Watlow® and Eurotherm® solutions help OEMs meet EudraLex Annex 1 sterilization control challenge

St. Louis, Missouri, USA: – High quality thermal components from leading Industrial heating solutions provider Watlow™, combined with innovative quality management systems from sister company Eurotherm® are helping life sciences companies meet the sterilization control issues raised by new regulations.

This is a particular issues in vaccine and injectables manufacture, for example, where sterilizers play a key role in production and administration processes.

Data integrity challenge

The new EudraLex Volume 4 Annex 1 guidance on manufacturing sterile medicinal products will take effect in late August of 2023 and aims to grow trust by applying data integrity and traceability to each and every heat sterilization cycle.

EudraLex Volume 4 Annex 1 challenges life science firms and the machine builders that support them to ensure they apply data integrity principles to the records of each sterilization, with Point 8.50 stipulating: “Each heat sterilization cycle should be recorded electronically or by hardcopy, using equipment with suitable accuracy and precision. The system should have safeguards and/or redundancy in its control and monitoring instrumentation to detect a cycle not conforming to the validated cycle parameter requirements and abort or fail this cycle (e.g., by the use of duplex/double probes connected to independent control and monitoring systems).”

Sterilization control issues

When handling the challenges of heat and steam sterilization with a focus on monitoring and controlling activities, life sciences stakeholders and their supplying original equipment manufacturers (OEMs) have the complex challenge of achieving compliance while balancing trade-offs between efficiency, cost and time-to-market.

Annex 1 changes the status quo for OEMs and potentially introduces more machine building cost, time and risk, since they must qualify any new device added to their equipment and minimize downtime risks, while also training staff, expanding maintenance capabilities and undertake extended testing procedures.

Monitoring sensors are the most critical device in the sterilization process. Any sensor failure can mean batch loss or delay, placing a premium on  high-quality sensors that enable a high-availability redundant monitoring solution that feeds in environmental data to the process control system, similar to the approach adopted in Building Management Systems.

Quality Control (QC) managers are also impacted by high volumes of dense new regulatory statutes that they need to recognize with need for access to trustable solutions to stay up-to-date and ahead of validation inspectors.

Separate qualification and validation

The key issue raised by EudraLex Volume 4 Annex 1 is the ability to document the positive completion of the sterilization process. This could be achieved through a separate monitoring system that provides the simplicity, robustness and accuracy expected by regulators.

Watlow is particularly well placed to meet the challenge with its in-depth understanding of the sterilization process and technologies involved, using its well-developed consultative approach to help OEMs and end users address new regulatory mandates with solutions that appropriately integrate the sensors, power supplies, heating control and sterilization monitoring required for full EudraLex sterilization compliance.

Jointly developed sterilization solution

Watlow’s recently acquired UK-based process control specialist Eurotherm , whose innovative paperless sterilization quality management system (QMS) combines industry regulatory knowledge with hardware and software components. This solution makes it easy for OEMs to integrate the new EudraLex Volume 4 Annex 1 requirement into their production machines.

A jointly developed solution also incorporates Watlow’s best-in-class sensor connected to a redundant solution to deliver the mandatory monitoring and recording. The solution digitally feeds the control system simultaneously achieving simplicity, robustness and an extremely high level of accuracy.

This allows OEMs to maintain current sensor placements, along with schematic drawings, thermal couplers and cabinet formats that are almost unchanged, greatly easing the training and maintenance challenges. In addition, high-quality sensors and better precision help to optimize energy efficiency, with enhanced accuracy generating far fewer alarms, helping to reduce quality control costs.

Regulatory inspectors recognize the system as EudraLex Volume 4 Annex 1, Point 8.50-compliant because of the built-in safeguards and/or redundancy that cross-check both the control system and the separate monitoring system, ensuring that each is operating within the low margin-of-error-prescribed safety performance parameters. The quality control functions within the system generate one single version of the truth via electronic format reports that can be attached to the operator batch reports submitted to the regulatory bodies.

About Watlow

Watlow is a global industrial technology company that uses its world-class engineering expertise, advanced thermal systems and manufacturing excellence to enrich everyday life.

Many of the world’s leading companies leverage Watlow’s technologies in vital applications such as semiconductor processing, environmentally-friendly energy solutions and lifesaving medical and clinical equipment, to name a few.

Founded in 1922, Watlow’s culture is driven by its mission of “Enriching Lives Through Inspired Innovation,” enabling the company to deliver high-impact solutions that improve its customers’ competitive advantage.

Learn more at: www.watlow.com

About Eurotherm

Based in West Sussex, England, Eurotherm was founded in 1965, making temperature controllers from a flat above shops in Worthing, and has expanded over 57 years to become one of Europe’s most respected supplier of world-class process control, recording and automation solutions.

As Eurotherm International, the company has remained true to its founding vision to be the preferred supplier of machine automation products, applications, systems and services for customers in specialist industries, with a core mission to act as ‘trusted advisors’ with specialist knowledge and experience to achieve process excellence through machine automation efficiency and regulatory compliance.

Eurotherm offers a wide range of feature-rich products and software for industrial automation that is designed for easy operation and reduced engineering time, incorporating industry-leading control algorithms, recording and data management strategies that add value to manufacturing processes, improving quality, reducing waste and ensuring data security.

In late 2022, Eurotherm became a member of the Watlow group of companies providing world class engineering expertise and innovative thermal products and systems to numerous industries across the Americas, Europe and Asia.

Learn more at: www.eurotherm.com/

Resources

Click on Life Sciences sterilization solutions for further information.
Click on EudraLex Volume 4 Annex 1 to learn more about new guidelines.
Click on Watlow acquires Eurotherm for background information
Click on Watlow Vision for Life Sciences to view video