Ellab Thermal Validation Systems
For more than 60 years Ellab has been a leading manufacturer of process validation and monitoring systems used in the food, medical device and pharmaceutical industries. These systems monitor temperature, pressure and RH and are designed for validation applications that require compliance with FDA guidelines and international GMP standards.
Ellab improves the quality of life by contributing to building confidence by providing solutions for measuring, recording, monitoring and validating critical parameters of thermal processing.
Real-time data monitoring equipment
Ellab brings together the advantages of real-time process information and the benefits of reduced setup time with wireless data loggers. Studies are monitored live from your computer using ValSuite Pro software.
The TrackSense® Pro Sky system allows you to view data collection of temperature, humidity and pressure during the application. It is often used in validation studies of lyophilizers, autoclaves, retorts, stability chambers, depyrogenation tunnels and freezers.
Real-time thermocouple system
E-Val Flex is Ellab’s real-time thermocouple system. This system can be run as a standalone or can be connected to a network via PC. Up to 128 channels can be run in one session.
Digital temperature-indicating device
ETI is a high-quality digital temperature-indicating device designed for displaying and documenting the processing temperature in retorts. It complies with FDA 21 CFR Part 113, and it is ideal for thermal processing of low-acid canned foods.
Thermal validation operating software
ValSuite Pro software has customizable reports such as statistics, lethality and validation, to name a few. These reports follow strict FDA guidelines and the software is 21 CFR Part 11 compliant. Once data has been collected, it cannot be tampered with and all user actions are monitored in the audit trail. Software is sold with documentation that states that ValSuite Pro was developed in accordance with GAMP guidelines.
Temperature, pressure and RH sensors
Ellab manufactures temperature, pressure and RH sensors that are interchangeable, allowing different sensors to be used in various applications. All certifications are included with Ellab sensors and are traceable to NPL and NIST standards. Sensors can be purchased that go down to -196°C or up to +400°C.
- Lyophilization – TrackSense® Pro Teflon sensors are generally used to monitor temperatures in freeze-drying processes; both product and shelf temperatures can be monitored simultaneously using Ellab Teflon sensors
- Depyrogenation – Ellab manufactures a TrackSense® Pro flexible sensor that can be used in dry heat tunnels; the sensors can withstand heat up to 400°C
- Sterilization – The TrackSense® Pro pressure / temperature sensor is ideal for validating steam sterilizers; this sensor monitors both pressure and temperature at the same time
- Stability – Stability trials are run on all pharmaceutical products and the TrackSense® Pro RH sensor for stability is an excellent tool for validating stability chambers
- EtO – TrackSense® Pro RH EtO sensors are made of an intrinsically safe material which is needed in the highly flammable EtO sterilization process; the sensors and loggers have been ATEX certified
Calibration systems and services
Ellab also provides calibration equipment such as dry blocks, baths and temperature standards. It is recommended that sensors and thermocouples are calibrated at least once a year. Equipment can also be sent to Ellab for service / calibration.
Products and Services
Temperature mapping is the process of determining the temperature profile of a particular temperature-controlled environment or process such as a freezer, refrigerator, incubator, stability chamber, warehouse or autoclave by measuring multiple points in a defined area over a specified study duration
Freeze Drying Theory
Freeze Drying, or Lyophilization, has become an accepted method of processing sensitive products that require long term storage at temperatures above freezing.
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