Standard Operating Procedure for Cleaning System for Equipment in Ocular Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to define the procedures for cleaning equipment used in the manufacturing of ocular dosage forms to ensure cleanliness, prevent cross-contamination, and maintain product quality.

2) Scope

This SOP applies to all equipment used in the production of ocular dosage forms, including but not limited to mixers, fillers, sterilizers, and packaging machines.

3) Responsibilities

Production personnel are responsible for implementing the cleaning procedures outlined in this SOP. Quality assurance personnel are responsible for verifying the effectiveness of cleaning procedures through inspection and testing.

4) Procedure

4.1 Pre-Cleaning Preparation

1. Notify relevant personnel and obtain clearance to clean the equipment.
2. Gather all necessary cleaning materials, including detergents, disinfectants, cleaning tools, and PPE (Personal Protective Equipment).
3. Review the equipment cleaning log to understand specific cleaning requirements and any previous issues.

4.2 Disassembly (if applicable)

1. If required, disassemble equipment following manufacturer’s instructions and using appropriate tools.
2. Label and segregate disassembled parts to prevent mix-ups during cleaning.

4.3 Cleaning Procedure

1. Remove visible residues and contaminants using dry cleaning methods (e.g., brushing, wiping).
2. Prepare cleaning solutions according to validated procedures and apply to equipment surfaces using suitable cleaning tools.
3. Scrub or rinse equipment surfaces thoroughly to ensure complete removal