Introduction; Features; Safety; Limitations - Sartorius Stedim Biotech BioWelder Total Containment TC 2000 Bedienungsanleitung

4

Introduction

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The BioWelder TC works by means of a thermal welding technique that uses no
laminar flow . In this welding technique the blade is kept sterile and pyrogen-free
during the welding process . This occurs according to the reaction equation or
Arrhenius's law by means of a temperature and time constant (Wallhäuser: The
D-value resistance indicator for bacillus subtilis is less than 1 sec at 200°C of dry
heat) . The inserted pre-sterilized tubing (gama irradiated and/or autoclaved) tubes
are separated by the heated blade and thermally welded to each other by the device .
The welding is completely automated and is released only after a finished cycle .
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BioWelder TC was developed and programmed to weld C-Flex
Pharmed BPT and SaniPure™ BDF™ . These parameters are validated at room temperature .
4.1

Features

y Fully automatic mode
y Welds thermoplastic tubes from different manufacturers up to 1 inch
y Liquid filled tubes
y Welds waste tubes without spilling fluid
y Suitable for the taking of samples
y Pre-installed standard settings for the most common tubes
y Reliable thermal welding
y Aseptic connections without laminar-flow bank
y Data logging and output to memory card or via Web browser to the computer
y Easy to validate with temperature validation set (option)
y Compact and portable design
y Easily expandable for new tube materials and tube geometries
y Simple operation via a touch screen
y Simple operation via a Web browser without additional installation of software
y Pre-installed languages, additional languages upon request
4.2

Safety

As the blade can reach temperatures of over 400°C during the welding process and
drives move with high forces, the cover must not be opened during the process to
avoid injury . The device releases the cover automatically as soon as the blade has
cooled off adequately . Use only tubes that are compatible with the device . Use only
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BioWelder TC single use blades from Sartorius . Use the blades only once to obtain
optimum results . Use the blade remover tool (accessory) all the time to remove the
blade from the device .
4.3

Limitations

The welds made with the BioWelder
and strength for sterile fluid transfer . However, it is ultimately the responsibility of
the end consumer to check and validate the device for suitability . Under no circum-
stances can data from this operating manual be presented to an official body as
reference to manufacture a clinical product without the written consent of the
Sartorius Stedim Biotech . The BioWelder
not be used for medical applications . Please refer to Chapter 1 Hazard Information
for additional limitations . The connection created by the BioWelder
the requirements for medical applications . It is the responsibility of the user to decide
whether the device is suitable . Examine welds thoroughly before using them .
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374, Advantaflex,
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TC are guaranteed to be of sufficient quality
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TC was designed for industrial use and may
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TC cannot meet
Introduction 9