Contaiment - EDS_10
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Contaiment
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:
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 (toxic 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
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
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.
AIR SHOWER
Air showers are enclosed chambers placed at the entry and exit points of a cleanroom or other controlled environment. Using high-velocity jets of air and HEPA air filter systems, cleanroom air showers remove loose contaminants from people and products before they enter the cleanroom, reducing or eliminating product defects for increased yields.
Cleanrooms are required to adhere to strict regulatory guidelines to prevent contamination. Coveralls and other protective gear are used to prevent outside contaminants from entering a cleanroom, but that isn’t always enough.
Contaminants are easily transported by people and objects and a simple spec of lint or debris could cause issues in some cleanroom environments. Therefore, cleanroom air showers have become a vital component in maintaining the cleanliness of cleanrooms and other clean-critical environments.
Cleanrooms are required to adhere to strict regulatory guidelines to prevent contamination. Coveralls and other protective gear are used to prevent outside contaminants from entering a cleanroom, but that isn’t always enough.
Contaminants are easily transported by people and objects and a simple spec of lint or debris could cause issues in some cleanroom environments. Therefore, cleanroom air showers have become a vital component in maintaining the cleanliness of cleanrooms and other clean-critical environments.
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.
Extreme Design Solution 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.
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