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.

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

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

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

5.3 Homogenization Steps

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

5.4 Precautions

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

5.5 Documentation

Fill out the Mixing and Homogenization Log (Annexure-1).
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

Mixing and Homogenization Log (Annexure-1)
Homogeneity Check Record (Annexure-2)
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