Standard Operating Procedure for Agitation Speed Adjustment Based on Batch Size in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/149/2025 |
| Supersedes | SOP/ELX/149/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To establish a standardized method for adjusting and verifying agitation speed (RPM) based on batch volume and product characteristics to ensure homogeneity and process consistency during elixir manufacturing.
2. Scope
This SOP applies to all variable speed mixers and agitators used in manufacturing tanks, blending vessels, and holding tanks within the Elixir Department, where batch sizes vary from minimum to maximum working capacity.
3. Responsibilities
- Production Operator:
- Adjust and verify agitation speed based on batch size and product viscosity.
- Record RPM and duration in the BMR and Agitation Logbook.
- Production Supervisor:
- Verify speed adjustments and ensure compliance with MFR instructions.
- Engineering Department:
- Calibrate tachometers and variable frequency drives (VFDs) periodically.
- QA Officer:
- Review speed settings during batch record review.
4. Accountability
The Production Head is accountable for proper implementation. The Engineering Head is responsible for calibration and maintenance of
agitation speed controls.
5. Procedure
5.1 Reference Table for Speed Adjustment
Refer to the Master Formula Record (MFR) or product-specific agitation chart to determine optimal RPM based on batch size.
| Batch Size (Litres) | Viscosity Level | Recommended RPM | Agitation Time (min) |
|---|---|---|---|
| 100–250 | Low | 80–100 | 20–30 |
| 251–500 | Medium | 60–80 | 30–45 |
| 501–1000 | High | 40–60 | 45–60 |
5.2 Setting Agitation Speed
- Determine the exact batch volume from the BMR and confirm the viscosity range.
- Refer to the agitation chart or MFR and identify the RPM and agitation time.
- On the VFD control panel, press “SET” and enter the desired RPM using the up/down arrows or keypad.
- Press “START” to initiate agitation. Observe the tachometer to confirm actual RPM.
- Allow the system to stabilize for 2–3 minutes and make fine adjustments if necessary.
5.3 Monitoring During Agitation
- Record the RPM, time of start, and time of completion in the Agitation Logbook (Annexure-1).
- Visually inspect the tank for vortex formation, splashing, or sedimentation during mixing.
- If RPM fluctuations or mechanical noise is observed, pause operation and report to Engineering.
5.4 Deviation Handling
- If RPM deviates from the recommended range due to equipment failure, stop the process.
- Inform Engineering and QA for evaluation and CAPA initiation.
- Document all deviations and their impact in the BMR and Deviation Report.
5.5 Post-Operation Procedure
- Stop the agitator and reset the VFD to “0” RPM after completion.
- Clean the control panel and label equipment as “READY FOR NEXT USE” or “TO BE CLEANED.”
6. Abbreviations
- SOP: Standard Operating Procedure
- RPM: Revolutions Per Minute
- BMR: Batch Manufacturing Record
- MFR: Master Formula Record
- QA: Quality Assurance
- VFD: Variable Frequency Drive
7. Documents
- Agitation Logbook (Annexure-1)
- Deviation Report (if applicable)
- Calibration Certificate (VFD/Tachometer)
8. References
- 21 CFR Part 211 – Equipment Calibration and Operation
- ICH Q8 – Pharmaceutical Development
- WHO TRS 992 – Mixing and Agitation Practices
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Agitation Logbook
| Date | Tank ID | Batch Size (L) | Set RPM | Actual RPM | Start Time | End Time | Operator | Remarks |
|---|---|---|---|---|---|---|---|---|
| 11/04/2025 | MXR-ELX-02 | 600 | 55 | 54.9 | 09:10 | 10:00 | Sunita Reddy | OK |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP Release | New SOP | QA Head |
| 11/04/2025 | 2.0 | Added reference table and deviation handling | Process Optimization | QA Head |