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Ellab-Data-loggers-TrackSense-Pro-ENG

Ellab-Data-loggers-TrackSense-Pro-ENG

Ellab-Data-loggers-TrackSense-Pro-ENG

Product catalog summary
Overview
TrackSense® Pro is a sophisticated wireless data logger by Ellab, designed for precision and adaptability in various data logging applications. It includes models like TSP Pro XL, TSP Pro X, TSP Pro, TSP Basic, TSP Compact, TS Frigo, TS Lab, TSP Mini, and TSP Micro, each suited for specific conditions.
Specifications
  • Accuracy: Temperature ±0.05 °C, Humidity ±2%, Pressure ±0.25% full scale, Time ±5 sec. per 24 hours, Conductivity ±1 μS/cm, CO2 ±0.2%, Vacuum ±15-20% of reading.
  • Performance: Operates from -80 to +150 °C, withstands up to 10 Bar pressure, and extends to -196 to +400°C with a thermal barrier. Stores up to 60,000 data points and supports up to 160 data loggers in one study.
Features
  • Versatility: Interchangeable sensors for specific applications, reducing costs and increasing flexibility.
  • Multi Reader Station: Simultaneous start-up and reading of 16 loggers for enhanced efficiency.
  • RF Data Transmission: Real-time data transmission with Sky module and Sky Access Point, ensuring data integrity.
Logger Models
  • Pro X Logger: Suitable for low and high-temperature applications, ranging from -80 to +150 ºC.
  • Pro XL Logger: Extended battery for significant temperature changes.
  • Basic Logger: For applications below 100 °C, like pasteurization.
Sensors
  • Interchangeable Sensors: Configurations for temperature, CO2, humidity, pressure, and conductivity studies.
  • Extreme Temperature Sensors: Measure down to -196 °C or up to +400 °C with protection.
Applications
  • Suitable for sterilization, lyophilization, and stability studies, with models for ultra-cold or high-temperature environments.
Accessories
  • Custom fittings and thermal barriers for specific applications, ensuring accurate data collection.
ValSuite Pro Overview
The document details the validation processes for sterilization and lyophilization using various sensors and data loggers, including sections on sensor adjustment, limit reports, statistics, advanced phase statistics, validation reports, and logger settings.
Sensor Adjustment
Lists sensors with IDs but lacks specific readings, indicating unavailable or unrecorded data.
Limit Report
Sterilization at 122°C with vacuum pulses met criteria set between 121.00°C and 124.00°C.
Statistics
Analyzed temperature readings confirm the process stayed within acceptable limits.
Advanced Phase Statistics
Details lyophilization phases with specific temperature set points and durations, all passing test criteria.
Validation Report
Confirms sterilization process met all specified criteria, including temperature fluctuation and pressure deviation limits.
Saturated Steam Analysis
Pressure deviation during sterilization was within allowed limits, ensuring effectiveness.
Lethality Calculation
Confirms required lethality levels were achieved.
TrackSense Logger Settings
Details logger settings, including start/stop times, sample rates, and firmware versions.
Software Overview
ValSuite Pro is an intuitive validation software supporting multiple languages and regulatory standards, offering detailed control over validation studies and data analysis.
Main Features
  • Supports TrackSense® Pro loggers and E-Val Pro wired systems, offering flexibility in monitoring parameters.
  • Operates on standalone PCs or server solutions, ensuring network security and data synchronization.
  • Supports up to 160 channels in one session with multilingual support.
  • Includes drivers for calibration equipment.
Reporting Capabilities
  • Generates reports like lethality, limit, statistics, calibration, and validation reports.
  • Reports can be printed or saved in PDF format, with features like comment fields and Word document attachments.
  • Advanced features include 3D visualization and heat factors/ball simulation.
Validation and Calibration
  • Fully compliant with 21 CFR, Part 11, ensuring data integrity and security.
  • Validation reports provide detailed analysis with pass/fail criteria and statistical summaries.
  • Calibration can be manual, semi-automatic, or fully automatic, using ETS temperature standards.
  • Calibration reports include detailed results linked to sensor IDs.
Compliance and Security
  • Complies with FDA guidelines, GAMP, and ISO 9001:2008 standards.
  • Features include an SQL database, audit trail reports, electronic signatures, and access management.
Additional Services
  • Ellab offers calibration certifications, service contracts, rental and demo systems, and training through the Ellab Academy.
  • Provides a 2-year warranty on loggers and components.
Contact Information
Ellab A/S is based in Denmark, with contact details provided for inquiries.
See more

Catalog excerpts

Ellab-Data-loggers-TrackSense-Pro-ENG-1

The ultimate wireless data logger

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Ellab-Data-loggers-TrackSense-Pro-ENG-2

TRACK SENSE® PRO I PAGE 3 The Ultimate Wireless Data Logger Time Temperature Pressure Vacuum Relative Humidity Conductivity CO2 Sky TrackSense® Pro parameter overview EUab has incorporated the latest in electronic technology and innovation to deliver a wireless multi channel data logger that is unmatched in accuracy, performance, and versatility. Accuracy The incorporation of state of the art technology and extensive testing has resulted in outstanding performances*: • Temperature: • Humidity: • Pressure: • Time: • Conductivity: • CO2: • Vacuum: ±0.05 °C ±2% ±0.25% full scale ±5 sec. per 24 hours...

