Holland Green Science Xiros 2 User Manual

Lyophilizer

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User Manual

10407001

Xiros 2 Lyophilizer

User Manual

Version 1.0

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Summary of Contents for Holland Green Science Xiros 2

Page 1 User Manual 10407001 Xiros 2 Lyophilizer User Manual Version 1.0...
Page 2: Table Of Contents
Table of Contents Disclaimer & Warranty ....................4 LIMITED WARRANTY & DISCLAIMER ..................4 LIMITATION OF LIABILITY ....................... 7 Safety ..........................8 III. Xiros 2 Lyophilizer Introduction .................10 Purpose ........................10 Hardware Diagram ......................10 Hardware ........................11 Software ........................11 Abbreviations ......................11 After Sales Support ....................11 Proper Use .........................12...
Page 3 User Manual Software Operating Instructions .................30 Recipe ........................31 Recipe Setting Parameters ..................32 Recipe Management ....................34 Parameter Manager ....................37 Flow 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...
Page 4: Disclaimer & Warranty
User Manual Disclaimer & Warranty • The intellectual property rights for this manual belongs to Holland Green Science Corporation (hereinafter referred to as “the Company”). • Products of the company are under the patent protection of China and other countries and regions (inclusive of obtained patents and patents currently under application).
Page 5 User Manual Company in writing upon the discovery of any defect, which notice shall include the product model and serial number (if applicable) and details of the warranty claim; and (b) after the Company's review, the Company will provide Buyer with service data and/or a Return Material Authorization ("RMA"), which may include biohazard decontamination procedures and other product-specific handling instructions, then, if applicable, Buyer may return the defective Products to the Company with all costs prepaid by Buyer.
Page 6 User Manual EVENT OF A DEFECTIVE PRODUCT. EXCEPT AS EXPRESSLY PROVIDED IN THIS WARRANTY STATEMENT, THE COMPANY DISCLAIMS ALL OTHER WARRANTIES, WHETHER EXPRESS OR IMPLIED, ORAL OR WRITTEN, WITH RESPECT TO THE PRODUCTS, INCLUDING WITHOUT LIMITATION ALL IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE OR USE.
Page 7: Limitation Of Liability
User Manual LIMITATION OF LIABILITY NOTWITHSTANDING ANYTHING TO THE CONTRARY CONTAINED HEREIN, THE LIABILITY OF THE COMPANY UNDER THESE TERMS AND CONDITIONS (WHETHER BY REASON OF BREACH OF CONTRACT, TORT, INDEMNIFICATION, OR OTHERWISE, BUT EXCLUDING LIABILITY OF THE COMPANY FOR BREACH OF WARRANTY (THE SOLE REMEDY FOR WHICH SHALL BE AS PROVIDED UNDER THIS SECTION) SHALL NOT EXCEED AN AMOUNT EQUAL TO THE LESSER OF (A) THE TOTAL PURCHASE PRICE THERETOFORE PAID BY BUYER TO THE COMPANY WITH RESPECT TO THE...
Page 8: Safety
User Manual Safety IMPORTANT Safety Items to be Observed. Safety Warnings The lyophilizer is designed in accordance with industry safety standards. Incorrect operation may result in safety hazards for personnel and/or the equipment. ! DANGER (May cause serious damage to property and or casualties) Verify that all discharging ports are properly connected.
Page 9 User Manual 8. It is recommended that every five (5) years the electric heater be replaced. 9. It is recommended that once a month a qualified person checks the solid-state relay to confirm the solid-state relay is running correctly to avoid breakdowns. Note: The electrical heater will continuously heat in the event the solid-state relay breaks down, leading to the potential of a serious hazard.
Page 10: Xiros 2 Lyophilizer Introduction
User Manual 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 Version 1.0...
Page 11: Hardware
User Manual 3.3 Hardware All processing automation is controlled by SIEMENS HMI (Human Machine Interface) 6AV2124-0GC01-0AX0 using an 8GB memory card. A screen is used for process monitoring and control. 3.4 Software The control and supervision of the lyophilizer is carried out by Portal V15 and the program monitors.
