Elixir Department: SOP for Agitation Speed Adjustment Based on Batch Size – V 2.0

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Elixir Department: SOP for Agitation Speed Adjustment Based on Batch Size – V 2.0

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.
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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

  1. Determine the exact batch volume from the BMR and confirm the viscosity range.
  2. Refer to the agitation chart or MFR and identify the RPM and agitation time.
  3. On the VFD control panel, press “SET” and enter the desired RPM using the up/down arrows or keypad.
  4. Press “START” to initiate agitation. Observe the tachometer to confirm actual RPM.
  5. Allow the system to stabilize for 2–3 minutes and make fine adjustments if necessary.
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5.3 Monitoring During Agitation

  1. Record the RPM, time of start, and time of completion in the Agitation Logbook (Annexure-1).
  2. Visually inspect the tank for vortex formation, splashing, or sedimentation during mixing.
  3. If RPM fluctuations or mechanical noise is observed, pause operation and report to Engineering.

5.4 Deviation Handling

  1. If RPM deviates from the recommended range due to equipment failure, stop the process.
  2. Inform Engineering and QA for evaluation and CAPA initiation.
  3. Document all deviations and their impact in the BMR and Deviation Report.

5.5 Post-Operation Procedure

  1. Stop the agitator and reset the VFD to “0” RPM after completion.
  2. 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
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7. Documents

  1. Agitation Logbook (Annexure-1)
  2. Deviation Report (if applicable)
  3. 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
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