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Ellab-Data-loggers-TrackSense-Pro-ENG-3

TRACK SENSE® PRO I PAGE 5 TrackSense® Pro Interchangeable Sensors EUab offers the largest range of different sensors with 1, 2 or 4 channels. The sensors are interchangeable, enabling the user to choose sensors for different applications. This reduces costs as one set of TrackSense® Pro loggers can be used for temperature, CO2, humidity, pressure and conductivity studies. All sensors (except quad sensors) are compatible with a Sky option to provide live data. The temperature sensors can be delivered in rigid, semi flexible and flexible material for ease of use. Rigid sensors are available with...

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Ellab-Data-loggers-TrackSense-Pro-ENG-4

TRACK SENSE® PRO I PAGE 7 TrackSense® Pro Integrated Sensors Compact X 0 2 mm The Compact X logger is configured to measure temperature with a rigid or flexible sensor. -50 to +140 °C 30,000 Data Points Diameter: 25 mm Height: 35 mm Compact 0 2 mm Length: 35, 50, 75, 100 mm The Compact logger is configured to measure temperature with a rigid sensor. -30 to +140 °C 30,000 Data Points Diameter: 25 mm Height: 35 mm Compact SemiFlex Length: 30, 50 cm The material is semi flexible stainless steel 0 1.5 mm. -30 to +140 °C 30,000 Data Point Diameter: 25 mm A large range of loggers with integrated sensors...

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Ellab-Data-loggers-TrackSense-Pro-ENG-5

Fittings & Accessories GVK On bottle necks use the GVK packing gland for pasteurization applications. Custom Fittings Packing glands and other fittings are available for placing loggers and inserting sensors into any variety of packaging material. The glands are threaded to accept sensors and will maintain the seal when pressurized. It is very important that sensors are placed correctly in the “cold/hot zone” to obtain true lethality values. See examples of typical applications and configurations below. Luer lock Positioned on the syringe with pressure sensor mounted on logger for pressure measurement...

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Ellab-Data-loggers-TrackSense-Pro-ENG-6

Operator: Process: Session Start: Session Stop: Session Name: Session Text: Validation Manager Autoclave Vessel: Sterilization Product: Medicine Time Zone: UTC offset 02:00:00 15-06-2017 08:50:00 15-06-2017 10:33:35 Sterilization @ 122 °C with vacuum pulses.d7x Sterilization @ 122 °C with vacuum pulses Validation Solutions Sensor Adjustment Report Autoclave Validation Manager Operator: Vessel: Product: Medicine Sterilization 15-06-2017 08:50:00 Deviation Time Zone: UTCCalibration Timestamp offset 02:00:00 Session Sensor Value Start: Standard Value 15-06-2017 10:33:35 N/A Session Stop: N/A N/A...

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Ellab-Data-loggers-TrackSense-Pro-ENG-7

Producing Reports Validation Report Report header: ValSuite™ Pro also maintains templates for reports designed to meet the specific requirements of tests such as EN17665 (EN554) for moist heat autoclaves This feature greatly reduces the time needed for the data analysis process. Reports can be reviewed with the print preview feature and saved in a PDF file format. Preselected Timestamps First possible start Revalidation of autoclave in room 66 or EN15883 for washer disinfectors and NFX 15-140 for stability chambers. The templates can be customized to organize the data and perform calculations...

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Ellab-Data-loggers-TrackSense-Pro-ENG-8

TRACK SENSE® PRO I PAGE 15 ValSuite™ Pro Calibration Ellab ValSuite™ Pro is not only a validation software but also a calibration software. This means that all sensors can be user calibrated at defined intervals and store offset values. Using the ETS temperature standard and appropriate reference instruments connected to the PC, a fully automatic calibration can be executed without any interference of operator - a very safe and time saving feature. A report is automatically generated that shows the overall calibration results. When using the Calibration Setup, users can choose Manual, Semi-Automatic,...

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Ellab-Data-loggers-TrackSense-Pro-ENG-9

Since the late 1940’s Ellab A/S has been a leading manufacturer of process validation and monitoring systems used in the food, medical device and pharmaceutical industries. Calibration Certifications and Service Ellab maintains a complete calibration facility for annual certifications and service. Ellab A/S temperature, resistance, pressure and humidity calibration laboratory is accredited according to ISO 17025 by DANAK under registration no. 520. Service and maintenance contracts are available. Rental & Demos Demo systems are available for trial and rental. Please contact your local Ellab representative...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.