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
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 |