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User Manual

Version 1.0 1

10407001

Xiros 2 Lyophilizer

User Manual

Summary of Contents for 10407001

Page 1: ...User Manual Version 1 0 1 10407001 Xiros 2 Lyophilizer User Manual ...

Page 2: ...hnical Specifications 13 V Inspection 17 5 1 Packing List 17 VI Installation 19 6 1 Safety Rule 19 6 2 Transportation 19 6 3 On Site Assembly 19 6 4 Tools needed 19 6 5 Chamber Set up 20 6 5 1 Chamber Location 21 VII Components Assembly 22 7 1 Vacuum System Assembly 22 7 2 Instrumentation Installation 23 7 3 Electric Cabinet Installation 23 7 4 Expansion Tank Installation 24 VIII Oil Refilling 26 ...

Page 3: ... Charts of Operations 39 10 1 Operation Sequences 43 10 2 Manual De icing Operation 45 10 3 Alarm Safety Message 47 10 3 1 Check Alarm Messages 47 10 3 2 Alarm Records 48 10 3 3 Alarm List 50 10 3 4 Events List 52 XI Final Commission Checks 53 11 1 Preparation 53 11 2 Inspection Prior to Operation 53 11 3 Utility Data and Parameters 53 XII Maintenance and Cleaning 54 ...

Page 4: ...liance with the applicable manufacturer s Published User Statement Limited User Statement or Limited License if any While this manual contains certain representations of the potential dangers from the instrument or equipment Buyer is solely responsible for conducting any research necessary to learn the hazards involved for any of its intended uses of the instrument or equipment purchased from the ...

Page 5: ...inal manufacturer or third party supplier In no event shall the Company have any obligation to make repairs replacements or corrections required in whole or in part as the result of i normal wear and tear ii accident disaster or event of force majeure iii misuse fault or negligence of or by Buyer iv use of the Product in a manner for which they were not designed v causes external to the Product su...

Page 6: ...R FITNESS FOR A SPECIFIC PURPOSE OR USE WHETHER ARISING FROM STATUTE OR OTHERWISE IN LAW OR FROM A COURSE OF DEALING OR USAGE OF TRADE THIS WARRANTY IS NOT TRANSFERABLE FROM THE ORIGINAL PURCHASER TO A SUBSEQUENT OWNER FURTHER THE COMPANY IS NOT LIABLE IN CASES OF DELIBERATE NEGLIGENT OR ACCIDENTAL MISUSE OF THE PRODUCTS USE WITH INAPPROPRIATE REAGENTS OR CONSUMABLES DAMAGE CAUSED BY DISASTER REPA...

Page 7: ...IVING RISE TO SUCH LIABILITY OR B ONE HUNDRED THOUSAND DOLLARS 100 000 WHICHEVER IS LESS With respect to any software products incorporated in or forming a part of the Product hereunder Buyer intends and agrees that such software products are being licensed and not sold and that the words purchase sell or similar or derivative words are understood and agreed to mean license and that the word Buyer...

Page 8: ...intenance and or operations inside the chamber ensure the door is securely held open 7 Ensure appropriate PPE is worn at all times Unprotected hands are not to open or close the door 8 Note Persons are not to enter the chamber 9 It is prohibited to use flammable liquids or gas inside or around the instrument The lyophilizer is not designed with explosion prevention WARNING May cause property damag...

Page 9: ...nd repair ATTENTION May affect operational performance or service life 11 The overall safe operation of the instrument is the responsibility of the owner of the instrument and their assigned operator s who in turn are responsible for ensuring the user manual guidance is applied to optimise the safety and protection of personnel and the Instrument before during and after lyophilizer operation 12 Ti...

Page 10: ...III Xiros 2 lyophilizer Introduction 3 1 Purpose This manual provides a basic overview of the Xiros 2 lyophilizer and guide to its operation Please read the user manual carefully before using the freeze dryer 3 2 Hardware Diagram ...

Page 11: ... or need technical assistance please contact the after sales service department The company may provide technical assistance and information regarding the instrument or equipment or service without charge at its sole discretion Buyer assumes sole responsibility for any reliance on or use of such assistance and information and the Company makes no warranty thereon Upon contact the following informa...

Page 12: ...g the invoice copy and by giving reasons for the claim 3 7 Proper Use The lyophilizer is designed for use in large scale manufacturing and mining operations It is ideal for academic and cooperate research laboratories To prevent damage to the lyophilizer it should only be used in clean and safe environments free of corrosive gases and intense magnetic fields ...

