Standard Operating Procedure for Vortex Mixer Operation for Lab Batches in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/138/2025 |
| Supersedes | SOP/ELX/138/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To outline the standard procedure for the operation and maintenance of vortex mixers used during small-scale/laboratory batch preparations in the Elixir Department. This ensures consistent mixing of elixir samples and homogeneity of test formulations.
2. Scope
This SOP applies to all laboratory vortex mixers used for pre-formulation studies, analytical sample preparation, or small lab-scale elixir batches in the R&D or QC sections of the Elixir Department.
3. Responsibilities
- QC/R&D Analyst:
- Operate the vortex mixer according to this SOP.
- Ensure the equipment is clean and functioning prior to use.
- Supervisor:
- Ensure training of personnel and review of logbooks.
- Engineering:
- Handle any equipment repairs or calibration issues.
- QA:
- Verify usage logs and cleanliness status before use.
4. Accountability
The QC/R&D Head is accountable for ensuring correct usage and documentation of vortex mixer operations. The Engineering Head is accountable for maintenance and calibration.
5. Procedure
5.1 Pre-Use Checks
- Ensure the vortex mixer is labeled “CLEANED” and has a valid calibration sticker (if applicable).
- Check that the power cord and plug are undamaged and properly connected to the power source.
- Ensure the platform or cup head is securely fitted and free from visible contamination.
5.2 Operating the Vortex Mixer
- Place the tube or container to be mixed on the center of the vortex platform or press gently onto the cup head.
- Set the mixing speed (RPM) and time using the control dial or digital panel as required by the procedure.
- Select “touch” mode for intermittent mixing or “continuous” mode for hands-free operation.
- Start the mixer and monitor the motion. Ensure the sample is properly secured and is not splashing or leaking.
- After mixing is complete, remove the tube carefully and wipe the platform if any spillage occurred.
5.3 Post-Use Cleaning
- Switch off the equipment and unplug it from the power source.
- Wipe the platform, head, and housing with a lint-free cloth moistened with 70% IPA.
- Label the equipment as “CLEANED” and record usage in the Equipment Logbook (Annexure-1).
5.4 Precautions
- Do not use damaged or cracked glassware with the vortex mixer.
- Do not apply excessive pressure to the cup head to avoid motor damage.
- Ensure the surface under the mixer is flat and vibration-resistant.
- Do not operate the mixer with wet hands or near water sources.
6. Abbreviations
- SOP: Standard Operating Procedure
- R&D: Research and Development
- QA: Quality Assurance
- IPA: Isopropyl Alcohol
7. Documents
- Equipment Usage Log (Annexure-1)
- Cleaning Log (if maintained separately)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice
- WHO TRS 1010 – Laboratory Practices
- Manufacturer’s Operating Manual
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Equipment Usage Log
| Date | Sample ID | Batch No. | Mixing Time (s) | Speed (RPM) | Mode Used | Operator | Remarks |
|---|---|---|---|---|---|---|---|
| 11/04/2025 | PRE-ELX-003 | DEV-ELX-12 | 60 | 2000 | Touch | Sunita Reddy | Uniform Mixing 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 | Updated log table and cleaning steps | Process Enhancement | QA Head |