Tailor-made containment system match with asepsis

FPS, leader company in the pharmaceutical and fine chemical fields, developing, manufacturing and installing worldwide its own range of Fine Size Reduction machines and Containment Solutions (Sterile and Highly Potent API), has recently delivered a very complex project that combines high containment within aseptic condition. 

It’s composed by N°2 ANFD (Agitated Nutsche Filter Dryers, respectively in AISI316L and HC22 material) system with integrated sampling, discharge, milling and packing-off station suitable to handle OEB4 dry product under sterile conditions. Discharged product can be moved to final dispensing containment system for the preparation of final product in different packages. As an alternative in case of ultra fine powder requirement, the product after preliminary drying and milling can be moved to dedicated Micronization and final dispensing isolator (with integrated FPS spiral Jetmill type PilotMill-6).

Key features of this system are:
·         Multi-chamber design providing defined barrier between the process and surrounding environment.
·         Full access to the micronization unit and the dispensing station installed inside the isolator.
·         Glove ports arrangement to provide best ergonomics and maximum viewing of all process operations.
·         Positive/negative pressure regime between enclosure and surrounding environment to ensure all potential contamination is kept inside and required sterility level is assured.

  The FPS Sales director and micronization expert, Eng. Stefano Butti, says: “It is a plant where the product is processed in conditions of high containment and asepsis, starting from its filtration and drying and passing through the milling, micronization and final dispensing.  All process steps and control system were managed entirely by us as main contractor, both for isolators and for the various process machines. The success of this challenge was certainly due to the experience gained in similar projects and the ability to combine these experiences, even in a critical way, with the aim of further improving what has already been done. “

A dedicated team worked closely with the client throughout the project to ensure that all specific requirements were met (sterility, containment, process performance), and superior quality of manufacture and containment levels were maintained. 

Tailor-made containment system match with asepsis