SOP for Setup and Adjustment of Nebulizer Assembly Line

Standard Operating Procedure for Setting Up and Adjusting Nebulizer Assembly Line

1) Purpose

The purpose of this SOP is to establish a standardized process for the setup and adjustment of the nebulizer assembly line to ensure efficient and consistent production while maintaining product quality.

2) Scope

This SOP applies to the initial setup, routine adjustments, and reconfigurations of all equipment and components in the nebulizer assembly line.

3) Responsibilities

Operators: Execute setup and adjustments as per the procedure.
Maintenance Team: Handle technical adjustments, repairs, and reconfigurations.
Quality Assurance (QA): Inspect and approve the assembly line setup for compliance with production standards.

4) Procedure

4.1 Pre-Setup Preparation

Inspect the assembly line equipment for cleanliness and ensure it has been cleaned as per the cleaning SOP.
Verify that all tools and materials required for the setup are available and in good condition.
Ensure the workspace is clear of unnecessary items to prevent accidents or contamination.
Check the power supply and connections to ensure the equipment is ready for operation.

4.2 Assembly Line Setup

Position each piece of equipment (e.g., filling machines, sealing machines, conveyor belts) in its designated area as per the layout plan.
Connect all equipment to the power supply and ensure

safety features such as grounding and emergency stops are functional.

Adjust the conveyor belt speed to match the production requirements for the batch.

Install and secure any tools or fixtures, such as guide rails or product holders, as required for the product being assembled.

4.3 Adjustment of Parameters

Set the filling volume on the filling machines to meet the product specifications.
Adjust the sealing temperature and pressure based on the material specifications.
Calibrate sensors, such as those for detecting product alignment and weight, using standard samples.
Ensure that the label printer is loaded with the correct labels and programmed for accurate placement.

4.4 Validation of Setup

Run a trial batch through the assembly line to validate the setup.
Inspect the trial products for defects, such as incorrect sealing, misaligned labels, or inconsistent filling volumes.
Document any issues encountered and make the necessary adjustments.
Perform a second trial if significant adjustments were made, and revalidate the setup.

4.5 Safety Precautions

Always wear personal protective equipment (PPE), including gloves, safety glasses, and antistatic footwear.
Ensure that all equipment is powered off during adjustments to prevent accidents.
Follow lockout/tagout (LOTO) procedures when working on high-voltage equipment.

5) Abbreviations

PPE: Personal Protective Equipment
QA: Quality Assurance
LOTO: Lockout/Tagout

6) Documents

The following documents should be maintained:

Assembly Line Setup Log
Trial Batch Validation Report
Equipment Adjustment Checklist

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: Assembly Line Setup Log

   Date  Equipment Name  Parameters Set  Operator Initials  Remarks  
  DD/MM/YYYY  Equipment Identifier  Speed, Temp, Volume, etc.  Operator Name  Setup completed as per SOP

Date	Equipment Name	Parameters Set	Operator Initials	Remarks
DD/MM/YYYY	Equipment Identifier	Speed, Temp, Volume, etc.	Operator Name	Setup completed as per SOP

Annexure Title: Trial Batch Validation Report

   Date  Batch No.  Parameters Validated  QA Approval  Remarks  
  DD/MM/YYYY  Batch Number  Speed, Temp, Volume, etc.  QA Name  Validation successful

Date	Batch No.	Parameters Validated	QA Approval	Remarks
DD/MM/YYYY	Batch Number	Speed, Temp, Volume, etc.	QA Name	Validation successful