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Thermal Validation

Thermal Validation is a must in applications where temperature is critical – for items stored in a fridge or freezer, or products that are subject to a cooking or heat treatment process.

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Thermal Validation Systems

Our thermal validation systems establish documentary evidence that a procedure carried out in testing maintains the desired level of compliance at all stages in production.

They help to qualify systems and equipment throughout your entire process:

• Design Qualification (DQ)
• Component qualification (CQ)
• Installation qualification (IQ)
• Operational qualification (OQ)
• Performance qualification (PQ)

Uncover the Possibilities with TrackSense® Pro

Streamline your operations with our intuitive TrackSense wireless data loggers, designed for easy, cable-free setup and efficient performance. These advanced systems simplify the validation process with a plug-and-play approach, offering a detailed breakdown of each component for a thorough understanding. ECEfast enhances your setup with a bespoke range of fittings and accessories tailored for various applications, enabling precise sensor placement and reliable measurements in any conditions. Our expert team, equipped with extensive product knowledge, is dedicated to providing customised solutions to meet your specific needs, ensuring your processes are optimised for maximum efficiency and effectiveness.

TrackSense® LyoPro: The Wireless Data Logger

The TrackSense LyoPro, a cutting-edge wireless data logger, is specifically designed for accurate monitoring in freeze-dryers with vial autoloading systems, ideal from pilot to production stages. This patented technology ensures compliance with industry standards, enhancing process development in the biotech and pharmaceutical sectors by offering precise control and optimisation of the freeze-drying process. It features universal vial compatibility through innovative components like StopperClip and LoggerNest, facilitating seamless integration with any vial size and ensuring smooth operation alongside vials on conveyor belts. TrackSense LyoPro allows for extensive coverage within freeze-dryers, supporting up to 100 data loggers in a single study for comprehensive data collection. Its robust data integrity and gap-free transmission, even during interruptions, guarantee reliable data. Key benefits include real-time monitoring, validated software for compliance, improved efficiency with live data, minimal downtime, and state-of-the-art software support, revolutionising freeze-drying operations.

E-Val™ Pro: The Ultimate
Thermal Validation Solution

The E-Val Pro thermocouple system provides a straightforward, lightweight solution for thermal validation, meeting FDA and GAMP standards. Capable of supporting up to 40 thermocouples and equipped with significant internal storage for 10 studies, this compact device also features an 8-hour battery, making it versatile for standalone or PC-connected use via LAN/USB. It includes interchangeable 4 and 12-channel sensor arrays for various thermocouple types and inputs, ensuring ease of calibration and service. Key advantages include its portability, precise temperature monitoring, user-friendly interface with touch display, USB convenience, password security, and suitability for clean rooms due to its fanless design, allowing for autonomous operation.

Unlock Endless Possibilities with ValSuite® Software

Meet ValSuite, the premier validation and calibration software known for its user-friendliness and versatility. It integrates all your equipment into one platform, enabling the combination of data loggers and thermocouple systems for enhanced possibilities. ValSuite is feature-rich, offering customized reporting, real-time monitoring, and comprehensive data analysis in line with GAMP guidelines, supporting multiple languages and compatible with Windows 7, 8, and 10. Available in four versions – Basic, Medical, Plus, and Pro – it caters to diverse needs. ValSuite simplifies reporting, allows seamless integration of equipment, and provides advanced data analysis tools, ensuring efficient validation processes. Whether used on a standalone PC or networked, its flexibility and power make it the ultimate tool for streamlining your validation tasks, supporting up to 160 TrackSense or 120 E-Val Pro channels, with easy session comparison and data grouping for thorough analysis.

Our Thermal Validation Solutions Include:

Food Production – Ensure regulatory compliance (including agencies such as the TGA) band optimal sterilization processes for food preservation.

Pharmaceuticals – Guarantee consistent outcomes in pharmaceutical processes with comprehensive compliance documentation.

