Water System Maintenance Procedures in MDI Production
1) Purpose
The purpose of this SOP is to establish procedures for the maintenance and operation of the water system in metered-dose inhaler (MDI) production to ensure quality, purity, and compliance with regulatory requirements.
2) Scope
This SOP applies to all water systems used in MDI production, including purified water, water for injection (WFI), and other water-based systems.
3) Responsibilities
The responsibilities for this SOP include monitoring water quality, conducting maintenance activities, and ensuring compliance with regulatory standards.
4) Procedure
4.1 Water System Monitoring
4.1.1 Regularly monitor water quality parameters such as conductivity, total organic carbon (TOC), microbial counts, and endotoxin levels.
4.1.2 Use validated methods and equipment to perform water testing according to defined sampling frequencies.
4.2 Preventive Maintenance
4.2.1 Establish a preventive maintenance schedule for water system components, including filters, pumps, valves, and monitoring equipment.
4.2.2 Conduct routine inspections, calibrations, and replacements as per manufacturer recommendations and standard operating procedures.
4.3 Cleaning and Sanitization
4.3.1 Develop and implement cleaning and sanitization procedures for water system components to prevent microbial growth and contamination.
4.3.2 Use validated cleaning agents and methods to ensure effectiveness and safety of cleaning operations.
4.4 System Change Control
4.4.1 Implement change control procedures for any modifications or upgrades to the water system, including risk assessment and validation activities.
4.4.2 Document changes, perform impact assessments, and obtain necessary approvals before implementing changes.
4.5 Emergency Response
4.5.1 Establish procedures for responding to water system failures, contamination incidents, or deviations from established parameters.
4.5.2 Implement contingency plans, corrective actions, and notify relevant personnel promptly in case of emergencies.
4.6 Documentation and Records
4.6.1 Maintain accurate records of water system maintenance activities, including preventive maintenance logs, cleaning records, test results, and change control documentation.
4.6.2 Document any deviations from SOPs, corrective actions taken, and follow-up measures to prevent recurrence.
5) Abbreviations, if any
MDI: Metered-Dose Inhaler
SOP: Standard Operating Procedure
WFI: Water for Injection
TOC: Total Organic Carbon
6) Documents, if any
Water system maintenance schedules, cleaning validation reports, change control documentation, and calibration certificates should be maintained as part of the quality management system.
7) Reference, if any
Refer to water system maintenance guidelines from regulatory agencies, pharmacopeial standards (e.g., USP), and internal quality management procedures.
8) SOP Version
Version 1.0
