SOP for Preventing Foaming During Manufacturing – V 2.0

Procedure for Preventing Foaming During Manufacturing

Department	Manufacturing/Production/Quality Assurance (QA)/Quality Control (QC)/Research and Development (R&D)
SOP No.	SOP/Ointment/192
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 establish a systematic approach to preventing excessive foaming during the manufacturing of pharmaceutical ointments. Foaming can lead to production inefficiencies, batch inconsistencies, air entrapment, and reduced product stability.

2. Scope

This SOP applies to all personnel involved in the manufacturing, processing, and quality control of ointments in the Manufacturing, Production, Quality Assurance (QA), Quality Control (QC), and Research and Development (R&D) departments.

3. Responsibilities

Production Supervisor: Ensures compliance with anti-foaming measures during manufacturing.
Process Operator: Monitors and controls mixing conditions to prevent foaming.
QA Officer: Verifies adherence to defoaming protocols and process control guidelines.
QC Analyst: Conducts quality testing to assess product homogeneity.
Maintenance Engineer: Ensures equipment operates within the defined parameters to minimize foaming.

4. Accountability

The Production Manager is accountable for ensuring that all procedures related to foaming prevention comply with GMP, FDA, ICH, WHO, and company policies.

5. Procedure

5.1 Identifying Potential Causes of Foaming

Common causes of foaming in ointment manufacturing:
- High-speed mixing leading to air incorporation.
- Incorrect surfactant concentration.
- Excessive agitation during emulsification.
- Use of incompatible

excipients.

Rapid cooling or sudden temperature shifts.

Document identified risks in the **Foaming Risk Assessment Log (Annexure-1).**

5.2 Process Optimization to Minimize Foaming

Set optimized mixing speeds and introduce emulsifiers in a **controlled manner.**
Use **vacuum mixing** where feasible to remove air incorporation.
Document optimized conditions in the **Process Optimization Log (Annexure-2).**

5.3 Use of Defoaming Agents

Use **pharmaceutically approved anti-foaming agents** such as Simethicone (0.01-0.1%).
Record all defoaming agent additions in the **Defoaming Agent Usage Log (Annexure-3).**

5.4 Temperature Control and Cooling Strategies

Maintain **optimal heating temperatures:** Petrolatum-based ointments: **55-70°C**; Emulsion-based ointments: **65-80°C**.
Ensure slow agitation during cooling to prevent **air trapping**.
Document cooling parameters in the **Temperature Control Log (Annexure-4).**

6. Abbreviations

GMP – Good Manufacturing Practices
QA – Quality Assurance
QC – Quality Control
ICH – International Council for Harmonisation
FDA – Food and Drug Administration

7. Documents

Foaming Risk Assessment Log (Annexure-1)
Process Optimization Log (Annexure-2)
Defoaming Agent Usage Log (Annexure-3)
Temperature Control Log (Annexure-4)

8. References

ICH Q8 – Pharmaceutical Development Guidelines
FDA Guidance on Topical Formulation Processing

9. SOP Version

Version 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Foaming Risk Assessment Log

Date	Batch No.	Identified Risk	Preventive Action	QA Approval

Annexure-2: Process Optimization Log

Date	Batch No.	Process Adjustment	Outcome	QA Approval

Annexure-3: Defoaming Agent Usage Log

Date	Batch No.	Defoaming Agent	Concentration (%)	QA Approval

Annexure-4: Temperature Control Log

Date	Batch No.	Heating Temp (°C)	Cooling Rate (°C/min)	QA Approval

12. Revision History

Revision Date	Revision No.	Details	Reason	Approved By
02/02/2025	2.0	Expanded Foaming Prevention Measures	Regulatory Compliance	QA Head