Standard Operating Procedure for Cleaning of Induction Sealer
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to outline the cleaning procedure for an induction sealer 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 induction sealers 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 induction sealer and approving it for further use.
- Supervisor: Oversees the cleaning process and ensures compliance with this SOP.
4. Procedure
4.1. Pre-Cleaning Preparations
- Notify the Production Supervisor of the need for induction sealer cleaning and obtain necessary approvals.
- Ensure that the induction sealer is not in operation and is safely isolated from the production process.
- Wear appropriate personal protective equipment (PPE), including gloves and safety goggles.
4.2. Inspection
- Visually inspect the induction sealer for any visible residues, contaminants, or blockages.
- If any residues, contaminants, or blockages are found, note their location and severity for documentation.
4.3. Disconnection
- Disconnect the induction sealer from the power source to ensure safety during the cleaning process.
- If applicable, disconnect any auxiliary equipment connected to the sealer (e.g., conveyor systems).
4.4. Pre-Rinse
- Rinse the exterior of the induction sealer with purified
water to remove visible residues or contaminants.
Use a soft brush or sponge to gently clean any stubborn residues or deposits on the exterior surfaces.
4.5. Cleaning Solution Preparation
- Prepare a cleaning solution as per the approved formula and concentration. Refer to the Cleaning Solution Formulation document (if available) for details.
- Ensure that the cleaning solution is suitable for the materials of construction of the induction sealer.
4.6. Cleaning Process
- Apply the prepared cleaning solution to the exterior surfaces of the induction sealer using suitable cleaning tools.
- Operate any cleaning mechanisms or brushes recommended by the manufacturer to clean the interior components of the sealer.
- Rinse the induction sealer with purified water to remove residual cleaning solution.
- Allow the sealer to dry thoroughly before reconnection and operation.
- Repeat the cleaning process as necessary until all residues, contaminants, or blockages are removed.
4.7. Post-Cleaning Inspection
- Visually inspect the induction sealer after cleaning to ensure that all residues, contaminants, or blockages have been effectively removed.
- If any issues persist, repeat the cleaning process.
4.8. Final Inspection and Approval
- Notify the QA Inspector that the induction sealer is ready for inspection.
- The QA Inspector will visually inspect the sealer and document the inspection results.
- If the sealer meets cleanliness criteria, it is 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