Standard Operating Procedure for Maintaining Nebulizer Storage Racks
1) Purpose
The purpose of this SOP is to define the procedure for maintaining nebulizer storage racks to ensure they remain clean, functional, and compliant with safety and quality standards.
2) Scope
This SOP applies to all storage racks used for holding nebulizer components, finished products, and associated materials within the facility.
3) Responsibilities
Operators: Perform routine checks and cleaning of the storage racks.
Maintenance Team: Address any repairs or replacements required for damaged racks.
Quality Assurance (QA): Validate maintenance activities and approve maintenance records.
Supervisors: Ensure compliance with this SOP and monitor storage conditions.
4) Procedure
4.1 Routine Inspection
- Inspect storage racks weekly for cleanliness, structural integrity, and signs of wear or damage.
- Ensure racks are free of dust, debris, or spilled materials.
- Check for loose bolts, broken welds, or bent metal components.
- Verify that all racks are correctly labeled and meet weight capacity guidelines.
- Document inspection findings in the Storage Rack Inspection Log.
4.2 Cleaning of Storage Racks
- Remove all stored items from the racks before cleaning.
- Dust the surfaces using a clean, dry cloth or vacuum with a soft brush attachment.
- Wipe down the racks with a cloth dampened with an approved cleaning
4.3 Preventive Maintenance
- Tighten any loose bolts or fasteners during inspections.
- Lubricate sliding or moving parts, such as rack sliders or wheels, as needed.
- Replace worn or damaged components immediately to prevent accidents or product damage.
- Repaint or coat racks showing signs of rust or corrosion using approved materials.
- Maintain a record of preventive maintenance activities in the Maintenance Log.
4.4 Corrective Maintenance
- Isolate any racks that are damaged or unsafe for use.
- Repair structural damage, such as bent or broken metal components, as soon as possible.
- Replace racks that are beyond repair and dispose of them according to facility guidelines.
- Conduct a post-maintenance inspection to ensure repaired racks meet safety and functional requirements.
- Document corrective maintenance activities in the Maintenance Report.
4.5 Safety Checks
- Ensure racks are not overloaded and comply with specified weight limits.
- Verify that stored items are organized securely to prevent falls or spills.
- Ensure all racks are stable and properly anchored, especially those in high-traffic areas.
4.6 Frequency of Maintenance
- Routine Inspection: Weekly
- Cleaning: Monthly or as required
- Preventive Maintenance: Quarterly
- Corrective Maintenance: As needed
4.7 Safety Precautions
- Wear appropriate personal protective equipment (PPE), such as gloves and safety boots, during cleaning and maintenance activities.
- Ensure all stored items are handled carefully and returned to their designated locations after cleaning or maintenance.
- Follow lockout/tagout procedures when working on racks with electrical components, such as motorized units.
5) Abbreviations
- QA: Quality Assurance
- PPE: Personal Protective Equipment
6) Documents
The following documents should be maintained:
- Storage Rack Inspection Log
- Maintenance Log
- Maintenance Report
7) References
Relevant regulatory guidelines and references include:
- ISO 13485: Medical Devices Quality Management Systems
- Good Manufacturing Practices (GMP) Guidelines
- Facility Safety Standards
8) SOP Version
Version: 1.0
Annexure
Annexure Title: Storage Rack Inspection Log
| Date | Rack ID | Condition | Inspected By | Remarks |
|---|---|---|---|---|
| DD/MM/YYYY | Rack Identifier | Good/Damaged | Inspector Name | Details of condition |
Annexure Title: Maintenance Log
| Date | Rack ID | Maintenance Type | Performed By | QA Approval | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | Rack Identifier | Routine/Corrective | Technician Name | QA Name | Details of activity |
Annexure Title: Maintenance Report
| Date | Rack ID | Issue Identified | Corrective Action | Performed By | QA Approval |
|---|---|---|---|---|---|
| DD/MM/YYYY | Rack Identifier | Description of issue | Details of corrective action | Technician Name | QA Name |