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 ensure microbial control, prevent contamination, and maintain product quality and safety.

2) Scope

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

3) Responsibilities

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

4) Procedure

4.1 Pre-Sanitization Preparation

1. Notify relevant personnel and obtain clearance to sanitize the equipment.
2. Gather all necessary sanitizing agents or disinfectants, cleaning tools, and PPE (Personal Protective Equipment).
3. Review the equipment sanitization log to understand specific sanitization 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 sanitization.

4.3 Sanitization Procedure

1. Apply validated sanitizing agents or disinfectants to equipment surfaces using approved methods (e.g., spraying, wiping).
2. Ensure thorough coverage of all equipment surfaces and components that come into contact with product or process materials.
3. Allow adequate contact time as per product label instructions or SOP requirements to achieve effective sanitization.

4.4 Rinse (if applicable)

1. Rinse sanitized equipment surfaces with purified water to remove residual sanitizing agents or disinfectants.
2. Ensure rinsing is performed according to validated procedures to prevent contamination of product or process materials.

4.5 Drying and Reassembly

1. Dry equipment surfaces thoroughly using lint-free cloths, air drying methods, or other validated drying procedures.
2. Reassemble equipment parts following validated assembly procedures and using appropriate torque specifications.

4.6 Post-Sanitization Inspection

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

4.7 Documentation and Verification

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

4.8 Equipment Release

1. Obtain clearance from quality assurance for equipment release based on satisfactory sanitization and inspection results.
2. Label equipment as sanitized and ready for use with appropriate status tags.

5) Abbreviations, if any

SOP: Standard Operating Procedure

PPE: Personal Protective Equipment

6) Documents, if any

1. Equipment sanitization log
2. Sanitization validation records
3. Swab sampling results

7) Reference, if any

GMP Guidelines for Pharmaceutical Manufacturing

8) SOP Version

Version 1.0