Elixir Department: SOP for Minimizing Foaming During Mixing – V 2.0

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Elixir Department: SOP for Minimizing Foaming During Mixing – V 2.0

Standard Operating Procedure for Minimizing Foaming During Mixing in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/079/2025
Supersedes SOP/ELX/079/2022
Page No. Page 1 of 8
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To outline the procedure for minimizing foam formation during the mixing process of elixir formulations, thereby ensuring uniformity, clarity, and quality of the product.

2. Scope

This SOP applies to all elixir batches manufactured in the Elixir Department where foaming during mixing is likely due to the nature of active ingredients, surfactants, excipients, or mixing speed.

3. Responsibilities

  • Production Operator:
    • Follow instructions to control speed, sequence, and defoamer addition.
    • Monitor foam generation during the mixing process.
  • Production Supervisor:
    • Ensure defoaming strategies are implemented as per the batch record.
    • Report excessive foam incidents to QA for impact assessment.
  • QA Officer:
    • Review foam control procedures and approve use of defoaming agents where applicable.
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4. Accountability

The Production Head is accountable for ensuring the implementation of foam control measures during mixing and maintaining batch quality.

5. Procedure

5.1 Preventive Measures

  1. Use low-shear mixers where applicable for foam-prone formulations.
  2. Control mixing speed:
    • Start at low RPM (100–200) and increase gradually.
    • Avoid sudden changes in speed or direction.
  3. Use properly sized mixing tanks to avoid splashing and turbulence.

5.2 Sequence of Ingredient Addition

  1. Follow the established sequence of ingredient addition in the BMR.
  2. Add surfactants or foaming agents last and under controlled mixing conditions.
  3. Avoid pouring powders rapidly into the vortex.
See also  Elixir Department: SOP for Recording Parameters in BMR - V 2.0

5.3 Use of Defoaming Agents (if applicable)

  1. Use only QA-approved defoaming agents (e.g., simethicone emulsion).
  2. Add the agent slowly under stirring after primary mixing is complete.
  3. Document usage in the BMR, including quantity and batch number of the defoamer.

5.4 Monitoring Foam Formation

  1. Visually inspect the tank during and after mixing for foam layer formation.
  2. If foam exceeds 10% of surface volume:
    • Stop agitation temporarily.
    • Skim excess foam using a sanitized ladle, if needed.

5.5 Documentation

  1. Record observations related to foam formation and any corrective actions in the Mixing Observation Log (Annexure-1).
  2. Attach supporting details to the BMR.

6. Abbreviations

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

  1. Mixing Observation Log (Annexure-1)
  2. Batch Manufacturing Record (BMR)
  3. Defoamer Approval Sheet (if used)

8. References

  • WHO TRS 1010 – GMP for Pharmaceutical Products
  • 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 Observation Log

Date Batch No. RPM Used Foam Level Observed Action Taken Operator
11/04/2025 ELX-1018 300 Moderate foam Reduced speed, added 1 ml simethicone 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 Added preventive foam control practices Process Consistency QA Head
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