Standard Operating Procedure for Cleaning of Bottle and Cap Conveyors

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the cleaning procedure for bottle and cap conveyors 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 bottle and cap conveyors 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 conveyors 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 conveyor cleaning and obtain necessary approvals.
2. Ensure that the conveyors 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 bottle and cap conveyors for any visible residues, contaminants, or blockages.
2. If any residues, contaminants, or blockages are found, note their location and severity for documentation.

4.3. Disassembly (if applicable)

If the conveyors have removable parts (e.g., belts, guides), follow the manufacturer’s instructions for disassembly before cleaning.

4.4. Pre-Rinse

1. Rinse the exterior of the conveyors with purified water to remove visible residues or contaminants.
2. Use a soft brush or sponge to gently clean any stubborn residues or deposits on the exterior surfaces.

4.5. 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 conveyors and any removable parts.

4.6. Cleaning Process

1. Apply the prepared cleaning solution to the exterior surfaces of the conveyors and any disassembled components using suitable cleaning tools.
2. Operate the conveyors according to the manufacturer’s specifications for a minimum of [insert duration] to ensure that the cleaning solution reaches all surfaces, including internal components.
3. Rinse the conveyors and their components with purified water to remove residual cleaning solution.
4. Reassemble the conveyors if they were disassembled.
5. Repeat the cleaning process as necessary until all residues, contaminants, or blockages are removed.

4.7. Post-Cleaning Inspection

1. Visually inspect the conveyors after cleaning to ensure that all residues, contaminants, or blockages have been effectively removed.
2. If any issues persist, repeat the cleaning process.

4.8. Final Inspection and Approval

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

4.9. 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

No external references are used in this SOP.

8. SOP Version

Version 1.0