SOP Guide for Pharma

Elixir Department: SOP for Use of Mixing Tanks with Variable Speed Agitators – V 2.0

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Elixir Department: SOP for Use of Mixing Tanks with Variable Speed Agitators – V 2.0

Standard Operating Procedure for Use of Mixing Tanks with Variable Speed Agitators

Department Elixir Department
SOP No. SOP/ELX/056/2025
Supersedes SOP/ELX/056/2022
Page No. Page 1 of 8
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To define the procedure for the safe and effective operation of mixing tanks equipped with variable speed agitators in the Elixir Department for ensuring homogeneous mixing of components.

2. Scope

This SOP is applicable to all mixing tanks with variable speed agitators used during the manufacturing of elixir formulations in the production area.

3. Responsibilities

  • Machine Operator:
    • Operate the agitator as per defined speed and time settings in the BMR.
    • Inspect, clean, and maintain agitator components before and after use.
  • Production Supervisor:
    • Ensure proper functioning and calibration of variable speed controller.
    • Verify process parameters and approve equipment for use.
  • Engineering Department:
    • Perform periodic preventive maintenance of the agitator system.
See also  Elixir Department: SOP for Transfer of Materials to Quarantine Area Post Dispensing - V 2.0

4. Accountability

The Production Manager is accountable for ensuring the equipment is used safely and effectively and maintained in validated condition.

5. Procedure

5.1 Equipment Setup

  1. Check that the tank is clean and labeled “CLEANED” as per SOP/ELX/051/2025.
  2. Ensure agitator shaft, blade, seals, and electrical connections are intact and secure.
  3. Connect the variable speed control panel and verify the operational display.

5.2 Pre-Operational Checks

  1. Ensure the emergency stop button is functional.
  2. Verify tank and agitator identification numbers match the BMR.
  3. Check RPM calibration tag and verify the last maintenance status.

5.3 Agitator Operation

  1. Start the agitator at the lowest speed setting (e.g., 20–30 RPM) for initial mixing.
  2. Gradually increase to the desired speed range based on batch type (e.g., 60–150 RPM).
  3. Refer to BMR for target mixing speeds for specific stages (e.g., dissolution, dispersion).
  4. Use timer function, if available, to monitor mixing duration.
  5. Record actual speed, mixing time, and temperature (if applicable) in Mixing Log (Annexure-1).
See also  Elixir Department: SOP for Transfer of Dispensed Materials to Manufacturing Area - V 2.0

5.4 During Operation

  1. Monitor the mixing visually for vortex formation, sedimentation, or splashing.
  2. Adjust speed gradually if change in viscosity or foaming is observed.
  3. If abnormal noise or vibrations occur, stop the agitator immediately and inform engineering.

5.5 Post-Operation

  1. Turn off the agitator and disconnect the power supply.
  2. Clean agitator shaft and blade thoroughly using purified water and approved detergent.
  3. Label the equipment as “TO BE CLEANED” or “CLEANED” with date and signature.

5.6 Maintenance and Calibration

  1. Ensure that the RPM controller is calibrated every 6 months by Engineering Department.
  2. Record calibration date and due date on the calibration tag (Annexure-2).

6. Abbreviations

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

7. Documents

  1. Mixing Log (Annexure-1)
  2. RPM Calibration Log (Annexure-2)
  3. Equipment Cleaning Record (Annexure-3)

See also  Elixir Department: SOP for Dispensing of Sweeteners in Elixirs - V 2.0

8. References

  • WHO TRS 986 Annex 2 – GMP for Pharmaceutical Production
  • 21 CFR 211.63 – Equipment Design, Size, and Location

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 No. Tank ID Start Time End Time RPM Operator Supervisor
11/04/2025 ELX-1002 MX-TNK-07 10:00 AM 10:45 AM 120 Rajesh Kumar Sunita Reddy

Annexure-2: RPM Calibration Log

Date Equipment ID Calibrated RPM Calibrated By Next Due
01/03/2025 MX-TNK-07 60–150 Vikram Chauhan 01/09/2025

Annexure-3: Equipment Cleaning Record

Date Equipment ID Cleaning Status Cleaned By Verified By
11/04/2025 MX-TNK-07 Cleaned Ajay Desai Manju Sharma

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Issue New SOP QA Head
11/04/2025 2.0 Included Preventive Maintenance and Calibration Process Control Improvement QA Head
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