Capsule Filling Operation and In-Process Checks Inspection

Inspection template for capsule filling and encapsulation operations covering in-process fill weight checks, capsule appearance, machine condition, and documentation controls.

Batch and Line Setup

• Batch record, product code, and target capsule specification match the line setup
• Line clearance completed and previous product, labels, and components removed
• Correct capsule size, shell type, and fill formulation loaded
• Environmental conditions within approved operating limits
  Record relative humidity at the filling area and confirm it remains within site-approved limits for capsule shell and blend handling.
• Required batch documentation available at point of use

Machine Condition and Safety Controls

• Machine guards, covers, and access panels in place and secure
• Emergency stop function available and unobstructed
• No visible product leakage, unusual vibration, or abnormal noise during operation
• Lockout-tagout status confirmed before maintenance or jam clearing
• Machine cleaning and lubrication status acceptable for current run

In-Process Fill Weight Checks

• Target fill weight
  Enter the approved nominal fill weight for the batch.
• Measured fill weight
  Record the sampled capsule fill weight from the current in-process check.
• Fill weight within approved tolerance
• Sampling time recorded
  Record the date and time the in-process fill weight sample was taken.
• Sample size meets SOP requirement

Capsule Appearance and Integrity

• Capsules properly closed with no separation at the seam
• Capsule shells free from cracks, dents, splits, or deformation
• Capsules free from visible powder on exterior surfaces
• Color, imprint, and appearance match approved standard
• Rejected capsules segregated and counted

Documentation, Deviations, and Release

• In-process check results recorded in the batch record
• Any out-of-specification result documented and escalated
• Inspector signature completed
• Supervisor or QA review completed when required