Standard Operating Procedure for UV Sterilization of Clean Equipment in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/184/2025 |
| Supersedes | SOP/ELX/184/2022 |
| Page No. | Page 1 of 9 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To define the procedure for effective ultraviolet (UV) sterilization of cleaned equipment in the Elixir Manufacturing Department to ensure microbial control before equipment is used for critical processing.
2. Scope
This SOP applies to cleaned product-contact equipment such as tanks, filters, transfer pipes, utensils, and accessories that undergo UV sterilization before use in the manufacturing of elixirs.
3. Responsibilities
- Production Operator:
- Perform UV sterilization following this SOP.
- Document sterilization time and equipment ID.
- QA Officer:
- Verify sterilization parameters and label equipment as “Sterile – Ready for Use”.
- Engineering Department:
- Ensure maintenance and calibration of UV cabinets or tunnels.
4. Accountability
The Production Head is accountable for compliance with this SOP. QA is responsible for verification of sterilization cycles. The Engineering Head ensures proper functioning and safety of UV devices.
5. Procedure
5.1 Equipment and Materials
- UV Sterilization Cabinet / Tunnel with validated wavelength (typically 254 nm)
- Timer and safety interlocks
- Clean trays and labeled bins
- UV-protective goggles for operators
5.2 Pre-Sterilization Checks
- Ensure cleaned equipment is completely dry before UV sterilization.
- Inspect equipment surfaces for visible cleanliness and absence of residues.
- Verify that UV cabinet is clean, functional, and calibrated as per maintenance schedule.
- Check the UV bulb operation, timer setting, and interlocks.
5.3 UV Sterilization Procedure
- Place cleaned items in the UV chamber on sterile trays without overlapping.
- Close the UV cabinet and set the timer for the validated exposure period (e.g., 30 minutes).
- Start the cycle and do not open the chamber during the operation.
- After completion, allow items to cool if heat was generated.
- Label each item as “STERILE – READY FOR USE” with:
- Equipment ID
- UV Sterilization Date and Time
- Operator Initials
5.4 Post-Sterilization Handling
- Use sterile gloves while handling sterilized equipment.
- Store sterilized equipment in designated sterile holding areas.
- Avoid touching critical contact surfaces after sterilization.
5.5 Documentation
- Record sterilization activity in the UV Sterilization Logbook (Annexure-1).
- Include equipment ID, sterilization time, operator name, and QA verification.
6. Abbreviations
- SOP: Standard Operating Procedure
- UV: Ultraviolet
- QA: Quality Assurance
- ID: Identification
7. Documents
- UV Sterilization Logbook (Annexure-1)
- Label Template for Sterile Equipment (Annexure-2)
8. References
- ICH Q7 – GMP for Active Pharmaceutical Ingredients
- WHO TRS 937 Annex 4 – Sterilization Methods
- 21 CFR Part 211.113 – Control of Microbiological Contamination
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: UV Sterilization Logbook
| Date | Equipment ID | Start Time | End Time | Operator | QA Verified | Remarks |
|---|---|---|---|---|---|---|
| 11/04/2025 | MXR-ELX-09 | 10:00 | 10:30 | Rajesh Kumar | Sunita Reddy | Sterile – Labeled |
Annexure-2: Sterile Equipment Label Template
| Label | Fields to Fill |
|---|---|
| STERILE – READY FOR USE | Equipment ID, Date, Time, Operator Initials |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Release | New SOP | QA Head |
| 11/04/2025 | 2.0 | Included cooling step and barcode option | Process Improvement | QA Head |