Standard Operating Procedure for Cleaning and Sanitization of FFS Machine

1) Purpose

The purpose of this SOP is to define the procedure for cleaning and sanitizing the Form-Fill-Seal (FFS) machine to prevent cross-contamination, ensure product quality, and comply with regulatory requirements.

2) Scope

This SOP applies to the cleaning and sanitization of all FFS machines used in pharmaceutical manufacturing processes within the facility.

3) Responsibilities

3.1 Production Operators
– Perform cleaning and sanitization tasks on FFS machines following established procedures.
– Ensure all cleaning materials and equipment are used and stored properly.
3.2 Cleaning Validation Team
– Validate cleaning procedures to ensure effectiveness in removing residues and contaminants.
– Document and report validation findings to Quality Assurance (QA).
3.3 Quality Assurance (QA) Personnel
– Review and approve cleaning procedures and validation reports.
– Conduct periodic audits to verify compliance with SOPs and regulatory standards.

4) Procedure

4.1 Pre-Cleaning Preparation
4.1.1 Power off and isolate the FFS machine from power sources and production areas.
4.1.2 Disassemble removable parts and components for thorough cleaning.
4.2 Cleaning Process
4.2.1 Remove visible residues and contaminants using appropriate cleaning agents and tools.
4.2.2 Rinse surfaces with clean water to remove cleaning agents and residues.
4.3 Sanitization