Sartorius Biowelder Total Containment, Руководство по эксплуатации

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Operating Manual Biowelder
®
Total Containment 9
Introduction
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
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Fully automatic mode
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Welds thermoplastic tubes from different manufacturers up to 1 inch
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Liquid filled tubes
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Welds waste tubes without spilling fluid
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Suitable for the taking of samples
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Pre-installed standard settings for the most common tubes
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Reliable thermal welding
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Aseptic connections without laminar-flow bank
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Data logging and output to memory card or via Web browser to the computer
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Easy to validate with temperature validation set (option)
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Compact and portable design
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Easily expandable for new tube materials and tube geometries
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Simple operation via a touch screen
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Simple operation via a Web browser without additional installation of software
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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 circumstances 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.