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EVal Pro thermocouple system for thermal validation

Description

E-Val Pro Thermocouple System

for thermal validation

E-Val™ Pro – Thermocouple System

The E-Val™ Pro thermocouple system for thermal validation is immensely easy to handle within controlled environments due to its compact size and light weight.

The thermocouple system complies with FDA regulations as well and GAMP guidelines and is designed to be the ideal solution for any thermal validation process.

Eval Pro

The E-Val™ Pro thermocouple system is packed with features that make validating processes with cables a whole lot easier. The FDA and GAMP compliant module is the ideal solution for traditional thermal validation methods.

The secure and password protected module can handle up to 40 thermocouples and the large internal memory is capable of holding up to 10 studies at a time. The wired thermocouple system has a built-in 8-hour battery and can be used as a stand-alone unit or be connected to a PC via LAN/USB.

The E-Val Pro is equipped with interchangeable sensor arrays, which can easily be removed for service and calibration. With 4 and 12-channel arrays available, the E-Val Pro can handle all thermocouple types as well as analog and digital inputs.

Key Features and Benefits

  • Light and compact module
  • Individual cold junction compensation
  • Easy to handle and transfer from study to study
  • Up to 40 sensors per module
  • USB connectorsGraphical Interface and touch display
  • Password protected module
  • Clean room suitable due to no fan
  • Stand-alone function

E-Val Pro Validation System Orders
Master Module
1 pcs. 4 channel sensor array
Optional 1-3 pcs 12 channel sensor arrays
Suitcase
USB Cable
12 V Power supply
USB Key with Software

E-Val Pro Introduction

  • The E-Val Pro Thermal Validation Cable System is a 4-40 channel system designed for validation applications that require compliance with the FDA guidelines and international GMP standards.
  • The E-Val Pro 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.
  • The E-Val Pro Module operates on OS Windows CE version 7. If only one E-Val Pro module is in used, 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 EVal Pro module, an Ethernet switch or USB Hub is required

E-Val Pro Module

  • The E-Val Pro 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 8” touch display and its functions. The module can handle from 4 to 40 probes and the internal memory can store up to 11.520.000 total samples. These samples can be spread out across 10 smaller sessions of up to 1.152.000 points or be allocated into one long study of up to 11.520.000 points.
  • The sensors can be temperature thermocouples, digital pressure – or input signals for I/O, 4 – 20 mA or 0-10 V. To measure according to 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 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 battery has an 8-hour capacity.
  • On the rear side of the E-Val Pro module, is an On/Off button. After pressing the On/Off button to start the E-Val Pro system. Once started all channels will be measuring within one minute. The E-Val Pro 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

Module:
4-40 Channel module (max 3 x 12 + 1 x 4)
512 MB flash Memory
Anodized Aluminum cabinet
1 second to 24 hours sample rate
Weight: 3.0 kg w.8-hour battery
USB port for PC connection
LAN port for Ethernet connection
USB port for data transfer
IP 40 (IEC standard 60529)

Module/Sensor array configuration

  • The Master module can accommodate one multipurpose, high power (100 mA/5V), 4 channel sensor array plus 1-3 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.

Coin Cell Battery for the E-Val Pro Clock

  • The E-Val Pro is equipped with an in-built clock, which runs on a coin cell battery with an estimated lifetime of 10 years when the module is turned off. When the module is on, the clock will draw energy from the main power supply instead, providing a longer lifetime for the coin cell battery. This battery will therefore last for 10 years + the amount of time the E-Val Pro has been turned on.

Eval Pro Sensors

  • The E-Val Pro Module can be connected to 1-40 temperature probes as well as 4-20mA, 0-
    10V, digital pressure, rotation, or deflection sensors via the Array USB interface.

Temperature Probes
The E-Val Pro modules are designed for the Ellab premium grade type T, 7 strand thermocouples. The Ellab thermocouples are equipped with an electronic ID, allowing for easy identification of the thermocouples. The standard SS* probes are supplied with threads that fit into packing glands, forming a no-leaking seal into packages or cans. 

