冻干机操作手册

1、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： LYOTK15Please hand the manual to the end user for keeping.请将该操作手册交D至G16最06终4-D用G0户1-O，M-并R0妥.0 善保存Page1of112PREFACE前言Thank you for purchasing Truking Lyophilizer.This operation manual int

2、roduces how to correctly operate LYOTK15Lyophilizer. 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 descr

3、iption, 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 the covers are installed and operate accord

4、ing to the manual description.The diagrams in this manual are only examples, whichmay 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 opera

5、tion 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 our company or the office sitting nearest to you i

6、n 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

7、底上记载的离您最近的本公司营业所订购。DG16064-DG01-OM-R0.0Page2of112DG16064-DG01-OM-R0.0Page PAGE 4of112Table of contentsTable of contents3 HYPERLINK l _TOC_250040 Safety Related Marks 与安全有关的标记说明5Safety notice安全注意事项5 HYPERLINK l _TOC_250039 Before Power-on 上电前6 HYPERLINK l _TOC_250038 Mechanical Safety 机械安全7 HYPERLINK

8、 l _TOC_250037 Emergency Stop 紧急停止7 HYPERLINK l _TOC_250036 Maintenance and Inspection维护与检查8 HYPERLINK l _TOC_250035 Lyophilizer Introduction 冻干机简介9Purpose 冻干机用途9Configuration 冻干机配置9Control System冻干机控制系统10 HYPERLINK l _TOC_250034 HMI Operation Description 上位机操作说明11System Introduction 上位机系统简介11Operat

9、ion instruction11 HYPERLINK l _TOC_250033 Menu Bar 菜单条12 HYPERLINK l _TOC_250032 Login 登陆13 HYPERLINK l _TOC_250031 Log out登出14 HYPERLINK l _TOC_250030 Flow Chart流程图14 HYPERLINK l _TOC_250029 Console 操作台16 HYPERLINK l _TOC_250028 PID Control MimicPID 控制画面30 HYPERLINK l _TOC_250027 Alarm mimics 报警画面3

10、1 HYPERLINK l _TOC_250026 Trend Mimic 曲线画面33 HYPERLINK l _TOC_250025 Loading and Unloading 进出料画面36 HYPERLINK l _TOC_250024 Setup Mimic 设置画面38 HYPERLINK l _TOC_250023 Recipe Edit 配方编辑38 HYPERLINK l _TOC_250022 Recipe running 配方运行44 HYPERLINK l _TOC_250021 PLC Input StatusPLC 输入状态45 HYPERLINK l _TOC_2

11、50020 PLC Output Status 输出状态45 HYPERLINK l _TOC_250019 Recorder 记录仪画面46 HYPERLINK l _TOC_250018 Application 应用画面46 HYPERLINK l _TOC_250017 Report 报表查询48 HYPERLINK l _TOC_250016 Maintenance维护49 HYPERLINK l _TOC_250015 System Configuration 系统配置49 HYPERLINK l _TOC_250014 Exit 退出50 HYPERLINK l _TOC_2500

12、13 Status Bar 状态条50 HYPERLINK l _TOC_250012 Operation Instruction 冻干机操作说明52Power on 上电52Manual Control 手动控制57Automatic Control 自动控制61 HYPERLINK l _TOC_250011 Freeze Drying Cycle 冻干周期62 HYPERLINK l _TOC_250010 Condenser Defrosting 冷阱除霜65 HYPERLINK l _TOC_250009 CIP 在线清洗67 HYPERLINK l _TOC_250008 SIP

13、在线灭菌71 HYPERLINK l _TOC_250007 Vacuum Leakage Test 真空泄漏测试75 HYPERLINK l _TOC_250006 Shelf Bellow Test 板层波纹管测试77 HYPERLINK l _TOC_250005 Main Valve Bellows Iitegrity Test 主阀波纹管测试78 HYPERLINK l _TOC_250004 Unloading Pusher Bellows Test 后推波纹管测试79Filter1 integrity test 过滤器 1 完整性测试81Filter2 integrity tes

14、t 过滤器 2 完整性测试82Operation Instruction of HMI85Manual operation interface86State monitoring interface87 HYPERLINK l _TOC_250003 Alarms and Failures Analysis 常见报警及故障分析89PC Failures PC 故障90Utility Failures 工艺故障90Instrumentation Failures 仪器仪表故障91Device Failure 部件故障94 HYPERLINK l _TOC_250002 Device State

