Sartorius Stedim Biotech propose un système de transfert innovant de double portes utilisant des conteneurs à usage unique pour le transfert stérile entrée et sortie de composants, de fluides et de poudres dans un isolateur, RABS, …

Aseptic Transfer System - Definition of the technology

Sartorius Stedim Biotech offers an innovative double door transfer system using single-use containers to transfer sterile components, fluids and powders in and out of an isolator or a RABS or a clean room while maintaining the barrier integrity of these critical processing areas and ensuring the security of operators. This patented system is called Biosafe®. This system is using two parts:

A Biosafe Port set up on the wall of the physical barriers : isolator, RABS and clean room.
A Single-Use Biosafe bag which is connected onto the Biosafe Port.

: Courtesy of Solvay Pharmaceuticals

Principle of operations

The highest quality insurance

Manufactured in ISO 9001 and ISO 13485 certified facilities,
100% quality control on Biosafe Ports – Dimensional & leak testing,
100% quality control on Biosafe bag connector assemblies,
Biosafe bags assembled in Class C (ISO 7) clean rooms.

Approach

Wipe down the Biosafe Port
Open package of the Biosafe bag and remove the protecting pouch

Docking

Docking is secured by magnetic guidance on the Biosafe Port
The magnetic connection is further secured by mechanical locks.

Opening and Transfer

Open the double-door either from inside or outside the critical area.
Aseptic transfer of components, fluids or powders.