Function; Blocked Device - Sartorius Stedim Biotech BioWelder Total Containment TC 2000 Bedienungsanleitung

10 Introduction
4.4

Function

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The BioWelder TC is used for the sterile welding of two tube pieces . Every piece of
tube is connected on one end to a container, bag or process unit . The other end is
sealed with a clamp, plug or another seal . To create a sterile connection, first place
the two tubes in the tube holder of the BioWelder
into the blade holders of the device . Closing the cover and pressing the start button
activates the steps in the welding programme . In the first step the blade is heated to
over 400°C and held for 5 seconds at this temperature . This step guarantees that the
blade is sterile and pyrogen-free . Then the blade is cooled to the required cutting and
welding temperature which depends on the type of tube . Afterwards the heated
blade simultaneously cuts through the two pieces of tube . The blade temperature is
controlled during the cutting process . Once the tubes have been cut through, the
device turns the tubes so that they line up . The blade is then pulled back, the tubes
pressed together and the weld cooled off . The release of the cover signals the end of
the welding and the device can be opened . The welded tube is taken out and is now
ready for use . The used blade and the waste tube are removed . The BioWelder
fully automatic unit and displays the successful conclusion of the welding if all steps
were followed properly . The process is completely reproducible .
The device is programmed with standard parameter sets for welding C-Flex
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AdvantaFlex , PharMed BPT and SaniPure™ BDF™ .
These parameter sets have been validated at room temperature .
The use of a new blade after each welding prevents cross-contamination and to
ensure proper welding quality . To simplify the logging of welding data for the user,
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the BioWelder TC has a memory card to which data can be written as needed . In
addition, data can be loaded to a computer through a Web browser . To simplify the
validation or to facilitate the validation process for the customer, a validation set
matching the device can be acquired for the BioWelder
4.5

Blocked device

Check all equipment inside the BioWelder
reliability . In addition, monitor every step during a sequence . If equipment such as a
drive or the heating gives out, or the execution of a step in a sequence fails, then an
error is present . Such a fault leads to a blocked device . When the device is blocked,
all on-going processes are stopped and the operator control displays this message:
"All runs blocked (X)"
A blocked device is present if the operator control displays the following text:
"All runs blocked (X)"
If a sequence of a process cannot be finished for some reason, this does not
necessarily indicate a defective device . It could be that the user has chosen a wrong
type of tube, for example .
A blocked device does NOT necessarily contain a defective component.
It is possible that a sequence could not be completed successfully.
If there is a blocked device because of a failed sequence, in most cases the device
can be reversed . In such a case the blockage can usually be resolved by switching the
device on and off .
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TC . Then a new blade is inserted
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TC as an option .
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TC device continuously for operational
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TC is a
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374,