In our previous update, we explained the challenges and decisions around the procurement of our new fill and finish line. In this blog post, we shine a little light on the process of selecting a supplier for our new freeze-dryer.
Selecting the right supplier
Procuring a new freeze-dryer and selecting a supplier is not a daily routine. Therefore we started with enrolling the support of a senior expert to guide us. With his expertise and knowledge of the pharmaceutical production equipment market, we narrowed down the number of potential suppliers to three reputable German companies, of which we finally opted for a collaboration with HOF, a leading specialist for building customized freeze-drying systems with over 30 years of experience.
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.
High expectations and quality requirements
Like with selecting the right supplier for our new aseptic vial fill and finish line, we also have high demands and quality requirements for our new freeze-dryer. One of our biggest challenges was the maximum allowed footprint for the new machine, as we are building the new production line in our existing facility and available floor space is therefore limited.
For our project, we found HOF the “best-in-class” partner and supplier we were looking for.
Compact and customized freeze-dryer
First of all, HOF was able to develop a freeze-dryer in a very compact arrangement. They placed the condenser under the freeze-drying chamber instead of next to it, a space-winning solution that was a true deal maker for us.
Another tremendous advantage of the HOF freeze-dryer is the fully automated loading and unloading system including RABS minimizing the chance of infection and enabling us to work sterile.
Other features of the HOF freeze-dryer:
- Adjustable freezing speed and full control over the freezing process;
- Reliable process control;
- Compliant with FDA requirements according to 21 CFR Part 11.
24-hour service and maintenance
HOF is strong in building innovative freeze-dryers that are tailored to customer needs and moreover also in long term service/ maintenance for which they have a dedicated team. They know like no other what is needed to maintain such complex freeze-dry machines. This offers BioConnection, but also our customers, certainty, and continuity.
With the freeze-dryer from HOF, 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.