Standard Operating Procedure for Use of Magnetic Stirrer in Small Batch Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/077/2025 |
| Supersedes | SOP/ELX/077/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To describe the procedure for the use, cleaning, and maintenance of magnetic stirrers during small batch preparation of elixirs in the Elixir Department, ensuring homogeneity and product quality.
2. Scope
This SOP is applicable to all magnetic stirrers used for preparing pilot batches, R&D formulations, or small-volume elixirs (≤5 liters) in the Elixir Department.
3. Responsibilities
- Production Operator / R&D Staff:
- Operate the magnetic stirrer as per procedure and record observations.
- Clean and store the equipment after use.
- Production Supervisor:
- Ensure availability of calibrated magnetic stirrers and monitor operation.
- QA Officer:
- Verify cleanliness and approve equipment before use.
4. Accountability
The Production Manager is accountable for proper operation, verification, and documentation of magnetic stirrer usage in small batch production.
5. Procedure
5.1 Pre-Use Checks
- Check the magnetic stirrer
for physical damage, cracks, or loose wires.
Ensure calibration label is valid and stir bar is clean and intact.
Wipe the surface of the stirrer with 70% IPA before placing the beaker or vessel.
5.2 Operation
- Place a clean, dry magnetic stir bar in the vessel containing the formulation.
- Position the vessel centrally on the stirrer plate.
- Switch ON the magnetic stirrer and set desired speed (RPM) using the knob or digital panel.
- Ensure vortex formation is adequate but not excessive to avoid foaming or aeration.
- Maintain stirring for the required time as per the batch record.
5.3 Temperature Control (If Applicable)
- If using a stirrer with a hot plate:
- Set temperature using the control dial (if heating is required).
- Monitor solution temperature using a calibrated thermometer.
- Do not exceed recommended temperature limits for alcohol-based or volatile elixirs.
5.4 Post-Use Cleaning
- Turn off and unplug the equipment after use.
- Wipe down the equipment with lint-free cloth soaked in 70% IPA.
- Clean the stir bar with distilled water and store in a clean container labeled “CLEANED.”
5.5 Documentation
- Record the batch number, date, RPM, stirring duration, and operator initials in the Magnetic Stirrer Usage Log (Annexure-1).
- Attach any temperature log or observations to the BMR or development report.
6. Abbreviations
- SOP: Standard Operating Procedure
- RPM: Revolutions Per Minute
- IPA: Isopropyl Alcohol
- QA: Quality Assurance
7. Documents
- Magnetic Stirrer Usage Log (Annexure-1)
- Calibration Certificate of Stirrer
- BMR or R&D Record
8. References
- 21 CFR Part 211.63 – Equipment Design, Size, and Location
- WHO GMP Guidelines – Equipment Cleaning and Maintenance
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Magnetic Stirrer Usage Log
| Date | Batch No. | RPM | Duration (Min) | Operator | Remarks |
|---|---|---|---|---|---|
| 11/04/2025 | ELX-1016 | 400 | 30 | Rajesh Kumar | Uniform stirring achieved |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Issue | New SOP | QA Head |
| 11/04/2025 | 2.0 | Included temperature control and log format | Process Enhancement | QA Head |