Standard Operating Procedure for Start-Up and Shutdown Procedures for Form-Fill-Seal (FFS) Machine

1) Purpose

The purpose of this SOP is to establish guidelines for the safe and efficient start-up and shutdown of the Form-Fill-Seal (FFS) machine to ensure consistent production and equipment longevity.

2) Scope

This SOP applies to all operators and maintenance personnel responsible for operating the FFS machine in the pharmaceutical manufacturing facility.

3) Responsibilities

3.1 Operators

• Execute start-up and shutdown procedures according to SOP.
• Monitor equipment performance during operation.

3.2 Maintenance Personnel

• Perform regular maintenance checks and minor adjustments.
• Report any equipment issues or abnormalities.

4) Procedure

4.1 Start-Up Procedure

1. Inspect the FFS machine for cleanliness and proper setup.
2. Power on the machine and ensure all safety features are functional.
3. Load necessary materials (e.g., film rolls, product components).
4. Set operational parameters according to product specifications.
5. Perform trial runs to verify machine performance.

4.2 Operation Monitoring

1. Monitor critical process parameters (e.g., temperature, pressure).
2. Adjust settings as necessary to maintain product quality.

4.3 Shutdown Procedure

1. Complete production batch according to batch record instructions.
2. Clean and sanitize machine components as per cleaning SOP.
3. Power off the machine and secure all components.

5) Abbreviations, if any

SOP: Standard Operating Procedure; FFS: Form-Fill-Seal

6) Documents, if any

• Start-Up and Shutdown Checklist
• Equipment Maintenance Logs
• Cleaning and Sanitization Records

7) Reference, if any

ISO 11607: Packaging for Terminally Sterilized Medical Devices
FDA Guidance for Industry: Current Good Manufacturing Practice for Combination Products

8) SOP Version

Version 1.0