XCell™ C410:V3 Controller
User Guide
46 repligen.com UG-C410v3-06
Figure 23. Filtration assembly prepared for autoclaving
Close all unprotected ports.
•
Depending on the size/configuration of the autoclave, the filtration assembly can be placed
inside the autoclave either vertically or at an angle if necessary. Most autoclaves are not
sufficiently tall for vertical placement.
•
Use caution during the procedure so not to damage attached parts or tubing. Avoid kinking
or stressing attached tubing.
5.2
Autoclave cycle
The XCell ATF® Devices have been designed to be sterilized using an autoclave. The features of the
recommended cycle are intended to ensure that the system will be effectively sterilized and that
there is minimal thermal stress imposed on the hollow fiber cartridge that could lead to integrity
XCell ATF® System Filter Preparation and Autoclave Guide
guidance on the entire procedure including the recommended filter integrity test procedures and
specifications.
The recommended cycle will require custom programming to incorporate a 90 minute preheat and 2
- 3 moderated prevac pulses to control the rate of temperature change within the cartridge to a rate
of 1° C/min during the warmup. Repligen recommends that during the cycle development, several
thermocouples should be positioned within the assembly to track the rate of temperature change
and confirm that all positions are at 121 - 123 ° C for the duration of the sterilization section of the
cycle.
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
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.