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

1) Purpose

The purpose of this SOP is to establish procedures for the sanitization of equipment used in the manufacturing of ocular dosage forms to prevent contamination, maintain cleanliness, and ensure product quality and safety.

2) Scope

This SOP applies to all equipment and machinery used in the production of ocular dosage forms, including but not limited to filling machines, mixing equipment, and packaging machinery.

3) Responsibilities

Production personnel are responsible for implementing the sanitization procedures outlined in this SOP. Quality assurance personnel are responsible for verifying compliance and ensuring that sanitization procedures meet regulatory requirements.

4) Procedure

4.1 Pre-Sanitization Preparation

1. Notify relevant personnel and obtain clearance to sanitize equipment.
2. Gather all necessary sanitizing agents or disinfectants, cleaning tools, and PPE (Personal Protective Equipment).
3. Review the equipment sanitization schedule and checklist for specific cleaning requirements and any previous issues.

4.2 Disassembly and Preparation

1. Prepare equipment for sanitization by removing removable parts, disassembling components as necessary.
2. Label and segregate disassembled parts for systematic cleaning and sanitization.

4.3 Cleaning and Sanitization

1. Clean equipment surfaces thoroughly using approved cleaning agents and methods.
2. Apply sanitizing agents or disinfectants to equipment surfaces, ensuring complete coverage and contact time as per SOP requirements.
3. Rinse equipment parts with purified water or as per specific procedures to remove cleaning residues.

4.4 Drying and Reassembly

1. Air-dry equipment parts or use validated drying methods to ensure complete removal of moisture.
2. Reassemble equipment components once dried, ensuring proper alignment and installation.

4.5 Inspection and Testing

1. Inspect sanitized equipment visually for cleanliness, ensuring no visible residues or contaminants remain.
2. Perform testing or validation checks to verify the effectiveness of sanitization procedures as required.

4.6 Post-Sanitization Verification

1. Verify completion of sanitization activities and document results in the equipment sanitization log.
2. Obtain clearance from quality assurance for equipment release based on satisfactory sanitization and inspection results.

5) Abbreviations, if any

SOP: Standard Operating Procedure

PPE: Personal Protective Equipment

6) Documents, if any

1. Equipment sanitization log
2. Sanitization validation records

7) Reference, if any

GMP Guidelines for Pharmaceutical Manufacturing

8) SOP Version

Version 1.0