Description
EvalPro Plus Wired Thermocouple System
Model: EvalPro Plus
Ellab – Denmark
The E-Val Pro Plus Thermal Validation Cable System is a 1-52 channel system designed for validation applications that require compliance with the FDA guidelines and international GMP standards.
The E-Val Pro Plus system has a full audit trail as well when using the stand-alone function. The ValSuite® Pro software keeps a complete database on all aspects of validation requirements – tracking probes and sensors, calibration reports, test setup, data analysis, specific user access, and final compliance report.
If only one E-Val Pro Plus module is in use, the module can be operated as a standalone unit – or be directly connected to the computer by USB or Ethernet port using a standard LAN cable. Upon using more than one E-Val Pro Plus module, an Ethernet switch or USB Hub is required.
The E-Val Pro Plus wired validation solution is designed for validation applications in life science that require compliance with FDA guidelines and international GMP standards.
It’s ideal for Temperature Controlled Units (TCUs, CTUs) with an extreme temperature range or where real-time measurements are needed, like:
Ultra Low Temperature Areas: E.g. Liquid Nitrogen Containers for the cryopreservation of living cell material at -196 °C, or Freezers.
High Temperature Areas” E.g. Heat Tunnels / Dry Heat Sterilization (for Depyrogenation – in the range of +180 to 300 °C).
Sterilization in Place: For SIPs at +121 °C, because you have a real-time measurement with a cycle rate of one second. Especially at initial qualifications where you can observe the measurement and react if something isn’t going as planned.
Autoclaves: For real time measurements in Steam Sterilization Processes at 121 to 134 °C.
E-Val™ Pro Plus – Thermocouple System
What you can expect with a Eval Pro Plus Wired Validation Solution from Ellab:
Reduce the risk to your biopharmaceutical products and go beyond compliance with Ellab’s wired validation solution, E-Val™ Pro Plus.
- Complete compliance with FDA, GAMP, and internal regulations.
- Faster time-to-market and more uptime.
- The end to data gaps and having to redo studies.
- Full sensor traceability and replaceability without compromising calibrations.
- Plug-and-play thermocouples with less drift.
- Elimination of manual tasks through automated setup, analysis, and reporting.
- Clear pass/fail indications.
- Purchase, rental, or service options as well as possible SOP rewrites.
E-Val Pro Plus Module
- The E-Val Pro Plus Master module is a small, user friendly, easy to operate, and very accurate measuring instrument. It is possible to configure and operate the module using the 10.1 touch display and its functions. The module can handle 52 probes and the internal memory can store up to 44.928.000 total samples. These samples can be spread out across 20 smaller sessions of up to 2.246.400 points or be allocated into one long study of up to 11.232.000 points.
- The sensors can be temperature thermocouples or digital pressure for I/O, 4-20 mA, or 0-10 V. To measure according to the specifications, connect the probes, power up the module and operate the module by the touch display or by the ValSuite® Pro software installed on PC. The data points are stored in the E-Val Pro Plus module memory as soon as a session is started – and transmits the data to the software once it is connected.
- The Master module is powered by a 12 V DC power supply with a built-in backup battery in place. The E-Val Pro Plus battery has a 12-hour capacity.
- On the rear side of the E-Val Pro Plus module, is an On/Off button. After pressing the On/Off button to start the E-Val Pro Plus system. Once started all channels will be measured within one minute. The
- E-Val Pro Plus can be shut down through the Menu systems shutdown function or by pressing the On/Off button on the rear side. The On/Off button needs to be held down for 5 seconds to turn off the power.
- The Master module can accommodate one multipurpose, high power (100 mA/5V), 4 channel sensor array plus low power (40 mA/5V) 12 channel sensor arrays. These arrays are delivered separately and are carefully mounted in the corresponding sensor array slots. This is done on the back of the Master module by removing the blind plate(s) once the power is completely turned off. After mounting, turn the power back on and the system will automatically initiate, allowing for the appropriate sensors to be connected.
- Every sensor array has a serial no.
Backup Battery Pack
- The E-Val Pro Plus module is equipped with a 12-hour capacity rechargeable battery pack by default. The purpose of which is to allow the module to continue operating, even when disconnected from the mains.
- The battery pack has a built-in safety system designed to avoid complete discharge, which would otherwise be damaging to the battery. The safety system slightly drains the battery over time and could eventually completely empty the battery if the module is not connected to the mains for more than 12 months. The battery pack will consequently need to be replaced at an Ellab Service Center.
ValSuite® Software
- The ValSuite® software is validated using Windows 10/11 64 Bits, language version: English operating system. Installing and using this software requires a basic knowledge of software installation and the Windows operating systems.
- ValSuite is the industry leading validation and calibration software, which is highly attributed to the countless reporting options, impenetrable data integrity, user-calibration options and data analysis features.
- The software is used to run all Ellab hardware and can combine various measuring systems to the same study. In addition to its wide range of features, ValSuite is also FDA 21 CFR Part 11 compliant and designed in accordance with GAMP guidelines.
Features and Benefits:
✓ FDA 21 CFR Part 11 compliant
✓ Safe and reliable
✓ Windows security option
✓ Compatible with Windows 10
✓ Available in several languages
✓ Suitable for all sorts of applications
✓ Multiple reporting options
E-val Pro Plus Probes:
+ SSA-TS Thermocouple sensor:
+ SSA-TF Thermocouple Sensor:
+ STC-AC Thermocouple sensor:
+ STC-ACS Thermocouple sensor:
Application
A Wired Validation Solution for Any Application
- Regardless of whether you’re working with autoclaves, SIP, ovens, liquid nitrogen, or freezers, you can reliably verify the performance of your biotech and pharmaceutical processes with our wired validation solution.
- Designed to be flexible and scalable, you can tailor your E-Val™ Pro Plus setup to support your specific needs.
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