TrackSense® LyoPro User Manual TrackSense® LyoPro User Manual Version BETA User Manual TrackSense LyoPro – MAN 7 Page 1 of 46
CONTENTS 1. Safety Information ............................................................................................................4 1.1. Warnings......................................................................................................................4 1.2. General.........................................................................................................................4 1.3. Electrical Hazards ..............................................................................
8. Calibration........................................................................................................................ 25 8.1. Ellab Factory Calibration ...................................................................................... 25 8.1.1. Calibration Types – TrackSense® LyoPro...................................................... 25 8.2. In-House Calibration Solutions ........................................................................... 26 8.2.1.
1. Safety Information Use this equipment only as specified in this manual. Otherwise, the protection provided by the equipment may be impaired. • • “Warning” identifies conditions and actions that may pose hazards to the user “Caution” identifies conditions and actions that may damage the equipment being used 1.1. Warnings Disclaimer: Ellab manufactures equipment intended for use in thermal validation, monitoring and stability studies.
1.3. Electrical Hazards These guidelines must be followed to ensure that the safety mechanisms in the equipment will operate properly. Equipment, when applicable, must be plugged into a 115 VAC (± 10%) or 230 VAC (± 10%) 50/60 Hz electric outlet as indicated on the label. The power cord of the instrument is equipped with a three-pronged grounding plug for your protection against electrical shock hazards. It must be plugged directly into a properly grounded three-prong receptacle.
1.4. Directives 1.4.1. EMC Ellab equipment has been tested to meet the European Electromagnetic Compatibility Directive (EMC Directive, 2014/30/EU). The Declaration of Conformity for your instrument lists the specific standards at which the unit was tested. 1.4.2. Low Voltage (Safety) In order to comply with the European Low Voltage Directive (LVD) 2014/35/EU), Ellab equipment has been designed to meet the EN 61010-1 standard. 1.4.3.
frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation.
When contacting Ellab for support, please have the following information available: • • • • • TrackSense® LyoPro User Manual Model Number Serial Number Voltage Complete description of the problem ValSuite Software Version Version BETA User Manual TrackSense LyoPro – MAN 7 Page 8 of 46
2. New Order Contents When a new system is ordered, the equipment is shipped in a custom Ellab suitcase. The suitcase contains the following products: 2.1. TrackSense® LyoPro Orders • • • • • • • • • • Suitcase Reader Station Power supply Accessories Box Screwdriver Pen for battery O-Ring Sealant USB Cable Quick Guide USB key with Software and other documents 3. TrackSense® LyoPro 10-slot Reader Station 3.1.
3.1.1. Master Reader Station • • • 3.2. Contains 10 logger positions Connected to PC via USB or LAN (ethernet) Only 1 master reader station can be used at a time Communication Setup All TrackSense LyoPro 10-slot Reader Stations can be connected to PC via USB or LAN (ethernet). 3.2.1. • Connect the USB cable to the reader station and PC (USB 3.
3.2.2. TrackSense® LyoPro User Manual LAN connection 1. Connect the 12 Vac power supply and ethernet cable to the reader station 2. Connect the reader station to the PC using the USB cable 3. Read and note the reader station IP address located under the station 4. Open the ValSuite user menu, LyoPro Hardware Settings 5.
6. Select “Add” and “OK”, then remove the USB cable from the reader station 7. Use the “Test” function to control the functionality 8. The reader station should now function remotely 3.3. ValSuite® Software Installation Requirements ValSuite Pro 6.X System Requirements or higher: • • • • • • Multi Core Processor i5/i7 2.
4. Activating ValSuite® ValSuite Pro is our reputable validation and calibration software ideal for lyophilization. It is fully FDA CFR21 Part 11 compliant and combines all equipment systems including LyoPro into a single platform.
The evaluation of the License key can have the following remarks: Icon Description The License Key is valid and can be activated The License Key has already been activated on another PC. 5. The License window will close if the key is valid, and the ValSuite software will be open 4.1.1. Manual Activation – The PC is Not Connected to the Internet 1. Select the Manual activation option if the PC is not connected to the internet 2.
4.1.2. Releasing the License Users who wish to release the license so that it may be used on another PC, must follow the procedure below: 1. Select Help About ValSuite 2. Click License 3. Click Clear License. This will remove the license from this PC. The license will then be released and ready to be used again on another PC 5. How to Start Logging Data with TrackSense LyoPro Starting TrackSense LyoPro Loggers: 1. Ensure that the battery has enough capacity to cover the expected session length.
3. Place the data logger(s) in the reader station slot(s) 4. Select LyoPro Hardware Settings in ValSuite main menu and chose USB (default) or Ethernet connection and click OK 5. Select LyoPro Start Logger. A New Session window will then appear. Enter a name for the session (mandatory), session text (optional) and click OK. A window will appear displaying a graphic representation of the reader station slots 6. Choose Select All and Scan.
