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REPLIGEN OPUS 14 - 4 OPUS Column Sanitization, Storage, and Disposal; Cleaning and Sanitization Notes; 5 Troubleshooting; Air in the Column

REPLIGEN OPUS 14
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UG-OPU 5-80R
13
OPUS® 5-80R Pre-packed Chromatography Columns
OPUS® Column Sanitization, Storage, and Disposal 4
4.1 Cleaning and Sanitization Notes
Please consult the resin supplier for recommended cleaning and storage protocols
OPUS® Columns can be cleaned with any sanitization agent that is compatible with the
materials of construction (see Table 5 for Solvent Compatibility Summary)
Prior to sanitizing your column, check for solvent compatibility with the chromatography
resin supplier
1. Once your chromatography process is completed, the column should be prepped for
disposal or storage.
1.1.1. Disposal: Clean and sanitize the column prior to disposal according to
local government regulations.
1.1.2. Storage: Clean, flush, and prepare the column for storage per the recommendations
of the resin supplier or other validated procedure.
2. Reuse post storage: Start with the general usage instructions in the “Connecting and
Operating Your OPUS® ColumnSection.
Troubleshooting 5
5.1 Air in the column
Potential Fixes
If air entered the inlet port and did not reached the column (to the best assessment of the
operator), follow the air purge procedure described in Appendix 1
If air entered the packed chromatography bed, recondition the column by running a solution
with low surface tension in reverse flow for 2-3 CVs. Increased backpressure on the column
effluent may aid in forcing air bubbles out from the column
o Examples of low surface tension solutions include 1% surfactant (e.g. Tween) and 20%
Ethanol for normal phase resins
o Contact Repligen Customer Support for specific troubleshooting tactics specified to
column dimension and packed resin
Retest column performance (Efficiency, Asymmetry) according to instructions in Appendix 3.
Results conforming to the provided CoA for your column will help justify release into
production
5.2 High pressure during first use of column
Causes
Undersized tubing, fitting, and/or gaskets
Incorrect column valve position
Flow path restriction
Operation under higher flow rate than recommended for the packed resin bed
Temperature shifts between buffers used in the column
Potential Fixes
Refer to Table 2 or 3 for flow path sizing
Check valve position

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