The presence of viable organisms and spores in production environments presents a risk of contamination in aseptically prepared products. Even the new Annex 1 highlights the importance of containing the risk of contamination requiring that:
- the transfer of materials into an aseptic production area is carried out in a one-way process
- prior to the material transfer, items have to be decontaminated through double door systems such as pass boxes or autoclaves.
The pharmaceutical companies should therefore pay considerable attention on between-class material transfer to avoid severe consequences in case of final product contamination.
Amira has been working in contamination control field with national and international pharmaceutical production companies for many years. This lasting co-operation allowed to perceive a concrete demand for a solution that could simplify:
- bio-decontamination and transfer of materials from/to clean rooms
- construction and renovation work required to install new systems in existing structures
To respond effectively and promptly to these requirements, Amira has launched Easypass.
The multi-purpose system
This new system offers a laminar flow trolley with VHP generator on-board and a fast-docking interface for cleanroom. This patent-pending solution allows to:
- perform optimised and pre-validated biodecontamination cycles for transferring materials between areas with different contamination classes
- grant material cleanliness grade during transferring thanks to the laminar flow available in the chamber
- move the trolley around the working areas easily and without power supply connection thanks to the on-board battery
- perform fast docking with Grade A-B cleanrooms through the interaction between the trolley and its wall interface
Easypass is designed to be used in many applications to meet different customers' needs.
1) Use in Grade A/B areas
Positioned inside Grade A/B areas and connected to its fast-docking interface, Easypass is a mobile VHP passbox allowing biodecontamination and transferring of materials from an external Grade C area. Once disconnected from its interface, it becomes a laminar flow trolley for handling biodecontaminated materials between Grade A areas within Grade B departments. In this way, a single trolley streamlines the handling of equipment needed to move materials and speeds up their transferring from dirty to clean grade areas.
2) Use in Grade C/D
With just one Easypass and multiple fast docking interfaces installed, it is possible to biodecontaminate and transfer materials from one Grade C/D area to several Grade A/B areas without equipping each room with dedicated fixed passbox.
Powerful and revolutionary
Easypass is powerful and revolutionary. This system is effective in eliminating the risk ofmicrobiological and particle contamination of the transported material. At the same time, it is also simple and fast to install as it does not require complex work and reduces the time of inactivity and plant downtime. That's why it's a flexible and convenient alternative to other traditional solutions available on the market.