Very well. Things have moved very fast. There was a demand from our customer base for FPS to be here and once we arrived a lot of projects accelerated.
Oh yes very much different. I often tell Europeans that the difference between Americans and Europeans is as wide as the difference between Japanese and Europeans. But because Europeans speak English and have access to a lot of American culture and entertainment they feel they know the US very well. I would say they don’t. They don’t realize that the values are completely different. Now it’s not so obvious at first but if you live here for a while you realize what makes America very unique. And I can tell from my own experience because I lived here for 25 years and I have been a US citizen for 23 years.
The majority of the sales are custom isolators for HPAPI. At FPS we really focus on the process of the user and find creative ways to improve ergonomics and ease of use while guaranteeing a low Containment Performance Target. When the toxicity of the product is lower we can design a semi-open structure such as a Laminar Air Flow or Down Flow Booth.
We also design isolators that work under aseptic conditions. This is typically used for liquids and during the process you must keep the sterility of the product.
For powder it can be just for charging a reactor, discharging a filter dryer, dispensing into smaller containers, packing off some material or doing some in-process control. We also design isolators for milling and micronization: particle size reduction generates a lot of dust so containment is key. Now for this process we also design and manufacture the equipment. For example, we have very small jet mills for R&D, medium size for pilot and very large size for production.
For sterile some of the applications include fill/finish applications, sterility testing, sterile cap feeding, etc.
More and more we deal with toxic powders that are sterile (ADCs are an example). The powder must be kept sterile until a certain point and then the isolator must protect the operator from that toxic product.
We won a bid for the largest isolator for HPAPI in the United States. It is also the most ergonomic because of its innovative design. It is very large in size (20 feet wide by 17 feet high by 16 feet deep) and has 4 levels with 3 platforms. The full system can be used for continuous milling and micronization of large commercial quantities but because of its unique design a few chambers can be used to make a small batch. Such flexibility in a large system is really unique and the containment level for such large quantities is also very high (50 nanogram/m3).
The United States has really struggled containing the spread of the virus and it seems that until we have vaccines available and the majority of the population vaccinated, things will probably not improve.
There is a huge push by some companies to pursue a vaccine. Other companies which are not involved in this search continue to operate almost at a normal level but because of the disruptions caused by Covid some investments are postponed. Now there is a certain level of stability in Pharmaceutical and Biotech industries so I expect the activity to resume to a normal level quickly after we overcome the pandemic.
Now that we are based here, we are really getting to know our existing and prospective customers very well and they better understand our capabilities. Our relationship with them is getting much stronger and that opens up another level of cooperation which is very exciting. I really expect a lot of success in the coming years.
