Procedure for Disassembling and Cleaning Filling Machines

Department	Production/Engineering/Quality Assurance (QA)
SOP No.	SOP/Ointment/053
Supersedes	V 1.0
Page No.	Page X of Y
Issue Date	[Insert Issue Date]
Effective Date	[Insert Effective Date]
Review Date	[Insert Review Date]

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define a standardized method for disassembling and cleaning filling machines used in ointment production. Proper disassembly and cleaning prevent cross-contamination, ensure product integrity, and maintain compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all personnel involved in the disassembly, cleaning, and reassembly of filling machines used in the ointment manufacturing process.

3. Responsibilities

• Production Supervisor: Ensures that cleaning is performed according to SOP guidelines.
• Machine Operator: Disassembles the machine and prepares it for cleaning.
• Cleaning Personnel: Conducts cleaning and sanitization of machine components.
• Quality Assurance (QA) Personnel: Verifies cleaning effectiveness and approves equipment for reuse.
• Engineering Technician: Provides technical assistance in case of complex disassembly or machine repair.

4. Accountability

The Production, Engineering, and QA Managers are accountable for ensuring that filling machine cleaning follows GMP standards and is properly documented.

5. Procedure

5.1 Pre-Cleaning Preparations

• Ensure the filling machine is switched off and disconnected from power sources.
• Depressurize any air or liquid lines before starting disassembly.
• Wear appropriate Personal Protective Equipment (PPE), including gloves, goggles, and aprons.
• Ensure that cleaning agents and sanitizers are available for use.

5.2 Disassembling the Filling Machine

• Follow the manufacturer’s instructions for machine disassembly.
• Remove filling nozzles, piston assemblies, hoppers, and tubing carefully.
• Place disassembled parts on a designated clean surface.
• Inspect components for signs of wear, damage, or residue buildup.

5.3 Cleaning Process

5.3.1 Initial Rinsing

• Flush internal components with purified water to remove visible residues.
• Ensure all product traces are drained completely before applying detergent.

5.3.2 Detergent Cleaning

• Prepare a cleaning solution using an approved detergent.
• Soak disassembled parts in the cleaning solution for at least 15 minutes.
• Scrub internal and external surfaces with soft-bristle brushes to remove residues.
• Ensure cleaning reaches all crevices, especially in nozzles and piston assemblies.

5.3.3 High-Pressure Rinsing

• Use high-pressure purified water to rinse off detergent residues.
• Repeat the rinsing process until all traces of detergent are removed.

5.3.4 Final Sanitization

• Apply an approved sanitizing agent (e.g., 70% ethanol or peracetic acid solution).
• Allow sufficient contact time (10-15 minutes) for effective disinfection.
• Perform a final rinse with purified water.

5.4 Drying and Reassembly

• Allow all cleaned parts to air dry in a designated clean area.
• Reassemble the filling machine according to the manufacturer’s guidelines.
• Ensure all connections are properly secured.
• Lubricate moving parts if necessary, using food-grade lubricants.

5.5 Post-Cleaning Inspection

• Perform a visual inspection to ensure no residues remain.
• Conduct swab testing for microbial contamination.
• Verify that all parts are correctly assembled and functioning properly.

5.6 Documentation and Approval

• Record all cleaning activities in the Cleaning Log.
• QA must approve the cleaned and reassembled filling machine before use.
• Retain cleaning records for audits and compliance checks.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• PPE – Personal Protective Equipment

7. Documents

• Cleaning Log (Annexure-1)
• Cleaning Validation Report (Annexure-2)

8. References

• WHO GMP Guidelines for Pharmaceutical Manufacturing
• 21 CFR Part 211 – Current Good Manufacturing Practices
• ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

9. SOP Version

Version 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Cleaning Log

Date	Machine ID	Cleaning Solution Used	Sanitization Agent	Verified By
01/02/2025	FM-101	Detergent Solution	70% Ethanol	QA Officer
02/02/2025	FM-102	Alkaline Cleaner	Peracetic Acid	QA Officer

Annexure-2: Cleaning Validation Report

Date	Machine ID	Swab Test Result	Microbial Limits	Final Status	Approved By
01/02/2025	FM-101	Pass	Within Limit	Approved	QA Head
02/02/2025	FM-102	Pass	Within Limit	Approved	QA Head

12. Revision History:

Revision Date	Revision No.	Details of Revision	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP	QA Head
01/02/2025	2.0	Updated SOP Format	Standardization of Document	QA Head