Chromatography Resin Lifetime and Reuse Inspection

Inspection template for validating chromatography resin reuse cycles, cleaning effectiveness, column performance, and end-of-life criteria before performance degrades.

Study Identification and Scope

• Study protocol ID and resin lot are identified
• Column, resin, and ligand type match the validated study scope
• Intended reuse cycle number is documented
• Acceptance criteria for performance and retirement are defined

Pre-Use Resin Condition

• Resin bed appears intact with no visible channeling, cracking, or collapse
• Storage buffer or hold solution is within approved specification
• Resin age since first use is recorded
• Pre-use visual inspection notes any discoloration, fouling, or particulate accumulation

Column Cycling and Process Controls

• Cycle number is recorded for the current run
• Load, wash, elution, and regeneration steps were executed per approved method
• Flow rate remained within validated operating range
• Pressure or backpressure remained within approved limits

Cleaning and Sanitization Verification

• Cleaning solution concentration and contact time met the validated cleaning procedure
• Rinse conductivity or pH returned to acceptance criteria before reuse
• Bioburden or contamination control checks were performed when required by the protocol
• Cleaning deviations or incomplete recovery were documented

Performance Trend and End-of-Life Review

• Binding capacity remains within validated acceptance criteria
• Resolution, selectivity, or recovery remains within trend limits
• Evidence of performance degradation is documented
• Resin retirement or continued-use decision is recorded