Standard Operating Procedure for Cleaning and Sterilizing Nebulizer Production Tools
1) Purpose
The purpose of this SOP is to outline a standardized procedure for cleaning and sterilizing tools used in nebulizer production to ensure product quality and prevent contamination.
2) Scope
This SOP applies to all tools and equipment used in the manufacturing, assembly, and maintenance of nebulizers within the facility.
3) Responsibilities
Operators: Perform routine cleaning and report any abnormalities.
Maintenance Team: Sterilize tools and ensure they are properly maintained.
Quality Assurance (QA): Validate cleaning and sterilization activities and approve records.
Supervisors: Oversee adherence to cleaning and sterilization schedules.
4) Procedure
4.1 Pre-Cleaning Activities
- Inspect all tools for visible contamination, wear, or damage before cleaning.
- Segregate tools based on their material and cleaning requirements.
- Prepare the cleaning area, ensuring all necessary cleaning agents and equipment are available.
- Wear appropriate personal protective equipment (PPE), including gloves and safety goggles.
4.2 Cleaning Procedure
- Rinse tools under warm running water to remove loose debris and residue.
- Prepare a cleaning solution using an approved detergent in a designated cleaning tank.
- Submerge the tools in the cleaning solution and allow them to soak for the recommended duration.
- Use brushes or cleaning swabs to scrub surfaces, focusing on
4.3 Sterilization Procedure
- Place cleaned tools in sterilization pouches or trays, ensuring they are not overcrowded.
- Load the sterilization equipment, such as an autoclave or dry heat sterilizer, according to the manufacturer’s guidelines.
- Set the sterilizer parameters (e.g., temperature, pressure, and time) based on the tool material and sterilization requirements:
- Autoclave: Typically 121°C at 15 psi for 15–20 minutes.
- Dry Heat Sterilizer: Typically 160°C for 2 hours.
- Run the sterilization cycle and monitor equipment readings to ensure compliance with the set parameters.
- Allow tools to cool down before removing them from the sterilizer.
4.4 Post-Sterilization Activities
- Inspect sterilized tools for any signs of damage or incomplete sterilization.
- Label sterilized tools with the sterilization date and expiration date, if applicable.
- Store tools in a clean, designated area to maintain sterility until use.
- Document cleaning and sterilization activities in the Sterilization Log and submit it to QA for approval.
4.5 Handling Non-Conforming Tools
- Segregate tools that fail cleaning or sterilization and label them as “Rejected.”
- Document the details in the Non-Conformance Report.
- Repair or replace damaged tools before reintroducing them into the production process.
4.6 Safety Precautions
- Wear appropriate PPE during cleaning and sterilization activities to protect against chemical and thermal hazards.
- Handle hot tools and sterilization equipment carefully to prevent burns.
- Ensure proper ventilation in the cleaning and sterilization areas to avoid exposure to fumes.
5) Abbreviations
- QA: Quality Assurance
- PPE: Personal Protective Equipment
6) Documents
The following documents should be maintained:
- Cleaning and Sterilization Log
- Non-Conformance Report
- Tool Inspection Checklist
7) References
Relevant regulatory guidelines and references include:
- ISO 13485: Medical Devices Quality Management Systems
- Good Manufacturing Practices (GMP) Guidelines
- Equipment Manufacturer’s Manual
8) SOP Version
Version: 1.0
Annexure
Annexure Title: Cleaning and Sterilization Log
| Date | Tool ID | Cleaning Method | Sterilization Method | Performed By | QA Approval |
|---|---|---|---|---|---|
| DD/MM/YYYY | Tool Identifier | Details of cleaning | Details of sterilization | Technician Name | QA Name |
Annexure Title: Non-Conformance Report
| Date | Tool ID | Issue Identified | Corrective Action | Performed By | QA Approval |
|---|---|---|---|---|---|
| DD/MM/YYYY | Tool Identifier | Description of issue | Details of corrective action | Technician Name | QA Name |
Annexure Title: Tool Inspection Checklist
| Date | Tool ID | Condition | Inspected By | Remarks |
|---|---|---|---|---|
| DD/MM/YYYY | Tool Identifier | Good/Damaged | Inspector Name | Comments |