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Ellab-E-Val-Pro-Thermocouple-System-ENG

Ellab-E-Val-Pro-Thermocouple-System-ENG
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Ellab-E-Val-Pro-Thermocouple-System-ENG

Product catalog summary
Overview
The E-Val™ Pro Thermal Validation System is an advanced solution for real-time thermal validation, ensuring compliance with FDA guidelines and international GMP standards. It streamlines the validation process and provides comprehensive documentation through the ValSuite Pro software, which manages thermocouples, calibration reports, test setups, data analysis, user access, and compliance reports.
Flexibility and Applications
The system is versatile and suitable for various thermal validation applications in the pharmaceutical and food industries. It can function as a stand-alone unit or be networked with a PC, handling up to 120 channels. Key applications include autoclave validation, lyophilization, and depyrogenation.
Quality and Design
The E-Val Pro features high-grade electronics for improved accuracy and reliability, with 512MB memory, battery backup, and cold junction compensation. Its aluminum housing ensures durability and minimizes electronic interference.
Features and Benefits
  • Stand-alone modules with 4 to 40 channels.
  • Wide measuring range from -200 to +1,300 °C.
  • USB and Ethernet connectivity for fast data transmission.
  • High accuracy with NIST traceability.
  • Real-time data display and statistics.
  • Compliance with 21 CFR Part 11 and GMP standards.
Accuracy and Time-Saving
The system ensures high accuracy with ID chips for factory certification and calibration offsets. It saves time with quick USB connections and automated calibration processes, reducing setup time and manual labeling.
Connectivity and Stand-alone Operation
The modules support USB and LAN connections, allowing for flexible network configurations. They can operate independently, storing up to 80 hours of data per session with password protection.
Probes and Sensors
Ellab offers a range of high-precision thermocouple probes and accessories for various applications, ensuring accurate and stable measurements. The system supports both temperature and pressure measurements.
ValSuite Pro Software
ValSuite Pro is an intuitive software that collects and presents validation data, designed for Windows 10. It offers detailed control of validation studies, data analysis features, and supports multiple languages. The software ensures complete documentation and procedural control, enhancing data security and analysis efficiency.
Technical Report Overview
The document is a technical report generated by ValSuite Pro, detailing various validation processes for sterilization and lyophilization in food and pharmaceutical sectors. It includes sensor adjustment, limit reports, statistical analysis, and validation results.
1. Sensor Adjustment Report
This section lists sensors with IDs and indicates that no calibration data is available for the listed sensors. The report is generated for a sterilization process at 121°C.
2. Limit Report
The report specifies criteria for passing temperature values between 90.00°C and 119.00°C. It includes data series from multiple channels and summarizes the session time from 18:46:37 to 23:19:41 on 02-03-2017.
3. Statistics Report
This section provides a detailed statistical analysis of temperature data, including minimum, maximum, average values, and standard deviation. The report highlights a maximum temperature of 115.69°C and an average of 103.17°C.
4. Advanced Phase Statistics Report
The report outlines the results of a lyophilization process, detailing phase durations and test results. All phases passed the test criteria with specific temperature and standard deviation limits.
5. Validation Report
This section includes validation results for sterilization at 134°C. It details process parameters, holding times, and pressure deviations. The report indicates both passed and failed test results for different cycles.
6. Lethality Overview
The lethality calculations are based on a reference temperature of 121.11°C, with various F0 values calculated for different sensors during the sterilization process.
7. Equipment and Configuration
The document lists equipment used, sensor configurations, and sample rates. It also describes the chamber mapping for heat distribution studies.
8. Software Features
ValSuite Pro offers features like real-time statistical calculations, alarm limits, and supports up to 160 channels in one session. It provides comprehensive reporting capabilities in both printed and PDF formats.
Specifications
The software supports sterilization processes at 134°C using steam with vacuum pulses. It is designed to produce comprehensive reports with pass/fail criteria, mapping positions, and statistical summaries. The software is compliant with standards such as EN17665 for moist heat autoclaves and EN15883 for washer disinfectors.
Procedures
ValSuite Pro allows for the configuration of validation reports with flexible input options for process parameters, start and end times, and measuring points. It supports both manual and automatic calibration of probes, with results linked to probe IDs for future reference.
Calibration
The software includes a calibration feature that supports manual, semi-automatic, and full-automatic calibration using ETS temperature standards. Calibration reports are generated automatically, showing overall results and deviations.
Compliance and Standards
ValSuite Pro adheres to FDA guidelines, GAMP guidelines, and ISO 9001:2008 standards. It features an audit trail, electronic signatures, and access management to ensure data integrity and traceability.
Additional Features
The software includes a report generator, access manager, and security setup. It is supported by Ellab's calibration facility accredited by ISO 17025 and offers training through Ellab Academy.
Conclusion
ValSuite Pro is a comprehensive solution for validation and calibration in the pharmaceutical industry, offering robust features for data management, compliance, and user training.
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Catalog excerpts

