XCell ATF Series, Руководство пользователя

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XCell TM ATF System with C410:V3 Controller User Guide
temperature change and confirm that all positions are at 121-123 oC for the
duration of the sterilization section of the cycle.
8.2.2 While autoclave conditions may vary based on requirements, the following are
typical autoclave conditions for the Filtration Assembly. Please refer to the
XCell™ ATF System Filter Preparation and Autoclave Guide for more details. The
entire cycle may take 4-5 hours.
•
The assembly should be placed in the autoclave at a 45 0 angle and be
allowed to warm up for a period not less than 60 minutes with steam in
the jacket, but not in the chamber.
•
The active cycle will begin with a 5 minute purge where steam flows
through the autoclave directly to the drain with minimal increase in
chamber pressure.
• Secondly, there are 2-3 vacuum pulses with “hold” periods in between.
These are critical to evacuate all of the air within the assembly and ensure
that there is a uniform temperature throughout the assembly prior to
engaging the ramp up to reach the sterilization temperature.
• Follow with a 1 minute steam purge to about 6psi, and 108 0 C
• Ramp up slowly, 1 0 C/min, to sterilization temperature / pressure, of 121 0 -
123 0 C / 16psi
• Sterilize for ~ 55-60 min.
• Ramp down slowly, with wet cycle exhaust protocol or 0.5-1 0 C/min to
100 0 C
• Allow the system to cool to 50 o C before handling
8.2.3 Open autoclave door, inspect the system, re-tighten all clamps (about ¼ turn).
8.2.4
Carefully
remove the Filtration Assembly from the autoclave.
8.2.5
Preferably
, remove the Filtration Assembly from autoclave into clean area.
8.2.6
Allow
system to cool to room temperature in a clean area.
8.2.7 Pressurize system to about 5psi using sterile air source through one of the
retentate vent filters. This step is optional.
8.2.9 After cool down to room temp or after pressurization of system, close all valves.
c1. The system may be stored until use.
8.3 Sterilization of Filtrate / Harvest line
The Filtrate / Harvest line with end filter will be sterile following autoclave. One must
assure however that the Harvest line has been prepared with the appropriate tubing for
use with the filtrate / harvest pump. One may also prepare the Filtrate / Harvest line,
post autoclaving, using a tube welder. If a tube welder cannot be used, a disposable
sterile coupling may be used.
9.
Connection to Bioreactor
Two types of connections between Filtration Assembly and bioreactor are commonly
available.
1
Hard connection that can be sterilized by SIP
2 Soft connection that use single use connectors such as the Kleenpak, AseptiQuik, Opta,
Readymate DAC, Pure-Fit , or other connectors now available from various vendors.