Standard Operating Procedure for Loading Film Rolls onto FFS Machine
1) Purpose
The purpose of this SOP is to define the procedure for safely and effectively loading film rolls onto the Form-Fill-Seal (FFS) machine to ensure smooth and efficient packaging operations.
2) Scope
This SOP applies to all personnel involved in the loading of film rolls onto FFS machines in the pharmaceutical manufacturing facility.
3) Responsibilities
3.1 Production Operators
- Inspect film rolls for defects, damages, or discrepancies before loading.
- Ensure proper alignment and loading of film rolls onto the FFS machine.
3.2 Quality Assurance (QA) Personnel
- Verify the condition of film rolls and compliance with specifications.
- Monitor loading process to prevent errors that could affect product quality.
4) Procedure
4.1 Pre-Loading Preparation
- Retrieve film rolls from designated storage area.
- Inspect each roll for damages, tears, or contamination.
4.2 Loading Process
- Align the film roll with the machine’s feed mechanism.
- Thread the film through the machine according to manufacturer’s instructions.
- Securely attach the film roll to the machine to prevent slippage or misalignment.
4.3 Verification
- Verify correct alignment and tension of the film roll.
- Confirm proper engagement of the film with machine components.
4.4 Post-Loading Checks
- Perform initial checks to ensure film roll is securely loaded and ready for operation.
- Document loading process details and any observations for traceability.
5) Abbreviations, if any
FFS: Form-Fill-Seal
6) Documents, if any
- Film Roll Inspection Checklist
- Loading Logbook
7) Reference, if any
ISO 13485: Medical devices — Quality management systems — Requirements for regulatory purposes
FDA Guidance for Industry: Current Good Manufacturing Practice for Finished Pharmaceuticals
8) SOP Version
Version 1.0