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.

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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.

PDF icon ste.disstehpapi_04.14-dispensingisolatorforsterilehpapi.pdf
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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
  • ...
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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…
PDF icon Syntesis Isolator - Technical Data Sheet _11.14
PDF icon Isolator for reactor charge - Technical Data Sheet _11.14
PDF icon Filter Dryer isolator - Technical Data Sheet _11.14
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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.

PDF icon Isolator for Cone Mill - Technical Data Sheet _ 04.14
PDF icon Cryomilling Isolator - Technical Data Sheet _ 02.17
PDF icon Half Suit Isolator for PM8 - Technical Data Sheet _ 02.17
PDF icon Half Suit Isolator for PM12 - Technical Data Sheet _ 04.14
PDF icon Isolator for Milling Micronization - Technical Data Sheet _ 04.14
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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
PDF icon In process Control Isolator - Technical Data Sheet 01.14
PDF icon Capsule Filling Isolator - Technical Data Sheet 01.14
PDF icon Integrated Dispensing Isolator - Technical Data Sheet 01.14
PDF icon Pan Coater Isolator - Technical Data Sheet 01.14
PDF icon Tablet Press Machine Isolator - Technical Data Sheet 01.14
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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.
PDF icon Blistering line Isolator -Technical Data Sheet 04.14
PDF icon Pack Off Systems in Isolator - -Technical Data Sheet 04.14
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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.
PDF icon lab_04.14-isolator_for_laboratories.pdf
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Reactor and vessel loading systems

Double chamber reactor charging system for larger quantity of product handling

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 trans pallet 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 especially 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 allows 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 isolator internally integrated drum handling system for safest product charging from drums. The system is especially 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 allows 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.
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RABS

Restricted Access Barrier System (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.

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Mock up

The ability to listen and to adapt to the needs of the customer are the strengths of FPS. The mock-up phase is a unique opportunity for the users and the designers to collaborate.

Is a mock-up really necessary?

Some companies feel that they have surveyed the needs of their internal users well enough that they don’t need to confirm the design with a mock-up and can save some money.

But decades of experience have proven otherwise. Mock-ups are critical to optimize ergonomics, maximize user friendliness (the devil is in the details) and get the end users buy-in (because they are associated to the design process). It also avoids misunderstandings that can lead to small design imperfections which would cost time and money to get solved later in the project.  

What is the goal of the mock-up?

A mock-up mimics the final system and help determine the optimal positioning of all the components, simulate the process tasks and the product flow as well as examine the issues that were not discussed previously. 

What exactly is a mock-up?

It is a structure that faithfully reproduces the machine on a 1:1 scale and provides a physical representation, as detailed as possible, of what the final system will look like. The structure is typically made of wood. It also allows the designer and the customer to quickly make changes and try different types of improvement during the mock-up review.

Who is involved in the mock-up phase?

It all starts with the ergonomic study from FPS which is carried out by an experienced design team. This results in a General Arrangement Drawing (GA) that is submitted to the customer. The customer project team is typically made of engineers, users and health & safety staff. They review the GA and offer comments.  These are integrated in an 3D Design which is the starting point for the mock-up (see below). 

What are the steps? 

  • 3D Model of the isolator
  • Drawing the mock-up
  • Construction of the mock-up
  • Construction of the internal components (or integrate equipment, tools, containers, etc)
  • Make the polycarbonate windows and position the glove ports
  • Mock-up review by the customer and the project team
  • Final report with the details of the findings and solutions found

What is the mock-up review? 

It is a simulation of the routine tasks that the operator will perform inside the isolator. It is preferred that the actual process equipment, tools, containers, etc, are used for this simulation but if not available FPS will simulate them.  

The great advantage of making a mock-up is to let real end users perform the tasks and "play" with the system and then critique how these tasks are actually performed with the isolator. 

Where is the mock-up review conducted?

Typically, customers visit FPS to perform the review in Italy along with the project manager, the designer and other project team members. For small and medium size isolators, the structure can be shipped to the customer site. It allows the review to take place with the highest number of users and stake holders. In that case some FPS members will visit the customer and a remote session can be organized with the rest of the FPS project team.

Using a mock-up can really help achieve the best possible ergonomics and user friendliness. It fosters strong collaboration between the isolator designers and users. The customer is supported and guided at each step by the FPS project team, that under the coordination of the Project Manager, works together with the customer to find the best design solutions.

contact us

Mock up

The ability to listen and to adapt to the needs of the customer are the strengths of FPS. The mock-up phase is a unique opportunity for the users and the designers to collaborate.

Is a mock-up really necessary?

Some companies feel that they have surveyed the needs of their internal users well enough that they don’t need to confirm the design with a mock-up and can save some money.

But decades of experience have proven otherwise. Mock-ups are critical to optimize ergonomics, maximize user friendliness (the devil is in the details) and get the end users buy-in (because they are associated to the design process). It also avoids misunderstandings that can lead to small design imperfections which would cost time and money to get solved later in the project.  

What is the goal of the mock-up?