Ellab-E-Val-Pro-Thermocouple-System-ENG-1

The next generation in real-time thermal validation

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Ellab-E-Val-Pro-Thermocouple-System-ENG-2

E-Val™ Pro 40 channel module Food: • Retorts • PiLot VesseLs • Freezers • ALarm Monitoring • Smoke Houses • Ovens • Roasters • Aseptic The E-VaL Pro Thermal Validation System is designed for validation applications that require compliance with FDA guidelines and international GMP standards. The E-Val Pro greatly simplifies and correctly documents the entire validation process. The ValSuite Pro software keeps a complete database on all aspects of your vaLidation requirements - tracking thermocoupLes, calibration reports, test setup, data analysis, specific user access and finaL compLiance reports....

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Ellab-E-Val-Pro-Thermocouple-System-ENG-3

Stand-alone 4 to 40 Channel Modules Wide Measuring Range USB and Ethernet Network Premium grade thermocouple Smart USB connection with ID and cold junction 512 MB Memory 8" touch display Battery Power Small size (3.0 kg / 6.6 lbs) Aluminum housing Compliance Reports Custom Reports Print Reports Security Compliance Same Software Platform for E-Val Pro and TrackSense® Pro Data Loggers Noise level Runs without PC on factory floor Expandable up to 120 channels logging every second -200 to +1,300 °C (ready for -270 °C to +1,820 °C) Fast and reliable data transmission / Compatible with most PC's High...

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Ellab-E-Val-Pro-Thermocouple-System-ENG-4

The E-Va[M Pro module has many expansion possibilities The E-Val Pro modules are available with 4 to 40 channels that can handle any type of thermocouple, analog or digital sensors (pressure/RH), as well as digital input/output signals. The LCD display automatically shows all active channels showing time, temperature, pressure, and lethality for each channel. Real-time statistics are also available on the display. Measuring range from -200 to +1,300 °C. Operating range from +5 to +50 °C. Resolution 0.01 °C. The sampling rate can be set from 1 second to 24 hours independent of the number of channels....

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Ellab-E-Val-Pro-Thermocouple-System-ENG-5

Since the late 1940’s Ellab has been combining hardware, software, probes and fittings in order to provide customers with customized “turn-key” Thermal Validation Solutions. The ValSuite™ Pro software is compatible with E-Val Pro, TrackSense® Pro loggers, temperature standards and a variety of baths/dry b

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Ellab-E-Val-Pro-Thermocouple-System-ENG-6

Fittings & Accessories Fittings and accessories for placing probes and inserting Custom Fittings Packing glands and other fittings are available for probe placement in a variety of packaging materials. The glands are threaded to accept the tips and will maintain the seal when pressurized. It is very important that the tips are placed correctly in the “cold/hot zone” to obtain true lethality values. See examples of typical applications and configurations below. ID Label ID labels are sold in sets of 1-16 pieces for easy identification during thermocouple placement. Feed Through Provides support...