Technical Specifications:

  • Operating Range: 5 °C to 50 °C
  • Environmental: 0 – 90% RH, non-condensing
  • Sample Rate: 1 Second to 24 Hours
  • Weight: 3.0 kg (including battery and 40 channels)
  • Electrical Protection Class: IP40
  • Power Consumption: Less than 9 Watts (40 temperature sensors)
  • Memory: 40 channels 1 second sample rate in 8 hours for 10 sessions
  • Number of Channels: 40 channels

Time:

  • Time Accuracy: ± 1 Second per 24 Hours

Temperature:

  • Measuring Range: -200 to +1,300 °C (ready for -270 °C to +1,820 °C) depending on sensor type
  • Measuring Range (Type T): -200 to +400 °C
  • Measuring Accuracy at an ambient temperature of 23 °C: ± 0.05 °C between -100 and +400 °C / ± 0.1 °C between -200 and <-100 °C
  • Total System Accuracy at an ambient temperature of 23 °C: ± 0.10 °C between -50 and +150 °C (type T)
  • Resolution: 0.01 °C

Pressure:

  • Measuring Range: 0 to 4 Bar ABS
  • Measuring Accuracy: ± 0.15% FS
  • Resolution: 1 mBar

Other Parameters:

  • Measuring Range: 4-20mA or 0-10V

The ValSuite® Pro Software

The ValSuite software, in conjunction with Ellab equipment, offers a complete system for the validation, monitoring, and documentation of critical parameters in thermal processes in the food, medical device, hospital, and pharmaceutical industries. Data can be collected, analyzed, displayed, and reported by ValSuite, which has been validated according to GAMP guidelines.
The ValSuite software allows for several process parameters and events such as container and chamber temperatures, pressures, relative humidity, and processing times to be recorded simultaneously in one or several data files. The data analysis enables calculation of F0, A0, P0, and C0 values and statistical analysis as mean kinetic temperature, combined uncertainty etc. The display function includes vertical and horizontal zoom, single or multichannel display, and graphical and list data output. The reporting function enables customized report generation. An export function is also available for more specialized statistical analysis and graphical display.
The ValSuite Pro software is a validated and extended version of the ValSuite software. In addition to the functionality included in ValSuite, this version also includes password protection, electronic signature, and audit trail functions.

All data is stored in an SQL database, data are stored as BLOB (Binary Large Object Blocks) in the ValSuite format V8x. This format can be exported out of the database include with session Audit trail for documentation of change. The V8x format is closed and is controlled by a CRC check. To comply with GMP, the V8x format cannot be changed.
Data can be exported to Excel spreadsheet, word, and CSV format. Please note that when exporting data from ValSuite to Excel / word data can be manipulated or deleted.
ValSuite uses the proprietary V8x file format. When exported to external formats, an audit trail can be included to comply with GMP.

  • 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.

Software 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

Highlighted Features

  • One software platform for all Ellab equipment
  • Combine TrackSense data loggers and the E-Val Pro wired thermocouple system in the same session
  • Automatic PDF report generation with clear pass/fail indication
  • Can run from a stand-alone PC or networked

Calculation Functions

  • Lethality Calculation: A0, C0, F0, P0, FH, Fd or Add Customer Lethality value (this will always be calculated pr. minute). ValSuite™ supports lethality calculations on all temperature sensors depending on user input. Lethality can be added in an online session and as a function after recalculation. Users are also able to change the constant during any step if deemed necessary. The lethality function supports a default value of F0.
  • Heat Penetration: A heat penetration study is about determining the heating and cooling behavior of a product/package combination in a specific retort system for the establishment of safe thermal processes and evaluating process deviations, and to find the “cold spot” in the product/container, and to ensure that all products receive the heat scheduled. ValSuite supports the heat penetration method known as The Ball Method which refers to the formula in Thermal Process Time for Canned Food (National Research Council Bulletin 7, Part 1, No. 37 [1923]) document.

       Typical Use of Heat Penetration

       Calculation of heat penetration constants.

       Simulation which can be performed in the Ball mode.

  • Mean Kinetic Temperature (MKT): Mean Kinetic Temperature is used as a statistical analysis to check if product has been decomposed due to fluctuation in the storage temperature.
  • Advanced Phase Statistics: is a multi-flexible analysis tool that can-do statistics and limit tests on automatically detected phases in a process. Advanced Phase Statistics works with ValSuite Sensor groups which can divide the sensors into groups representing a location or temperature zones in a tunnel.
  • Electronic Bowie Dick Test: The Electronic Bowie Dick test report is used for daily routine control of sterilizers as well as analyzing sterilization processes.
  • Door Opening Test Report: The Door Opening Test Report is new to ValSuite 6.0, This is created according to the qualification methods: Test open door study in chapter: 14.4.3 Performance Qualification in Handbook of Stability Testing in Pharmaceutical Development (springer) ISBN: 978-0-387-85626-1. The overall purpose of this test is to provide a framework for temperature-recovery upon a door/hatch being opened and allowing outside air into the enclosure. This will affect the maintained temperature in the enclosure and the temperature will therefore need to be restored within an acceptable timeframe without also fluctuating outside the acceptable band.

Ellab Applications

  • Ellab provides a wide range of diverse products and solutions for the pharmaceutical, medical and food industries all around the world.

 

 

 

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