7. If an immediate start (unprogrammed) is required, press Start 8. The slots will turn green and begin showing the first live data. The data loggers are now active and can be placed in the process. Press Close 9. Alternatively, the data loggers can be programmed: Choose Settings at the bottom of the screen. The Logger Settings window will appear. Define Sample Rate and optionally Programmed Start/Stop conditions and activate Primary Control. Choose Select All Apply Close 10.
Reading TrackSense LyoPro Data Loggers and Creating Reports: 12. Place the data loggers into the Reader Station. Go to LyoPro Read Logger, then Select All and Scan 13. Select Read. The software will read all data loggers and display the data in the graph. Select Close 14. From the main menu, choose Session Add to select the appropriate Reports and Data Analyzes 15. To print a report, click File Print. A Print window will appear with various options.
6.1.2. • • • • • • • • • 6.1.3. Proper Use Never use the data loggers outside their designated temperature range. Damage may occur to the electronics and can cause outgassing of the battery Treat the data loggers as you would any other sensitive electronic equipment. Dropping or exposing them to heavy mechanical shock may loosen or damage the electronic connections Check the o-rings and replace them when necessary Do not remove data loggers from the reader station while they are being read.
6.1.4. Disassembling / Assembling Data Loggers Battery: Disassemble the battery compartment of the data logger by unscrewing the top spanner by hand. Then remove the top lid by turning the spanner around and use it as lift for the lid. Insert the activated* battery according to the indication on the housing (+ pole downwards). Put the lid back and tighten the spanner by hand.
6.1.5. Procedure for Cleaning TrackSense® LyoPro Data Loggers If any corrosion is present near the battery contacts, verify that no leaking is occurring. Lightly clean the contacts with a cotton swap and alcohol. Change the o-ring if necessary. Let the area dry before placing the battery in the data logger. 6.1.6. Procedure for Changing the Data Logger O-Ring The TrackSense LyoPro data logger contains one o-ring, which is located at the battery compartment lid.
• • • 6.1.9.
• Ordering code Type Temp. Range Expected lifetime Battery type Shelf time 31200050 TSL-BAT-150 with Activator -50 to +150 °C -80 to +150 °C * 2,400 hours* Lithium 10 years 31200051 TSL-BAT-150 without activator -50 to +150 °C -80 to +150 °C * 2,400 hours* Lithium 10 years Measured at -60°C with 30 second sample rate Note: Do not directly touch the battery poles and ensure that unused batteries are placed at moderate ambient temperatures under +25 °C.
Note: Always inspect and if needed change o-ring when changing batteries. Note: For -30 to -80 °C applications, the voltage requirements differ. 7.1.1.1. Proper Storage and Handling WARNING: It is of utmost importance that batteries are stored separately in bags or trays to avoid short circuiting. Leaving batteries in bundles where they come in contact with each other is highly risky as it may cause a short circuit and thereby a small-scale explosion or fire hazard.
• A weak battery will typically show less than 3.1V when inserted into the activator, at the end of its lifespan, it can also show 3.53.7V. In both cases, the initial voltage will begin to drop after a few minutes in the activator. Note: Leaving the battery in the activator for more than 1 hour will cause the battery to drain at a rate of 2.0 mAh an hour. 8. Calibration 8.1.
• 8.2. Special: at +70 °C for approximately 5 hours In-House Calibration Solutions 8.2.1. Ellab Temperature Standard (ETS) The ETS can be operated as an integrated part of the ValSuite software. It is a temperature standard that can be started, stopped and used in report analysis and calibrations. 8.2.1.1. Ordering code ETS Versions and Measuring Ranges Type Temp. Range Accuracy 20000190 ETS10 -80 to +250 °C ± 0.025 °C ± 0.015 °C* 20000191 ETS20 -50 to +150 °C ± 0.
Note: In order to protect the ETS, the upper part of the sensor stem (see picture below) should never be exposed to temperatures outside -50 °C to +200 °C (transition limit). 8.2.1.3. Setting up the ETS The ETS can be setup in 3 different ways. It can be used as a standalone unit with a display, in connection with the ETS Suite software or it can be setup in connection with the ValSuite software. Setup – Stand Alone Unit w/ Display: 1. Connect the ETS using a USB cable to the ETS display 2.
8.2.2. Installation for Windows 7, 8 and Windows 10 Note: This section is only relevant for users with ETS firmware versions older than 2.0. 8.2.3.
8.2.3.1. 1. Proper Use and Setup Reference the user manual before unpacking and setup 2. Before the dry blocks can be used in conjunction with the ValSuite software, JofraCal needs to be installed 3. Connect the USB cable from the USB port on the computer, to the USB port on the dry block 4. Connect the power cable to an appropriate outlet and turn the bath on Note: Ensure that the power supply is grounded and connected to the bath USB port and PC before connecting the power. 5. 8.3.
9.1. LyoStopper The LyoStopper is made of EPDM rubber and a PEEK tube that covers the two internal neck diameters, namely ø7 mm for 2R and 4R vials, ø12.6 mm for 6R100R vials. As all vials have different heights, the PEEK tube part of the LyoStopper is made in lengths that fit exactly according to the actual size of vial to steer the thermocouple into right position repeatedly.
