Procedure for Operating a Deaerator in Ointment Manufacturing

Department	Production/Engineering/Quality Assurance (QA)
SOP No.	SOP/Ointment/050
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 operating a deaerator during ointment manufacturing. Proper deaeration removes air bubbles, ensures product consistency, and improves product stability.

2. Scope

This SOP applies to all personnel responsible for handling, operating, and maintaining a deaerator in the ointment production process.

3. Responsibilities

• Production Supervisor: Ensures deaeration is performed as per batch requirements.
• Machine Operator: Operates and monitors the deaerator.
• Quality Assurance (QA) Personnel: Verifies air removal efficiency and product uniformity.
• Engineering Technician: Conducts preventive and corrective maintenance on the deaerator.

4. Accountability

The Production and QA Managers are accountable for ensuring that deaeration operations comply with GMP standards and are properly documented.

5. Procedure

5.1 Pre-Operational Checks

• Ensure the deaerator is clean and free from previous batch residues.
• Verify that vacuum pumps and pressure gauges are functional.
• Check for any leaks in the system before operation.
• Ensure the product temperature is within the specified range for deaeration.

5.2 Loading the Product into the Deaerator

• Transfer the pre-mixed ointment into the deaeration chamber.
• Ensure that the filling level does not exceed the recommended capacity.
• Secure all chamber seals to maintain vacuum integrity.

5.3 Deaeration Process

• Start the vacuum pump and gradually increase vacuum pressure.
• Monitor pressure levels to prevent excessive product foaming.
• Maintain vacuum conditions for the specified duration (e.g., 10-20 minutes).
• Ensure uniform removal of air bubbles by observing product clarity.

5.4 Monitoring the Deaeration Cycle

• Check for visible air pockets in the product.
• Verify that the vacuum system maintains stable pressure.
• Record deaeration time, temperature, and pressure in the Deaeration Log.

5.5 Completion of Deaeration

• Gradually release vacuum pressure before opening the chamber.
• Inspect the product for consistency and homogeneity.
• Transfer the deaerated ointment to the next processing stage.

5.6 Cleaning and Shutdown

• Turn off the vacuum pump and disconnect power supply.
• Flush the deaerator with an approved cleaning solution.
• Sanitize all parts and record cleaning details in the Equipment Cleaning Log.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• BMR – Batch Manufacturing Record

7. Documents

• Deaeration 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: Deaeration Log

Date	Batch Number	Vacuum Pressure (Bar)	Temperature (°C)	Deaeration Time (Min)	Verified By
01/02/2025	SOP/Ointment/001	-0.8	40°C	15	QA Officer
02/02/2025	SOP/Ointment/002	-0.85	42°C	18	QA Officer

Annexure-2: Equipment Cleaning Log

Date	Deaerator ID	Cleaning Agent Used	Sanitization Method	Verified By
01/02/2025	DA-101	Sodium Hypochlorite	Rinsed and Dried	QA Head
02/02/2025	DA-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