Since its founding 20 years ago, FPS has grown to be the leading manufacturer of custom containment systems and jet mills for the handling and production of active pharmaceutical ingredients and sterile pharmaceuticals; FPS is dedicated to pharmaceutical, biopharmaceutical and Fine Chemical manufacturers all over the world and operates three sites: the headquarters in Como, a large 7,000 m3 production plant in Fiorenzuola d'Arda and a commercial office in Philadelphia (USA).
With over 100 employees and more than 1,400 systems in operation worldwide for handling pharmaceutical substances, FPS is very flexible can easily adapt to its customers’ varying needs.
For example, FPS has recently designed and manufactured an isolator designed to introduce up to 100kg of potent sterile API and dispense it in specific containers to be connected to the process equipment.
During the initial phase of listening to the customer's needs, the different stages of the process were analyzed, from the introduction of the material into the airlock, to the decontamination cycle for both the airlock and the working chamber to ensure sterility during the operations, to the dispensing of the weighed material either into a rigid container through a split butterfly vale or into bags through a continuous liner port
With this initial analysis completed, FPS pulled on almost two decades of experience in powder containment to design and build the system.
The main challenge of this project was the characteristics of this particular API powder, which was both toxic (OEL < 1µg/m3) and sterile. In addition, the installation room and isolator had to be classified according to the ATEX directive (II 2G external, II 2GD internal), and sterile conditions had to be ensured and monitored throughout the activities. Finally, the isolator control system and the installation monitoring system had to be interconnected.
The proposed design by FPS allows the decontamination system to ensure keeping the sterility first and then to protect the operators thanks to an adaptable control system that can switch from a positive (sterile) to a negative (toxic) pressure regime during specific process steps.
The advantages of this solution are many, particularly the adaptable control system guarantees both the API and the operator protection by switching from positive to negative pressure regime during specific phases:
- Positive during the decontamination cycle and the dispensing activities
- Negative during the final washing phase
Also the control system of the isolator is connected to the centralized monitoring system of the plant, so that the process and the alarms can be monitored in real time.
The split butterfly valve is connected to the vaporized hydrogen peroxide decontamination system to guarantee the sterility when the dispensed product is removed from the isolator
A drum lifter raises and lowers rigid containers to be connected to the isolator through the split butterfly valve The rapid transfer port is also used to introduce the cleaning tools at the end of the operations. In addition a special beta container is fitted with the connections to the washing medium and drying nitrogen lines so that no dedicated connection is required inside the working chamber.
