Bio-Rad Bio-Scale™ Mini UNOsphere SUPrA™ Affinity Cartridges - Manual (Page 13)

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Section 7
Operation and Maintenance
UNOsphere SUPrA™ media are designed to achieve high productivity, usability and
scalability, to allow users to process at high linear velocities. A linear flow rate of
up to 600 cm/hr is well within the operational capabilities of the media.
UNOsphere SUPrA media can be used with all buffer systems common in
monoclonal antibody purification. The media are also designed to withstand multiple
compression and decompression cycles at the recommended compression rate of
12%
.
Section 8
Cleaning-in-Place (CIP)
During operation it is recommended that the column bed be periodically cleaned to
remove bound substances that can adversely impact the separation performance of
the column. The accumulated substances fall into two general categories: a) difficult
to remove precipitated or denatured substances, and b) substances that are
hydrophobically bound to the column bed. To ensure that all bound substances are
released and washed out of the column, the following CIP cleaning protocols are
recommended.
CIP Protocols
The following protocols are suggested to remove precipitated or denatured
substances from the bed.
Wash the bed with 2–5 column volumes in reverse flow with one of the following
solutions:
• 6 M guanidine hydrochloride
• 10 mM hydrochloric acid
• 0.1 M sodium hydroxide*
• 1 M acetic acid/20% ethanol
Followed by a reverse flow wash with at least 5 column volumes of binding buffer at
neutral pH (7-8).
To remove any hydrophobically bound substances from the bed, wash the column
with 2–5 column volumes in reverse flow of a non-ionic surfactant/detergent,
followed by a reverse-flow wash with at least 5 column volumes of binding buffer at
neutral pH.
* Suggested contact time per cycle is 15 min at room temperature.
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