How FPS Pharma's Mock-Ups Make a Difference in Custom Isolator Performance

At FPS Pharma, the creation of custom isolators is more than a process; it’s a journey of collaboration, innovation, and precision.
From the moment customer needs are reviewed to the final testing phase, every step of the design and production process is meticulously carried out at our Fiorenzuola d’Arda (PC) plant.

Central to this journey is the mock-up phase—a pivotal step that brings the isolator to life at full scale.
FPS Pharma strongly encourages the use of mock-ups, allowing customers to physically interact with the isolator and assess its ergonomics and functionality before final production.

The design and production of FPS Pharma custom isolators are carried out entirely at the Fiorenzuola d’Arda (PC) plant. It starts with a detailed review of the customer needs and culminates with a final test before delivery.

The initial project study is a collaborative effort: a dedicated technical team from FPS closely works with the customer to ensure full compliance with the project technical specifications.
For custom isolators, FPS recommends making a mock-up of the isolator which allows the customer to experience and evaluate physically the ergonomics and the features of the system to be built.

“Each mock-up faithfully reproduces the isolator at a 1:1 scale, it really provides a detailed and realistic physical representation of the final system,” explains Ms Ilenia Lindi, Head of Project Management at FPS. “Running the process in this at-scale model allows both the project team and the customer to easily make changes and improvements on the fly during the mock-up review.”

“The mock-up outlines aspects and details of the final isolator. It enables the optimal positioning of components, simulates planned operations, and highlights potential issues not identified previously. It is also a great test of the isolator ergonomics. Our customers are guided and supported throughout the mock-up review by the project team which is headed by FPS dedicated Project Manager. The entire FPS team works closely the customer to find the best solutions.”

 

The steps in creating the mock-up are as follows:

3D design of the isolator Drawing the mock-up Manufacturing the isolator mock-up (with wood or plastic) 3D printing replicas of internal components (e.g. process equipment) Assembling the polycarbonate windows and positioning the glove ports Reviewing the mock-up with the customer and the dedicated project team Compiling a final report with updates and solutions Before building the mock-up, a thorough preliminary study is conducted, starting with the customer technical specifications and considering the space available for installation site as well as any integrated components (such as process equipment or various containers to be handled).
The 3D model of the plant serves as the foundation for the mock-up design.

To ensure the best results, FPS simulates all the operations that will be performed inside the isolator, including any container or process equipment either with the actual system or with 3D-printed replicas .

“Sometimes the importance of this process is undervalued, as the customer may view it as redundant, given FPS extensive experience in designing and building isolators.

However, physical interaction with the isolator is key. To have a user mimic the process and move material or components allows for alternate solutions to those initially considered to emerge.  
“Given the complexity of these systems, this ensures that our customers invest in top-performing solutions, built to last which require minimal maintenance, and offer the highest safety and operator comfort” Lindi adds.

This process also offers significant benefits from an electrical perspective.
Mr Luca Abbà, Head of the Electrical Department, explains: “While the mock-up primarily helps in ergonomic, mechanical, and spatial assessments, it also provides substantial benefits for electrical evaluations. For example it helps evaluate the size and optimal placement of electrical cabinets and guarantee the easiest access for maintenance.

For the above-mentioned reasons, at FPS Pharma, we firmly believe in the importance of this crucial phase, as it provides a clear vision of the final isolator, optimizes ergonomics, and ensures superior performance, translating into significant cost and time savings, not only in the short to medium term but also in the long run.