SOP for Operation of Nebulizer Filling Nozzles

Standard Operating Procedure for Operating Nebulizer Filling Nozzles

1) Purpose

The purpose of this SOP is to define the procedure for the operation of nebulizer filling nozzles to ensure accurate, consistent, and contamination-free filling during production.

2) Scope

This SOP applies to all filling nozzles used in nebulizer manufacturing processes within the facility.

3) Responsibilities

Operators: Operate filling nozzles and monitor their performance during production.
Maintenance Team: Conduct regular checks and address nozzle-related issues.
Quality Assurance (QA): Validate the filling process and approve batch records.
Supervisors: Ensure compliance with the SOP and oversee operations during production shifts.

4) Procedure

4.1 Pre-Operation Checks

Inspect filling nozzles for cleanliness and ensure they are free of residues from previous operations.
Verify that the nozzles are properly aligned and securely attached to the filling machine.
Check for any physical damage or wear on the nozzles.
Ensure the filling machine and nozzles are calibrated for the required filling volume.
Document pre-operation inspection details in the Filling Nozzle Log.

4.2 Setup and Adjustment

Connect the nozzles to the filling machine and ensure all fittings are secure.
Set the filling parameters, such as volume, speed, and cycle time, according to the batch requirements.
Run a trial filling with a small number

of containers to verify nozzle performance and accuracy.

Adjust the nozzles if necessary to achieve optimal performance.

4.3 Operating the Filling Nozzles

Start the filling process and monitor the operation to ensure consistent and accurate filling.
Inspect filled containers periodically to confirm proper volume and absence of spills or overfills.
Maintain a steady supply of containers to avoid interruptions in the filling process.
Record operational details, including batch number and operator initials, in the Operation Log.

4.4 Post-Operation Activities

Stop the filling process and disconnect the nozzles from the machine.
Clean the nozzles thoroughly according to the cleaning SOP to prevent cross-contamination.
Inspect the nozzles for any wear or damage and report findings to the maintenance team.
Document post-operation activities in the Filling Nozzle Log.

4.5 Handling Non-Conforming Products

Segregate containers with incorrect fill volumes or visible defects and label them as “Rejected.”
Document the details of rejected containers in the Defective Product Report.
Investigate the root cause and implement corrective actions before resuming production.

4.6 Preventive Maintenance

Inspect the nozzles for wear or damage monthly and replace any faulty parts as necessary.
Calibrate the filling nozzles quarterly to ensure accuracy.
Lubricate any moving parts associated with the nozzles according to the manufacturer’s recommendations.
Document maintenance activities in the Maintenance Log.

4.7 Safety Precautions

Wear appropriate personal protective equipment (PPE), such as gloves and safety glasses, during operation and cleaning.
Ensure the filling machine is powered off before attaching, detaching, or cleaning the nozzles.
Handle nozzles carefully to prevent damage or misalignment.

5) Abbreviations

QA: Quality Assurance
PPE: Personal Protective Equipment

6) Documents

The following documents should be maintained:

Filling Nozzle Log
Operation Log
Defective Product Report
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: Filling Nozzle Log

   Date  Nozzle ID  Pre-Operation Check  Post-Operation Check  Operator Initials  Remarks  
  DD/MM/YYYY  Nozzle Identifier  Pass/Fail  Pass/Fail  Operator Name  Details of operation

Date	Nozzle ID	Pre-Operation Check	Post-Operation Check	Operator Initials	Remarks
DD/MM/YYYY	Nozzle Identifier	Pass/Fail	Pass/Fail	Operator Name	Details of operation

Annexure Title: Defective Product Report

   Date  Batch No.  Issue Identified  Quantity  Reported By  Remarks  
  DD/MM/YYYY  Batch Identifier  Description of issue  Number of units  Operator Name  Details of resolution

Date	Batch No.	Issue Identified	Quantity	Reported By	Remarks
DD/MM/YYYY	Batch Identifier	Description of issue	Number of units	Operator Name	Details of resolution

Annexure Title: Maintenance Log

   Date  Nozzle ID  Maintenance Type  Performed By  QA Approval  Remarks  
  DD/MM/YYYY  Nozzle Identifier  Routine/Corrective  Technician Name  QA Name  Details of activity