Standard Operating Procedure for Operating Nebulizer Mixing Tanks
1) Purpose
The purpose of this SOP is to outline the correct operating procedure for nebulizer mixing tanks to ensure uniform mixing of solutions used in the manufacturing process.
2) Scope
This SOP applies to all mixing tanks used for solution preparation in the production of nebulizers.
3) Responsibilities
Operators: Ensure proper operation and cleaning of mixing tanks.
Maintenance Team: Perform regular maintenance and address technical issues.
Quality Assurance (QA): Verify the mixing process and maintain relevant records.
4) Procedure
4.1 Preparation Before Operation
- Inspect the mixing tank for any visible damages or residues from previous batches.
- Verify that all valves and seals are functioning properly and that there are no leaks.
- Ensure the tank is cleaned as per the cleaning SOP prior to use.
- Check the agitator and ensure it is securely attached and free of obstructions.
- Confirm that the required ingredients and tools are available and properly labeled.
4.2 Mixing Tank Operation
- Start the tank by turning on the main power supply and control panel.
- Set the appropriate speed and duration for mixing based on the batch size and material properties.
- Begin adding raw materials sequentially, as per the batch manufacturing record (BMR), to avoid clumping or inconsistent mixing.
- Monitor the temperature, if heating or cooling is required, and adjust settings as needed.
- Check the mixing progress at regular intervals using sampling tools to ensure homogeneity.
4.3 Post-Mixing Activities
- Turn off the agitator and allow the solution to settle before transferring.
- Transfer the solution to the designated storage or filling unit using sanitized transfer lines.
- Clean the tank immediately after use as per the cleaning SOP to prevent residue buildup.
4.4 Safety Precautions
- Always wear personal protective equipment (PPE), including gloves, masks, and safety glasses.
- Ensure proper grounding of the equipment to avoid electrical hazards.
- Handle chemicals carefully and follow the material safety data sheet (MSDS) for each material used.
5) Abbreviations
- PPE: Personal Protective Equipment
- BMR: Batch Manufacturing Record
- MSDS: Material Safety Data Sheet
6) Documents
The following documents should be maintained:
- Batch Manufacturing Record (BMR)
- Mixing Tank Cleaning Log
- Equipment Operation Log
7) References
Relevant regulatory guidelines and references include:
- Equipment Manufacturer’s Manual
- ISO 13485: Medical Devices Quality Management Systems
8) SOP Version
Version: 1.0
Annexure
Annexure Title: Batch Manufacturing Record for Mixing Tanks
| Batch No. | Start Time | End Time | Mixing Speed | Operator Initials | Remarks |
|---|---|---|---|---|---|
| Batch Number | HH:MM | HH:MM | RPM | Operator Name | Mixing completed as per SOP |
Annexure Title: Mixing Tank Cleaning Log
| Date | Tank ID | Cleaning Method | Operator Initials | Supervisor Signature |
|---|---|---|---|---|
| DD/MM/YYYY | Tank Identifier | Manual/Automated | Operator Name | Supervisor Name |