What the expansion entails, including milestones and timelines
We’ve announced expanding our business investing €12 million in a new production line with enhanced capacity. With the expansion we can keep up with growing customer demands and ensure future company growth. But, what are we going to do exactly? In this article you’ll find out more details about our new production line.
NEW production line with enhanced capacity
First of all, the new production line is going to meet our perusal service and quality requirements. Our service level in CMO business is outstanding and our GMP facility has an excellent manufacturing and regulatory track record, including EMA and US-FDA. We strive to achieve and maintain this level for the new production line as well.
The new production line is a fully automated filling line in ‘tunnel’ design with RABS technology coupled to a 10m2 freeze dryer. This way we can manufacture:
- Up to 12 million vials per year
- Liquid products: from 30L up to 250L per batch
- Freeze dried products: from 30L up to 200L per batch
- Speed: up to 200 vials per minute
- Vial sizes: 2 RDIN up to 50ml vials
- 160 batches per year, 4 batches per week
Milestones and timelines
|November 2019||approval detailed engineering|
|December 2019||start construction phase in our facility|
|April 2020||freeze dryer ready for transfer to our facility|
|May 2020||fill & finish line ready for transfer to our facility|
|May 2020||hoisting in of freeze dryer in our facility|
|June 2020||hoisting in of fill & finish line in our facility|
|July 2020||realization cleanrooms|
|July 2020||facility acceptance equipment|
|September – December 2020||qualification of equipment and cleanrooms|
|January 2021||aseptic process simulations|
|March 2021||approval Dutch Healthcare Inspectorate (IGJ)|
|April 2021||ready for GMP productions|
Some of these ‘events’ may not immediately seem very spectacular. Yet, they are. For installing the freeze dry and filling equipment in to our facility for example, we have to first remove a significant part of the facade of our building and hereinafter hoist in several 1000’s of kilo’s of equipment to the third floor. As with other milestones of this project, we’ll document this and share it with you.
Follow the construction of our second production line
We will be documenting the construction of our second production line on this website, sharing updates via LinkedIn. Follow our LinkedIn company page to stay informed about milestones, more details about the production line and our thoughts about the project.
In case of questions, do not hesitate to reach out. We’re happy to tell you all about this exciting project.
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