SOP Guide for Pharma

SOP for Operation of Nebulizer Filling Nozzles

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
               

    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
               

    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
               
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