Elixir Department: SOP for Setup and Operation of Mixing Vessel – V 2.0

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Elixir Department: SOP for Setup and Operation of Mixing Vessel – V 2.0

Standard Operating Procedure for Setup and Operation of Mixing Vessel in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/121/2025
Supersedes SOP/ELX/121/2022
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 standard procedure for the proper setup, operation, monitoring, and shutdown of mixing vessels used in the manufacturing of elixir formulations to ensure uniformity, process control, and compliance with cGMP requirements.

2. Scope

This SOP is applicable to all fixed and portable mixing vessels (jacketed or non-jacketed, with or without agitators) used in the Elixir Department for batch processing, pre-mixing, and solution preparation activities.

3. Responsibilities

  • Production Operator:
    • Carry out vessel setup, operation, and cleaning according to defined instructions.
  • Production Supervisor:
    • Verify vessel readiness and ensure parameters are maintained during operation.
  • Engineering Department:
    • Perform preventive maintenance and calibration of control systems and motors.
  • QA Officer:
    • Approve the equipment for use post-cleaning and verify log entries.
See also  Elixir Department: SOP for Control and Use of Primary Containers During Dispensing - V 2.0

4. Accountability

The Production Head is accountable for ensuring the correct setup and operation of mixing vessels in accordance with GMP and this

SOP.

5. Procedure

5.1 Pre-Setup Checks

  1. Check the equipment ID and match with the BMR or Equipment Usage Log.
  2. Ensure that the vessel is labeled as “CLEANED” and has been released by QA.
  3. Inspect vessel internals and externals for cleanliness, absence of damage, and proper connection of accessories (valves, manholes, gaskets).
  4. Confirm that the temperature and RPM control panels are operational and calibrated.

5.2 Setup Procedure

  1. Secure the vessel in its operating position (if portable).
  2. Connect:
    • Inlet/outlet hoses
    • Temperature probes
    • Jacket inlet (if applicable)
    • Control panel to power supply
  3. Install agitator and verify its free rotation by manual turning (if applicable).
  4. Check for leak tightness by running a water test before product addition.
See also  Elixir Department: SOP for Remote Monitoring of Batch Parameters - V 2.0

5.3 Operation Procedure

  1. Switch on the main power and control panel.
  2. Set the required mixing speed (RPM) as per BMR instructions.
  3. Gradually start the agitator and observe for vibration or abnormal noise.
  4. Monitor and adjust the temperature if heating/cooling is required.
  5. During mixing:
    • Record RPM and temperature at defined intervals
    • Check time, visual consistency, and presence of air bubbles or stratification

5.4 Shutdown Procedure

  1. Stop the agitator and turn off heating/cooling functions.
  2. Switch off the control panel and isolate power supply.
  3. Label the vessel as “TO BE CLEANED.”
  4. Record shutdown time and observations in Equipment Usage Log (Annexure-1).

5.5 Safety and Precautions

  1. Always wear PPE during setup and operation.
  2. Do not open the lid during operation unless specified in BMR.
  3. Ensure earthing of all portable vessels and components.
  4. Report abnormalities like overheating, leakage, or misalignment immediately to the supervisor.

See also  Elixir Department: SOP for Troubleshooting of Mixing Equipment - V 2.0

6. Abbreviations

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

7. Documents

  1. Equipment Usage Log (Annexure-1)
  2. Preventive Maintenance Record
  3. BMR/Manufacturing Instruction Sheet

8. References

  • 21 CFR Part 211.63 – Equipment Design, Size, and Location
  • WHO GMP Guidelines – Equipment Qualification
  • 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 Equipment ID Batch No. Start Time End Time RPM Temperature Operator
11/04/2025 MIX-306 ELX-1054 09:00 10:45 80 25°C Rajesh Kumar

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 and temperature logging steps Process Control Improvement QA Head
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