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Run: Low-pH Viral Inactivation Hold Step Record

Record the low-pH viral inactivation hold step for each batch, including pH, temperature, timing, deviations, and release review in one controlled form.

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Batch and Process Identification

Batch ID (required)

Product Name (required)

Process Step (required)

Manufacturing Suite / Area

Hold Conditions

Target pH (required)

Actual pH at Hold Start (required)

Actual pH at Hold End (required)

Target Temperature (°C) (required)

Actual Temperature (°C) (required)

Temperature Monitoring Method

Hold Timing

Hold Start Date and Time (required)

Hold End Date and Time (required)

Planned Hold Duration (minutes) (required)

Actual Hold Duration (minutes) (required)

Verification and Deviations

Was the hold within approved specification? (required)

Did any deviation, excursion, or alarm occur? (required)

Deviation / Excursion Details (required)

Corrective Action Taken

Submitter and Review

Submitted By (required)

Submission Date (required)

Review Status (required)

Reviewer Comments

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Email (required)

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