For a project such as our new production line with enhanced capacity, important choices have to be made, such as determining the required machines and suppliers. For the development and construction of our new fill & finish line, we opted for a collaboration with the German company Groninger.
Start of the process
Procuring a fill & finish line is not a daily routine. The choice for a supplier is therefore not made in one day. A lengthy process preceded this. First, we enrolled the support of a senior expert with a profound experience and knowledge of the pharmaceutical production equipment market.
Together we narrowed the number of suppliers down to ten, selecting only those who could meet our quality requirements. Finally, we made a pre-selection of three reputable German suppliers.
For our project, we found Groninger the “best-in-class” partner and supplier for the aseptic vial fill & finish line that could meet our high expectations and quality requirements. Groninger with nearly 40 years of experience is a technology leader in building customized machines for the Pharmaceutical, Cosmetics and Consumer Healthcare industry.
In addition, their company values meet ours closest ensuring a seamless collaboration. Both our companies value service (with a short- and above all long-term horizon) as well as a pragmatic/ non-nonsense working attitude.
Truly unique customized machine
One of the challenges for a new production line is the total required footprint for the machines. We have limited space available as we built the new line in our existing facility, forcing us to come up with creative solutions. Our new high-speed aseptic fill & finish line consists in fact of 4 components (being: a washing machine + a sterilizing/ depyrogenisation tunnel + a filling machine + a capping machine) which are partly standard components but also include a few innovations from Groninger such as:
- The sterilizing and depyrogenization tunnel is built compactly, which meets the dimensions of our limited available floor space;
- Due to an innovative closing technique of the vials, the chance of infection is minimized;
- The proven technology of the capping machine is best in class and easily adjustable;
- The whole filling line is made of tool parts that are easily exchangeable, speeding up our change over time and therefore improving the production capacity of batches significantly.
With the fill & finish equipment from Groninger we are able to meet the highest quality requirements in the (bio) pharmaceutical industry which enables us to have our new production line validated as per the EMA and US-FDA quality guidelines.
The fill & finish line will be coupled to a fully automated freeze-dryer. Information on our new freeze-dryer will come soon. So stay tuned.