Page 12: Proper Use
User Manual For claims under the warranty please contact your local supplier. You may also send the instrument directly to manufacturer, enclosing 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.
Page 13: Technical Specifications
User Manual Technical Specifications 10407001 Model Xiros 2 lyophilizer Product Name Chamber A. Design Specifications Description Specifications Chamber type Cylindrical Ra≤0.8µm Internal finish B. Technical Configuration Name Chamber internal material SS 304 External plate SS 304, thickness 1.5mm Insulation Polyethylene material Temp.
Page 14 User Manual Description Specifications According to user’s requirements Main door open direction Main door open angle 110° Ra≤0.8µm Internal finish B. Technical Configuration Name Material of main door SS 304 External cover of door SS 304 Sight glass without illuminated DN150 Coils A.
Page 15 User Manual A. Design Specifications Description Specifications Approx 1°C/min（unloaded, from -35℃ to +25℃ Heating rate ） Silicon oil viscosity 5cSt@25°C B. Technical Configuration Name Circulation pump WILO, Top-SD40/10 Thermal fluid Low viscosity silicone oil Heater Plate heat exchanger Alfalaval Temp. sensors of thermal fluid Jumo, A level Pt-100 Hot resistance Vacuum System A.
Page 16 User Manual Protection class IP22 Software function Freeze drying (manual and automatic). De-icing (manual) Max recipe number Six(6) Date History date, history audit, history alarm can be stored for a maximum of one month Permissions Level permissions. (administrator, operator, parameter) User management B.
Page 17: Inspection
User Manual V Inspection 5.1 Packing List Unpack the equipment carefully and check for any damage which may have arisen during transport. In the event of identified damage, please contact the supplier / manufacturer for technical support. • Carefully unpack the shipping container. •...
Page 18 User Manual Unit Type Name Qty. Remark Spare part Gasket ISO38 Spare part Clamp KF40 Spare part Gasket KF40 Spare part Older KF40 Spare part Vacuum pipe Spare part After pressure pipe Uninterruptible power supply Spare part (UPS） Spare part Silicon oil Document File package...
Page 19: Installation
User Manual Installation 6.1 Safety Rule Please read the user manual carefully before operating the lyophilizer. Only properly trained and qualified personnel should operate the lyophilizer. 6.2 Transportation Before transporting the lyophilizer, drain the silicon oil and refrigerant into separate containers to avoid leakage during transportation.
Page 20: Chamber Set Up
User Manual Fig 2: Laser Leveller 6.5 Chamber set up Benchmark choice of the general chamber The vertical surface of the box frame is the vertical reference. Fig 3 Version 1.0...
Page 21: Chamber Location
User Manual Adjust the standard of the left and right sides of the box to the upper surface of the box door frame. Fig 4 6.5.1 Chamber location (consider the chamber and the frame as a whole) • When the lyophilizer arrives, move it to the location it will be used before removing the skids.
Page 22: Components Assembly
User Manual VII. Components Assembly 7.1 Vacuum System Assembly After 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. Fig 5 Fig 6 Prior to Installation Vacuum Pipeline...
Page 23: Instrumentation Installation
User Manual 7.2 Instrumentation Installation The vacuum gauge measures the chamber and the pump vacuum pressure. The vacuum gauge is connected to the chamber with a quick union. See Fig 8 below. Vacuum Gauge Fig 8 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: •...
Page 24: Expansion Tank Installation
User Manual • The alarm indicator is to be installed on the top of the electrical cabinet as shown in Fig 10. 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.
