Adjustment of the production system of vaccine developer Bilthoven Biologicals

Cutting-edge technology for vaccines: protecting children around the world against infectious diseases. That is the ambition of our customer Bilthoven Biologicals (BBio). BBio employs more than 500 passionate and responsible experts who work day and night to create vaccines that give the world’s population a chance of living their lives without disease. They contribute to the polio eradication initiative and treatment of serious diseases. Each day, 200 children per BBio employee are protected against polio. 

You can understand that producing vaccines is a costly and complex process. As living cells and viruses are involved, many highly changeable factors can affect the production process. The risks of contaminating the product increase the vulnerabilities in the process and ultimately determine the quality of the batch.

To reduce these risks as much as possible, BBio has implemented several control measures. Some of these measures relate to the control system (BioCS) that handles automation in the production process. And when you think of automation, you naturally think of DWG. BBio certainly did. They enlisted our help to roll out process automation management measures for one of their production plants, which they refer to as the A10.

The control system for the A10 plant is based on PCS7 and BATCH version 7.0. In addition, GMP guidelines obviously apply in the plant to provide adequate assurance regarding the quality of the products and the production process. So ensuring that modifications to validated systems are fully and demonstrably built, tested and documented beforehand is of the utmost importance. Only then may these modifications be implemented in the production system.

To manage these changes effectively, we designed a change list. We used this change list as a verification and reference matrix for tracking, checking and linking all modifications to the customer’s specifications and the GMP rules.

To meet all GMP requirements, we built a virtual environment that replicated the physical plant. In it, we were able to create and perfect software and perform internal testing and sampling in an isolated environment. This virtual environment consists of PCS7 systems such as an Engineering Station, Operator and BATCH servers and clients. And because the servers and clients used for BioCS are part of a computer domain, we also virtualised the domain controller. The server handles administrative tasks for the domain, such as the permissions for users who are allowed to use the system.

In addition to the software changes, the electrical installation also needed attention. We extended this installation and integrated additional actuators and sensors. And that brings us to the additional challenge for this assignment. This work all had to be done during the short shutdown period for plant maintenance. So a detailed and realistic plan was needed: what needs to be done when to ensure that we can work as efficiently as possible? This short time frame required thorough preparation and well-coordinated teamwork. Analyse. Install. Test. Repeat. Wondering if we succeeded?

The highly detailed project approach, the extensive change list and the virtual environment all contributed to a successful result: flawless and properly phased implementation in the production system! Thanks to our close collaboration with Bilthoven Biologicals, we were able to successfully tackle all the challenges and arrive at an efficient solution. Before, during and after the project.

The Installation Qualification (IQ), Operational Qualification (OQ) and Performance/Product Qualification (PQ) were performed adequately. Without the change list and the associated specifications, test protocols and reports, this would not have been possible! The final result? Full implementation of the control measures in the production environment, achieved within the critical time lines and in accordance with quality requirements. We couldn’t be more proud! This is what makes our work so enjoyable.

“In recent months, DWG made modifications to the BioCS software that controls the bioreactors in our A10 plant. This was done to achieve a higher level of assurance regarding the sterility of the bioreactors. That project was performed and completed to our full satisfaction.”

Frans Vos, Manager Industrial Automation, Bilthoven Biologicals