15、Failure 部件状态故障94 HYPERLINK l _TOC_250001 Device IO Failure 元件 IO 故障97Process Failure 过程故障102 HYPERLINK l _TOC_250000 Terminology and Abbreviation 术语和缩写111Page PAGE 6of112DG16064-DG01-OM-R0.0Safety 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

16、，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。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。may cause

17、However, even the attention itemsmajor accident based on the actualsituation.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 “attention”, wealso 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。Safety notice 安全注意事项Before Power-on 上电前Attention注意Please confirm w

18、hether the voltage of the external maincircuit 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 componentswil

19、l 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 cannotchange 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，

20、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 specifiedtorque; otherwise the fire willbe 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 instructionson the cabinet and cleaning machine; otherwise it will result ininjury

21、 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 -15 45，and relative humidity between40%-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, temper

22、ature switch, thermal resistor,gauge) are undamaged and reliably connected; otherwise the operating equipment will be seriously 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; other

23、wise electricshock 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; 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 groundingterminals connect reliably; othe

24、rwise 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。Mechanical Safety 机械安全The equipment is designed 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

25、 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。Emergency Stop 紧急停止Three emergency 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 sh

26、ared with the loading/unloading system installed in the sterile room. Once anybuttonispressed,thehardwareinterlockoftherelevantsafetycircuit(safety switch+safety relay) will cut off theall the control power except the instrument power. All the power equipments will stop and valves will be in origina

27、l status (single electric control) or current status (double electriccontrol). All the instruments power will be saved to monitor the equipment status and relevant process parameters. Details are as follows:Location位置Name名称 equipment input status(e.g.opened/closed) 设备输入状态（如：开关状态）vacuum and pressure

28、transmitter真空和压力变送器Temperature sensor 温度传感器PLC (not include PLC output)PLC（不包括 PLC 输出）Recorder记录仪Control output from PLC to alarming 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）Power电压Site现场DC24VDC24VDC24VElectric control cabinet电器控制柜AC230VAC230VDC24V三个急停按钮安装在这台设

29、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：Emergency Stop Reset：紧急停止复位:After resetting the emergency stop button, alarming confirm button and reset button shall be p

30、ressed 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”，紧急停止将复位。DG16064-DG01-OM-R0.0Page7of112Page PAGE 9of112DG16064-DG01-OM-R0.0Danger危险Make sure the freeze dryer stops before resetting the emergency stop and the failure have been removed. Otherwise the command wil

31、l 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。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 wi

32、ll 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 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 s

33、upply of the main loop, confirming the charging indicator is out, and thenmaintain 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 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 (wa

34、tch, 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 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 di

35、smount 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LyophilizerIntroduction 冻干机简介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。No. 序号12Base Machine 基本型Configu

36、ration 配置3Model 设备型号Language 语言Safety Conformance Certification 安全认证LYOTK15English+Chinese 英文+中文NO 无4Main Power Supply 主电源3P/AC400V/50HZControl Power: 24V DC56783P/AC400V/50HZ 控制电源: 24V DC220-240VYes 有Yes 有Yes 有9City Power Supply 单相电源SIP CIPSlot Door 小门Auto Loading/Unloading system 自动进出料系统Flammable

37、Solvent Product 可燃溶剂产品High Potent Product 危险产品Unit 单位Yes 有10NO 无1112NO 无Unit 公制Configuration 冻干机配置Optional configurations are as follows:本项目的选项配置如下：No. 序号1234567891011Options 可选项Configuration 配置Pressure Vessel Codes 压力容器标准Cooling Jacket 冷却夹套Chamber Rib Material 加强筋材料Hydraulic Stoppering 液压压塞Shelf Ra

38、m Bellows 板层波纹管Main Valve Bellows 主阀波纹管Back Pusher Bellows 后推波纹管Shelf Stack 板层Variable Shelf Spacing 可变板层间距Sterile Filter 无菌过滤器Filter Auto Test 过滤器自动检测GB150Yes 有Carbon steel 碳钢Yes 有Yes 有Yes 有Yes 有10+1Fixed 固定1Yes 有121314151617Sanitary Valves 卫生级阀门Vacuum Pump 真空泵Mechanical Booster Pump 机械增压泵Compresso

