Standard Operating Procedure for Cleaning of Heating and Cooling Systems

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the cleaning procedure for heating and cooling systems used in pharmaceutical manufacturing to ensure product quality, safety, and compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all personnel involved in the cleaning of heating and cooling systems within the pharmaceutical manufacturing facility.

3. Responsibilities

• Production Operator: Responsible for initiating the cleaning process.
• Quality Assurance (QA) Inspector: Responsible for verifying the cleanliness of the heating and cooling systems and approving them for further use.
• Supervisor: Oversees the cleaning process and ensures compliance with this SOP.

4. Procedure

4.1. Pre-Cleaning Preparations

1. Notify the Production Supervisor of the need for heating and cooling system cleaning and obtain necessary approvals.
2. Ensure that the heating and cooling systems are not in operation and are safely isolated from the production process.
3. Wear appropriate personal protective equipment (PPE), including gloves and safety goggles.

4.2. Inspection

1. Visually inspect the heating and cooling systems for any visible contaminants or deposits.
2. If any contaminants or deposits are found, note their location and severity for documentation.

4.3. Cleaning Solution Preparation

1. Prepare a cleaning solution as per the approved formula and concentration. Refer to the Cleaning Solution Formulation document (if available) for details.
2. Ensure that the cleaning solution is suitable for the materials of construction of the heating and cooling systems.

4.4. Cleaning Process

1. Apply the prepared cleaning solution to the surfaces of the heating and cooling systems using suitable cleaning tools (brushes, sponges, etc.).
2. Scrub the surfaces to remove contaminants and deposits thoroughly.
3. Rinse the surfaces with purified water to remove residual cleaning solution.
4. Repeat the cleaning process as necessary until all contaminants and deposits are removed.

4.5. Post-Cleaning Inspection

1. Visually inspect the heating and cooling systems after cleaning to ensure that all contaminants and deposits have been effectively removed.
2. If any contaminants or deposits persist, repeat the cleaning process.

4.6. Final Inspection and Approval

1. Notify the QA Inspector that the heating and cooling systems are ready for inspection.
2. The QA Inspector will visually inspect the systems and document the inspection results.
3. If the systems meet cleanliness criteria, they are approved for further use. If not, the cleaning process is repeated.

4.7. Documentation

Properly document the cleaning process, including cleaning dates, personnel involved, cleaning solutions used, inspection results, and any deviations from the procedure.

5. Abbreviations

• GMP: Good Manufacturing Practices
• PPE: Personal Protective Equipment
• QA: Quality Assurance

6. Documents

• Cleaning Solution Formulation – Document specifying the approved cleaning solution formula and concentration.

7. Reference

[Insert any relevant references or standards applicable to the cleaning of heating and cooling systems in the pharmaceutical industry]

8. SOP Version

This is version 1.0 of the “Cleaning of Heating and Cooling Systems SOP,” issued on [insert issuance date].