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Run: Hard Capsule Dip-Molding Production SOP

Hard Capsule Dip-Molding Production SOP template for gel preparation, mold pin handling, dipping, drying, stripping, joining, and in-process quality checks. ...

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Steps

Confirm the batch record is released, the correct product and lot are staged, and the line clearance checklist is complete before production starts.
Verify the approved product specification, material labels, and batch record match the intended capsule shell material and formulation before processing begins.
Measure the gel temperature with a calibrated thermometer every 15 minutes and confirm it remains within 45–50 °C (±1 °C) before and during dipping; stop the run and escalate any reading outside this range.
Visually inspect each mold pin under adequate line lighting for cracks, corrosion, residue, or misalignment; segregate any nonconforming pin and clean only conforming pins with approved supplies before use.
Immerse the mold pins using the approved depth and dwell time for the batch, and verify each dip stays within the validated process limits.
Move coated molds to the drying area using the approved handling method and place them on the drying rack or into the drying tunnel without visible deformation or contamination.
Maintain the validated drying temperature and humidity settings, monitor the environmental log continuously, and continue drying until shells reach the approved dryness target for stripping.
Remove the dried shells using only the approved stripping force and inspect each shell during removal for tearing, cracking, or major deformation.
Inspect each shell against the dimensional, visual, and moisture acceptance criteria, photograph any defect found, and segregate nonconforming shells immediately.
Align the cap and body components at the joining station and confirm the assembled capsule meets the approved fit tolerance before release.
Record production output, inspection results, and any out-of-tolerance temperature, drying, stripping, or joining result in the batch record and deviation log, then escalate the issue to the supervisor or quality unit.

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