As far as containment systems are concerned, spray-drying is a commonly adopted technology in pharmaceutical to obtain a powder from a liquid solution. Given that pharmaceutical companies are handling High Potent API more than ever before, high containment solutions are necessary to safely operate the equipment.
In the past year, some of the isolators that FPS has designed and manufactured have been specifically to contain spray drying equipment. By using an isolator, pharmaceutical manufacturers want to ensure full operator protection without the need for bulky Personal Protection Equipment full-suits that can be cumbersome, costly and may provoke falls.
One of the key requirements that pharmaceutical companies have for isolator manufacturers is not to alter the current process. The goal is to avoid lengthy and costly process re-validation. Another requirement is to ensure excellent ergonomics to avoid operating errors, product loss and work injuries. The FPS design team is very familiar with those aspects and can also accommodate others. For example, one of FPS customers flagged that their multi-cultural team had a very wide variation in height. Their workers were very concerned that the isolator would be too low or too high for their own height and they worried about potential long-term health issues. Another customer had to fit the isolator into a very tight space and the equipment had to be brought in the installation room through narrow doors.
To address those issues FPS engineers worked in close collaboration with the end-user technical, safety and process engineering departments to design the isolator. Mock-up of those systems were built to simulate the activities and validate the technical solutions. Operators were also part of the process.
In the end these isolators had the following features:
“The users were very excited to do away with the cumbersome personal protective equipment. The ergonomics are much improved to perform the process and they like the flexibility of going in and out of the lab without gowning and disgowning” says Frederic Le Pape, the FPS America General Manager.
One customer uses a micronization step in a separate chamber of the spray drying isolator and sees many benefits. For example, there is no need to use a split butterfly valve for product collection which are costly and time consuming to assemble, disassemble and clean.
Finally, the isolator protects the product from moisture during feeding and collecting phases for the spray dryer (and for the jet mill when used after the spray drying).
As always, the objective of FPS is to be of service to the Pharmaceutical and Fine Chemical industries. The mock-up is one of the tools that helps us fulfill 100% of the needs of our customers.