E-Val Pro Plus

The E-Val Pro Plus is a wired validation solution designed for life sciences applications requiring compliance with FDA guidelines and international GMP standards. It is particularly suitable for environments with extreme temperature ranges or where real-time measurements are crucial, such as ultra-low temperature areas like liquid nitrogen containers for cryopreservation at -196°C, high-temperature areas like heat tunnels for dry heat sterilization between +180 to 300°C, sterilization in place (SIP) at +121°C, and autoclaves operating at 121 to 134°C.

This system features temperature validation equipment with interchangeable sensors, offering 52 individual sensor inputs for thermocouples or analog/digital inputs. The traceable and interchangeable thermocouples include a smart USB connector with built-in cold junction compensation, maintaining calibration offsets and reducing calibration time and effort.

In addition to temperature, the E-Val Pro Plus can measure several other parameters, thanks to its Sensor Interface that accommodates various sensors. These parameters include pressure and vacuum, relative humidity, CO2, and conductivity.

The intuitive validation software associated with E-Val Pro Plus facilitates data gathering, analysis, and reporting, maintaining a comprehensive database of validation requirements. It supports FDA 21 CFR Part 11 compliance through digital signatures and automated audit trails, and it automates data analysis and report generation with clear pass/fail indicators. The software also streamlines study setup with session and report templates, enhancing efficiency and audit readiness.

Key Benefits:

• Ensures complete compliance with FDA, GAMP, and internal regulations.
• Reduces time-to-market and increases uptime.
• Eliminates data gaps and the need to redo studies.
• Provides full sensor traceability and replaceability without compromising calibrations.
• Features plug-and-play thermocouples with minimal drift.
• Automates setup, analysis, and reporting, reducing manual tasks.
• Offers clear pass/fail indications.
• Available for purchase, rental, or service, with potential SOP rewrites.

Ellab's team is available to assist in tailoring a validation solution to specific processes, ensuring that your biopharmaceutical products are safeguarded and compliant.