XCell™ C410:V3 Controller
User Guide
45 repligen.com UG-C410v3-06
5.
Sterilization
5.1
Preparation of filtration assembly for autoclaving
Repligen recommends sterilization of the filtration assembly by autoclaving. An appropriately sized
autoclave is required. Contact Repligen for dimensional analysis of the autoclave. Sterilization of the
filtration assembly by autoclaving is one of the simplest methods to sterilize the system.
Pre-Autoclaving check list:
•
Thoroughly wet the HFM with appropriate wetting agent
•
Fully assemble filtration assembly as shown in
•
Perform a pressure test
•
Vent all ports blocked with 0.2 micron vent filters
With both the filtrate and retentate sides vented, formation of pressure gradients across the hollow
fibers membranes during sterilization is minimized. This assures free flow of steam into the unit and
unobstructed pressure equilibration between all compartments within the unit; particularly, the
filtrate and retentate sides are at the same pressure during the sterilization and cool down
procedures.
Note:
Use high-capacity vent filters to allow unobstructed high flow of steam into and from the
system.
Please refer to the XCell ATF® System Filter Preparation and Autoclave Guide for detailed guidance
on the entire procedure including the recommended filter integrity test procedures and
specifications.
WARNING:
These procedures refer to steam sterilization procedures.
Steam is supplied at high pressure and at high temperature,
over 100°C and can exceed 125°C. All parts of the filtration
assembly are rapidly heated. Use similar precautions after
removal of a system from an autoclave. Such heated systems
should only be handled by qualified personnel taking all proper
safety precautions.