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 of residues and cleaning agents.
4. Rinse cleaned surfaces with purified water to remove any remaining cleaning agents.

4.4 Sanitization

1. Apply validated sanitizing agents or disinfectants to equipment surfaces using approved methods.
2. Ensure adequate contact time as per product label instructions or SOP requirements.
3. Rinse sanitized surfaces with purified water to remove residual sanitizing agents.

4.5 Drying and Reassembly

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

4.6 Post-Cleaning Inspection

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

4.7 Documentation and Verification

1. Document all cleaning activities in the equipment cleaning log, including cleaning 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 cleaning and inspection results.
2. Label equipment as cleaned 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 cleaning log
2. Cleaning validation records
3. Swab sampling results

7) Reference, if any

GMP Guidelines for Pharmaceutical Manufacturing

8) SOP Version

Version 1.0