equipment requiring sterilization and aseptic assembly in the aseptic processing areas, including but not limited to filling machines, transfer piping, holding vessels, and filtration units.

3. Responsibilities

• Production Operator: Carries out cleaning, sterilization, and assembly of equipment.
• Production Supervisor: Ensures validation protocol adherence and reviews batch documentation.
• QA Executive: Verifies sterilization and assembly parameters and signs off line clearance.
• Engineering Personnel: Maintains autoclave and sterilizer calibration and readiness.

4. Accountability

The Head of Production is accountable for ensuring proper validation, documentation, and compliance with sterilization and assembly protocols for all sterile manufacturing equipment.

5. Procedure

5.1 Equipment Cleaning

1. Ensure equipment is free from previous batch residue.
2. Disassemble equipment parts and rinse with WFI (Water for Injection).
3. Clean all contact surfaces using approved detergent solution.
4. Rinse with WFI thoroughly until no visible foam remains.
5. Dry parts using sterile compressed air or in a drying chamber.

5.2 Sterilization

1. Load cleaned parts into a double-door autoclave under unidirectional flow.
2. Use sterilization cycle parameters: 121°C for 30 minutes (unless otherwise validated).
3. Place biological indicators in designated areas for validation batches.
4. Post-cycle, ensure drying phase is complete before opening sterile side door.
5. Transfer sterilized equipment into Grade B cleanroom using validated handling techniques.

5.3 Aseptic Assembly

1. Operators shall don sterile gowning and gloves prior to entry.
2. Assemble sterilized parts within the LAF or isolator using aseptic technique.
3. Use only sterile tools for assembly; no reuse of equipment during session.
4. Inspect assembled equipment for integrity and seal tightness.
5. Document assembly activities in the Equipment Assembly Log (Annexure-2).

5.4 Validation of Sterilization and Assembly

1. Validation shall be conducted during initial qualification and any major change.
2. Temperature distribution and penetration tests shall be recorded.
3. Three consecutive successful cycles must be recorded for validation approval.
4. Review validation report and maintain as per documentation policy (Annexure-3).

5.5 Documentation and Line Clearance

1. Record sterilization data in Sterilization Log (Annexure-1).
2. QA must verify all documentation before approving the batch for production.
3. Affix “Sterilized” and “Ready for Use” tags on equipment.

6. Abbreviations

• SOP: Standard Operating Procedure
• WFI: Water for Injection
• LAF: Laminar Air Flow
• QA: Quality Assurance
• GMP: Good Manufacturing Practice

7. Documents

1. Sterilization Log – Annexure-1
2. Equipment Assembly Log – Annexure-2
3. Sterilization Validation Report – Annexure-3

8. References

• WHO TRS 961 Annex 6
• EU GMP Annex 1
• ICH Q9 – Quality Risk Management

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Manufacturing Executive	QA Executive	Head QA
Department	Production	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Sterilization Log

Date	Equipment ID	Cycle No.	Parameters	Operator	QA Verified
17/06/2025	VES-103	CYC-221	121°C / 30 min	Anita Deshmukh	Yes

Annexure-2: Equipment Assembly Log

Date	Equipment ID	Parts Assembled	Assembled By	QA Checked
18/06/2025	FILL-450	Needles, Tubes, Valves	Sachin Kale	Yes

Annexure-3: Sterilization Validation Report

Validation Date	Equipment	Run No.	BI Result	Validated By
15/06/2025	Autoclave-A	Run-3	Pass	QA – Priya Mehta

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
05/05/2022	1.0	Initial release	New SOP	QA Head
18/06/2025	2.0	Updated validation section and annexure log format	Scheduled Review	QA Head