9.2.1. Standard Versions & Reference Numbers Ordering code Description 31203021 31203041 31203061 31203081 31203101 31203151 31203201 31203251 31203301 31203501 31203001 LoggerNest for 2R vials LoggerNest for 4R vials LoggerNest for 6R vials LoggerNest for 8R vials LoggerNest for 10R vials LoggerNest for 15R vials Logger Nest for 20R vials LoggerNest for 25R vials LoggerNest for 30R vials LoggerNest for 50R vials LoggerNest for 100R vials 9.3.
9.3.1. 9.4.
9.4.1. 10.
This is required for a complete 4R system setup using buffer vial: 1. 31201000 – LyoPro data logger with thermocouple sensor 2. 31203041 – 4R LoggerNest 3. 31203042 – 4R Logger Clip 4. Buffer Vial 4R w. rubber stopper 5. 31203044 – 4R Buffer Clip 6. Vial 4R w/o rubber stopper 7. 31203023 – 4R LyoStopper This is required for a complete 6R system setup using buffer vial: 1. 31201000 – LyoPro data logger with thermocouple sensor 2. 31203061 – 6R LoggerNest 3. 31203062 – 6R LoggerClip 4.
This is required for a complete 100R system setup using buffer vial: 1. 31201000 – LyoPro data logger with thermocouple sensor 2. 31203001 – 100R LoggerNest 3. 31203062 – 100R LoggerClip 4. Buffer Vial 100R w. rubber stopper 5. 3120303004 – 100R BufferClip 6. Vial 100R w/o rubber stopper 7. 31203003 – 100R LyoStopper 11. Firmware Update 11.1. Reader Station and LyoPro Loggers Purpose: Firmware updater for reader station and logger.
2. Select Next. 3. Select a folder in the Change Directory if necessary and click select Next.
4. Select Next 5. Select Close to finish installation. 11.1.1. Procedure for Updating the LyoPro Logger and Reader Station Firmware WARNING: Before updating, users must check the current battery power, since updating loggers will use a lot of battery power. If the battery power is depleted in this process, the logger will need to be shipped to Denmark in order to be re-flashed, as it cannot be restarted manually.
TrackSense® LyoPro User Manual 1. Open the firmware updater, which is placed under Programme (x86) by default, and select Ellab TS LyoPro Firmware Update 2. Select the Loggers button and push Scan. 3. Push Select/Deselect to toggle all checkmarks – only positions check marked will be considered. 4.
TrackSense® LyoPro User Manual 5. Latest FW version will be shown (if Update to latest firmware is check marked) or a complete list of available versions. 6. Highlight the requested FW version and push Select Firmware 7. The firmware updater program will proceed through 4 stages (write file, verify file, flash and reboot) which will be shown as in window below. 8. Once done, the logger will appear with the new firmware as shown below.
11.1.2. TrackSense® LyoPro User Manual Procedure for Updating the LyoPro Reader Station firmware 1. Open the firmware updater, which is placed under Programme (x86) by default and select Ellab TS LyoPro Firmware Update 2. Select the Reader Station button. 3. Push Update.
TrackSense® LyoPro User Manual 4. A list will show available firmware versions to choose from. 5. Highlight and push Select FW 6. The firmware update program will go through multiple cycles updating the interface and main board inside the Reader Station (writing, verifying and flash bootloader and firmware). Progress will be shown as in window below.
Once done, the reader station will appear with the new firmware as shown below. 12. Ellab Service Contract Ellab offers annual service agreements. Contact your local Ellab sales representative for pricing and details. 12.1. TrackSense® LyoPro Equipment Warranty Ellab offers an industry leading 2-year warranty on the LyoPro logger. The thermocouple sensor is not covered, neither is physical damage. 12.2.
13. Sensor Specification Temperature Measuring Range: -60 to +62 °C Calibrated Temperature Range: -60 to +60 °C Sensor Element Type: Thermocouple type T Temperature Accuracy: +/- 0.3 °C Sensor Dimensions: ø 0.5 x 300 mm Data Logger Specification Ambient Temperature Range: -65 to + 140 °C Ambient Pressure Range: 0 to 4 Bar ABS Temperature Measuring Range: -62 to +62 °C Housing Material: PEEK Diameter: 18 mm (each compartment) Height: 32 mm Weight: 27 Gram Memory Capacity: 100.
14. FAQ For additional questions and answers (FAQ), visit Ellab’s FAQ page at: www.ellab.com/contact/faq. What could be the cause of a spike in a temperature channel in ValSuite while all other channels remain constant? A battery failure and a disconnected sensor have similar results in ValSuite. The temperature will spike just before the data logger shuts down. One way to differentiate between the two is to check the temperature just before the spike.
Can I use my computer for other jobs while running a TrackSense LyoPro session? Yes , you can completely close your computer down if necessary. Upon reopening the ValSuite software, the software will automatically allocate the data loggers to the session that they were started in.
15. Edition 1.
