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Run: Chromatography Resin Lifetime and Reuse Inspection

Chromatography Resin Lifetime and Reuse Inspection template for documenting resin condition, cycle controls, cleaning verification, and end-of-life decisions...

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Study Identification and Scope

Study protocol ID and resin lot are identified critical (required)

Column, resin, and ligand type match the validated study scope critical (required)

Yes No N/A

Intended reuse cycle number is documented

Acceptance criteria for performance and retirement are defined critical (required)

Yes No N/A

Pre-Use Resin Condition

Resin bed appears intact with no visible channeling, cracking, or collapse critical (required)

Yes No N/A

Storage buffer or hold solution is within approved specification critical (required)

Yes No N/A

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 critical (required)

Load, wash, elution, and regeneration steps were executed per approved method critical (required)

Yes No N/A

Flow rate remained within validated operating range critical (required)

Note (optional)

Pressure or backpressure remained within approved limits critical (required)

Note (optional)

Cleaning and Sanitization Verification

Cleaning solution concentration and contact time met the validated cleaning procedure critical (required)

Yes No N/A

Rinse conductivity or pH returned to acceptance criteria before reuse critical (required)

Yes No N/A

Bioburden or contamination control checks were performed when required by the protocol critical (required)

Yes No N/A

Cleaning deviations or incomplete recovery were documented

Performance Trend and End-of-Life Review

Binding capacity remains within validated acceptance criteria critical (required)

Yes No N/A

Resolution, selectivity, or recovery remains within trend limits critical (required)

Yes No N/A

Evidence of performance degradation is documented

Note (optional)

Resin retirement or continued-use decision is recorded critical (required)

Note (optional)

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