冻干机操作手册范文.docx

1、冻干机操作手册范文LYOTK15Operation 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： LYOTK15 Please 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Preface 前 言 Thank you for purchasing Truking Lyophilizer. This operation manual introduces how to

2、 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 includes: safety, introduction, PC operation description, lyophi

3、lizer 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 the covers are installed and operate according to the man

4、ual 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 specification updates. If you need to order the operation manua

5、l 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 our company or the office sitting nearest to you in the bac

6、k 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

7、本公司营业所订购。Table of contents1 Safety Related Marks 与安全有关的标记说明This manual 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。Incorrect usage may cause injuries or death.表示错误使用时，将会引发危险情况，导致人身伤亡。 I

8、ncorrect 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。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。Even items do not belong to “danger” or “attentio

9、n”, 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，也在相关的地方同时进行了标记。1.1 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

10、result in injury and fire. 请确认外接交流主回路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-st

11、affs cannot change the circuits. Otherwise 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

12、 will be caused. 请按指定的力矩来紧固端子螺丝；否则会有引发火灾的危险。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

13、 40%-70%RH. Or it will result in casualties 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

14、 damaged and result in personal casualties.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

15、by the professional electrician; otherwise 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。Please 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 desig

16、ned 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 emergenc

17、y stop 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 i

18、nterlock 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 instrumen

19、ts 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

20、下：Location位置Name 名称Power 电压Site现场equipment input status(e.g. opened/closed)设备输入状态（如：开关状态）DC24Vvacuum and pressure transmitter 真空和压力变送器DC24VElectric control cabinet 电器控制柜Temperature sensor 温度传感器DC24VPLC (not include PLC output)PLC（不包括PLC输出）AC230VRecorder 记录仪AC230VControl output from PLC to alarming h

21、orn 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:After resetting the emergency stop button, alarming confirm button and reset button shall be pressed at the same time. The emergency stop will reset. 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

22、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

23、.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 it is powered on. If the cover need to be

24、 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，确认充电指示灯熄灭后，再进行维护与检查作业。Except the specified

25、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，请使用进行了绝缘处理的工具。When using the lifter, please ta

26、ke 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2 Lyophilizer Introduction 冻干机简介2.1 Purpose

27、 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 S

28、upply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 SIPYes 有7 CIPYes 有8 Slot Door小门Yes 有9 Auto Loading/Unloading system自动进出料系统Yes 有10 Flammable Solvent Product可燃溶剂产品NO 无11 High Potent Product危险产品NO 无12 Unit单位Unit 公制Optional configurations are as fo

29、llows:本项目的选项配置如下：No.序号Options可选项Configuration配置1 Pressure Vessel Codes 压力容器标准GB1502 Cooling Jacket冷却夹套Yes 有3 Chamber Rib Material加强筋材料Carbon steel 碳钢4 Hydraulic Stoppering液压压塞Yes 有5 Shelf Ram Bellows 板层波纹管Yes 有6 Main Valve Bellows 主阀波纹管Yes 有7 Back Pusher Bellows 后推波纹管Yes 有8 Shelf Stack 板层10+19 Varia

30、ble Shelf Spacing可变板层间距Fixed 固定10 Sterile Filter 无菌过滤器111 Filter Auto Test 过滤器自动检测Yes 有12 Sanitary Valves 卫生级阀门Yes 有13 Vacuum Pump 真空泵214 Mechanical Booster Pump 机械增压泵Yes 有15 Compressor压缩机MYCOM16 ChamberExpansion Valve箱冷膨胀阀Electronic 电子17 CondenserExpansion Valve阱冷膨胀阀Thermal 热力 18 Refrigerant 制冷剂R40

31、4A19 PLC Brand PLC品牌SIEMENS20 Recorder 记录仪YOKOGAWA 24通道21 Absolute Pressure Measurement 绝对压力测量Yes 有22 MKS真空调节阀MKS Vacuum Modulating ValveNo 无23 Electronic Signature电子签名(CFR 21 Part 11 Compliance) （遵从联邦法规21章第11款）Yes 有24 Configurable Batch Report可选择报表Yes 有25 UPS不间断电源6KVA26 PLC Remote Access Modem 远程访问模块Yes 有27 IQ/OQYes 有28 GAMP