Run: Chromatography Column Packing and Qualification SOP

The operator verifies that the approved packing request matches the column hardware, resin lot, intended process use, and current revision of the qualification method. The operator records the acceptance criteria for bed height, packing pressure, HETP, asymmetry, and any method-specific limits. If any requirement is missing or unclear, the operator stops and escalates to the supervisor or process owner before proceeding.

The operator inspects the column body, frits, seals, adapter, tubing, and connectors for damage, residue, or wear. The operator verifies that the resin is within expiry, properly stored, and visually acceptable. The operator confirms that the chromatography system is available, calibrated, and free of active maintenance locks or unresolved alarms. If damage, contamination, or expired material is found, the operator records a non-conformance and escalates.

The operator positions absorbent pads, waste containers, and the packing adapter according to the approved setup. The operator confirms that all required PPE is worn and that the work area is clear of unrelated materials. The operator routes waste lines to the designated container and verifies that the system can be isolated if a leak or deviation occurs.

The operator measures the resin and packing buffer according to the approved method. The operator mixes the slurry until it is homogeneous and free of visible clumps or trapped air. The operator records the slurry concentration, buffer identity, and lot numbers. If the slurry does not disperse uniformly, the operator stops and investigates before packing.

The operator transfers the slurry into the column and begins packing at the approved flow rate or pressure. The operator monitors bed formation, pressure, and effluent clarity throughout the packing run. The operator continues until the bed reaches the target height within tolerance and the bed surface appears level and stable. If pressure exceeds the limit, the bed collapses, or channeling is observed, the operator stops and escalates as a deviation.

The operator allows the packed bed to settle for the specified time and then equilibrates the column with the approved buffer until the outlet conditions meet the method requirement. The operator confirms that the bed remains stable and that no air pockets or voids are visible.

The operator loads the qualified test solution and runs the approved qualification method at the specified flow rate, injection volume, and detection settings. The operator records the chromatogram, pressure profile, and any relevant system parameters. The operator ensures that the run is complete and that the data file is saved to the controlled record system.

The operator calculates HETP and asymmetry using the approved method and the recorded chromatogram. The operator verifies that the calculation inputs match the run conditions and that the correct peak is used for evaluation. The operator documents the results in the controlled record and compares them to the acceptance criteria.

The operator reviews the qualification results against the approved limits for HETP, asymmetry, bed height, pressure behavior, and any additional method criteria. The operator determines whether the column is acceptable for use or whether the result requires investigation.

The operator records the final qualification status as accepted and identifies the column as released for the intended purification step. The operator files the completed record in the controlled document system and notifies the relevant team that the column is available for use.

The operator records the non-conformance, including the observed failure mode, chromatogram reference, and any suspected cause such as packing inconsistency, bed instability, or equipment issue. The operator quarantines the column if required and escalates to the supervisor, quality unit, or process owner for disposition. The operator does not release the column until the investigation is closed and approval is documented.