39、r 压缩机ChamberExpansion Valve 箱冷膨胀阀CondenserExpansion Valve 阱冷膨胀阀Yes 有2Yes 有MYCOMElectronic 电子Thermal 热力181920Refrigerant制冷剂PLC Brand PLC 品牌Recorder记录仪R404ASIEMENS YOKOGAWA24 通道21Absolute Pressure Measurement绝对压力测量Yes 有22MKS真 空 调 节 阀 MKSVacuum23Modulating ValveElectronic Signature 电子签名(CFR 21 Part 11

40、Compliance)（遵从联邦法规 21 章第 11 款）Configurable Batch Report 可选择报表UPS 不间断电源PLC Remote Access Modem远程访问模块IQ/OQ GAMP5Special Requirements 特殊要求:No 无Yes 有2425Yes 有6KVA26Yes 有272829Yes 有Yes 有None 无Note:If there is no specific clarification, use ubar，mbar and BarA as vacuum and pressure units for the metric un

41、its, and psia as pressure unit for the imperial unit.注意：如果未明确规定，对于公制单位，使用uBar，mBar 和 BarA 作为真空和压力单位。对于英制单位，使用psia 作为压力单位。Control System 冻干机控制系统Name 名称PC Operation SystemPC 操作系统SCADA SoftwareSCADA 软件PLC TypePLC 型号Recorder 记录仪Windows7 HITE SIEMENSYOKOGAWA 24 通道Description 描述DG16064-DG01-OM-R0.0Page10o

42、f112Page PAGE 13of112DG16064-DG01-OM-R0.0HMI Operation Description 上位机操作说明System Introduction 上位机系统简介HMI mimic is developed based on the Windows XP operation system, which can assist you with monitoring and controlling the production process, as well as optimizing the production equipment and enterp

43、rise resource management. It provides visual production, electronic signature, alarm, and data report, etc, which ensures the stability and reliability of the products.HMI 界面基于Windows 7 操作系统开发，可以帮助您精确监视控制生产过程，并优化生产设备和企业资源管理。它提供了可视化生产、电子签名、报警及数据报表等功能，保证产品的稳定可靠性。Operation instructionOperation of the H

44、MI will be described in details in this section. The images in the document may not be consistent with your device.本节将对上位机操作进行详细描述。文档中的图片与您购买的机型可能不一致。After opening, the system will automatically monitor withdefault IDL account. The default mimic in diagram 3.1 will be shown in the IPC.Main Mimic主画面M

45、enu bar菜单条Diagram 3.1 Process Mimic (default login mimic)流程界面（登陆默认画面）开机后，系统将以默认 IDL 账户自动启动监控系统，工控机上出现如图 3.1 所示默认界面:Each area and mimic will be described in details in following section下面对各区域和画面进行详细描述。Menu Bar 菜单条It provides navigations for different pages. Different monitoring mimics will be shown i

46、n main mimic area after clicking each button.提供不同页面的导航，单击各按钮，将在主画面区域显示不同监控画面。 Table 3.1 lists the operation buttons and functions in the menu bar. 表 3.1 给出了菜单条的操作按钮名称及其功能Table 3.1 Function Description of the Menu Bar菜单条功能描述Button按钮Name名称Home首页Login登陆按钮Logout登出按钮Flow Chart流程图按钮Console操作台按钮PID Control

47、PID 控制按钮Alarm报警画面按钮Trend曲线图显示按钮Loading进出料按钮Parameter Setup设置参数按钮Recipe Edit配方编辑按钮Function功能Back to the default mimic返回默认画面Activate the login dialogue box and select the account激活登陆对话框，选择登陆账户Log off the account, and the default user is IDL注销当前登录账户，用户名默认为 IDLOpen the flow chart mimic打开流程图画面Open the fl

48、ow chart mimic打开控制台画面Open the PID control mimic打开 PID 控制画面Open the alarm mimic(real-time and history alarm)打开报警画面(实时及历史报警）Display real-time/history trend显示实时/历史趋势Open the loading and unloading mimic打开进出料画面Open the parameter setup mimic打开参数设置画面Enter the freeze drying recipe edit and monitor mimic进入冻干

49、机冻干配方编辑和监控页面Comment注释Button按钮Name名称Function功能Comment注释PLC InputDisplay all PLC input statusPLC 输入状态按钮 显示所有 PLC 输入点状态PLC OutputDisplay all PLC output statusPLC 输出状态按钮 显示所有 PLC 输出点状态Recorder记录仪按钮Open the recorder mimic打开记录仪显示画面Query or export alarm record, operationQueryrecord or data record of the se