Page 25 User Manual • Secure the bottom bracket bolt of the expansion tank. Bracket Bolt Fig 12 • 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. Clamp Fig 13 Note: Above-mentioned components are optional and may not be included.
Page 26: Oil Refilling
User Manual VIII. Oil Refilling The lyophilizer is shipped unassembled without silicon or hydraulic oil. Once the lyophilizer is properly installed the silicon and hydraulic 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. 8.1 Vacuum Pump Oil Level The vacuum pumps oil level should be between the ‘MAX’...
Page 27: Refilling The Silicon Oil
User Manual 8.2 Refilling the Silicon Oil The silicon oil contains air when filling which needs to be removed before operation according to the following steps: Clamp Mirror Fig 16 • Fill the silicon oil in the expansion tank until full as shown in Fig 16. •...
Page 28: Software Operation
User Manual Software Operation 9.1 User Permission Management Start at the ‘Main’ page and click the ‘UserManage’ tab as shown in Fig 17 below. Fig 17 Once the page is shown as in Fig 18, select which password to modify under the “Password”...
Page 29 User Manual A dialog box (shown below in Fig 19) will pop up prior to modifying the password. Type in the new password then retype the new password under “Confirmation”. Then click “OK”. Fig 19 Once the above steps are completed the password is modified. NOTE: Initial ID and password of the system (Level 1) (Level 2)
Page 30: Software Operating Instructions
User Manual (Level 3) (Level 2) (Level 1) Description Operator Parameters Administrator Ability to Download Recipe Ability to View Audit Ability to View History Data 9.2 Software Operating Instructions Main: Return to main interface. Control: Enter control interface. Parameter: Set up parameters. Recipe: ‘Recipe’...
Page 31: Recipe
User Manual 9.3 Recipe Once the following recipe setting page is shown(Fig 20), locate and click on the “Recipe” tab. Fig 20 The next page will be displayed as shown in Fig 21. Click on “Recipe Setting” tab boxed in red. Fig 21 Version 1.0...
Page 32: Recipe Setting Parameters
User Manual The Recipe Management page will then be shown and a recipe can be created, saved, deleted, modified or downloaded. Refer to section 11.5 for detailed recipe management. Fig 22 9.4 Recipe Setting Parameters • Set Temp H (℃): Sets the upper limit of the process temperature. •...
Page 33 User Manual • System Evacuation: the Vacuum value • Set Vacuum: Set the level of the vacuum pressure (P1) required to start of heating during drying. If current vacuum > alarm P1, stop the heater. • Primary Drying: Set Temp (℃), Ramp Time(min) and Soak Time(min): Sets the process temperatures and time as required.
Page 34: Recipe Management
User Manual • Unloading Cooling: An option for unloading in a certain temperature, it will be performed if 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.
Page 35 User Manual Click ‘Save Recipe’ from the menu to save the recipe (See Fig 24). Fig 24 Click ‘Modify’ icon (see Fig 25 below, icon is circled in red) and modify the recipe. Fig 25 Version 1.0...
Page 36 User Manual Click the ‘Download’ icon (see Fig 26 below, icon is circled in red) to download the selected recipe. Fig 26 Click the ‘Delete’ icon (see Fig 27 below, icon is circled in red) to delete the selected recipe. Fig 27 Version 1.0...
Page 37: Parameter Manager
User Manual Click the ‘New Recipe’ icon (see Fig 28 below, icon is circled in red). Fig 28 9.6 Parameter Manager Return to the main page and click the ‘Parameter’ tab. Fig 29 Version 1.0...
Page 38 User Manual You should now be in the ‘LYO Parameters’ page (see Fig 30 below). Fig 30 Additional parameters may be set 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...
Page 39: Flow Charts Of Operations
User Manual Flow Charts of Operations Start Enter BatchNo. and Product Name Select Recipe and download Is Utility Ok Lyophilize AUTO Start Select Shelf Pre-cooling Version 1.0...
Page 40 User Manual Loading Close The Door The Door Close or Alarm Shelf Freezing Shelf Pre-cooling Shelf Pre-cooling Complete Loading Close The Door The Door Close or not Alarm Manual Confirm Shelf Freezing Version 1.0...
