Standard Operating Procedure for Operating Nebulizer Storage and Retrieval Systems
1) Purpose
The purpose of this SOP is to establish a standardized procedure for the operation of nebulizer storage and retrieval systems, ensuring efficient and secure handling of inventory while maintaining product quality.
2) Scope
This SOP applies to all automated and manual storage and retrieval systems used for storing nebulizers and related components in the production and distribution facilities.
3) Responsibilities
Operators: Operate the storage and retrieval system according to this SOP.
Warehouse Personnel: Maintain accurate inventory records and monitor system performance.
Maintenance Team: Perform routine maintenance and troubleshoot system malfunctions.
Quality Assurance (QA): Validate the storage conditions and ensure compliance with quality standards.
4) Procedure
4.1 Pre-Operation Checks
- Inspect the storage and retrieval system for cleanliness and ensure all components are functioning correctly.
- Verify that the system’s software is operational and all required data, such as product codes and storage locations, is updated.
- Ensure storage areas meet temperature and humidity requirements as per product specifications.
- Document pre-operation checks in the Storage System Operation Log.
4.2 Loading Nebulizers into the Storage System
- Verify the identification details of the nebulizers, such as batch numbers and product codes.
- Place nebulizer units
4.3 Retrieving Nebulizers from the Storage System
- Enter the required product details, such as batch number or product code, into the system interface.
- Allow the system to retrieve the specified items automatically or manually access the designated location.
- Verify the retrieved items against the requested details to ensure accuracy.
- Document the retrieval in the Storage and Retrieval Log.
4.4 Post-Operation Activities
- Inspect the system for any signs of wear or damage after operation.
- Update inventory records to reflect storage and retrieval activities accurately.
- Clean the system as per the cleaning SOP to prepare it for the next operation.
- Record the operation details, including start and end times, in the Storage System Operation Log.
4.5 Handling System Malfunctions
- If a malfunction occurs, stop the system and report the issue to the maintenance team immediately.
- Document the malfunction and corrective actions taken in the Maintenance Incident Report.
- Do not resume operations until the system is repaired and validated by the QA team.
4.6 Safety Precautions
- Ensure personal protective equipment (PPE), such as gloves and safety boots, is worn while handling products.
- Do not attempt to manually retrieve items from automated systems without disabling them first.
- Follow the manufacturer’s safety guidelines for operating the storage and retrieval system.
5) Abbreviations
- QA: Quality Assurance
- PPE: Personal Protective Equipment
6) Documents
The following documents should be maintained:
- Storage System Operation Log
- Storage and Retrieval Log
- Maintenance Incident Report
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: Storage System Operation Log
| Date | System ID | Activity Type | Performed By | Remarks |
|---|---|---|---|---|
| DD/MM/YYYY | System Identifier | Storage/Retrieval | Operator Name | Details of activity |
Annexure Title: Storage and Retrieval Log
| Date | Batch No. | Product Code | Location | Operator Initials | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Identifier | Product Code | Location Identifier | Operator Name | Details of activity |
Annexure Title: Maintenance Incident Report
| Date | System ID | Issue Identified | Corrective Action | Performed By | QA Approval |
|---|---|---|---|---|---|
| DD/MM/YYYY | System Identifier | Description of issue | Details of action | Technician Name | QA Name |