Medical Sterilization – Validate autoclaves for medical equipment, ensuring critical temperature maintenance and regulatory alignment.

Cross-Industry Adaptability – Versatile solutions for diverse industries, establishing unified compliance documentation for streamlined operations.

NATA World Recognised Accreditation

Ensuring accurate measurements is essential for your applications, and it all starts with properly calibrating your measuring equipment. However, for temperature and humidity-dependent processes, a basic laboratory calibration may not suffice. In such cases, you need to obtain an ISO 17025 calibration certificate from an accredited laboratory like ECEFast, recognized by the National Association of Testing Authorities (NATA).

This certificate is crucial in demonstrating that your measuring devices have unbroken traceability to the National Measurement Institute (NMI) and/or the National Institute of Standards and Technology (NIST), ensuring their accuracy and reliability.

Meet Our Validation Experts

ECEFast’s team of thermal validation experts are here to help. They ensure precision and reliability in temperature instrumentation by providing high quality customer service, specialist advice and solutions customised to your needs.

Brendan Dineen

General Manager Monitoring and Validation

Ash Vaez

Business Development Manager, Validation & Monitoring Solutions VIC, SA, WA, TAS

Colin Davidson

Business Development Manager QLD

Arvind Rao

Business Development Manager, NSW, ACT

Frequently Asked Questions

How does the Validation system ensure compliance with TGA guidelines?

ECEFast’s Validation systems ensures compliance with TGA guidelines through meticulous documentation, high-quality components, and precise temperature measurement capabilities. As well as an optional upgrade with GAMP 5 Standard validation documentation, Its commitment to quality, and automated calibration ensure precision and compliance with TGA’s rules for ensuring safe and high-quality therapeutic goods.

Where can the ECEFast validation products be used?

The ECEFast Validation products are versatile and can be used in various settings. These products are designed to cater to validation needs across industries such as pharmaceuticals, food and beverage, healthcare, and manufacturing. Whether it’s validating processes in pharmaceutical production, ensuring food safety, maintaining temperature control in healthcare facilities, or verifying equipment performance in manufacturing plants, ECEFast Validation products offer reliable solutions. Their flexibility allows for application in diverse environments where compliance with regulatory standards and quality assurance are paramount.

What mediums do the ECEFast validation products measure?

ECEFast validation products are equipped to measure a wide range of mediums across various industries. These mediums include temperature, pressure, humidity, and other critical parameters essential for validating processes. Whether it’s monitoring temperature during pharmaceutical or food production, measuring pressure in industrial equipment, or assessing humidity levels in controlled environments like cleanrooms, ECEFast validation products offer accurate and reliable measurements. Their versatility makes them suitable for a diverse array of applications where precise data collection is essential for ensuring quality, safety, and compliance with industry standards.

What features does the software provide?

Combination of Systems: Integrates data loggers and traditional thermocouple systems.

Custom Reports: Users can create customized reports with pass/fail criteria.

Data Analysis: Tools simplify data location, graph zooming, and calculations.

Session Management: Handles data from multiple systems simultaneously.

Automatic Reporting: Generates PDF reports with pass/fail indicators.

Compliance: Compliant with TGA guidelines for data integrity and traceability

Validation Documentation: Includes structured documentation compliant with GAMP 5 and TGA 21 CFR Part 11.

Monitoring: Offers statistical calculations, alarms, and notifications.

User Support: Embedded manuals and links to support resources are available.

Alarms: custom and general alarms for deviations. Notifications can be sent via email or an ethernet relay box (iTach).

Can ECEFast offer ongoing Service and Support?

Yes, ECEFast offers comprehensive ongoing service and support. From providing a wide range of validation products to delivering full solutions, installation, and calibration, including onsite and in-house services, we are equipped to meet your diverse needs. With an onsite NATA accredited lab and experienced technicians, we ensure continuous support for your equipment, ensuring optimal performance and reliability.

Request a FREE, No Obligation Consultation. Enquire Now!

 

Free Call 1800 811 818