Cutting-edge batch production
With some of the strictest legislation on the planet, the life sciences industry has to address many major issues. However, thanks to advanced batch control systems and software, we are able to help address these issues in this highly demanding sector.
Human blood plasma is something special – it is the starting point for the production of vital drugs that are indispensable for the treatment of blood clotting disorders and immunodeficiencies as well as in intensive care and wound treatment. The whole production process, from the blood plasma stage through to the usable drug, is subject to strict quality and safety regulations that are defined and verified by organizations like the FDA, the US health authority.
For this very reason, CSL Behring AG, based in Bern, Switzerland, a pharmaceutical company specialising in the production of plasma products such as immunoglobulin and albumin, ensures that its 750 staff apply innovative procedures to separate the plasma using multi-phase processes to help deactivate and reduce viruses.
Although the scope of the project included new control hardware for the individual production steps, the focus was really on renewing the software for the existing process steps and product recipes
To keep pace with the constantly high demand for blood plasma products, the company was prompted to fundamentally revamp its highly complex production processes and update them to state-of-the-art technology. However, it was absolutely essential to ensure that this radical modernisation did not lead to any lowering of the health authorities’ high standards and that production processes would only be stopped for a very short time.
To ensure high quality levels, CSL Behring AG only works with validated manufacturing systems, which comply with inspection regulations at all times. “Every modification is followed up with extensive tests, which is why it was a real challenge to complete the alterations and upgrade the production systems in the shortest possible time,” remembers Reto Camastral, project manager at CSL Behring AG. CSL Behring AG decided to bring in Rockwell Automation with its proven track record in the industry.
The batch software controls adherence to the formulation process and, as such, is at the heart of the production of plasma compounds
Although the scope of the project included new control hardware for the individual production steps, the focus was really on renewing the software for the existing process steps and product recipes. As production could only be interrupted for an extremely brief period of three weeks, a very close and intensive cooperation between the two companies was essential. This made thorough preparations even more important, including the selection of the right staff.
Soon after the project started, a specific dilemma arose. Although the pharmaceutical company wanted to keep its existing validation and only modernise and “future proof” the production systems rather than completely change them, in practice it soon became clear that there was a significant need for changes to the software configuration. By way of example, the original software vendor no longer supported the existing batch software. For this reason, the system had to be updated by converting to Factory Talk in order to ensure that production would continue to run consistently with the highest level of reliability.
The batch software controls adherence to the formulation process and, as such, is at the heart of the production of plasma compounds. Staff use the software to define which products are to be manufactured and in what quantities. The composition of the formula, including operations such as the addition of ingredients that are then heated, blended and processed, runs completely automatically with the command “Start Batch”.
In the highly sensitive area of pharmaceutical manufacturing, it is also extremely important to monitor production in real time. This is why FTBatch 8.0 software delivers several online measurements while the process is running. In addition, peripheral devices connected to the systems register a variety of different measurements, such as temperatures, pH and guideline values, and these are entered into the control systems via a data station and trigger any necessary calculations. With that in mind, it is hardly surprising that the optimal configuration of the batch software was the core task in CSL Behring AG’s project.
“To ensure high quality levels, CSL Behring AG only works with validated manufacturing systems, which comply with inspection regulations at all times”
Camastral confirms that the technological aspects were the main focus of the collaboration with Rockwell Automation. “Because of the short conversion time, we had to bring the existing system – which Rockwell Automation has continued to develop – right up to date using conversions as well as standard procedures. At the same time we had to work so that that the formulations of our products hadn’t been modified.” This meant that the production systems needed to continue working exactly as they had been before the update, because pharmaceutical product manufacturing is so strictly controlled by the American FDA (Food and Drug Association) and other pharmaceutical authorities.
Updating the systems with FTBatch also made sense from a business point of view. “Rebuilding from scratch or installing a completely new product would have meant going through the validation process all over again. In the best-case scenario, this process takes half a year,” elaborates Camastral, who is also responsible for software modifications, error tracking and optimisations. He has nothing but praise for Rockwell Automation as a partner. “From my point of view the collaboration was very competent and well managed. I was particularly impressed with the commitment of each participant to complete the project on schedule and hand over the production systems ready for use.”
Thomas Pung, Rockwell Automation account manager, in charge of the project, also sees the cooperation with CSL Behring AG as very positive. “That project was a bit like a heart transplant,” he notes. “Within a strictly predefined timeframe, the software had to be renewed and revalidated with pharmaceutical regulations in mind. There were also quite a few personalised functions installed in the production systems and most of those could be incorporated as standard.”
For more information please send an email to: lifesciences@ra.rockwell.com
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