Introduction 9
4 Introduction
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 .
BioWelder
®
TC was developed and programmed to weld C-Flex
®
374, Advantaflex,
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
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
®
TC are guaranteed to be of sufficient quality
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
®
TC was designed for industrial use and may
not be used for medical applications . Please refer to Chapter 1 Hazard Information
for additional limitations . The connection created by the BioWelder
®
TC cannot meet
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 .