Paolo Barilli, FPS Process Engineer, talks about his design approach for FPS

December 10, 2020

1. What is the design approach of FPS?

FPS is highly specialized in the design and manufacture of custom isolators for potent actives and sterile solutions. The strength of FPS is certainly its flexibility and its commitment to guarantee complete customer satisfaction. The solution that we offer is always tailor-made based on the customer needs. To do that we really drill down on the specifics of the process. This leads to a first drawing which is reviewed with our customer. This phase will generate a second design that is used to build a real-scale mock up to test the ergonomics of the system along with the customer. That study leads to a detailed design which includes a P&ID, a Functional Design Specification and a study of safe interlocks for the isolator.

2. Which kind of isolators are manufactured by FPS?

We only design and manufacture tailor-made systems for HPAPI or sterile solutions. Each process is unique in its own way so the isolator must reflect that. Here are some broad categories for HPAPI: • Dispensing Isolator • Reactor Charging Isolator • Filter Dryer Discharging Isolator • Milling & Micronization isolators • Pack-Off systems • Synthesis, Filtration and Drying isolators Any of those systems can guarantee down to very low nanogram containment.

3. What is the Functional Design Specification approach?

Writing a FDS for each system is key. This document describes how the proposed system will operate, how people will interact with it and what to expect when different operations scenarios occur. Because each process is different, creating one FDS for each isolator we design will ensure that the customer needs are met 100%.

4. What about sterile solutions?

Our sterile isolators can handle typical sterile products but also sterile products which are toxic. The machine manufactured by FPS are:

• Aseptic Dispensing isolator

• Aseptic Milling isolator

• Aseptic Filter Dryer Discharging isolator

• Filling line

To achieve the aseptic conditions, FPS perform decontamination cycles using Hydrogen Peroxide or steam sterilization.