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:

  • Laboratory,
  • Synthesis,
  • Filtration & Drying,
  • Production Reactor Charging,
  • Process vessel discharging,
  • Pilot Milling & Micronization,
  • Production Milling & Micronization,
  • Dispensing…

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.

Reactor and vessel loading systems

The project definition always starts from on-site supervision to check installation area and discuss with end user about specific needs. In function of possible physical constraint first evaluation is about the possibility to use gravity discharge or to evaluate alternative system like Vacuum Transport System (VTS).

First of all, a preliminary design is realized and once the real project starts an ergonomic study on a 1:1 scale mock-up is performed to check real activities to be performed.

Once this critical step is completed the final manufacturing of the system is started.

FPS propose different configurations:

  • Single chamber mobile reactor loading system for small quantity of product handling, up to OEB4 category (CPT down to 1mg/m3). The system was designed to be movable, flexible and interchangeable on different reactors thanks to adjustable height and transpallet connection system. Product coming in bags (max 8-10 kg each) was safely loaded by FPS bag-in system into main chamber. From main chamber was discharged by gravity or by VTS (Vacuum Transport System) directly into reactor and waste bags removed from back installed FPS Continuous liner system. System rated for ATEX installation area, with full cleaning in place system by integrated spray balls and washing gun. System can be manufactured in AISI316L SS, HC22 or with different surface treatment/coating to meet strict working condition in chemically aggressive atmosphere.
     
  • Single chamber reactor charging system for larger quantity of product handling, up to OEB4 category (CPT down to 1mg/m3). The system is provided with FPS integrated drum handling system for safe and easy product charging from drums. The system is especailly designed in fixed or mobile configuration, suitable for gravity discharge or for connection to VTS (Vacuum Transport System). The special design of drum integrated handling system allow the safe use of the system with all available type of drums. Product is charged automatically into main working chamber where an FPS Continuous liner System is installed for safe removal of waste. An FPS Bag-in system is also integrated, so the system is suitable for loading of smaller quantity of product. System rated for ATEX installation area, with full cleaning in place system by integrated spray balls and washing gun. System can be manufactured in AISI316L SS, HC22 or with different surface treatment/coating to meet strict working condition in chemically aggressive atmosphere.
     
  • Double chamber reactor charging system for larger quantity of product handling, up to OEB5/OEB6 category (CPT down to 0.1 and 0.01 mg/m3). The double chamber system is provided with FPS integrated drum handling system for safe and easy product charging from drums. The system is especailly designed in fixed or mobile configuration, suitable for gravity discharge or for connection to VTS (Vacuum Transport System). The special design of drum integrated handling system allow the safe use of the system with all available type of drums. Product is charged automatically into side pre-chamber, to increase the overall level of containment of the system. By special pre-chamber design the product (up to 25kg kegs) is moved into main working chamber where an FPS Continuous liner System is installed for safe removal of waste. An FPS Bag-in system could also be  integrated, so the system is suitable for loading of smaller quantity of product with CPT down to CPT down to 0.01 mg/m3 . System rated for ATEX installation area, with full cleaning in place system by integrated spray balls and washing gun. System can be manufactured in AISI316L SS, HC22 or with different surface treatment/coating to meet strict working condition in chemically aggressive atmosphere.
     
  • Double chamber reactor charging system for larger quantity of product handling, up to OEB5 category (CPT down to 0.1mg/m3). The double chamber system is provided with FPS isolato internally integrated drum handling system for safest product charging from drums. The system is especailly designed in fixed or mobile configuration, suitable for gravity discharge or for connection to VTS (Vacuum Transport System). The special design of drum integrated handling system allow the safe use of the system with all available type of drums, where drums are completely handled into full tight isolator pre-chamber. Drum is positioned and opened inside Isolator pre-chamber, to increase the overall level of containment of the system. By special drum handling and connection system the product (up to 25kg kegs) is moved into main working chamber where an FPS Continuous liner System is installed for safe removal of waste. System rated for ATEX installation area, with full cleaning in place system by integrated spray balls and washing gun. System can be manufactured in AISI316L SS, HC22 or with different surface treatment/coating to meet strict working condition in chemically aggressive atmosphere.