A mock-up mimics the final system and help determine the optimal positioning of all the components, simulate the process tasks and the product flow as well as examine the issues that were not discussed previously. 

What exactly is a mock-up?

It is a structure that faithfully reproduces the machine on a 1:1 scale and provides a physical representation, as detailed as possible, of what the final system will look like. The structure is typically made of wood. It also allows the designer and the customer to quickly make changes and try different types of improvement during the mock-up review.

Who is involved in the mock-up phase?

It all starts with the ergonomic study from FPS which is carried out by an experienced design team. This results in a General Arrangement Drawing (GA) that is submitted to the customer. The customer project team is typically made of engineers, users and health & safety staff. They review the GA and offer comments.  These are integrated in an 3D Design which is the starting point for the mock-up (see below). 

What are the steps? 

  • 3D Model of the isolator
  • Drawing the mock-up
  • Construction of the mock-up
  • Construction of the internal components (or integrate equipment, tools, containers, etc)
  • Make the polycarbonate windows and position the glove ports
  • Mock-up review by the customer and the project team
  • Final report with the details of the findings and solutions found

What is the mock-up review? 

It is a simulation of the routine tasks that the operator will perform inside the isolator. It is preferred that the actual process equipment, tools, containers, etc, are used for this simulation but if not available FPS will simulate them.  

The great advantage of making a mock-up is to let real end users perform the tasks and "play" with the system and then critique how these tasks are actually performed with the isolator. 

Where is the mock-up review conducted?

Typically, customers visit FPS to perform the review in Italy along with the project manager, the designer and other project team members. For small and medium size isolators, the structure can be shipped to the customer site. It allows the review to take place with the highest number of users and stake holders. In that case some FPS members will visit the customer and a remote session can be organized with the rest of the FPS project team.

Using a mock-up can really help achieve the best possible ergonomics and user friendliness. It fosters strong collaboration between the isolator designers and users. The customer is supported and guided at each step by the FPS project team, that under the coordination of the Project Manager, works together with the customer to find the best design solutions.

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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.

PDF icon Downflow booth 4S
PDF icon Downflow booth 3S
PDF icon Downflow booth 4S
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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.
PDF icon g.clero_02.15-cleanrooms.pdf
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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" 

 

Here below you can watch the operating video:

 

 

Click HERE for the video presentation.
 
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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

PDF icon Technical Data Sheet - Pack-off system
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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
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STS - Swab testing station for COVID19

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
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Inert gas containment

Spare Parts for Containment systems

Assistance and spare parts service have always been our strong point, because fps never stops!

Original spare parts maintain the performance of your FPS containment systems, ensuring safety and reliability, minimizing down time and maximizing productivity.

FPS is at the side of its customers even after installation and validation of the system and offers them a specific service for spare parts. Thanks to the expertise of our team, we are able to provide customized spare parts lists to plan the periodic replacement of wear parts, managing the entire life cycle of the spare parts.

Our range of approved replacement parts include:

  • HEPA filters + Prefilters
  • Gloves + O-Rings
  • Liner + O-Rings
  • Cutter + Crimping tool
  • Inflatable Gaskets 
  • Spray-balls and Spray-guns
  • Fast hose clamp
  • ....

FPS always recommends to schedule the purchase of spare parts to avoid unpleasant inconveniences. For this reason, for those who buy the prevention package offers a 20% discount.

Complete the form and contact our team today!

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After-sales

Fps supports his customers during all the life cycle of their equipment.

We offer tailor-made assistance packages designed to constantly support our customers to get the maximum performance of their systems.

FPS skilled technicians are available to make sure that a small issue doesn’t become a big problem!

Our maintenance services include:

  • General conditions inspection
  • Help desk and online assistance
  • On-call maintenance visits
  • Annual service/maintenance contracts
  • Equipment upgrades or revamping
  • Validation - IQ/OQ protocols and execution
  • Training sessions (also remotely)
  • SMEPAC Test support
  • Periodic validation 

FPS firmly believes in Preventative Maintenance Programs and works closely with each customer to customize the final scope. These packages also include priority for on-site maintenance visits and a special discount for spare parts.

Contact our After-sales team and customize your own program!

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Spare Parts for Containment systems

Assistance and spare parts service have always been our strong point, because fps never stops!

Original spare parts maintain the performance of your FPS containment systems, ensuring safety and reliability, minimizing down time and maximizing productivity.

FPS is at the side of its customers even after installation and validation of the system and offers them a specific service for spare parts. Thanks to the expertise of our team, we are able to provide customized spare parts lists to plan the periodic replacement of wear parts, managing the entire life cycle of the spare parts.

Our range of approved replacement parts include:

  • HEPA filters + Prefilters
  • Gloves + O-Rings
  • Liner + O-Rings
  • Cutter + Crimping tool
  • Inflatable Gaskets 
  • Spray-balls and Spray-guns
  • Fast hose clamp
  • ....

FPS always recommends to schedule the purchase of spare parts to avoid unpleasant inconveniences. For this reason, for those who buy the prevention package offers a 20% discount.

Complete the form and contact our team today!

contact us