Sterile Contained PM8 Micronizing systems

Sterile Contained PM8 Micronizing systems
Product Description

The equipment, designed to be installed across different floors, is composed of a glovebox to discharge the batches from a filter dryer without affecting the product sterility; a jet mill isolator provides a confined environment in which the product is micronized; downflow booths are integrated on the airlocks of the pack-off isolator to guarantee the high sterility grade.
The system is fully automated. FPS internally develops the software that controls all the equipment functionalities. The machine is sterilized with both hot steam and VHP.
The ground-breaking unit will allow the customer to complete different phases of a sterile production of APIs avoiding the risk of contaminating the product and reducing the operator’s exposure to the potent compound.

Milling operations may result in dust clouds, exposing operators and environment to HPAPI, due to high energy involved in process operations and size reduction down to few μm.
Proven solutions are available for laboratory, pilot unit or production units of:

  • Conical mills
  •  Hammer mills
  •  Pin Mills
  •  Fluid energy mills (jet mill and QMills)
 Also containment of cryogenic milling operations is assured.
Glove ports or half suits configurations are available depending on space availability and operator ergonomics.


FPS Pharma

  • IT
  • 2015
    On CPHI since
  • 3
    Certificates
  • 50 - 99
    Employees
Company types
Consultancy
Engineering
Machinery and Equipment Supplier/Manufacturer
Manufacturer/Innovator
Primary activities
Cleanroom Technology
Laboratory, Analytical, Biotechnology Equipment
Other
Specifications
  • Selling Points
    Brand Name; Convenience; Price; Product Performance; Quality Service
  • Supplied from
    Italy
  • Measured In
    milligram

FPS Pharma

  • IT
  • 2015
    On CPHI since
  • 3
    Certificates
  • 50 - 99
    Employees
Company types
Consultancy
Engineering
Machinery and Equipment Supplier/Manufacturer
Manufacturer/Innovator
Primary activities
Cleanroom Technology
Laboratory, Analytical, Biotechnology Equipment
Other

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FPS Pharma resources (2)

  • News 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.
  • Brochure Pharmaceutical Micronization and Milling Equipment

    Explore FPS’ micronization and jet milling systems. Achieve exact PSD targets, enhanced bioavailability, and cGMP compliance for superior formulations.