vessels, pipelines, transfer containers, and filter assemblies used in sterile injectable manufacturing at [Insert Facility Name].

3. Responsibilities

• Manufacturing Operator: Perform sterilization procedures as per SOP and batch record instructions.
• Production Supervisor: Ensure execution, documentation, and verification of sterilization activities.
• QA Executive: Verify equipment readiness and perform pre- and post-sterilization checks.

4. Accountability

The Head – Production is accountable for effective implementation and compliance with this SOP.

5. Procedure

5.1 Preparation for Sterilization

1. Ensure equipment is cleaned as per relevant SOPs and verified by QA.
2. Affix “To Be Sterilized” status label on the equipment.
3. Check and record equipment cleaning status in Annexure-1: Equipment Cleaning Checklist.

5.2 Assembly of Components

1. Assemble the equipment under LAF using sterile gloves and garments.
2. Ensure connections are leak-tight and clamped appropriately.
3. Seal open ends of transfer pipes and accessories using sterile end caps.

5.3 Sterilization Methods

Select the sterilization method based on equipment type:

• Autoclaving: For stainless steel vessels, filters, tubing, etc.
• Dry Heat Sterilization: For glass components and metal tools not compatible with moist heat.
• SIP (Steam In Place): For fixed transfer lines, manufacturing tanks, and bioreactors.

5.4 Autoclaving Procedure

1. Load equipment into the autoclave ensuring separation for steam circulation.
2. Use a validated sterilization cycle (e.g., 121°C for 30 minutes at 15 psi).
3. Place chemical/biological indicators inside to verify sterilization.
4. Record cycle details in Annexure-2: Autoclave Run Log.

5.5 Steam In Place (SIP)

1. Connect steam inlet and outlet lines securely to the equipment.
2. Start SIP cycle and monitor critical parameters like temperature, pressure, and time.
3. Maintain temperature above 121°C for a minimum of 30 minutes.
4. Record SIP data in Annexure-3: SIP Monitoring Log.

5.6 Dry Heat Sterilization

1. Place glassware or metal parts inside a depyrogenation tunnel or dry heat oven.
2. Operate at validated conditions (e.g., 250°C for 30 minutes).
3. Use thermocouples to confirm uniform temperature distribution.

5.7 Post-Sterilization Activities

1. Affix “Sterilized” status label with sterilization date and expiry date (if applicable).
2. Transfer sterilized items to sterile area using validated pass-throughs or trolleys.
3. Maintain equipment in covered, sterile conditions until use.

5.8 Filter Integrity Testing

1. Conduct pre- and post-use filter integrity tests for sterilized filter assemblies.
2. Document results in Annexure-4: Filter Integrity Test Log.

5.9 Documentation

1. Ensure all logs and annexures are completely filled, reviewed, and archived.
2. QA to perform a line clearance check before equipment use.

6. Abbreviations

• SOP: Standard Operating Procedure
• SIP: Steam In Place
• QA: Quality Assurance
• cGMP: current Good Manufacturing Practice

7. Documents

1. Equipment Cleaning Checklist – Annexure-1
2. Autoclave Run Log – Annexure-2
3. SIP Monitoring Log – Annexure-3
4. Filter Integrity Test Log – Annexure-4

8. References

• WHO TRS 961 – Annex 6: Good Manufacturing Practices for Sterile Products
• ICH Q9 – Quality Risk Management
• ISO 17665 – Sterilization of Healthcare Products

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: Equipment Cleaning Checklist

Equipment Name	ID	Cleaning Done On	Done By	Checked By
Preparation Vessel	VSL-101	17/06/2025	Vikas Sharma	QA – Ritu Malhotra

Annexure-2: Autoclave Run Log

Date	Batch No.	Cycle Time	Temperature	Pressure	Status
18/06/2025	ST-0425	30 min	121°C	15 psi	Pass

Annexure-3: SIP Monitoring Log

Equipment	Start Time	End Time	Max Temp	Hold Time	Status
Tank-201	09:00	10:00	124°C	32 min	Pass

Annexure-4: Filter Integrity Test Log

Date	Filter ID	Pre-Test Result	Post-Test Result	Status
18/06/2025	F-8971	Pass	Pass	Compliant

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/04/2022	1.0	Initial SOP creation	New process documentation	QA Head
18/06/2025	2.0	Included SIP and updated annexures	Annual Review	QA Head