Page 13: ...olyethylene material N A 4 Temp sensors of thermal fluid JUMO A level Pt 100 hot resistance 2 Shelf A Design Specifications SN Description Specifications 1 Production methods Plug welding 2 Design pressure 3barg 3 Temperature Range 35 25 C 4 Finish Ra 0 8µm 5 Level 1mm m B Technical Configuration SN Name MSM QTY 1 Shelf material SS 304 N A 2 Shelf gross dimensions 650 600 12mm N A 3 Shelves spacin...

Page 14: ...Maximum ice capacity 10Kg batch 2 Minimum coiled temp 50 C B Technical Configuration SN Name MSM QTY 1 Coils pipe material SS 304 N A 2 Temp sensors of coils Jumo A level Pt 100 Hot resistance 1 Refrigeration System A Design Specifications SN Description Specifications 1 Shelf cooling speed on empty load Silicone oil inlet 25 35 C 60min 2 Coils cooling speed on empty load 20 40 C 30min B Technical...

Page 15: ...ors of thermal fluid Jumo A level Pt 100 Hot resistance 2 Vacuum System A Design Specifications SN Description Specifications 1 Final vacuum 2 6Pa 2 Evacuation speed From 1 atm to 10pa 30min 3 Leakage rate 5 10 3pa m3 sec B Technical Configuration SN Name MSM QTY 1 Vacuum pump Youcheng TRP 36 1 2 Valve for condenser isolation DN50 1 3 Vacuum gauge Edwards 1 Aeration System A Technical Configuratio...

Page 16: ...r operator parameter 7 User management B Technical Configuration SN Name MSM QTY 1 PLC Siemens CPU 1200 1 2 Touch screen Siemens TP700 smart Comfort 1 Utility Requirements Approx SN Description Requirements 1 Total power 19Kw 480V 60Hz 3P 5W 2 Clean air for aeration system 40L min 0 5 1bar 3 Room environment temperature 25 Standard Documentation SN Name QTY 1 Operation Manual OM 1 2 Installation M...

Page 17: ...nd to be incorrect or the accessories are incomplete or abnormal please contact the supplier manufacturer No Type Name Unit Qty Remark 1 Main Unit Lyophilizer pcs 1 2 Quick Setup Card 1 3 Spare part Tray pcs 14 4 Spare part Alarm light pcs 1 5 Spare part Bellows of vacuum pump inlet pcs 1 6 Spare part Vacuum gauge EDWARDS pcs 1 7 Spare part Moisture filter DAB 90 90 pcs 1 8 Spare part Electric bal...

Page 18: ...part Gasket KF40 pcs 2 20 Spare part Older KF40 pcs 2 21 Spare part Vacuum pipe pcs 1 22 Spare part After pressure pipe pcs 1 23 Spare part Uninterruptible power supply UPS pcs 1 24 Spare part Silicon oil L 20 25 Document File package box 1 Note If you find any visible damage please do not connect the instrument to a Power supply ...

Page 19: ...rtation 6 3 On Site Assembly Before assembling the lyophilizer make sure the area of use meets the following conditions Remove any caustic flammable and explosive materials from the workshop area The lyophilizer should be located on a level flat surface The lyophilizer should be operated in a temperature controlled environment between 5 to 30 The workshop area must be free of excessive vibration f...

Page 20: ...User Manual Version 1 0 20 6 5 Chamber set up Benchmark choice of the general chamber Fig 2 Laser Leveller Fig 3 The vertical surface of the box frame is the vertical reference ...

Page 21: ... lyophilizer arrives move it to the location it will be used before removing the skids Then secure and lock the pulleys to finish the chamber setup Install the cable and bracket of the electric tank Adjust the standard of the left and right sides of the box to the upper surface of the box door frame Fig 4 ...

Page 22: ...fter securing the vacuum pumps as shown in Fig 6 connect the vacuum pipeline to the pump and chamber and clamp and secure the fixtures as shown in Fig 5 Install the pump isolation valve Vacuum Pipeline Prior to Installation Fig 5 Pump Isolation Valve Lock Nut and Bolts Fig 6 Fig 7 ...

Page 23: ...ed to the chamber with a quick union See Fig 8 below 7 3 Electric Cabinet Installation The UPS Uninterrupted Power Supply electrical connections are disconnected during shipping for packing convenience and must be assembled on site as follows Connect the power line to the lyophilizer as shown in Fig 9 below Vacuum Gauge Power Line Connection Fig 8 Fig 9 ...

Page 24: ...s to be installed on the top of the electrical cabinet as shown in Fig 10 7 4 Expansion Tank Installation The expansion tank is to be positioned on the chamber or frame using bolts to compensate for silicone oil expansion Expansion Tank Fig 10 Fig 11 ...

Page 25: ... of the expansion tank Position the expansion tank on the bracket connect the bottom of the expansion tank and oil pipe with a clamp as shown in Fig 13 below Note Above mentioned components are optional and may not be included Bracket Bolt Clamp Fig 12 Fig 13 ...

