SOP Guide for Pharma

Elixir Department: SOP for Agitator Operation and RPM Calibration – V 2.0

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Elixir Department: SOP for Agitator Operation and RPM Calibration – V 2.0

Standard Operating Procedure for Agitator Operation and RPM Calibration in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/124/2025
Supersedes SOP/ELX/124/2022
Page No. Page 1 of 10
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To define the standardized procedure for the safe and accurate operation of agitators and calibration of their speed (RPM) in mixing vessels used for elixir production. This ensures consistent product homogeneity and compliance with process validation parameters.

2. Scope

This SOP applies to all agitators—mechanical, magnetic, and variable-speed—installed in mixing vessels used in the Elixir Department for blending APIs, excipients, solvents, and syrups.

3. Responsibilities

  • Production Operator:
    • Start and monitor agitator operation as per the defined process parameters.
  • Engineering Department:
    • Perform RPM calibration using calibrated tachometers and maintain calibration records.
  • Production Supervisor:
    • Verify agitator speed settings and ensure calibration is within due date.
  • QA Officer:
    • Review and approve agitator calibration reports and compliance documentation.
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4. Accountability

The Production Head is accountable for ensuring correct operation of agitators, and the Engineering Head is accountable for periodic RPM calibration and its documentation.

5. Procedure

5.1 Pre-Operation Checks

  1. Check that the mixing vessel and agitator are labeled as “CLEANED” and approved for use.
  2. Ensure that the agitator motor is connected and the control panel is functional.
  3. Verify the RPM calibration tag and ensure it is within the valid calibration period.

5.2 Agitator Operation

  1. Switch on the main power and the agitator control panel.
  2. Set the desired RPM based on BMR specifications (e.g., 80 RPM for syrup dispersion).
  3. Start the agitator gradually and ensure stable rotation without vibrations or unusual noise.
  4. During operation, monitor:
    • Actual RPM display on the panel
    • Mixing time and consistency
    • Absence of splashing, vortex formation, or foam generation
  5. Log observations in the Equipment Usage Log (Annexure-1).

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5.3 RPM Calibration Procedure

  1. Use a calibrated digital handheld tachometer (contact or non-contact type).
  2. Run agitator at a fixed set point (e.g., 50 RPM, 100 RPM, 150 RPM).
  3. Take three consecutive readings at each set point and calculate the average.
  4. Record readings and compare with panel display. Allow ±2% deviation from the set point.
  5. Paste calibration label with date, next due date, and calibrated by.
  6. Fill RPM Calibration Record (Annexure-2).

5.4 Post-Operation

  1. Turn off the agitator after mixing is complete.
  2. Switch off the control panel and main power.
  3. Mark the agitator “TO BE CLEANED” and update the status label.

5.5 Safety and Precautions

  1. Do not touch the shaft or blade while agitator is running.
  2. Ensure emergency stop buttons are accessible and functional.
  3. Wear PPE including gloves, apron, and face shield during operation.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • BMR: Batch Manufacturing Record
  • RPM: Revolutions Per Minute

7. Documents

  1. Equipment Usage Log (Annexure-1)
  2. RPM Calibration Record (Annexure-2)
  3. Preventive Maintenance Log
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8. References

  • 21 CFR Part 211 – cGMP for Finished Pharmaceuticals
  • WHO TRS 986 – Equipment Qualification Guidelines
  • ICH Q8 – Pharmaceutical Development

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Equipment Usage Log

Date Batch No. Agitator ID Set RPM Mixing Time Operator Remarks
11/04/2025 ELX-1057 AGT-301 80 30 min Rajesh Kumar Normal

Annexure-2: RPM Calibration Record

Date Agitator ID Set Point (RPM) Reading 1 Reading 2 Reading 3 Average RPM Deviation (%) Status Calibrated By
11/04/2025 AGT-301 100 98 99 100 99 1% Pass Sunita Reddy

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 Included RPM tolerance and calibration procedure GMP Enhancement QA Head
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