM-R0.0 Page 7 of 113Please make sure the grounding terminals connect reliably; otherwise electric shock and fire will be caused.请务必确保接地端子 接地可靠；否则会有引发触电和火灾的危险。1.1.2 Mechanical Safety 机械安全The equipment is designed

23、 and manufactured following the ISO 12100 part 1, part 2 and ISO 61508 related mechanical safety standards. The specific risk analysis and solutions please refer to FS Mechanical Safety 本设备根据ISO 12100 第1及第2部分、ISO 61508等相关的机械安全标准设计及制造的，具体风险分析及方案请参考FS中机械安全的描述。1.1.3 Emergency Stop 紧急停止Three emergency s

24、top buttons are mounted in the equipment. One is fitted on the control panel of the cabinet and the other in the control box beside the main door in the machine room. The rest one is shared with the loading/unloading system installed in the sterile room. Once any button is pressed, the hardware inte

25、rlock of the relevant safety circuit (safety switch + safety relay) will cut off the all the control power except the instrument power. All the power equipments will stop and valves will be in original status (single electric control) or current status (double electric control). All the instruments

26、power will be saved to monitor the equipment status and relevant process parameters. Details are as follows: 三个急停按钮安装在这台设备上，一个安装在控制柜的控制面板上，一个并联到机器房箱体主门旁边的控制盒，另外一个与手动进出料系统共用安装在无菌室内，任何一个被按下后，相应的安全回路（安全开关 + 安全继电器）的硬件连锁将切断除仪表电源外的所有控制电源，所有的动力设备将停止，阀门将处于原始状态（单电控）或当前状态（双电控） 。所有仪表电源将被保留以监视设备状态及相关的过程参数，具体如下：

27、Location位置Name 名称Power 电压equipment input status(e.g. opened/closed)设备输入状态（如：开关状态） DC24VSite现场 vacuum and pressure transmitter 真空和压力变送器 DC24VTemperature sensor 温度传感器 DC24VPLC (not include PLC output)PLC（不包括 PLC 输出） AC230VRecorder 记录仪 AC230VElectric control cabinet 电器控制柜Control output from PLC to alar

28、ming horn and alarming light (close of the main valves)PLC 到报警喇叭、总报警灯等的控制输出。 （如：主阀的关闭等）DC24VEmergency Stop Reset：紧急停止复位 :DG16064-DG01-OM-R0.0 Page 8 of 113After resetting the emergency stop button, alarming confirm button and reset button shall be pressed at the same time. The emergency stop will re

29、set. 复位急停开关后，同时按下电控柜面板上“报警确认按钮”及“复位按钮” ，紧急停止将复位。Danger 危险Make sure the freeze dryer stops before resetting the emergency stop and the failure have been removed. Otherwise the command will be executed immediately after resetting, which may cause personal injury and equipment damage. 复位紧急停止前，请务必确保冻干机处

30、于停止状态，且故障被排除，否则复位后，指令将立即进行，导致人员受伤或设备损坏的危险。1.1.4 Maintenance and Inspection 维护与检查Danger 危险It is extremely dangerous that the cabinet has high-pressured terminals inside. Do not contact or you will get an electric shock. 电控柜内有高压端子，非常危险。请勿随意触摸，否则会有触电的危险。Never attempt to remove the protection cover when

31、 it is powered on. If the cover need to be removed, do cut off the breaker for wiring or you will get an electric shock.在通电状况下，请务必不要拆卸保护罩。如果需要拆卸保护罩时，请务必断开接线用的断路器。否则会有触电的危险。Do cut off the power supply of the main loop, confirming the charging indicator is out, and then maintain and check. 请切断主回路的电源，确

32、认充电指示灯熄灭后，再进行维护与检查作业。Except the specified personnel, others do not maintain, check and replace the components. 除指定的人员以外，其它人请勿进行维护、检查或更换部件。Before operation, please take off the metal accessories (watch, ring) and use insulated tools, or you will get an electric shock. 作业前，请摘下身上的金属饰物( 手表、戒指等)。作业时，请使用进

33、行了绝缘处理的工具。When using the lifter, please take protections to avoid lower. Otherwise there are risks to get hurt. 使用升降机时，请在机器侧采取以防落下等的安全措施。否则会有受伤的危险。Attention 注意Never attempt to change the wiring or dismount jumper while it is powered on, otherwise it will cause injury. 正在通电时，请勿变更接线或拆装跳线，否则会有导致受伤的危险DG

34、16064-DG01-OM-R0.0 Page 9 of 1132 Lyophilizer Introduction 冻干机简介2.1 Purpose 冻干机用途The lyophilizer is one product integrates freezing technology, drying technology with fluid technology. 冻干机是集冷冻技术、干燥技术、流体技术于一体的产品。2.2 Configuration 冻干机配置No.序号 Base Machine 基本型 Configuration 配置1 Model 设备型号 LYOTK152 Language 语言 English+Chinese 英文+ 中文3 Safety Conformance Certification 安全认证 NO 无4 Main Power Supply 主电源 3P/AC400V/50HZ Control Power: 24V DC 3P/AC400V/50HZ 控制电源: 24V DC5 City Power Supply 单相电源 220-240V6 SIP Yes 有7 CIP Yes 有8 Slot Door 小门 Yes 有9 Auto Loading/Unloading system 自动进出料系统 Yes