Page 26: ...ic oil tanks should be filled with the oils Make sure to check the compressor and vacuum pumps oil level and add additional oil as needed 8 1Vacuum Pump Oil Level The vacuum pumps oil level should be between the MAX line and the MIN markers as shown in Fig 14 below If the level is below the MIN line marker add vacuum pump oil at the injection port shown in Fig 15 below Fig 14 Fig 15 ...

Page 27: ...n the expansion tank until full as shown in Fig 16 Connect the circulation pipeline discharging valve and expansion tank with the flexible hose and then press START to start the circulation pump Open the discharge valve to vent any air inside the pipeline Add silicon oil into the balance barrel until the silicon oil level indicated on the clip on sight glass shows it is full Clamp Mirror Fig 16 ...

Page 28: ...eration 9 1User Permission Management Start at the Main page and click the UserManage tab as shown in Fig 17 below Once the page is shown as in Fig 18 select which password to modify under the Password column and click to modify Fig 17 Fig 18 ...

Page 29: ...system Description Level 1 Administrator Level 2 Parameters Level 3 Operator User ID 1 2 3 Password 111 222 333 Group Member Permissions Description Level 3 Operator Level 2 Parameters Level 1 Administrator Ability to Access Level Modify No No Yes Ability to Start Stop AUTO Manual Lyophilisation Operation Yes No Yes Ability to Setup Parameter Changes for Each Phase No Yes Yes Ability to Create Rec...

Page 30: ...Recipe Recipe permits the following operations View NewRecipe Save Delete Modify Download Current recipe View a current recipe History Data View history data Audit View logged data User Manage Manage user accounts Log in Off Log in or out the system Alarm View current alarm items Alarm History View alarm historical data Alarm Reset Reset the alarm Curve View the curve Force Mode Manually open or c...

Page 31: ...sion 1 0 31 9 3Recipe Once the following recipe setting page is shown Fig 20 locate and click on the Recipe tab The next page will be displayed as shown in Fig 21 Click on Recipe Setting tab boxed in red Fig 20 Fig 21 ...

Page 32: ...e the P2 set time duration is over air flow will be stopped and the shelf freeze initiated The alarm is stopped when the vacuum pressure value is lower than P1 Alarm Keep Time S After alarm is triggered for the set time air intake stops and the system begins cooling of the shelves Shelf Precooling An option for constant temperature regulation Shelf Freezing Shelves cooling Set Temp Ramp Time min a...

Page 33: ...repeated after drying is completed for a predefined time If several tests fail the operator needs to manually select continue run or abort the process Secondary Drying Set Temp Ramp Time min and Soak Time min Sets the process temperatures and time as required There are 12 possible phases available for process control The required time and temperature of each phase is controllable The process may b...

Page 34: ...it is selected This temperature is the set temperature and the temperature range is 35 0 25 0 Set Temp The set temperature for the shelf Note During the cycle of the recipe interface you cannot load a recipe or make a new recipe etc 9 5Recipe Management Select one recipe from the drop down menu See Fig 23 below Fig 23 ...

Page 35: ...User Manual Version 1 0 35 Click Save Recipe from the menu to save the recipe See Fig 24 Click Modify icon see Fig 25 below icon is circled in red and modify the recipe Fig 24 Fig 25 ...

Page 36: ...ersion 1 0 36 Click the Download icon see Fig 26 below icon is circled in red to download the selected recipe Click the Delete icon see Fig 27 below icon is circled in red to delete the selected recipe Fig 26 Fig 27 ...

Page 37: ...User Manual Version 1 0 37 Click the New Recipe icon see Fig 28 below icon is circled in red 9 6Parameter Manager Return to the main page and click the Parameter tab Fig 28 Fig 29 ...

Page 38: ... when freeze drying and are listed below Items Range Heating PID_ P 0 000 9999 000 Heating PID_ I 0 000 99999 000 Heating PID_ D 0 000 99999 000 Cooling PID _ P 0 000 99999 000 Cooling PID_ I 0 000 99999 000 Cooling PID PID_ D 0 000 99999 000 Heating PID out 0 100 Cooling PID out 0 100 CP1 is on duty CP2 is on duty Fig 30 ...

Page 39: ...User Manual Version 1 0 39 X Flow Charts of Operations Start Enter BatchNo and Product Name Select Recipe and download Select Shelf Pre cooling 2 1 YES NO Is Utility Ok YES NO Lyophilize AUTO Start ...

