Standard Operating Procedure for Operating Nebulizer Component Sorting Machines
1) Purpose
The purpose of this SOP is to establish a standardized procedure for operating nebulizer component sorting machines to ensure the accurate and efficient sorting of components as per production requirements.
2) Scope
This SOP applies to all nebulizer component sorting machines used in the manufacturing process within the facility.
3) Responsibilities
Operators: Operate sorting machines and ensure proper sorting of components.
Maintenance Team: Perform regular maintenance and troubleshoot any issues with the machines.
Quality Assurance (QA): Validate the sorting process and approve related documentation.
Supervisors: Oversee the sorting process and ensure compliance with this SOP.
4) Procedure
4.1 Pre-Operation Checks
- Ensure the sorting machine is clean and free from any debris or previous batch residues.
- Verify the machine is connected to the power supply and is in working condition.
- Inspect the machine for any physical damage or misalignment of components.
- Confirm that the required component specifications are loaded into the machine’s program.
- Record the pre-operation inspection details in the Machine Inspection Log.
4.2 Setting Up the Sorting Machine
- Load the hopper or input section of the sorting machine with the nebulizer components.
- Set the sorting parameters, such as size, shape, or
4.3 Operating the Sorting Machine
- Start the sorting process using the machine’s control panel.
- Monitor the operation to ensure components are being sorted accurately.
- Regularly check the output bins to verify that sorted components meet the specified criteria.
- Document the operation details, including batch number and operator initials, in the Operation Log.
4.4 Post-Operation Activities
- Turn off the sorting machine and disconnect it from the power supply.
- Clean the machine thoroughly to remove any remaining components or debris.
- Inspect the machine for wear or damage and report any findings to the maintenance team.
- Record the completion of the operation in the Machine Operation Log.
4.5 Handling Non-Conforming Components
- Segregate components that do not meet sorting criteria and label them as “Rejected.”
- Document the details of rejected components in the Rejected Component Log.
- Investigate the root cause of sorting errors and recalibrate the machine if necessary.
4.6 Preventive Maintenance
- Inspect and clean the sorting machine’s internal parts, such as sensors and conveyors, weekly.
- Lubricate moving parts as per the manufacturer’s recommendations.
- Perform a full calibration of the machine quarterly to ensure sorting accuracy.
- Document maintenance activities in the Maintenance Log and submit them to QA.
4.7 Safety Precautions
- Wear appropriate personal protective equipment (PPE), such as gloves and safety goggles, during operation and maintenance.
- Ensure hands and tools are kept away from moving parts during machine operation.
- Follow the manufacturer’s safety guidelines for handling sorting machines.
5) Abbreviations
- QA: Quality Assurance
- PPE: Personal Protective Equipment
6) Documents
The following documents should be maintained:
- Machine Inspection Log
- Operation Log
- Rejected Component Log
- Maintenance Log
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: Machine Inspection Log
| Date | Machine ID | Pre-Operation Check | Post-Operation Check | Inspected By | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | Machine Identifier | Pass/Fail | Pass/Fail | Inspector Name | Details of inspection |
Annexure Title: Rejected Component Log
| Date | Batch No. | Component Type | Reason for Rejection | Quantity | Inspected By |
|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Identifier | Component Details | Reason for rejection | Number of units | Inspector Name |
Annexure Title: Maintenance Log
| Date | Machine ID | Maintenance Type | Performed By | QA Approval | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | Machine Identifier | Routine/Corrective | Technician Name | QA Name | Details of activity |