Improving medicine safety in the animal health industry

Eurotherm collaboration helped provide an environmental monitoring system in compliance with data integrity guidelines and GMPs.

Environmental monitoring system helps improve animal medicine safety

Just like pharmaceuticals for human use, animal medicines must be produced in compliance with regulations and guidelines, such as FDA 21 CFR Part 11, Data Integrity ALCOA+ and Good Manufacturing Practice (GMP).

When a global manufacturer or veterinary medicines needed an environmental monitoring systems (EMS) for monitoring freezers, refrigerators and incubators in its new production facilities, the Eurotherm EMS solution was chosen as part of a collaboration of best-of-breed suppliers.

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Key Challenges

Separating the EMS from the BMS and meeting GMPs

The end customer was looking for a Building Management System (BMS) and EMS solution:

Segregate the EMS from the BMS (in line with latest ISPE guidance)
Monitoring and alarming of critical process parameters (CPPs) (temperature, relative humidity (RH), differential pressure (DP) and calculated DP)
Monitoring approximately 500 input/output points across three buildings
Meet GMPs based on a Pharma 4.0 approach
Integration into the company’s existing operations process system, AVEVA System Platform

Solution

High availability system architecture

Designed using a 'zero downtime' approach, with features to enhance operational performance.

A successful collaboration

The project was carried out through a collaboration of best-of-breed suppliers, including Eurotherm, a third-party control system integrator, sustainable engineering firm, and Schneider Electric as the BMS provider.

Eurotherm was chosen to supply the EMS equipment to the system integrator based on our experience and knowledge of the Life Science industry’s requirements, combined with innovative technology including Digital Engineered Solutions (DES).

„All collaborators appreciated our expertise and were grateful for our input to help define the EMS specification to achieve the best solution for the end customer.“

Tom Slusser
CPG Account Manager – North America

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Fit for purpose technology based on T2750 PAC and AVEVA System Platform

„Key attributes of our redundant EMS solution with Store & Forward technology enabled the end customer to reduce their data integrity and data archiving reliability risks, some of which they had not previously considered.“

Tom Slusser
CPG Account Manager – North America

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Benefits

Validation proven Pharma 4.0 BMS and EMS solution meeting GMPs

Redundant high availability process control and high integrity data acquisition, with a tamper-resistant audit trail and electronic signatures for improved traceability
Single, common information stream, including remote notification of alarm conditions, helping to improve operational efficiencies
Meaningful visualization of contextualized data in a GMP environment, including real-time alarm management
Faster informed decision-making and insights into operational performance
Easy creation and distribution of reports and dashboards
Centralized, real-time control and management across enterprise buildings

Good understanding of the validated system requirements

„The site validation engineers were impressed with our documentation package designed to help simplify the system validation process.“

Rick Jarrell
Business Development Manager – USA, Life Sciences

Environmental Monitoring Systems

Digitalize environmental monitoring aiding Life Sciences regulatory compliance.

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