Standard Operating Procedure for Cleaning and Sanitization Procedures in Ointment Formulation

1) Purpose

The purpose of this SOP is to establish procedures for the cleaning and sanitization of equipment and facilities used in ointment formulation to prevent contamination and ensure product quality and safety.

2) Scope

This SOP applies to all personnel involved in the cleaning, sanitization, and maintenance of equipment and facilities used in ointment formulation.

3) Responsibilities

– Production Staff: Responsible for cleaning and sanitizing equipment after use.
– Quality Assurance (QA): Responsible for verifying the effectiveness of cleaning procedures.
– Maintenance Team: Responsible for maintaining equipment in good working condition.

4) Procedure

1. Pre-Cleaning Preparations:
1.1 Equipment Disassembly:
1.1.1 Disassemble equipment as per manufacturer’s instructions, if applicable.
1.1.2 Separate removable parts for individual cleaning.

1.2 Inspection:
1.2.1 Inspect equipment for visible residues or contaminants.
1.2.2 If necessary, perform initial rinsing or wiping to remove bulk residues.

2. Cleaning Process:
2.1 Cleaning Agents:
2.1.1 Select appropriate cleaning agents based on equipment materials and residues.
2.1.2 Prepare cleaning solutions according to approved procedures.

2.2 Manual Cleaning:
2.2.1 Clean equipment surfaces using approved cleaning tools (brushes, wipes).
2.2.2 Ensure thorough coverage of all surfaces prone to contamination.

3. Rinsing and Drying:
3.1 Rinsing Procedures:
3.1.1 Rinse equipment with purified water to remove cleaning agents and residues.
3.1.2 Use appropriate water quality standards (e.g., purified water) for rinsing.

3.2 Drying Methods:
3.2.1 Air dry equipment in designated drying areas or use validated drying methods.
3.2.2 Verify dryness before reassembling or storing equipment.

4. Sanitization Process:
4.1 Sanitizing Agents:
4.1.1 Select sanitizing agents based on equipment and facility requirements.
4.1.2 Prepare sanitizing solutions according to approved procedures.

4.2 Sanitization Application:
4.2.1 Apply sanitizing agents to all cleaned surfaces using appropriate methods (spraying, wiping).
4.2.2 Ensure sufficient contact time as per manufacturer’s recommendations.

5. Verification and Inspection:
5.1 Effectiveness Verification:
5.1.1 Verify the effectiveness of cleaning and sanitization through visual inspection and testing.
5.1.2 Conduct microbial testing if required by procedures or regulations.

5.2 Documentation:
5.2.1 Document cleaning and sanitization activities, including cleaning agents used and verification results.
5.2.2 Maintain cleaning logs and records for regulatory compliance.

5) Abbreviations, if any

– QA: Quality Assurance
– SOP: Standard Operating Procedure

6) Documents, if any

– Cleaning and Sanitization Logs
– Verification Reports

7) Reference, if any

– FDA Current Good Manufacturing Practice (CGMP) Regulations
– WHO Guidelines on Sanitization

8) SOP Version

Version 1.0