Standard Operating Procedure for Changeover Procedures for Different Product Runs on FFS Machine

1) Purpose

The purpose of this SOP is to define the procedure for efficient and effective changeovers between different product runs on Form-Fill-Seal (FFS) machines to minimize downtime, prevent cross-contamination, and ensure product quality.

2) Scope

This SOP applies to changeover procedures performed on all FFS machines used in pharmaceutical manufacturing processes within the facility.

3) Responsibilities

3.1 Production Operators

• Execute changeover procedures following established protocols and guidelines.
• Ensure proper cleaning and inspection of FFS machine parts and components during changeovers.

3.2 Quality Assurance (QA) Personnel

• Verify completion of changeover procedures and compliance with cleaning and sanitization requirements.
• Conduct visual inspections and checks to confirm readiness for production.

4) Procedure

4.1 Preparation for Changeover

1. Review and obtain production schedule and changeover instructions.
2. Prepare changeover tools, materials, and components for the upcoming production run.

4.2 Machine Setup and Adjustment

1. Perform machine setup and adjustments as per the new product specifications.
2. Verify correct installation and alignment of filling nozzles, sealing jaws, and other critical components.

4.3 Cleaning and Sanitization

1. Clean and sanitize parts and surfaces that come in contact with the product, following approved procedures.
2. Document cleaning activities and verify cleanliness through visual inspection and swab testing.

4.4 Trial Run and Validation

1. Conduct trial runs with the new product to ensure proper functionality and quality compliance.
2. Verify process parameters and product specifications during the validation phase.

4.5 Final Checks and Approval

1. Perform final checks and inspections to confirm readiness for full-scale production.
2. Obtain approval from QA or designated personnel before commencing commercial production.

5) Abbreviations, if any

FFS: Form-Fill-Seal
QA: Quality Assurance

6) Documents, if any

• Changeover Checklist
• Cleaning and Sanitization Records
• Validation Reports

7) Reference, if any

ISPE Baseline Guide Volume 3: Commissioning and Qualification
FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing

8) SOP Version

Version 1.0