Page 40: ... 0 40 1 Loading Close The Door The Door Close or not Shelf Freezing Alarm YES NO 2 Shelf Pre cooling Shelf Pre cooling Complete Loading Close The Door The Door Close or not Shelf Freezing Alarm YES YES NO Manual Confirm NO ...

Page 41: ...ete Perform Evacuation Evacuation complete Change mode from Auto to manual Operator action Cycle end Perform Primary drying Primary drying complete Is PRT selected Is PRT complete Secondary drying complete 5 YES ABORT YES YES YES YES NO YES YES Remarks PRT pressure rise test Perform Secondary drying Perform PRT NO NO NO NO NO ...

Page 42: ... PRT Complete or abort Is aeration selected Is aeration complete Is Cooling before unload selected Perform Cooling before unload Is Cooling before unload complete Operator unlock door open manual Cycle end YES YES NO YES YES NO YES NO Perform aeration NO NO NO ...

Page 43: ...d then open the pump isolation valve to achieve the chamber vacuum required the value is already set The temperature of condenser should be approximately 40 8 Sequence 8 Primary drying Step 8 1 When the pressure of chamber is lower than the value as set in Recipe start the electric heater to begin primary drying Step 8 2 The rate of heating of the product should be in accordance to the process rec...

Page 44: ...st fails again rerun the test until it succeeds 12 Sequence 12 The secondary drying is over if sequence 11 already occurred 13 Sequence 13 Vacuum break and aeration When chamber is still under vacuum open the chamber air inlet valve sv393 and begin sequence 14 when the pressure valve reaches the set point 14 Sequence 14 Shelf cooling is optional and will regulate temperature when unloading 15 Sequ...

Page 45: ...rsion 1 0 45 10 2 Manual De icing Operation Click Entering Control System tab See Fig 31 Type Username and Password and enter into the Control page See Fig 32 Click Control to go to the next page Fig 33 Fig 31 Fig 32 ...

Page 46: ... COM1 and the de icing valve SV395 When the coil temperature rises to 20 C close the de icing valve SV395 and stop the compressor COM1 Please see Fig 34 for reference Note Should Ice be on the coil or Ice has fallen under the box it is necessary to run the de icing program several times to clear Fig 33 Fig 34 ...

Page 47: ...User Manual Version 1 0 47 10 3 Alarm Safety Message 10 3 1 Check Alarm Messages Click Alarm icon as shown in Fig 35 You should now be in the page as shown by Fig 36 Fig 35 Fig 36 ...

Page 48: ...plays the alarm information 5 Icon Click to check the information 6 Icon Click to check the the selected alarm message information and confirm the alarm 7 Icon Click to confirm the alarm 10 3 2 Alarm Records Click the AlarmHistory icon as shown in Fig 37 Fig 37 ...

Page 49: ...User Manual Version 1 0 49 You should now be in the page as shown by Fig 38 below Note Operation steps to apply are the same as Section 12 3 1 Check Alarm Messages Fig 38 ...

Page 50: ...ult 5 Chamber vacuum alarm 1 Check vacuum setting during drying 2 High rate of temperature increase 3 Component failure 4 Vacuum system failure or pipeline leak 5 Improper parameter setting 6 Compressor 1 high pressure alarm 1 Insufficient condenser cooling 2 Low pressure leak 3 Component failure set error 4 Line Fault 7 Compressor 1 oil pressure alarm 1 Oil pipes are blocked oil level is low 2 Co...

Page 51: ... abnormal alarm 1 Motor overload 2 High or excessive current surge 3 Component failure line fault 4 Current setting value is incorrect 14 Shelf inlet temperature higher alarm 1 Check the high temperature during drying 2 Too high rate of temperature increase 3 Component failure 4 Vacuum system failure or pipeline leak 5 Improper parameter setting 15 Shelf inlet temperature lower alarm 1 Check the h...

Page 52: ... No Description 1 Login and logout system 2 User login and logout 3 Start and stop automatic mode 4 Start and stop manual mode 5 Open and close each valve or pump 6 Change parameters 7 New recipe 8 Download recipe 9 Delete recipe 10 Modify recipe ...

Page 53: ...n Prior to Operation Test the electric motor in the forward and reverse directions Confirm the product temperature probe is in the correct position and secured Confirm all switches on the control system are reset Confirm all alarms are off Confirm the key in the electrical cabinet is turned to ON 11 3 Utility Data and Parameters Utilities Parameters No Specification Category Specification 1 Electr...

Page 54: ... or near the lyophilizer please immediately disconnect the power supply and contact the service department Power must be disconnected before any maintenance or cleaning Surface stains on the lyophilizer should be cleaned only by a clean soft rag and detergent Keep the product clean and ensure no cleaning solution is spilled inside the lyophilizer Avoid cleaning the lyophilizer with any corrosive c...

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