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8.0 Sterilization
WARNING:
These procedures refer to steam sterilization procedures. Steam is supplied at high pressure
and at high temperature, over 100ºC and can exceed 125ºC. 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.
8.1 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. In addition
to the procedure below, please refer to the “XCell™ ATF System Filter Preparation and Autoclave
Guide” for further details.
Pre-Autoclaving check list:
8.1.1 Thoroughly wet the HFM with appropriate wetting agent
8.1.2 Fully assemble Filtration Assembly as shown in Figure 9.
8.1.3 Perform a pressure test.
8.1.4 Vent all ports blocked with 0.2micron 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.
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