Biomedical Engineering Reference
In-Depth Information
tubes. The main welding systems available today include Sterile Tube Fuser
(GE Healthcare), BioWelder (Sartorius-Stedim), Aseptic Sterile Welder 3960
(SEBRA,
www.Sebra.com
), TSCD (Terumo,
www.terumotransfusion.com
),
and SCD 11B (Terumo). (Terumo supplies its equipment mainly to the blood
transfusion industry.) Both GE Healthcare and Sartorius-Stedim lead the
installations in the bioprocessing industry.
The Hot Lips Tube Sealer by GE Healthcare is a portable device used to
thermally seal thermoplastic tubing for the transport and setup of inoculums,
culture, media, and buffers. The seal forms a tamperproof and leakproof clo-
sure. Preprogrammed for a wide range of tubing types, diameters, and wall
thicknesses, a single button initiates the sealing operation. The instrument is
self-calibrating, and a microprocessor-controlled motor ensures repeatable
performance without the need for tubing adaptors.
The Sterile Tube Fuser also from GE Healthcare is an automated device for
welding together a wide range of tubing types intended for aseptic opera-
tion. Operated via a single push-button operator interface, it connects tubing
between sterile containers, Cellbag bioreactors, and process equipment for
the aseptic transfer of large volumes of fluids such as inoculum, media, buf-
fers, and process intermediates.
Aseptic Transfer Systems
Moving the product across clean rooms may involve, at times, long dis-
tances; while transfer tubings between upstream and downstream areas and
passthrough autoclaves are common, larger volumes transfer systems are
offered by Sartorius-Stedim, ATMI Life Sciences, Getinge, and LaCalhene,
which essentially constitute double-door systems using disposable contain-
ers. In using these systems, the main reusable port is always permanently
fixed in the separating wall (in a clean room or isolator) and represents the
containment barrier. The second connecting part is an integral part of the
disposable container that stores or conducts the components, fluids, and
powders to be transferred. Both the connecting parts and the reusable con-
tainers and transfer systems can be coupled to the main port. After coupling,
the ports are opened from inside the cleaner area and the transfer is started.
The disposable container is normally the package for the fluid and the sterile
barrier for the fluid conduction.
Biosafe
®
Aseptic Transfer Equipment: The Biosafe
®
range of aseptic trans-
fer ports offers reliable and easy-to-use solutions for the secure transfer of
components, fluids, and powders while maintaining the integrity of the
critical areas (such as isolators, Restricted Access Barriers (RABS), and clean
rooms).
