Procedure for Using a Homogenizer in Ointment Production

Department	Production/Engineering/Quality Assurance (QA)
SOP No.	SOP/Ointment/042
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 the proper method for operating a homogenizer during ointment production. Homogenization ensures uniform particle distribution, enhances stability, and improves the texture of the final product.

2. Scope

This SOP applies to all personnel involved in the operation, maintenance, and monitoring of homogenizers used in ointment manufacturing.

3. Responsibilities

• Production Supervisor: Ensures homogenization is carried out as per batch requirements.
• Machine Operator: Operates and monitors the homogenizer.
• Quality Assurance (QA) Personnel: Conducts in-process checks to confirm uniformity.
• Engineering Technician: Maintains and calibrates the homogenizer.

4. Accountability

The Production and QA Managers are accountable for ensuring that the homogenization process follows GMP standards and is properly documented.

5. Procedure

5.1 Pre-Operational Checks

• Ensure the homogenizer is clean and sanitized.
• Verify the calibration status of pressure and speed settings.
• Inspect seals, valves, and moving parts for wear or damage.
• Check that all connections are secure and there are no leaks.

5.2 Loading the Ointment for Homogenization

• Transfer the pre-mixed ointment into the homogenization chamber.
• Ensure the temperature is within the required range (e.g., 40°C–50°C).
• Close the homogenizer lid securely before starting the operation.

5.3 Homogenization Process

• Set the homogenizer speed and pressure according to batch specifications.
• Start the homogenizer and allow the ointment to circulate through the system.
• Maintain homogenization for the defined duration (e.g., 20–30 minutes).
• Monitor the pressure gauge to ensure it stays within the prescribed limits.

5.4 Monitoring During Homogenization

• Observe the consistency and flow of the ointment.
• Check for uniform particle size and dispersion.
• Ensure that no air bubbles are introduced into the mixture.

5.5 Completion of Homogenization

• Stop the homogenizer and allow the batch to settle.
• Verify that the product meets viscosity and uniformity specifications.
• Record final parameters (pressure, time, speed) in the Homogenization Log.

5.6 Cleaning and Shutdown

• Drain any remaining ointment from the system.
• Flush the homogenizer with an approved cleaning solution.
• Sanitize all parts and reassemble for the next batch.
• Record cleaning details in the Equipment Cleaning Log.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• RPM – Revolutions Per Minute
• BMR – Batch Manufacturing Record

7. Documents

• Homogenization Log (Annexure-1)
• Equipment Cleaning Log (Annexure-2)

8. References

• WHO GMP Guidelines for Pharmaceutical Manufacturing
• 21 CFR Part 211 – Current Good Manufacturing Practices
• Equipment Manufacturer Guidelines

9. SOP Version

Version 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Homogenization Log

Date	Batch Number	Pressure (Bar)	Speed (RPM)	Time (Min)	Verified By
01/02/2025	SOP/Ointment/001	100	5000	20	QA Officer
02/02/2025	SOP/Ointment/002	120	4800	25	QA Officer

Annexure-2: Equipment Cleaning Log

Date	Homogenizer ID	Cleaning Agent Used	Sanitization Method	Verified By
01/02/2025	HM-101	Sodium Hypochlorite	Rinsed and Dried	QA Head
02/02/2025	HM-102	Ethyl Alcohol	Wiped and Flushed	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