Keeping contamination under control during materials transfer in aseptic pharma production now it’s ‘easy’
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 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:
To respond effectively and promptly to these requirements, Amira has launched Easypass.
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:
Easypass is designed to be used in many applications to meet different customers' needs.
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.
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.
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.