Procedure for Transferring Ointments to Filling Machines

Department	Production/Quality Assurance (QA)/Engineering
SOP No.	SOP/Ointment/027
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 standardized process for transferring ointments from the manufacturing vessel to the filling machine. Proper transfer ensures product integrity, prevents contamination, and maintains consistency in filling operations.

2. Scope

This SOP applies to all personnel involved in the transfer of ointments from storage tanks or processing vessels to automatic or semi-automatic filling machines in the production area.

3. Responsibilities

• Production Supervisor: Oversees the transfer process and ensures compliance with SOP guidelines.
• Machine Operator: Operates and monitors the transfer equipment.
• Quality Assurance (QA) Personnel: Verifies product integrity and ensures compliance with GMP standards.
• Engineering Technician: Maintains and troubleshoots the transfer system.

4. Accountability

The Production and QA Managers are accountable for ensuring that the ointment transfer process is conducted as per GMP standards and properly documented.

5. Procedure

5.1 Pre-Transfer Preparations

• Ensure that the filling machine, transfer hoses, and storage tanks are clean and sanitized.
• Verify that the ointment batch has been approved for filling by the QA department.
• Check the temperature of the ointment to ensure it is within the specified range for transfer.
• Ensure that all valves, pumps, and transfer lines are correctly assembled.

5.2 Selection of Transfer Method

• Gravity Transfer: Used for small-scale manual filling.
• Pneumatic Transfer: Utilizes compressed air to push the product through transfer lines.
• Positive Displacement Pump Transfer: Ensures uniform flow to the filling machine.

5.3 Transferring the Ointment

• Connect the transfer hoses securely to prevent leaks.
• Activate the transfer system and monitor the flow rate.
• Ensure there are no air bubbles or interruptions in the transfer process.
• Maintain constant agitation (if required) to prevent phase separation.

5.4 Monitoring During Transfer

• Observe the transfer for any signs of clogging or foaming.
• Ensure that all connections remain sealed to avoid contamination.
• Check that the transfer rate is consistent with the filling machine’s capacity.

5.5 Completion of Transfer

• Shut off the transfer system once the required volume has been transferred.
• Disconnect and flush the transfer lines with an approved cleaning solution.
• Perform a final weight verification of the transferred batch.

5.6 Documentation and Approval

• Record all process parameters in the Ointment Transfer Log.
• QA must verify and approve the transferred batch before filling begins.
• Label the filled machine hopper as “Ready for Filling.”

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• R&D – Research and Development
• BMR – Batch Manufacturing Record

7. Documents

• Ointment Transfer Log (Annexure-1)
• In-Process Quality Control Report (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: Ointment Transfer Log

Date	Batch Number	Transfer Method	Temperature (°C)	Transfer Time (Min)	Verified By
01/02/2025	SOP/Ointment/001	Pneumatic	55°C	20	QA Officer
02/02/2025	SOP/Ointment/002	Gravity	50°C	15	QA Officer

Annexure-2: In-Process Quality Control Report

Date	Batch Number	Test Parameter	Specification	Result	Final Status
01/02/2025	SOP/Ointment/001	Temperature	50-60°C	55°C	Pass
02/02/2025	SOP/Ointment/002	Transfer Efficiency	≥98%	99%	Pass

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