Standard Operating Procedure for Cleaning Nebulizer Component Storage Containers
1) Purpose
The purpose of this SOP is to establish a standardized cleaning procedure for nebulizer component storage containers to ensure the prevention of contamination and maintain product quality.
2) Scope
This SOP applies to all storage containers used to store nebulizer components in the production and quality control areas.
3) Responsibilities
Operators: Perform the cleaning process as outlined in this SOP.
Quality Assurance (QA): Verify the cleaning process and approve the cleaning records.
Maintenance Team: Ensure the proper functioning of cleaning equipment and address any issues.
4) Procedure
4.1 Pre-Cleaning Checks
- Inspect the storage containers for visible debris, residues, or damage.
- Ensure that all cleaning tools, such as brushes and cloths, are clean and ready for use.
- Prepare the approved cleaning agents as per the manufacturer’s instructions.
- Wear appropriate personal protective equipment (PPE), including gloves and safety glasses.
4.2 Cleaning Process
4.2.1 Manual Cleaning
- Disassemble any removable parts of the storage container, such as lids or handles.
- Scrub the container surfaces with a brush or cloth using the prepared cleaning solution.
- Rinse the container thoroughly with potable water to remove all cleaning agent residues.
- Perform a final rinse with purified or deionized water to ensure complete cleanliness.
4.2.2 Automated Cleaning
- Load the storage containers into the cleaning machine, ensuring they are properly secured.
- Select the appropriate cleaning cycle based on the material and contamination level.
- Start the cleaning cycle and monitor the machine for proper operation.
- After cleaning, inspect the containers for any remaining residues or stains.
4.3 Drying
- Wipe down manually cleaned containers with a lint-free cloth.
- Allow containers to air dry in a designated clean area or use a drying oven for faster drying.
- Ensure all containers are completely dry before storage or use.
4.4 Post-Cleaning Inspection
- Inspect the cleaned containers visually to ensure there are no residues or contamination.
- Document the cleaning process in the Cleaning Log for Nebulizer Component Containers.
- Label the containers with the cleaning date, next due date, and operator initials.
4.5 Frequency of Cleaning
- Routine Cleaning: Weekly or after each batch use.
- Deep Cleaning: Monthly or after prolonged storage of components.
- Emergency Cleaning: Immediately after contamination or spillage.
5) Abbreviations
- PPE: Personal Protective Equipment
- QA: Quality Assurance
6) Documents
The following documents should be maintained:
- Cleaning Log for Nebulizer Component Containers
- Cleaning Agent Preparation Record
- Cleaning Inspection Report
7) References
Relevant regulatory guidelines and references include:
- ISO 13485: Medical Devices Quality Management Systems
- Good Manufacturing Practices (GMP) Guidelines
- Equipment Manufacturer’s Cleaning Instructions
8) SOP Version
Version: 1.0
Annexure
Annexure Title: Cleaning Log for Nebulizer Component Containers
| Date | Container ID | Cleaning Method | Cleaning Agent Used | Operator Initials | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | Container Identifier | Manual/Automated | Agent Name | Operator Name | Details of cleaning |
Annexure Title: Cleaning Agent Preparation Record
| Date | Agent Name | Concentration | Prepared By | QA Approval | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | Agent Identifier | Concentration (%) | Operator Name | QA Name | Details of preparation |
Annexure Title: Cleaning Inspection Report
| Date | Container ID | Inspection Status | Inspected By | QA Approval | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | Container Identifier | Pass/Fail | Inspector Name | QA Name | Details of inspection |