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.