SOP for Operating Mixing Tanks – V 2.0

Procedure for Operating Mixing Tanks

Department	Production/Engineering/Quality Assurance (QA)
SOP No.	SOP/Ointment/041
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 operating mixing tanks during ointment manufacturing. Proper operation ensures uniform mixing, product consistency, and compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all personnel responsible for handling, operating, and maintaining mixing tanks in the manufacturing process.

3. Responsibilities

Production Supervisor: Ensures mixing operations comply with batch requirements.
Machine Operator: Controls mixing speed, temperature, and time.
Quality Assurance (QA) Personnel: Verifies process compliance and records deviations.
Engineering Technician: Maintains and calibrates mixing tanks.

4. Accountability

The Production and QA Managers are accountable for ensuring that mixing tank operations are conducted as per GMP standards and properly documented.

5. Procedure

5.1 Pre-Operational Checks

Ensure the mixing tank is clean and sanitized.
Verify the calibration status of temperature and speed control systems.
Check for any leaks, loose fittings, or signs of equipment malfunction.
Ensure all ingredients are measured and available per the Batch Manufacturing Record (BMR).

5.2 Loading Ingredients

Start by adding base materials (e.g., waxes, oils) into the mixing tank.
Maintain the required temperature to facilitate ingredient dispersion.
Gradually add active ingredients and

excipients as per the formulation.

Ensure slow-speed stirring during the addition to avoid splashing.

5.3 Mixing Operations

Set the mixing speed according to the process specifications.
Monitor temperature to prevent degradation of heat-sensitive ingredients.
Use a scraper blade to ensure uniform mixing and prevent material buildup.
Maintain agitation for the specified duration in the Batch Manufacturing Record.

5.4 Monitoring During Mixing

Check viscosity and homogeneity at regular intervals.
Ensure no phase separation or foaming occurs.
Verify that all ingredients are fully incorporated.

5.5 Completion of Mixing

Gradually reduce mixing speed to a complete stop.
Check for uniform consistency and absence of lumps.
Record final temperature, mixing time, and RPM in the Mixing Log.
Proceed to the next processing stage as per the manufacturing plan.

5.6 Cleaning and Shutdown

Transfer the batch to the next stage or storage container.
Flush the mixing tank with an approved cleaning agent.
Sanitize the equipment and ensure it is ready 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

Mixing 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: Mixing Log

Date	Batch Number	Mixing Speed (RPM)	Temperature (°C)	Mixing Time (Min)	Verified By
01/02/2025	SOP/Ointment/001	500	45°C	20	QA Officer
02/02/2025	SOP/Ointment/002	600	40°C	25	QA Officer

Annexure-2: Equipment Cleaning Log

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