Hard Capsule Dip-Molding Production SOP

Standard operating procedure for controlling hard capsule dip-molding production, including gel preparation, temperature control, dipping, drying, stripping, joining, and in-process quality checks.

Steps

• The Supervisor verifies batch readiness and line clearance
  Confirm the batch record is released, the correct product and lot are staged, and the line clearance checklist is complete before production starts.
• The Technician confirms gel formulation and material identity
  Verify the approved product specification, material labels, and batch record match the intended capsule shell material and formulation before processing begins.
• The Process Technician sets and verifies gel temperature within tolerance
  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.
• The Technician inspects and prepares mold pins
  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.
• The Operator dips the mold pins into the gel bath
  Immerse the mold pins using the approved depth and dwell time for the batch, and verify each dip stays within the validated process limits.
• The Operator transfers coated molds to the drying area
  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.
• The Process Technician dries the capsule shells under controlled conditions
  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.
• The Operator strips the dried shells from the molds
  Remove the dried shells using only the approved stripping force and inspect each shell during removal for tearing, cracking, or major deformation.
• The Quality Inspector inspects stripped shells for defects
  Inspect each shell against the dimensional, visual, and moisture acceptance criteria, photograph any defect found, and segregate nonconforming shells immediately.
• The Operator joins the cap and body components
  Align the cap and body components at the joining station and confirm the assembled capsule meets the approved fit tolerance before release.
• The Line Lead records output and escalates deviations
  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.