Page 41 User Manual Shelf Freezing control Freezing control ABORT complete Or abort Change mode from Auto to manual Perform Coils cooling Operator action Coils cooling Cycle end complete Perform Evacuation Evacuation complete Perform Primary drying Primary drying complete Is PRT selected Perform PRT Is PRT complete...
Page 42 User Manual Is PRT selected Perform PRT Is PRT Complete or abort Is aeration selected Perform aeration Is aeration complete Is Cooling before unload selected Perform Cooling before unload Is Cooling before unload complete Operator unlock door & open manual Cycle end Version 1.0...
Page 43: Operation Sequences
User Manual 10.1 Operation Sequence 1. Sequence 1: Enter main page (See Fig 17). 2. Sequence 2: Manage parameters (see 11.6). • Click each parameter to set proper value. 3. Sequence 3: Lyophilization • Lyophilizer automatically runs the process according to the parameters that have been set in sequence 2.
Page 44 User Manual chamber also limits heat transfer. Therefore, it is necessary to decrease the pressure inside the chamber in order to speed up the rate of evaporation and enhance drying. 11. Sequence 11: The rate of chamber pressure increases may be used as an indication the process is complete and the cycle may be ended.
Page 45: Manual De-Icing Operation
User Manual 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). Fig 31 Fig 32 Click ‘Control’ to go to the next page (Fig 33). Version 1.0...
Page 46 User Manual Click ‘Manual’ and then Select ‘Manual Start’ as shown in Fig 33. Fig 33 Start the compressor (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).
Page 47: Alarm/Safety Message
User Manual 10.3 Alarm/Safety Message 10.3.1 Check Alarm Messages Click ‘Alarm’ icon as shown in Fig 35. Fig 35 You should now be in the page as shown by Fig 36 Fig 36 Version 1.0...
Page 48: Alarm Records
User Manual No.: 1 Time Status: Text (displays the alarm information) Icon (Click to check the information) Icon (Click to check the the selected alarm message information and confirm the alarm) Icon (Click to confirm the alarm) 10.3.2 Alarm Records Click the ‘AlarmHistory’...
Page 49 User Manual You should now be in the page as shown by Fig 38 below. Fig 38 Note: Operation steps to apply are the same as Section 12.3.1 Check Alarm Messages. Version 1.0...
Page 50: Alarm List
User Manual 10.3.3 Alarm List Alarm Message Possible Cause 1. No power. Power phase 2. Component failure. abnormal 3. Line fault. Chamber 1. Circulating pressure is low. recirculation 2. Circulating pump 1 fault. pressure 1 signal 3. Component failure. abnormal alarm 4.
Page 51 User Manual Alarm Message Possible Cause 1. Motor overload. Compressor 1 2. High or excessive current surge. overload alarm 3. Component failure & line fault. 4. Current setting value is incorrect 1. Motor overload. Vacuum pump 1 2. High or excessive current surge. overload alarm 3.
Page 52: Events List
User Manual 10.3.4 Events List Description Login and logout system User login and logout Start and stop automatic mode Start and stop manual mode Open and close each valve or pump Change parameters New recipe Download recipe Delete recipe Modify recipe Version 1.0...
Page 53: Final Commission Checks
User Manual Final Commissioning Checks 11.1 Preparation • Clean the chamber thoroughly and remove all grease, dirt etc. • Ensure that the chamber is dry and place the product evenly on the shelves. • Confirm the chamber door and seal are free of contaminates. 11.2 Inspection Prior to Operation •...
Page 54: Maintenance And Cleaning
User Manual XII. Maintenance and Cleaning Proper maintenance and operation of the lyophilizer as stated below will ensure the equipment stays in good working condition during its service life. The lyophilizer should be kept dry and cleaned after routine operations. Take care to clean the outer surface with a non-abrasive cleanser and only connect the power supply when the entire instrument surface is dry.

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