PHARMACEUTICAL

Through our principals M/s. ELLAB A/S Denmark, we offer most accurate and reliable turnkey pharmaceutical validation systems with automated generation of reports as per international norms ( EN 554, EN 285, EN 17665) etc. with IQ/OQ documentation and with fully Automatic Calibration Lab. The ValSuite Software is validated and is fully compliant to FDA 21 CFR Part 11.

Validation of Temperature, Pressure, Humidity, pH, Conductivity etc

Special dedicated System for Batch monitoring of Lyophilizers with alarms .

Unmatched Accuracy for Temperature sensors : +/-0.05 deg C.

Special fittings and fixtures for Heat Penetration applications

Automatic Pyrogen Monitoring Systems as per International Pharmacopeia

ValSuite Pro Software validated and fully compliant to FDA 21 CFR part 11

Automatic Generation of Reports as per EN 554, EN 285 and EN 17665

Equipment CE marked

Heat Penetration ( Terminal Sterilization) Accessories to simulate actual processing conditions.

EVAL FLEX CABLE BASED 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  is validated and fully compliant to FDA 21 CFR Part 11, 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.

Read More
TS PRO Wirless Online Datalogger  VALIDATION SYSTEM  

TS Pro Wireless Loggers are the Ultimate Solution in Wireless Thermal Validation with an unmatched accuracy of +/-0.05 deg C.

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.

The TrackSense® Pro loggers are designed to operate under extreme conditions without ever losing 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. It can measure upto +400 deg C using thermal barriers.

The small size and convenience of wireless data loggers make them exceptionally easy to use in countless validation applications such as;  Autoclave Steam Sterilization, SIP Validation, Depyrogenation, Lyophilization, Heat Penetration / Terminal Sterilization, Stability Chambers,  EtO Sterilization,  H2O2 Sterilization, Warehouse Validation,  Incubation etc.

Read More
HEAT PENETRATION ACCESSORIES   

In order to get the accurate and reliable data during validation ( especially when performing heat penetration / terminal sterilization in autoclaves), it is important to use correct fittings and fixtures to  simulate the actual processing conditions.

ELLAB have developed a large selection of probes, sensors, packing glands, and tools which are available for correct mounting in various styles and designs of containers. The range of fittings available is being continually expanded and improved with the following parameters taken into consideration:

Correct positioning of the measuring device : It is very important that the packing gland and probe are correctly positioned in the “cold spot”. If this is not obtained it can result in “false” measurements, risking high Fo-values.

• Elimination of steam and water ingression : It is pertinent that the packing gland and the probe are mounted so that the integrity of the container is maintained. Properly mounting the gland will also ensure that water/steam ingression cannot occur, which would lead to false data and high Fo values.

• Minimizing risks of heat conduction : It is recommended that the probe and gland are mounted from the side of the container  with the longest distance to the “cold spot” so that heat conduction from the water/steam is avoided. Even if the probe/gland is as small as possible and made of materials with the lowest conductivity there will always be a risk of heat conduction.

• Minimizing the probe assembly inside the container : It is very important that the probe and fi xture are as small as possible so that the impact on the internal environment (product) of the container, including the headspace, is minimized.

Read More

VALSUITE PRO SOFTWARE   

The ValSuite software  is validated and fully compliant to FDA 21 CFR Part 11, 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. It automatically generates reports as per international norms ( EN 554, EN 285, EN 17665) etc

Multiple calculations such as min/max, standard deviation, average, deltaT and lethality can be calculated on any block of data displayed eliminating the need to export data thus improving data security.

The ValSuite™ software documents and guides you through the complete thermal validation process. The database structure in the software enables complete documentation and procedural control for the operators.

Templates allow detailed test criteria to be pre set in the software by the assigned administrator. Information on sensor placement, operator, test, vessel, required temperature limits, start and stop time, monitoring interval and specific calculations can all be pre set and saved. This ensures accurate documentation and correct implementation of required procedures for consistent repeatable tests

ValSuite™ collects and presents validation data from both E-Val Flex and TrackSense® Pro data logging systems. The data from both systems can be presented and analyzed in the same session. The system can run up to 128 channels which can be identified and displayed in different groups such as penetration and distribution. Any grouping or specific channels can be displayed in a separate data block and analyzed.

Read More