The FPS Pharma Engineering Process – Paolo Barilli
"We are highly specialised in the design and manufacture of custom isolators for potent active ingredients and sterile solutions. Our collaborative design process includes creating full-scale mock-ups to validate ergonomics and functionality, ensuring tailored solutions for each client." - Paolo Barilli - FPS Pharma Process Engineer
Let's explore the FPS Pharma Engineering Process.
What is the design approach of FPS?
FPS Pharma
is highly specialised in the design and manufacture of custom isolators for
potent active ingredients and sterile solutions.
Through our
custom-engineered systems for handling and processing HPAPIs, toxic and/or
sterile pharmaceutical ingredients, we ensure unparalleled safety, efficiency,
and product excellence.
Our
solutions meet stringent regulatory requirements, including cGMP, FDA, EU, and
UL standards, ensuring reliable performance in even the most demanding
environments.
Our
strength lies in our flexibility and unwavering commitment to complete customer
satisfaction. We offer containment solutions, as well as micronisation and
milling systems, tailored to meet the unique needs of our clients, from
small-scale R&D to full-scale production.
We achieve
this by thoroughly analysing customer requirements, the specifics of each
process, and space constraints, then designing our systems accordingly.
This
detail-oriented approach begins with an initial design, collaboratively
reviewed with the customer. The design phase includes an in-depth assessment of
process requirements, material suitability, and containment levels. This
results in a refined design, followed by the creation of a full-scale mock-up
to test the system’s ergonomics with the customer.
Once the
mock-up is validated, we proceed with a comprehensive study, culminating in a
detailed design that incorporates key documentation such as the Piping and
Instrumentation Diagram (P&ID) and the Functional Design Specification
(FDS). This ensures that all safety interlocks and performance criteria are
meticulously addressed.
We pride
ourselves not only on delivering high-performance systems but also on providing
ongoing post-sales support, including maintenance services, operator training,
and worldwide technical support.
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