SOP for Use of Nebulizer Component Sorting Machines

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

weight, based on the batch requirements.

Run a trial batch to confirm proper sorting functionality and make adjustments if needed.

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

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

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