Standard Operating Procedure for Water System Maintenance in Aerosol Production

1) Purpose

The purpose of this SOP is to establish procedures for the maintenance and operation of water systems used in aerosol production. This ensures that water quality is maintained at appropriate standards to prevent contamination of aerosol products and comply with regulatory requirements.

2) Scope

This SOP applies to all water systems used in aerosol production at [Company Name], including purified water (PW) systems and water for injection (WFI) systems.

3) Responsibilities

Facilities Manager: Oversee maintenance of water systems and ensure compliance with procedures.
Water System Operators: Perform routine monitoring, maintenance, and sanitization of water systems.
Quality Assurance (QA) Manager: Ensure that water system operations comply with regulatory requirements and quality standards.
All Personnel: Report any water system issues or deviations from normal operation.

4) Procedure

4.1 Routine Monitoring and Sampling:
4.1.1 Conduct daily monitoring of water quality parameters such as conductivity, pH, and microbial counts.
4.1.2 Collect water samples for analysis according to schedule and procedures outlined in the water quality control plan.
4.1.3 Document monitoring results and maintain records as per regulatory requirements.

4.2 Preventive Maintenance:
4.2.1 Develop and implement a preventive maintenance schedule for water system components, including filters, membranes, and pumps.
4.2.2 Perform routine inspections of water system equipment for signs of wear, leaks, or other issues.
4.2.3 Replace consumable components and perform adjustments as necessary to maintain system performance.

4.3 Cleaning and Sanitization:
4.3.1 Clean and sanitize water system components according to validated procedures and schedule.
4.3.2 Use approved cleaning agents and methods that do not leave residues harmful to water quality or product safety.
4.3.3 Validate cleaning and sanitization procedures periodically and after any significant system modifications.

4.4 Emergency Response:
4.4.1 Establish procedures for responding to water system failures, contamination incidents, or alarms.
4.4.2 Implement corrective actions promptly to mitigate potential risks to product quality.
4.4.3 Notify appropriate personnel and regulatory authorities as required in case of significant water system issues.

4.5 Calibration and Validation:
4.5.1 Calibrate instrumentation used for monitoring water quality parameters to ensure accuracy and reliability.
4.5.2 Validate water system performance through periodic testing, including microbial control, endotoxin testing, and conductivity.
4.5.3 Document calibration and validation activities and maintain records for regulatory inspections.

4.6 Change Control and Documentation:
4.6.1 Implement change control procedures for any modifications to the water system, including equipment upgrades or process changes.
4.6.2 Document all changes to the water system in accordance with company procedures and regulatory requirements.
4.6.3 Review and update SOPs and related documentation based on system changes and regulatory updates.

5) Abbreviations, if any

PW: Purified Water
WFI: Water for Injection
QA: Quality Assurance
SOP: Standard Operating Procedure

6) Documents, if any

Water System Maintenance Schedule
Water Quality Monitoring Records
Cleaning and Sanitization Validation Reports
Calibration and Validation Certificates

7) Reference, if any

GMP Guidelines
USP Standards for Water Quality
FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing

8) SOP Version

Version 1.0