Procedure for Cleaning Homogenizers

Department	Production/Engineering/Quality Assurance (QA)
SOP No.	SOP/Ointment/052
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 cleaning homogenizers post-manufacturing to prevent cross-contamination, maintain product quality, and comply with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all personnel responsible for cleaning and sanitizing homogenizers used in the ointment manufacturing process.

3. Responsibilities

• Production Supervisor: Ensures that homogenizer cleaning is performed as per the SOP.
• Machine Operator: Conducts preliminary rinsing and prepares the homogenizer for cleaning.
• Cleaning Personnel: Executes the detailed cleaning procedure.
• Quality Assurance (QA) Personnel: Inspects and approves the cleanliness of the homogenizer.

4. Accountability

The Production and QA Managers are accountable for ensuring that homogenizer cleaning procedures are properly followed and documented.

5. Procedure

5.1 Pre-Cleaning Preparations

• Ensure the homogenizer is switched off and safely disconnected from the power supply.
• Wear appropriate Personal Protective Equipment (PPE), including gloves, goggles, and aprons.
• Remove any remaining product from the homogenizer.
• Identify and remove any detachable parts for separate cleaning.

5.2 Initial Rinsing

• Flush the homogenizer chamber and blades with warm purified water.
• Drain the water completely before proceeding to detergent cleaning.

5.3 Cleaning Process

5.3.1 Detergent Cleaning

• Prepare a cleaning solution using an approved detergent.
• Circulate the solution through the homogenizer system for 15 minutes.
• Scrub internal and external surfaces with soft brushes.
• Ensure the removal of any ointment residues from the homogenization chamber.

5.3.2 High-Pressure Rinsing

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

5.3.3 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 to remove sanitizing residues.

5.4 Post-Cleaning Inspection

• Conduct a visual inspection to ensure no residues remain.
• Perform swab testing to verify microbial cleanliness.
• Record the results in the Cleaning Log.

5.5 Documentation and Approval

• Log all cleaning activities in the Cleaning Record.
• QA personnel must review and approve the cleaning before the next batch.
• Store records for compliance audits.

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

Annexure-2: Cleaning Validation Report

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