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 |