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

1. Ensure cleaned equipment is completely dry before UV sterilization.
2. Inspect equipment surfaces for visible cleanliness and absence of residues.
3. Verify that UV cabinet is clean, functional, and calibrated as per maintenance schedule.
4. Check the UV bulb operation, timer setting, and interlocks.

5.3 UV Sterilization Procedure

1. Place cleaned items in the UV chamber on sterile trays without overlapping.
2. Close the UV cabinet and set the timer for the validated exposure period (e.g., 30 minutes).
3. Start the cycle and do not open the chamber during the operation.
4. After completion, allow items to cool if heat was generated.
5. Label each item as “STERILE – READY FOR USE” with:
   • Equipment ID
   • UV Sterilization Date and Time
   • Operator Initials

5.4 Post-Sterilization Handling

1. Use sterile gloves while handling sterilized equipment.
2. Store sterilized equipment in designated sterile holding areas.
3. Avoid touching critical contact surfaces after sterilization.

5.5 Documentation

1. Record sterilization activity in the UV Sterilization Logbook (Annexure-1).
2. 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

1. UV Sterilization Logbook (Annexure-1)
2. 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