available and meet pre-heating specifications.

Document pre-heating checks in the **Pre-Heating Checklist (Annexure-1).**

5.2 Setting Up the Heating Equipment

• Use **double-jacketed heating vessels** or **steam-heated kettles** for uniform heating.
• Set **temperature control settings** based on the formulation:
  • Petrolatum-based ointments: 55-70°C
  • Emulsion-based ointments: 65-80°C
  • Wax-based formulations: 75-90°C
• Ensure **continuous agitation** to prevent localized overheating.
• Monitor **real-time temperature readings** on display panels.
• Record equipment settings in the **Equipment Setup Log (Annexure-2).**

5.3 Heating Process

• Turn on the **heating source** and gradually increase the temperature.
• Ensure a **uniform heating rate of 1-2°C per minute** to avoid thermal degradation.
• Check for complete **melting of waxes and dispersal of emulsifiers.**
• Stir the mixture continuously using a **mechanical agitator at 100-300 RPM.**
• Maintain **target temperature for 15-30 minutes** for proper homogenization.
• Document process parameters in the **Heating Process Log (Annexure-3).**

5.4 Temperature Monitoring and Quality Control

• Use **infrared thermometers or probe sensors** for temperature validation.
• Measure and record temperatures at:
  • 0 minutes (Start of heating)
  • Every 5 minutes during heating
  • At target temperature
  • After holding phase
• Conduct **viscosity and consistency tests** at different stages.
• Record findings in the **Temperature Monitoring Report (Annexure-4).**

5.5 Cooling and Post-Heating Handling

• After achieving the required heating duration, **gradually cool** the ointment base.
• Use **controlled cooling (1-2°C per minute)** to avoid crystallization or phase separation.
• Continue mixing to ensure uniform consistency.
• Store **processed ointment bases in designated holding tanks** before further processing.
• Document post-heating handling in the **Cooling and Storage Log (Annexure-5).**

5.6 Equipment Cleaning and Shutdown

• Turn off heating systems and allow **equipment to cool to ambient temperature.**
• Perform **clean-in-place (CIP) or manual cleaning procedures**.
• Ensure no residue is left inside heating vessels.
• Document cleaning activities in the **Equipment Cleaning Log (Annexure-6).**

6. Abbreviations

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

7. Documents

• Pre-Heating Checklist (Annexure-1)
• Equipment Setup Log (Annexure-2)
• Heating Process Log (Annexure-3)
• Temperature Monitoring Report (Annexure-4)
• Cooling and Storage Log (Annexure-5)
• Equipment Cleaning Log (Annexure-6)

8. References

• ICH Q8 – Pharmaceutical Development Guidelines
• FDA Guidance on Ointment Processing
• WHO Guidelines on Topical Drug Manufacturing

9. SOP Version

Version 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Pre-Heating Checklist

Date	Batch No.	Ingredient Availability	QA Approval
02/02/2025	OINT-1002	Complete	Approved

Annexure-2: Equipment Setup Log

Date	Equipment Name	Calibration Status	QA Approval
02/02/2025	Steam-Jacketed Kettle	Validated	Approved

12. Revision History

Revision Date	Revision No.	Details	Reason	Approved By
02/02/2025	2.0	Expanded Heating Parameters	Regulatory Compliance	QA Head