SOP applies to all portable water systems, including storage tanks, pipelines, distribution loops, and points-of-use outlets used within the facility for sterile injectable production.

3. Responsibilities

• Utility Operator: Execute the sanitization process as per schedule.
• Engineering Department: Maintain sanitization records and ensure availability of sanitization chemicals.
• QA Department: Verify post-sanitization results and release the system for use.
• Microbiology Team: Conduct and evaluate microbial sampling post-sanitization.

4. Accountability

The Head of Engineering is accountable for ensuring compliance with this SOP and that sanitization activities are conducted as per the approved schedule.

5. Procedure

5.1 Preparation

1. Review the preventive maintenance and sanitization schedule.
2. Ensure availability of sanitizing agent (e.g., hot water or 1% peracetic acid solution).
3. Check all instrumentation—temperature gauges, valves, and pressure sensors—for correct function.
4. Inform QA department before starting the sanitization process.

5.2 Sanitization Process – Thermal

1. Set the system to thermal sanitization mode if equipped.
2. Heat the water in the storage tank to 80–85°C.
3. Recirculate hot water through the complete loop for 60 minutes minimum.
4. Ensure the outlet points reach at least 80°C using calibrated thermometers.
5. Maintain circulation for the required duration and monitor temperature trends continuously.
6. After completion, flush the system with pre-filtered cold water until temperature stabilizes below 30°C.

5.3 Sanitization Process – Chemical

1. If thermal sanitization is not possible, proceed with chemical sanitization.
2. Prepare a 1% peracetic acid solution or other validated disinfectant in the sanitization tank.
3. Recirculate the solution through the system loop for a minimum of 45 minutes.
4. Monitor conductivity and pH throughout the process.
5. Post-sanitization, flush the system with purified water until no traces of disinfectant are detected (check pH ~6–7).

5.4 Post-Sanitization Activities

1. Collect water samples from at least five representative points including the return loop.
2. Send samples to microbiology for analysis of:
   • Total microbial count
   • Endotoxins (if applicable)
   • Conductivity and TOC (if required)
3. QA shall review analytical reports and provide clearance before restarting water usage.

5.5 Documentation

1. Record all parameters including sanitization start and end times, temperatures, flow rates, and chemical concentrations.
2. Fill the Sanitization Log Sheet (Annexure-1) and attach microbiological test reports.
3. Update Preventive Maintenance Calendar with sanitization date and initials of responsible technician.

5.6 Frequency

1. Thermal sanitization: Weekly
2. Chemical sanitization: Monthly or as backup if thermal fails
3. Immediate sanitization: After planned or unplanned shutdown exceeding 48 hours

5.7 Deviation Handling

1. If sanitization fails or microbial load is above limit:
   • Repeat the sanitization process immediately.
   • Document deviation and inform QA.
   • Investigate root cause and implement CAPA.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• TOC: Total Organic Carbon
• CAPA: Corrective and Preventive Action

7. Documents

1. Sanitization Log Sheet – Annexure-1
2. Microbial Analysis Report – Annexure-2
3. Preventive Maintenance Calendar – Annexure-3

8. References

• WHO Technical Report Series 970
• EU GMP Annex 1 – Clean Water Systems
• 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: Sanitization Log Sheet

Date	System ID	Method	Start Time	End Time	Performed By
23/06/2025	PWS-01	Thermal	06:00 AM	07:15 AM	Ravi Sharma

Annexure-2: Microbial Analysis Report

Date	Sample Point	Total Count (cfu/mL)	Result	Analyst
23/06/2025	Return Loop	<10	Pass	Sunita Reddy

Annexure-3: Preventive Maintenance Calendar

Month	Planned Date	Activity	Status	Technician
June 2025	23/06/2025	Thermal Sanitization	Completed	Ravi Sharma

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/04/2022	1.0	Initial version	New SOP	QA Head
24/06/2025	2.0	Added chemical sanitization protocol and updated annexures	Annual Review	QA Head