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 (Vaporized Hydrogen Peroxide 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:

  • 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.

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.

Mock up

The ability to listen and the flexibility in adapting to the needs of the customer are the strengths that over the years have rewarded FPS.

In FPS the initial study of the project is carried out by several hands: a specialized team works closely with the customer to ensure compliance with the technical specifications required.

FPS usually proposes the construction of a mock-up of the system to be supplied.
It is a structure that faithfully reproduces the machine on a 1:1 scale and provides a visual representation, as detailed as possible, of what the final system will look like. The way in which the mock-up is created allows the designer and the customer to easily make any changes and improvements during the verification stage.

A mock-up is created to outline the aspects and some details that will make up the final machine, in order to establish the optimal positions of all the components, simulate the planned operations and examine any problems that were not discussed in the offer stage. 

The steps to consider when making the mock-up are:

  • 3D Design of the isolator
  • Drawing the mock-up
  • Creating the insulator mock-up
  • Creating the internal components
  • Creating the polycarbonate windows and positioning the glove ports
  • Checking the mock-up with the customer and the project team
  • Final report with the details of the findings and solutions found

Before making the mock-up, a careful preliminary study of the machine is carried out, starting from the supply specifications, considering the spaces available at the installation site and the components integrated into the machine (such as process machines or different types of containers to handle). The 3D model of the plant is the starting point for the construction of the mock-up.

In order to achieve the best result, it is necessary to simulate all the operations that the operator will perform inside the isolator; FPS therefore not only simulates the system, but also the main internal components on which the desired operations will be performed. 

The customer is supported in each stage by the project team, that under the coordination of the Project Manager, works together with the customer to find the best solutions.

The great advantage of making a mock-up is to let real end users perform the manipulations and "play" with the machine and then define/observe the operations as they will actually be performed. 

FPS strongly believes in this sensitive stage because it allows to get a very accurate idea of the machine that will be manufactured, to optimize the ergonomics and logistics for the flow of components and to achieve savings in terms of costs and time on both sides. 

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.

STS - Swab Testing Station for Covid-19

FPS is pleased to announce the launch of a new innovating solution for swabbing, that will ensure the absolute safety of operators and patients: the Swab Testing Station (STS).

Inspired by the Korean hospital of Yangji in Seoul, FPS has designed and constructed the first system to safely swab potentially infected patients by healthcare personnel located outside the station.

Tests only take a few minutes and are very safe because both the operator and the patient are never in direct contact. The cabins are easily transportable and, once positioned at strategic points (entrances of hospitals, pharmacies, neighborhoods, squares...), the STS will allow operators to perform 10 swabs in one hour. 

The Swab Testing Station includes a completely safe removal system for the waste generated by the swabbing activities by means of a special container inside each cabin.

The STS is composed of 2 cabins and each is equipped with powerful ventilation that speeds up the aeration phase after sanitization to reduce the downtime between tests. The ventilation also allows the achievement of negative dynamic pressure inside each of the two cabins. Best in class filtration dramatically reduces the risk of potentially contaminated air escaping the station.

An intercom allows clear communication between the patient and the operator with the possibility to use pre-recorded audio with standard instructions (which can be done in different languages).

Carlo Corsini, FPS owner and General Manager, says: “I’m very proud of the FPS team for working together and putting their technical skills at the service of public health on such short notice. The team worked with enthusiasm despite the difficulties that we are all going through at this time

 
Click HERE for the video presentation and HERE the operating video
 

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

STS - Swab Testing Station for Covid-19

FPS is pleased to announce the launch of a new innovating solution for swabbing, that will ensure the absolute safety of operators and patients: the Swab Testing Station (STS).

Inspired by the Korean hospital of Yangji in Seoul, FPS has designed and constructed the first system to safely swab potentially infected patients by healthcare personnel located outside the station.

Tests only take a few minutes and are very safe because both the operator and the patient are never in direct contact. The cabins are easily transportable and, once positioned at strategic points (entrances of hospitals, pharmacies, neighborhoods, squares...), the STS will allow operators to perform 10 swabs in one hour. 

The Swab Testing Station includes a completely safe removal system for the waste generated by the swabbing activities by means of a special container inside each cabin.

The STS is composed of 2 cabins and each is equipped with powerful ventilation that speeds up the aeration phase after sanitization to reduce the downtime between tests. The ventilation also allows the achievement of negative dynamic pressure inside each of the two cabins. Best in class filtration dramatically reduces the risk of potentially contaminated air escaping the station.

An intercom allows clear communication between the patient and the operator with the possibility to use pre-recorded audio with standard instructions (which can be done in different languages).

Carlo Corsini, FPS owner and General Manager, says: “I’m very proud of the FPS team for working together and putting their technical skills at the service of public health on such short notice. The team worked with enthusiasm despite the difficulties that we are all going through at this time

 
Click HERE for the video presentation and HERE the operating video

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