Isolators

Isolator technology assures the possibility to execute contained operations when it is requested to give total product protection (sterile application) or operator and environment protection (highly potent application).

We combine a proven design with devices and components specifically manufactured for isolator applications to create unique solutions that fit any specific requirement.

The isolator can therefore designed and built around new or existing equipment, with excellent ergonomic operations and performances.

Sterile

Containment systems for sterile applications may be proposed in the form of closed isolators or Restricted Access Barrier Systems (RABS).

A sterile isolator allows to avoid the use of sterile cleanrooms, reducing the sterile volume around the process being executed.

Turbulent or unidirectional flow may be adopted for airflow.

Typical applications are:

  • sterility testing
  • aseptic filling lines
  • vessel charging
  • Dispensing
  • sterile jet milling
  • dryers discharge of sterile products

Integrated decontamination system (VHP generator) is generally adopted.

Highly potent

Production and handling of HPAPI or toxic products (in gas or powder form) need the total product separation from the environment to protect operators. Negative pressure regime is maintained within the closed volume of the isolator. Turbulent flow is generally adopted.

Operator access to isolator inside via glove ports or half-suit configuration.

Containment levels from 10µg/m3 down to 0,01µg/m3 are available, with different manufacturing solutions and configurations.

Negative pressure isolators are available for many applications:

  • mechanical or fluid energy mills
  • dryers
  • product synthesis
  • dispensing and sampling
  • formulation and packaging
  • laboratory
  • In Process Control
  • Compounding
  • ...

Synthesis, Filtration and drying

Operations around chemical reactors, filters, centrifuges and dryers need to be executed under containment conditions when handling HPAPI or intermediates. Depending on process equipment dimensions, the isolator system is designed fully enclosing the equipment or only the parts where product transfer occurs.

Typical applications are:

  • Reactor charging, with manual operations or drum tilting system;
  • Centrifuge discharge;
  • ANFD discharge, including final product packing in drums or IBC;
  • Tray dryer charging / discharging.

Milling

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.

Formulation

 

Formulation operations involve a large number of process equipment and need to handle small or large batch size.

Integration of containment system with the process equipment is a goal to allow best operator use of the machines while assuring requested quality and productivity.

Typical applications are:

  • Dispensing units
  • Granulation lines
  • Extruders
  • Tablet press, complete with metal checker and de-dusters
  • Capsule filling
  • Pan coaters

Packaging

Final product packaging may need containment isolator as a final step of operator protection.

Already delivered solutions include:

  • FIBC charging;
  • Drum charging with product filling inside double bag;
  • Blistering machine.

Laboratory

Every time a HPAPI is manufactured, all laboratory activities are required with the same operator protection foreseen for process machines.

Typical laboratory applications are:

  • In Process Control;
  • Quality Control activities;
  • HPLC preparation;
  • Sterility testing.

RABS

For flexible and secure production in existing cleanrooms, the RABS is the right choice. A RABS can be designed as open or closed system (i.e. for toxic products), in active or passive execution. Because of the variability, a RABS can be optimized for the requirements of each project.

FPS can propose:

  • Active RABS, complete with HVAC and T/RH control
  • Passive RABS, with control integration for process machine (filling line)

Retrofitting of existing units is possible with limited downturn time.