Standard Operating Procedure (SOP) for Cleaning of Electric Fumigator in Sterile Injectable Area
Objective
To establish a standard procedure for cleaning the electric fumigator used in the sterile injectable area, ensuring its proper maintenance, functionality, and compliance with Good Manufacturing Practices (GMP).
Scope
This SOP applies to all electric fumigators used in the sterile injectable manufacturing areas.
Responsibility
- Operators: Responsible for performing the cleaning activities.
- Supervisors: Responsible for verifying the cleaning process.
- Quality Assurance (QA): Responsible for monitoring compliance and maintaining records.
Materials and Equipment
- Clean lint-free cloths
- Soft brushes
- Isopropyl alcohol (IPA) 70% solution
- Detergent solution (GMP-approved)
- Deionized (DI) water
- Personal Protective Equipment (PPE)
- Cleaning logbook
Procedure
1. Preparation
1.1 Ensure the electric fumigator is switched off and disconnected from the power supply before beginning the cleaning process. 1.2 Wear appropriate PPE, including gloves, masks, and gowns. 1.3 Gather all required cleaning materials and equipment.
2. Pre-Cleaning Inspection
2.1 Inspect the fumigator for any visible dust, debris, or residue. 2.2 Check for any damages or malfunctions and report them to the supervisor if identified.
3. Cleaning Procedure
3.1 External Cleaning
3.1.1 Wipe the external surfaces of the fumigator with a clean lint-free cloth dampened with detergent solution. 3.1.2 Use a soft brush to clean vents and other hard-to-reach areas to remove dust or debris. 3.1.3 Wipe the surfaces with another cloth dampened with DI water to remove any detergent residue. 3.1.4 Disinfect the external surfaces using a lint-free cloth dampened with 70% IPA. 3.1.5 Allow the surface to air dry before proceeding.
3.2 Internal Cleaning
3.2.1 Open the fumigator’s internal chamber or any removable parts, following the manufacturer’s guidelines. 3.2.2 Gently clean the internal parts with a lint-free cloth dampened with detergent solution. Use soft brushes for intricate areas. 3.2.3 Wipe the cleaned parts with a cloth dampened with DI water to remove any detergent residue. 3.2.4 Disinfect the internal surfaces with 70% IPA and allow them to air dry completely.
3.3 Nozzle and Fan Cleaning
3.3.1 Detach the nozzle and fan components as per the manufacturer’s instructions. 3.3.2 Clean the nozzle with detergent solution using a soft brush to remove any residue. 3.3.3 Rinse the nozzle with DI water and disinfect with 70% IPA. 3.3.4 Gently wipe the fan blades with a cloth dampened with detergent solution and then with DI water. 3.3.5 Disinfect the fan blades with 70% IPA and allow them to air dry.
4. Reassembly and Final Inspection
4.1 Reassemble all components of the fumigator as per the manufacturer’s guidelines. 4.2 Inspect the fumigator to ensure all parts are clean, dry, and correctly reassembled.
5. Post-Cleaning Activities
5.1 Reconnect the fumigator to the power supply and perform a functional check to ensure proper operation. 5.2 Record the cleaning activity in the cleaning logbook, including the date, time, and name of the operator.
6. Frequency of Cleaning
- Daily: External cleaning of the fumigator.
- Weekly: Comprehensive cleaning of both external and internal components.
- After Use: Immediate cleaning if the fumigator has been used for fumigation purposes.
Precautions
- Ensure the fumigator is disconnected from the power supply before cleaning to prevent electrical hazards.
- Avoid using excessive liquid to prevent damage to electrical components.
- Follow the manufacturer’s instructions for handling and cleaning specific parts.
Records
- Cleaning Logbook
- Maintenance Reports (if applicable)
References
- Manufacturer’s Instruction Manual
- GMP Guidelines for Cleaning and Maintenance
Approval
Prepared By: ___________________________ Date: _________________________________
Reviewed By: ___________________________ Date: _________________________________
Approved By: ___________________________ Date: _________________________________