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.