Equipment Cleaning Procedures for MDIs
1) Purpose
The purpose of this SOP is to outline the procedures for cleaning and sanitizing equipment used in the manufacturing of metered-dose inhalers (MDIs) to prevent cross-contamination, ensure product quality, and comply with regulatory requirements.
2) Scope
This SOP applies to all personnel involved in the cleaning and maintenance of equipment used for MDIs at the manufacturing facility, including operators, technicians, and cleaning personnel.
3) Responsibilities
The responsibilities for this SOP include performing equipment cleaning as per defined procedures, documenting cleaning activities, and ensuring compliance with Good Manufacturing Practice (GMP) standards. Specific roles include:
Equipment Operators: Prepare equipment for cleaning and verify cleanliness.
Technicians: Perform scheduled and unscheduled cleaning of equipment.
Quality Assurance: Verify cleaning procedures and document compliance.
4) Procedure
4.1 Pre-Cleaning Preparation
4.1.1 Wear appropriate personal protective equipment (PPE).
4.1.2 Disassemble equipment as per the cleaning instructions.
4.2 Cleaning Process
4.2.1 Rinse equipment surfaces with water or appropriate solvent to remove visible residues.
4.2.2 Apply cleaning agents as specified in the cleaning procedure.
4.2.3 Scrub or wipe equipment surfaces to ensure thorough cleaning.
4.2.4 Rinse equipment with clean water to remove cleaning agents.
4.3 Sanitization
4.3.1 Apply sanitizing agents to disinfect equipment surfaces.
4.3.2 Allow sufficient contact time as per the sanitization procedure.
4.4 Drying and Inspection
4.4.1 Air dry or use validated drying methods to ensure equipment is dry.
4.4.2 Inspect equipment for cleanliness and completeness of cleaning.
4.5 Reassembly and Verification
4.5.1 Reassemble equipment components according to assembly instructions.
4.5.2 Verify equipment cleanliness and functionality before next use.
4.6 Documentation
4.6.1 Record all cleaning and sanitization activities in the equipment cleaning logbook.
4.6.2 Document any deviations or issues encountered during cleaning.
5) Abbreviations, if any
MDI: Metered-Dose Inhaler
GMP: Good Manufacturing Practice
PPE: Personal Protective Equipment
6) Documents, if any
Cleaning validation reports, equipment cleaning logs, and cleaning agent specifications should be maintained.
7) Reference, if any
Refer to regulatory guidelines from agencies such as the FDA, EMA, and ICH for cleaning validation and equipment cleaning procedures.
8) SOP Version
Version 1.0
