High Containment What´s the Best for sterile Transfer?
When using High Containment-Technology Rapid-Transfer-Ports are State-of-the-Art for sterile transfer. The authors are presenting a study which compares different systems showing need for improvement.
Sterile transfer of components and other materials from one confined space to another has always been a major concern for the pharmaceutical production industry. Isolation technology has a solution for transferring materials between two chambers of similar cleanliness, or for connecting two chambers of similar cleanliness without altering their environmental and containment properties.
The solution is the use of RTP (Rapid Transfer Port) systems installed on enclosures such as isolators or production lines.
The first system of this type was built by Getinge-La Calhène in the 1960s in response to the nuclear industry’s needs for safe transfer of highly dangerous radio-active substances. The system is based on the interaction of two distinct parts as shown in the figure.
How does the system work
- a) The Alpha port which is fixed to a surface (e.g. the wall of an isolator) and consists of a door, a lip seal and a flange.
- b) The Beta port, which is the mobile part and consists of a door, a lip seal and a flange connected to a container, isolator or suitable chamber.
The Beta and Alpha ports join together to form a single unit when they are connected by rotation. At the same time both the doors are detached from their respective flanges and fixed together, while the flanges and seals continue to maintain the leaktightness of this new joined assembly.
This first secure transfer system was named “DPTE” for Double Porte pour Transfert Étanche (Double Door for Sealed Transfer). Applications were found in many industries where leaktight safe transfer of sterile and/or toxic material is a major issue.
Today the DPTE is used for a great many applications in life sciences, in particular in the pharmaceutical industry. It is recognized as a successful industry standard for transfer systems with around 30 000 units in use around the world.
As a result, it has inspired many other transfer systems which are marketed today as reliable alternatives to the DPTE system.
A study was made comparing the DPTE-190 secured transfer system with equivalent RTP systems. The study examined five standard secured RTP systems (Alpha and Beta ports) manufactured by the major players in the nuclear and pharmaceutical applications market. Four of these RTPs have a rotating docking system; the fifth does not require rotation to lock the assembly.