Function; Function Function Function Function - Sartorius stedim BioWelder Operation Manual

Interchangable tube holders
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3. 3. 3. 3.

Function

Function Function Function
The BioWelder® is used to connect two pieces of thermoplastic tubing together
under sterile conditions. Each piece of tubing is connected on one end to a
container, bag, or process equipment. The other end is sealed by a clamp, plug,
or other closure.
To make a sterile connection, first insert both hoses which have to be welded
together in the left and right tube holder of the BioWelder® in the correct position.
Insert then a new cutting blade into the blade holder in the unit.
The dosing of the cover initiates the steps in the welding program. In the first step,
the cutting blade is heated up to more than 400°C and held there for 5 seconds.
This step ensures that the blade is sterile and depyrogenated. Next, the blade is
allowed to cool to a preset welding temperature depending on the type of tubing
to be connected. The heated blade is then moved so that it melts through the two
tubing pieces simultaneously. During this operation the blade temperature is
controlled and the tubing is forced against both sides of the blade so that the
operation remains sterile. Once the tubing has been cut, the machine slides the
cut tubing pieces into alignment. The blade is then extracted while the tubing is
pushed together. The tubing pieces remain at all times in contact with the hot
blade ensuring sterile operation. Once the blade is fully extracted, the weld is
allowed to cool. The release of the cover indicates the end of the welding and the
machine can be opened.
The connected tubing can then be removed, and is ready for use. The used blade
and cut tubing ends are discarded.
The BioWelder® is a fully automated device, and will only indicate the successful
completion of the welding cycle if all operations have functioned properly.
The procedure is completely reproducible and independent of operator skill.
Therefore it can be readily validated to assure a sterile connection. Use of a new
disposable blade for each cycle eliminates any potential cross-contamination
concerns.
The BioWelder® starts an initialization after every 9 welding cycles as soon as the
cover will be closed.
To simplify the documentation of the welding parameters the BioWelder® is
equiped with, a printer interface with which the welding date can be protocolled
after each welding.
To simplify the validation and|or to allow the validation to the client, an optional
adapted calibration set can be obtained.