R&D and Pilot Plant Isolator

Early drug development is increasingly important, and FPS supports that activity by offering new custom solutions that fit the specific needs of the Pharmaceutical, Biotech and Fine Chemical sectors.

• What do we mean by isolators for R&D and Pilot Plants?

These machines are installed in research laboratories and/or pilot production plants, to ensure safe handling of active substances in a contained environment.

• When is a containment system needed?

When you must prevent external contamination during all potent powder handling activities and to ensure the safety of the operator from the potent substances. In the study of new drugs, it happens often that during the chemical reaction phase, intermediates are created. The issue is that, at that stage, their toxicity and their potential averse effects are unknown. Using a barrier isolator will prevent the operator exposure to this compound.

• How do choose the best containment system?

The type of containment system is determined by the quantity of product handled, by the OEL “occupation exposure limit” which is expressed in μg/m3, by the chemical/physical characteristics of the substances and by the type of activities performed inside the isolator.

• What are the benefits of using an isolator?

First, compared to any other system, an Isolator is designed to guarantee a perfect separation between the working area and the surrounding environment. An isolator, working under a pressure differential regime, guarantees an additional barrier to avoid contamination. Using an isolator, the operator can work without a breathing device, a protective mask or any other cumbersome PPE (Personal Protective Equipment). Also the ergonomics are greatly improved with an isolator and the operator safety is significantly increased.  

Secondly, another way to ensure operator safety is the safe filter change feature. And after the filter change the contaminated HEPA filter can be safely removed through a Bag-In Bag-Out port.

A third benefit is that an isolator can guarantee a low level of moisture or a low oxygen level inside the working chamber, this is crucial for some sensitive products.

• Can you share with us the typical milestones of a project at FPS?
  • Phase 1: FPS visits the customer – Scope: Understand the real needs, see the installation, preliminary technical discussions
  • Phase 2: FPS submits the technical and Commercial Offer– Scope: Describe the technical solution and list the project costs
  • Phase 3: Contract award and Project launch – Scope: first system design, customer feedback
  • Phase 4: Mock Up Phase –  Scope: Ergonomic study, mimic the process and the material flow, optimize isolator design, final dimensions of the machine
  • Phase 5: Design Phase –  Scope: Finalize the 3D model, final approval of the GA drawing and P&ID Diagram
  • Stage 6: Manufacturing, Assembly and Factory acceptance Test – Scope: the isolator is made 100% in-house, FAT test executed with the end user
  • Stage 7: Delivery, Installation and Site Acceptance Test –  Scope: Installation at user site, final validation testing
  • Stage 8: Maintenance & Spare Parts – Scope: Provide a custom maintenance plan, offer a maintenance contract. FPS provides supports for the entire life of the equipment

And here are some example of applications for which FPS designed tailor-made solutions:

• Isolator integration in a pilot plant with glass reactors, vacuum distillers, filter dryers
• Isolator integration with a static dryer
• Isolator integration with a milling or micronization equipment
• Isolator integration with laboratory equipment such as weighing system or processing system

Contact us and define together with us your suitable configuration to your needs