SOP Guide for Pharma

Elixir Department: SOP for Mixing and Homogenization of Elixir Components – V 2.0

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Elixir Department: SOP for Mixing and Homogenization of Elixir Components – V 2.0

Standard Operating Procedure for Mixing and Homogenization of Elixir Components

Department Elixir Department
SOP No. SOP/ELX/054/2025
Supersedes SOP/ELX/054/2022
Page No. Page 1 of 8
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To establish a standard procedure for the uniform mixing and homogenization of all ingredients in elixir formulations to ensure product consistency and compliance with quality standards.

2. Scope

This SOP is applicable to all batches of elixirs manufactured in the Elixir Department using fixed or variable speed agitators, inline homogenizers, or other mixing equipment.

3. Responsibilities

  • Manufacturing Operator:
    • Perform mixing operations as per the instructions outlined in the BMR.
    • Ensure equipment is set up and operated correctly.
  • Production Supervisor:
    • Verify mixing time, speed, and completion.
  • QA Officer:
    • Monitor and record in-process checks, including homogeneity tests.

See also  Elixir Department: SOP for Line Clearance in Dispensing Area - V 2.0

4. Accountability

The Production Head is accountable for ensuring that mixing and homogenization activities are conducted as per validated procedures and documented accurately.

5. Procedure

5.1 Equipment Preparation

  1. Ensure the manufacturing tank or mixing vessel is clean
and ready as per SOP/ELX/051/2025.
  • Verify agitator blades and homogenizer components are intact and properly assembled.
  • Check calibration status of speed controller (if applicable).

    • 5.2 Mixing Operation

    1. Start agitator at low speed (e.g., 30–40 RPM) for initial dispersion of components.
    2. Gradually increase to the required speed as per the BMR (typically 60–150 RPM).
    3. Continue mixing for the specified time (e.g., 30–60 minutes), ensuring uniformity.
    4. For high-viscosity mixtures or multi-phase systems, initiate inline or mechanical homogenization as per instructions.
    5. Record start and end times in the Mixing Log (Annexure-1).

    5.3 Homogenization Steps

    1. Transfer the batch through an inline homogenizer (if applicable) operating at recommended pressure (e.g., 100–150 bar).
    2. Alternatively, recirculate the batch through the homogenization loop until desired consistency is achieved.
    3. Perform in-process homogeneity check (see Annexure-2).

    5.4 Precautions

    1. Do not exceed the maximum agitation speed defined for the equipment.
    2. Avoid vigorous agitation of volatile or alcohol-based formulations to minimize evaporation and foaming.
    3. Ensure batch temperature is within limits during mixing (as specified in BMR).

    5.5 Documentation

    1. Fill out the Mixing and Homogenization Log (Annexure-1).
    2. Attach process observations and results of homogeneity check.

    6. Abbreviations

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

    7. Documents

    1. Mixing and Homogenization Log (Annexure-1)
    2. Homogeneity Check Record (Annexure-2)
    3. Equipment Verification Log (Annexure-3)

    8. References

    • WHO TRS 961 Annex 3 – GMP for Liquid Oral Preparations
    • 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: Mixing and Homogenization Log

    Date Batch No. Start Time End Time RPM Mixed By Verified By
    11/04/2025 ELX-1001 09:30 AM 10:15 AM 120 Rajesh Kumar Sunita Reddy

    Annexure-2: Homogeneity Check Record

    Sample Point Time Appearance Assay Result Status Checked By
    Top 10:20 AM Clear 98.5% Pass Sunita Reddy
    Middle 10:21 AM Clear 98.7% Pass Sunita Reddy
    Bottom 10:22 AM Clear 98.6% Pass Sunita Reddy

    Annexure-3: Equipment Verification Log

    Date Equipment ID Agitator Status Verified By
    11/04/2025 MX-TNK-05 Operational Manju Sharma

    Revision History:

    Revision Date Revision No. Revision Details Reason for Revision Approved By
    01/01/2024 1.0 Initial SOP Release New Document QA Head
    11/04/2025 2.0 Included Homogenization Section and Annexures Process Control Enhancement QA Head
    See also  Elixir Department: SOP for Verification of Raw Materials Before Dispensing - V 2.0
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