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.

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