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Test & Measurement / Process Validation Equipments / Thermal Validation Equipment
 
     
 

Thermal validation is performed to document that a sterilization process is working properly and according to regulations.

Thermal validation solutions from Ellab have been developed according to GAMP standards and the performance carefully documented. Several large pharmaceutical customers have audited our equipment and our QA system and FDA accepts validation data from Ellab solutions.

Of course our software is 21 CFR, part 11 compliant.

 
     
  TrackSense® Pro  
  The ultimate solution in wireless thermal validation.  
     
 

Ellab has incorporated the latest in electronic technology and innovation to deliver a wireless multi-channel data logger unmatched in accuracy, performance and versatility. The flexible system is easily adapted to your requirements and provides an elegant solution to the most demanding validation applications.

Accuracy
The incorporation of state of the art technology and extensive testing have resulted in:

 
 
Temperature: ±0.05 °C
Humidity: ±2%
Pressure: ±0.25% Full Scale
Time: ±5 Sec. Per 24 Hours
Rotation: ±1%
 
     
 

Compare and you will find TrackSense® Pro the most accurate data logger available on the market today.

Perfomance
The robust loggers are designed to operate under extreme conditions without ever loosing valuable data. They can tolerate temperatures from -80 °C to +150 °C and withstand pressures up to 10 Bar fully immersed. The non-volatile memory stores up to 60,000 data points. Recent improvements in battery technology have dramatically improved performance and lifetime even at high temperatures.

 
     
  E-Val Flex  
  The flexible solution in real-time thermal validation.  
     
 

Val Flex - Thermal Validation System
The E-Val Flex thermal validation system is designed for validation applications that require compliance with FDA guidelines and international GMP standards. The E-Val Flex greatly simplifies and correctly documents the entire validation process. The ValSuite™ software keeps a complete database on all aspects of your validation requirements - tracking thermocouples, calibration reports, test setup, data analysis, specific user access, to final compliance reports.

Flexibility For Different Validation Applications
E-Val Flex was designed as a single solution for all thermal validation applications. It can be ran as a stand-alone unit or networked with your PC. The software, which handles up to 128 channels, documents and controls each step reducing errors and maintaining guidelines for more complex regulated applications that require tight compliance control. The easy expandability makes this a complete validation solution for a facility with a variety of applications.

Quality
The highest quality electronics were incorporated into the design greatly improving efficiency and accuracy. With 8MB of memory and a battery backup, data will never be lost due to a power outage. Pt-1000 sensors are installed on each individual thermocouple channel eliminating gradient errors through the cold junction dramatically improving accuracy. The case is made in 316 stainless steel ensuring durability and reducing noise in the electronics which makes the unit ideal for the harsh environments on a factory floor.

Accuracy
Dramatic improvements in accuracy with enhanced engineering:

 
 
Pt-1000 sensors are installed on each individual thermocouple channel eliminating gradient errors through the cold junction
Implementation of ID chips enabling factory certification and storage of calibration offsets in each individual thermocouple
Use of high quality sealed thermocouples
 
     
 

The E-Val Flex system reduces the need for frequent calibration saving a tremendous amount of time. Competitive systems require calibrations before every study. We recommend running a one point verification test to find any damaged or degraded thermocouples. If you need to replace a damaged thermocouple a system calibration is not required. Since the Ellab type T thermocouples are pre-calibrated and hold the offsets in the ID chip, a 0.05 oC accuracy is held.

 
     
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