Advanced vaccine technology
Protecting children around the world from infectious diseases – that’s the ambition of our client, Bilthoven Biologicals (BBio). Bbio has more than 500 passionate and responsible experts working day and night to make vaccines that give our world population a chance to enjoy a life without disease. For their part, they contribute to the polio eradication programme and the treatment of serious illnesses. Every day, 200 children are protected against polio for every employee of BBio.
Producing vaccines with as few risks as possible
It is a well-known fact that producing vaccines is a costly and complex process. This is because they comprise of living cells and viruses, which means that many variable factors can influence the production process. The risks of contamination of the product make the process very vulnerable and can ultimately determine the quality of the batch.
In order to reduce these risks as much as possible, BBio has taken various control measures. Some of these measures relate to the control system (BioCS) that automates the production process. And when you think of automation, you naturally think of DWG. Well, Bbio did. They called us in to help roll out process automation control measures for one of their production plants, called: A10.
The operating system for the A10 plant is based on PCS7 and BATCH version 7.0. In addition, GMP guidelines apply in the plant to guarantee the quality of products and the production process. It is therefore of the utmost importance that the modifications of validated systems are fully and demonstrably built, tested and provided with evidence. Only then may these modifications be implemented in the production system.
We designed a change list to manage these changes. We used this as a verification and reference matrix so we could track, check and link all the adjustments to the specifications and GMP rules of the customer.
To meet all GMP requirements, we built a virtual environment of the plant. This enabled us to write software and carry out internal tests and sampling in an isolated environment. This virtual environment is made up of PCS7 systems such as an Engineering Station, Operator and BATCH servers and clients. And because the servers and clients of BioCS are part of a computer domain, we also virtualised the domain controller. The server manages the domain, i.e. the rights for users who are allowed to use the system.
Extra challenge: a tight schedule
In addition to the software changes, the electrical installation also underwent some changes. We expanded the installation and equipped it with additional actuators and sensors. But an extra challenge came into play as a result. These activities had to be completed during the short maintenance period of the plant. So we needed a well thought-out plan: what should be done and when so we can work as efficiently as possible? This short period required good preparation and strict mutual agreements. Analyse. Install. Test. Repeat. Do you think we succeeded?
Did we get to the finish line?
The excellent project approach, the extensive change list, and the virtual environment – together they led to a flawless, phased implementation in the production system. Thanks to the close cooperation we had with Bilthoven Biologicals, we were able to tackle all the challenges and arrive at an efficient solution. Before, during and after the project.
Because our DWG employees are blessed with a high I.Q., the Installation Qualification (IQ), Operational Qualification (OQ) and Performance/Product Qualification (PQ) could be carried out sufficiently. Without the change list and the corresponding specifications, test protocols and reports, this would never have been possible. The end result? The control measures were fully implemented in the production environment within the critical timelines and quality requirements. We couldn’t be more proud.
“In recent months, DWG has made adjustments to the BioCS software of A10’s bioreactors. This was done to better safeguard the sterility of the bioreactors. The project was completed satisfactorily.”Frans Vos (Manager Industrial Automation), Bilthoven Biologicals