The year 2020 was, for us, all about expansion. We have built a brand-new fully automated production line with a total annual production capacity of up to 50 million vials per year. On this dedicated website, you were able to follow the process as we have shared regular updates about the construction. At the start of the year 2021, we look back to share the biggest milestones with you.
The biggest achievements in 2020
In December 2019, we shared the timelines and milestones of our expansion project. Now, a year later, we are in the position to say that we have met all our construction timelines. We are extremely proud of this achievement, especially because the Covid-19 pandemic brought some extra challenges to realizing our complex project. Those challenges were mainly due to planning ingenuities to respect the 1,5-meter social distance. Succeeding in realizing the project right on schedule is a direct result of the outstanding collaboration between our dedicated BioConnection project team and all parties involved.
A special thanks to our partners and suppliers Kropman Contamination Control, Cleanroom Combination Group, The Getinge Group, HOF, and Groninger.
Besides the completion of all construction work we also already welcomed in the last quarter of 2020 our first customers on the new production line to start their large-scale productions in 2021. We are very proud of this milestone as it reflects the trust that our customers have in our company.
More milestones in 2020
Tuesday, May 12, was the first of some exciting moments in realizing our new manufacturing line: the freeze dryer was delivered by Hof. It had to be lifted three floors high to be placed in our new production area, so at some point, the entire 12-ton machine hung three floors high in the air. A breathtaking moment, also because there was a safety margin of only five centimeters to get the machine safely into the building.
Another major milestone was the arrival of the ‘heart of our production line’, the 20 meters long fill and finish line, produced by Groninger. It wasn’t ‘just’ an arrival of material, the lifting operation to bring the machine into our building lasted three days! Several long and heavy components (the vial depyrogenisation oven alone weighs already a robust 5000 kg) had to be lifted to the third floor in our facility.
Around October, there was a certain period available where all production equipment is in and could be accessed with ease before the facility was closed for all non-authorized persons. Therefore, we invited a small group of press to offer them one-off access to our facility. This led to many publications in daily newspapers, local media, and trade magazines.
Almost ready for GMP production
The first weeks of 2021 will be occupied with aseptic process simulations to get ready for approval from the Dutch Healthcare Inspectorate (IGJ). From April 2021 on, we anticipate being ready for GMP productions on the new production line on which we can accommodate customers that require production at a scale of up to 1,000L for liquid products and a fully automated 10 m² freeze drier for freeze-dried products in an EMA and US-FDA certified facility.
Want to find out more? Download the specifications of our new production line.