Standard Operating Procedure for Mixing Time Optimization in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/086/2025 |
| Supersedes | SOP/ELX/086/2022 |
| 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 a validated procedure for optimizing the mixing time of elixir formulations to ensure uniformity, product quality, and process efficiency during batch manufacturing.
2. Scope
This SOP applies to all mixing operations involving active ingredients, excipients, solvents, and additives during the batch processing of elixirs in the Elixir Department.
3. Responsibilities
- Production Operator:
- Perform mixing as per batch instructions and monitor time, speed, and parameters.
- Production Supervisor:
- Ensure that the optimized mixing time is followed and recorded accurately.
- Verify homogeneity tests when applicable.
- QA Officer:
- Approve optimized time based on validation data and verify adherence during batch execution.
4. Accountability
The Head of Production is accountable for implementation and periodic review of mixing time optimization protocols to ensure consistent batch performance.
5. Procedure
5.1 Basis for Optimization
- Determine mixing time through development studies
using:
Final optimized mixing time shall be recorded in the Master Formula Record (MFR).
- Visual inspection
- pH uniformity
- Content uniformity sampling
- Viscosity measurement (if applicable)
5.2 Mixing Time Execution
- Set the mixing equipment to the validated speed (RPM) and time duration.
- Start timer immediately when mixing begins and record start time in the BMR.
- Do not interrupt mixing unless an alarm or deviation occurs.
5.3 Monitoring During Mixing
- Observe vortex formation, fluid movement, and any signs of foaming or sedimentation.
- Record RPM, batch volume, and equipment ID in the Mixing Log (Annexure-1).
- Perform in-process sampling if required after mixing completion to confirm homogeneity.
5.4 Adjustment of Mixing Time
- If any parameter deviates (e.g., incomplete dissolution), extend mixing time by 5–15 minutes after consultation with QA.
- Document justification, revised time, and responsible personnel in the Deviation Record.
5.5 Documentation
- Record start and end times, RPM, equipment used, and observations in the Mixing Log.
- Attach log to the BMR for QA review.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- BMR: Batch Manufacturing Record
- MFR: Master Formula Record
- RPM: Revolutions Per Minute
7. Documents
- Mixing Log (Annexure-1)
- Deviation Record (if applicable)
- Batch Manufacturing Record (BMR)
8. References
- 21 CFR Part 211.100 – Written Procedures; Deviations
- ICH Q8 – Pharmaceutical Development
- WHO TRS 986 – GMP for Pharmaceuticals
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. | Start Time | End Time | RPM | Equipment ID | Operator | Remarks |
|---|---|---|---|---|---|---|---|
| 11/04/2025 | ELX-1025 | 09:30 AM | 10:00 AM | 250 | MX-04 | Rajesh Kumar | Uniform mix achieved |
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 optimization methods and adjustment protocol | Process Improvement | QA Head |