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Ellab-E-Val-Pro-Thermocouple-System-ENG-7

GLK Probes can be mounted in plastic ampoules in moist heat sterilization applications. TPJ Probes can be mounted in pouches for sterilization applications. GVJ Measurements inside ampoules and vials is possible with this packing gland. GPK Probes can be mounted in vials for terminal sterilization. GEJ This fitting is ideal for very small plastic containers. GVK This packing gland can be mounted on bottle necks for liquid applications. GNK Probes can be mounted on ampoules in moist heat sterilization applications. GKJ Probes can be mounted externally with this packing gland.

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Ellab-E-Val-Pro-Thermocouple-System-ENG-8

Probes & Sensors High Precision Thermocouple Probes Using premium grade probes dramatically improves accuracy and stability, resulting in more successful studies. Ellab develops and manufactures a wide range of type T thermocouples for a variety of purposes (probes for frozen applications, special probes for liquids and air, probes for hot air ovens and autoclaves, high temperature probes, etc). The standard and penetration probes are supplied with threads that fit into packing glands for a leak-free seal into packages or cans. Smart USB Connectors The USB connectors consist of copper/constantan...

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Ellab-E-Val-Pro-Thermocouple-System-ENG-9

Digital Pressure Sensor Piezoresistive measuring principle Temperature compensated to +150 °C Material: Stainless steel Cable length: 5 m Operating range: 0 to 4 bar (abs.) Accuracy: ±6 mbar SSA-TS Operating range: -20 to +135 °C Accuracy: < 0.2 °C/calibrated ±0.05 °C Response time: 1.0 sec (T63)/1.8 sec (T90) Electrode material: Stainless steel Electrode 0: 1.2 mm Electrode end: Round/sharp/conic Cable material: Silicone Cable dimensions: 0 4.0 mm SSA-TF “ Operating range: -50 to +135 °C t Accuracy: < 0.2 °C/calibrated ±0.05 °C F Response time: 1.0 sec (T63)/1.8 sec (T90) Electrode material:...

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Ellab-E-Val-Pro-Thermocouple-System-ENG-10

Intuitive and user friendly software The easy way to put the ValSuite Pro software to work: 1 Login, program and start the E-Val Pro using a Repeat function, which includes a unit configuration and a selection of reports. Place the probes in the load or process and run the cycle. Record the data. Data analysis and reports are made automatically. E-Val Pro Print the reports and logout. Valsuite Pro Data Integrity is approved by Quality Compliance Partners Inc. ValSuite™ Pro Software ValSuite Pro is an intuitive validation software which collects and presents validation data from all Ellab measuring...

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Ellab-E-Val-Pro-Thermocouple-System-ENG-11

E - V A L P R O I P A G E 11 Operator: Process: Session Start: Session Stop: Session Name: Session Text: Validation Manager Food 02-03-2017 18:46:37 02-03-2017 23:19:41 Sterilization 121°C Sterilization at 121 °C Vessel: Product: Time Zone: Retort Food UTC offset 07:00:00 Validation Solutions Sensor Adjustment Report Sensor Adjustment Report Operator: Sensor adjustment report Limit report Retort Validation Manager Vessel: Product: Food Process: Food Sensor Value Standard Value Deviation Calibration Timestamp Time Zone: UTC offset 07:00:00 Session Start: 02-03-2017 18:46:37 N/A N/A N/A N/A Session...

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Ellab-E-Val-Pro-Thermocouple-System-ENG-12

Producing Reports A complete set of reports can be produced with Pass/ Fail criteria, detail on mapping positions, operator and vessel ID, calibration offsets for probes, data list and statistical summaries on the data. EN15883 for washer disinfectors and NFX 15-140 for stability chambers. The templates can be customized to organize the data and perform calculations to exact criteria. ValSuite Pro also maintains templates for reports designed to meet the specific requirements of tests such as EN17665 for moist heat autoclaves or This feature greatly reduces the time needed for the data analysis...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.