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

1) Purpose

The purpose of this SOP is to establish procedures for the sanitization of manufacturing areas used in the production of ocular dosage forms to ensure microbial control, prevent contamination, and maintain a clean and safe environment.

2) Scope

This SOP applies to all manufacturing areas within the facility where ocular dosage forms are produced, including cleanrooms, filling areas, packaging areas, and ancillary rooms.

3) Responsibilities

Production personnel are responsible for implementing the sanitization procedures outlined in this SOP. Facility management and quality assurance personnel are responsible for overseeing compliance and verifying the effectiveness of sanitization procedures.

4) Procedure

4.1 Pre-Sanitization Preparation

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

4.2 Area Segregation

1. Segregate the manufacturing area into zones or sections for systematic sanitization.
2. Ensure proper labeling and signage to indicate areas under sanitization or restricted access.

4.3 Surface Cleaning and Sanitization

1. Clean all surfaces, including floors, walls, ceilings, equipment, and fixtures, using validated cleaning agents and methods.
2. Apply sanitizing agents or disinfectants to surfaces using approved methods (e.g., spraying, wiping).
3. Ensure thorough coverage and contact time as per product label instructions or SOP requirements to achieve effective sanitization.

4.4 Equipment and Tool Sanitization

1. Sanitize all equipment, tools, and accessories used in the manufacturing area, ensuring they are free from residues and contaminants.
2. Verify the compatibility of sanitizing agents with materials and surfaces to prevent damage or corrosion.

4.5 Air Handling and HVAC Systems

1. Sanitize air handling units (AHUs), filters, ducts, and HVAC systems to maintain air quality and prevent airborne contamination.
2. Follow validated procedures for cleaning and sanitization of HVAC components and ensure minimal disruption to manufacturing operations.

4.6 Waste Disposal

1. Dispose of waste generated during sanitization, including cleaning materials, PPE, and disposable items, in designated waste bins or containers.
2. Ensure proper segregation and disposal of waste according to facility waste management procedures and environmental regulations.

4.7 Post-Sanitization Inspection

1. Inspect sanitized areas and equipment visually for cleanliness, ensuring no visible residues or contaminants remain.
2. Perform environmental monitoring or swab sampling to verify the effectiveness of sanitization and absence of microbial contamination.

4.8 Documentation and Verification

1. Document all sanitization activities in the area sanitization log, including cleaning agents used, contact times, and inspection results.
2. Verify completeness and accuracy of documentation by authorized personnel.

4.9 Area Release

1. Obtain clearance from quality assurance and facility management for area release based on satisfactory sanitization and inspection results.
2. Remove signage and labels indicating restricted access, and update area status in the facility management system.

5) Abbreviations, if any

SOP: Standard Operating Procedure

PPE: Personal Protective Equipment

AHU: Air Handling Unit

HVAC: Heating, Ventilation, and Air Conditioning

6) Documents, if any

1. Area sanitization log
2. Sanitization validation records
3. Environmental monitoring results

7) Reference, if any

GMP Guidelines for Pharmaceutical Manufacturing

8) SOP Version

Version 1.0