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.

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

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

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

Date	Batch No.	Deviation Observed	Action Taken	Performed By	QA Approval
DD/MM/YYYY	Batch Identifier	Deviation Description	Action Details	Operator Name	QA Name