Containment

Containment is an issue more and more addressed by authorities and companies in fine chemical and pharmaceutical industries with increasing demand also in energy, aerospace, food and cosmetic applications. Product protection, as well as environment and operator protection, are the driving requirements in new projects or in equipment re-vamping.

We offer a complete range of containment systems that satisfies all possible needs and requirements.

Our approach to a containment system is to discuss with the end user the specific needs in terms of protection, quality, productivity in order to identify the equipment that best fits the specifications:

  • Isolators, for highest protection levels
  • Laminar flow booths, for small volumes protections
  • pack-off, to safely discharge and pack powders
  • Cleanrooms, as general operation environment
  • Inert Gas Containment systems.

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.

Laminarflow booths

Laminar flow booths assure the respect of specific air quality requirements in a confined space

They are a convenient solution for process protection, dispensing or sampling activities. 

FPS proposes a standard modular solutions for:

-Vertical Laminar Air Flow units, to be  used when a class A (as per EUcGMP) is requested to protect a process/equipment, typically installed for the protection of filling, transfer, packaging in sterile operations.

-Horizontal laminar flow booths, to be installed where operator/environment protection is required (dust reduction within the operation area – OEB 2-3), i.e. for discharge stations, drum to equipment powder transfer and other.

-Down-Cross units, to be adopted installed when the protection of product, operator and environment has to be achieved during sampling and dispensing activities.

Cleanrooms

Cleanrooms solutions allow product protection in a variety of materials and configurations.

FPS may design and install turnkey solutions, up to ISO8 classification, complete with:

  • Partitioning walls, manufactured with high pressure laminated sheets, stainless steel, carbon steel, complete with coving and accessories when required, access doors, windows.
  • The whole system is designed assuring co-planar surfaces with best cleaning results. 
  • HVAC systems, with required air flows and HEPA filtration according to desired ISO class and containment needs. The HVAC is complete with the T and RH control system; it is possible to design the system assuring special thermo-hygrometric conditions, down to RH<20%.
  • Flooring, with PVC mats or epoxy resins lining.
  • Illumination of rooms with LED or neon lamps.
  • Access control system, to prevent direct communication of external environment with working areas (available even in ATEX rated areas).
  • Qualification documentation.
  • Qualification service.

Pack off

Pack-off systems assure product protection and reduce operator dust exposure during discharging operations from silos, bins, cyclones, driers, reactors, centrifuges, …

It is possible to install pack-off systems on existing equipment, reducing to a minimum the requested modification, in full compliance with all the final customer standard.

Custom designed configurations are also available integrated with:

- weighting platform

- dosing valve

- sampling system

- continuous liner 

- inflating head

- horizontal flow booths

Local extraction arms

Extraction arms are designed for the air suction around the area close to a dust emission point.

Available in different lengths, they can be adapted to many possible different configurations. Their containment performance falls between OEB 1 and 2. Main applications are represented by: vessel charging, drums charging and equipment charging

Inert gas containment

Inert solutions allow for execution of activities within the enclosure without contamination or exposure to atmospheric conditions.

Nitrogen and Argon are typically adopted as ventilation gas.

Possible applications are:

  • Electronics
  • Aerospace
  • Research Centers
  • Laser welding
  • Lithium applications
  • Medical devices