SOP Guide for Pharma

SOP for Operation of Nebulizer Solution Preparation Vessels

Auditor

SOP for Operation of Nebulizer Solution Preparation Vessels

Standard Operating Procedure for Operating Nebulizer Solution Preparation Vessels

1) Purpose

The purpose of this SOP is to establish a standardized procedure for the operation of solution preparation vessels used in the manufacturing of nebulizer formulations to ensure consistent and high-quality production.

2) Scope

This SOP applies to all solution preparation vessels used in the formulation process for nebulizer products within the production facility.

3) Responsibilities

Operators: Perform solution preparation and operate the vessels as per the defined procedure.
Maintenance Team: Conduct routine maintenance and troubleshooting of the vessels.
Quality Assurance (QA): Inspect and approve the prepared solutions and operational logs.

4) Procedure

4.1 Pre-Operation Checks

  • Ensure the vessel is cleaned as per the cleaning SOP and visually inspect for any residual material or contamination.
  • Verify that the vessel components, such as agitators, valves, and seals, are functional and in good condition.
  • Ensure that the raw materials required for the solution are approved and available as per the batch record.
  • Check the calibration status of temperature and pressure gauges attached to the vessel.
  • Document the vessel’s ID, batch number, and pre-operation checks in the Vessel Operation Log.
See also  SOP for Cleaning of Nebulizer Solution Mixing Equipment

4.2 Solution Preparation

  • Add the required volume of purified water to the vessel, ensuring it
meets the specified quality standards.
  • Initiate the mixing process by starting the agitator at the recommended speed to create a vortex.
  • Gradually add raw materials, such as active pharmaceutical ingredients (APIs) and excipients, into the vessel while mixing.
  • Monitor the temperature, pH, and viscosity of the solution during the mixing process using in-line sensors or handheld devices.
  • Adjust mixing parameters, such as speed and duration, based on the solution specifications outlined in the batch record.

    • 4.3 Post-Preparation Activities

    • Stop the agitator and allow the solution to settle as per the defined time in the batch record.
    • Perform in-process quality checks, such as sampling for clarity, particle size, and pH, to validate the solution’s quality.
    • Transfer the solution to the designated storage container or production line using sanitized transfer lines.
    • Clean the vessel and associated equipment as per the cleaning SOP to prepare it for the next batch.
    • Document the preparation details and quality checks in the Vessel Operation Log.

    4.4 Safety Precautions

    • Always wear personal protective equipment (PPE), including gloves, goggles, and lab coats, during the operation.
    • Ensure that all electrical connections are secure and equipment is grounded to prevent accidents.
    • Handle raw materials as per their respective material safety data sheets (MSDS).
    • Follow lockout/tagout (LOTO) procedures during maintenance or troubleshooting.

    4.5 Emergency Handling

    • If the vessel malfunctions during operation, stop the process immediately and notify the maintenance team.
    • Isolate the affected solution batch and inform the QA team for further action.
    • Document any deviations or incidents in the Deviation Report.

    5) Abbreviations

    • QA: Quality Assurance
    • PPE: Personal Protective Equipment
    • LOTO: Lockout/Tagout
    • MSDS: Material Safety Data Sheet
    • API: Active Pharmaceutical Ingredient

    6) Documents

    The following documents should be maintained:

    • Vessel Operation Log
    • Batch Preparation Record
    • Deviation 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: Vessel Operation Log
    Date Vessel ID Batch No. Parameters Monitored Operator Initials Remarks
    DD/MM/YYYY Vessel Identifier Batch Number Temp, pH, Speed Operator Name Details of operation
               

    Annexure Title: Batch Preparation Record
    Date Batch No. Raw Materials Used Final Parameters QA Approval Remarks
    DD/MM/YYYY Batch Identifier Material Names Temp, pH, Viscosity QA Name Details of preparation
               

    Annexure Title: Deviation Report
    Date Batch No. Deviation Observed Action Taken Performed By QA Approval
    DD/MM/YYYY Batch Identifier Deviation Description Action Details Operator Name QA Name
               
    See also  SOP for Inspection and Testing of Nebulizer Components
    Exit mobile version