50、lected batch or time period报表查询按钮查看或导出选择的批次或时间段的报警记录、操作记录或者数据记录APPTemperature Calibration: motor and cycle operation time statistics应用按钮画面进行温度的校准；电机和周期运行时间统计System Configuration 系统配置按钮Maintenance维护按钮The authorized user can setup the NetSCADA system授权用户可以对 NetSCADA 系统进行配置Enter the database maintenanc

51、e and report maintenance,etc进入数据库维护和报表文件维护等PrintScreen截图按钮Intercepte the current screen and save to the specified directory截取当前画面，保存到指定目录Exit退出按钮Exit the system退出系统Note: If the current button ispressed down, the mainmimic enters into the relevant mimic. Repeated click is invalid.注：若当前按钮显示为按下状态，则表示主画

52、面已进入该按钮所对应画面，再次点击将无效。Login 登陆The login window shown in diagram3.2 will pop up if clicking the login button. The window will disappear after entering the correct user name and password, and clicking confirmation.The current user will be displayed in the status bar, which means the user has login the

53、system and can operate with the given authority.DG16064-DG01-OM-R0.0Page PAGE 16of112点击“登陆”按钮，弹出如图 3.2 所示登陆对话框。输入正确的用户名和密码，点击“确定”后，对话框消失，状态条上将显示当前用户名，说明该用户已登陆系统，并将按给定的权限进行操作。Diagram 3.2 Login 登陆界面Note:The login process will be recorded by the system and saved in the operation log.注：该登陆过程将由系统记录，并保存到操

54、作日志。Logout 登出Clicking the logout button, the current user will log out. The user name in the status bar will be renewed as IDL.点击“登出”按钮，当前用户退出控制，状态条上相应用户名恢复为“IDL”。Note:The logout process will be recorded by the system and saved in the operationlog.注：该登出过程将由系统记录，并保存到操作日志。Flow Chart 流程图The flow chart

55、mimic contains two parts. One is the main mimic which is the same with lyophilizer P&ID drawing to display the flow system of the lyophilizer. Another part is the footer which displays the relevant information of the automatic cycle. When the system stops and is in manual status, the footer doedsins

56、platy.流程图界面包括两部分，一部分为主画面，主画面与冻干机 P&ID 图一致，以图形方式呈现冻干机流程系统；另一部分为页脚，显示自动周期的相关信息，当系统为停止和手动时，页脚不显示。Main Mimic 主画面The main mimic will be displayed as in diagram3.3 after clicking the process button in the menu bar.点击菜单条“流程”按钮后，主画面区域显示如图 3.3 所示画面。Diagram3.3 Flow Chart 流程图画面In the mimic, the green represent

57、s opened or operating components and the red means alarm. For the gray one, it means stop or close as in table 3.2. The following process parameters will be in the flow chart mimic at the same time.画面中，绿色通常表示部件运行或打开，红色通常表示报警，灰色通常表示停止或关闭，各图例如下表 3.2 所示。同时，以下过程参数显示在流程图画面中：1Shelfinlet temperature shall

58、be accurate to one decimal place with as the unit板层入口温度，精确到小数点后 1 位，单位2Shelfoutlet temperature shall be accurate to one decimal place with as the unit板层出口温度，精确到小数点后 1 位，单位3Condenser coil temperature 1 shall be accurate to one decimal place with as the unit冷阱盘管温度 1，精确到小数点后 1 位，单位4Condenser coil tempe

59、rature 2 shall be accurate to one decimal place with as the unit冷阱盘管温度 2，精确到小数点后 1 位，单位5Chamber drain temperature shall be accurate to one decimal place with as the unit箱体排出温度，精确到小数点后 1 位，单位6Condenserdrain temperature shall be accurate to one decimal place with as the unit冷阱排出温度，精确到小数点后 1 位，单位7Filte

60、rdrain temperature 1 shall be accurate to one decimal place with as the unit过滤排出温度 1，精确到小数点后 1 位，单位8Chamber pressure shall be accurate to two decimal places with BarA as the unit.箱体压力，精确到小数点后 2 位，单位 BarA9Condenser pressure shall be accurate to two decimal places with BarA as the unit冷阱压力，精确到小数点后 2 位