SOP for Operation of Nebulizer Mixing Tanks

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

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

Date	Tank ID	Cleaning Method	Operator Initials	Supervisor Signature
DD/MM/YYYY	Tank Identifier	Manual/Automated	Operator Name	Supervisor Name