Ellab Wireless Data Logger
Ellab – Denmark
Thermal Validation Solutions for pharmaceutical, Food, …
The TrackSense® wireless data loggers are the most complete validation solution available today. With a wide range of measuring parameters, Ellab’s data loggers are ideal for most applications.
Ellab 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.
TrackSense® Pro Logger
- Each logger has multiple channels for recording data with a memory capacity of up to 120,000 data points. The state of the art technology allows for variable sample rates. A logger can be programmed to auto start or increase the sample rate at a specific time or temperature. The logger is made of AISI 316L stainless steel and the electronics are sealed in heat and moisture resistant material. The Pro logger is designed for adaptation of interchangeable sensors and all loggers have user replaceable batteries and are ATEX certified. The ATEX temperature range for each logger can be found on the certificate.
The incorporation of state of the art technology and extensive testing has resulted in outstanding performances:
• 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: ±10-50% of reading
- The TrackSense Pro X/XL loggers are designed to operate under extreme conditions without ever losing valuable data. They operate in temperatures from -80 to +150°C and can withstand pressure up to 10 Bar fully immersed.
When keeping the Pro X/XL logger outside and using a flexible sensor inside the process you can extend the measuring range down to -196°C. When using at thermal barrier and a logger with high temperature sensor the measuring range is extended up to +400°C. The nonvolatile memory stores up to 120,000 data points and it is possible to have up to 160 data loggers in one validation study.
- With the unique feature of interchangeable sensors it is possible to configure the logger for any specific application by mounting different interchangeable sensors and, if required, an RF module for online data collection. This unique feature is highly beneficial when it comes to flexibility and lowered operation costs.
Multi Reader Station
- Starting up and reading loggers can now be performed within seconds. 16 loggers can be started or read simultaneously, saving time, especially when 160 data loggers have to be started for one study.
Single Reader Station
- When only a few loggers are needed, a single reader station can be used. Available for all types of loggers.
- The Sky module contains all the necessary components for wireless online communication between the logger and the Sky Access Point.
- The standard Sky module comes with an internal antenna. Should communication stop, data will be stored in the logger for transmission once communication has been restored or the logger has been returned to the reader station. No data will ever be lost or corrupted due to loss of wireless communication. The sky module is ATEX certified for use in environments such as EtO processes.
Sky Access Point
- The Sky Access Point offers many advantages over standard wireless Access Points. The proprietary wireless protocol significantly reduces battery consumption in the data logger. All other wireless equipment is rejected by the Sky Access Point, greatly improving transmission success and security. A channel test function is available to eliminate data interference. The Sky Access Point comes with a standard antenna, but optional remote antennas are available for more difficult transmission environments. To cover larger areas or longer distances, multiple Access Points can be operated simultaneously.
- Ellab 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 or without LED that shows the status of the logger. An active logger is identified by the light flashing green. This feature makes it easier to start larger groups of loggers and helps to avoid the use of non programmed loggers.
In the case of an LED sensor being used in combination with a Sky module, the LED will also confirm communication status.
Extreme Temperature Sensors
- The standard temperature range goes up to +150 °C, but it is possible to order sensors which can measure down to -196 °C or up to +400 °C. The logger has to be placed outside of the environment when measuring at -80 °C to -196 °C. When measuring from +150 °C up to +400 °C, a thermal barrier is required to protect the battery. The principle is to insulate the logger keeping the battery temperature below +150 °C.
- 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.
ValSuite® Validation Software
- The ideal solution for any thermal validation process
- The FDA 21 CFR Part 11 compliant ValSuite® software is at the core of everything that Ellab offers. ValSuite will keep your process running smoothly and guard your data to secure its integrity. ValSuite® collects and presents validation data from the E-Val™ Pro and TrackSense® Pro data logging systems. The software can run up to 160 TrackSense channels or 120 E-Val Pro channels at a time.
- ValSuite offers features like customized reports with clear pass/fail criteria, test templates, data analysis, monitoring, live data and much more. ValSuite is developed according to GAMP principles and is available in multiple languages for Windows 7, 8 and 10 (32/64-Bit). ValSuite is availabe in four generic versions: ValSuite Basic, ValSuite Medical, ValSuite Plus and ValSuite Pro.
Key Features and Benefits
- FDA 21 CFR Part 11 compliant
- Windows security option
- Compatible with Windows 10
- Multiple reporting options
- ValSuite® app available
- Real time data with the SKY module
- A complete set of reports can be produces containing Pass/Fail criteria, map over measuring positions, current operator and vessel ID, calibration offsets for the probes, data lists and statistical summaries of the data.
- ValSuite Pro also allows users to create and save templates for reports in order to meet the specific requirements of tests like EN17665 for moist heat autoclaves, EN15883 for washer disinfectors or NFC 15-140 for stability chambers. These templates can be customized to organize the data and perform calculations to match various criteria. These features greatly reduce the data analysis process.
Once ready, reports can be reviewed using the print preview feature and then be saved as a PDF file.
Validation Report Types
The different reports include, but are not limited to:
- Lethality Report
- Limit Report
- Statistics Report
- Advanced Phase Statistics Report
- Calibration Report
- Autoclave Validation
- Washer Disinfection Validation
- MKT Report
- Combined Uncertainty Report
- Leak Test Report
- Advanced Validation Report
- Dew Point Calculation
- And more…
Reports designed to meet specific requirements
ValSuite offers an outstanding Datapoint Process Report Generator (DPRG), which produces fully compliant user reports in accordance with current norms and standards related to validation processes and equipment qualifications.
ValSuite also maintains templates for reports designed to meet specific requirements of tests, such as:
- EN 13060 Qualification Report
- EN 285 Qualification Report (incl. special templates for different sizes)
- EN 285/13060 Air Leakage Report
- EN17665 (EN554) Report for evaluating the sterilization processes of healthcare products
- FDX-140 Combined Uncertainty for a statistical analysis of the stability in a chamber
- ISO 15883 Basic and Advanced Washer Disinfector Evaluation Report
- USP 1079 Mean Kinetic Temperature Report for evaluating the products contained in pharmaceutical warehouses
- ISO 11140-4/17665 Electronic Bowie Dick Test