Standard Operating Procedure for Operating Nebulizer Product Transfer Systems

1) Purpose

The purpose of this SOP is to define a standardized procedure for operating nebulizer product transfer systems to ensure efficient and contamination-free movement of products between production stages.

2) Scope

This SOP applies to all transfer systems used for handling nebulizer components, semi-finished products, and finished goods within the facility.

3) Responsibilities

Operators: Operate the transfer system and monitor its performance.
Maintenance Team: Perform routine and preventive maintenance on the system.
Quality Assurance (QA): Validate operational performance and approve related records.
Supervisors: Oversee operations to ensure adherence to this SOP.

4) Procedure

4.1 Pre-Operation Checks

• Inspect the transfer system for cleanliness and functionality.
• Ensure all belts, rollers, and conveyor components are intact and securely fastened.
• Verify the system is free of debris or obstructions.
• Check that the control panel and emergency stop buttons are operational.
• Document pre-operation checks in the Transfer System Log.

4.2 Starting the Transfer System

• Switch on the main power supply to the transfer system.
• Set the system parameters, such as speed and load capacity, according to the batch requirements.
• Conduct a trial run with an empty system to ensure smooth operation.
• Address any issues identified during the trial run before proceeding.

4.3 Operating the Transfer System

• Load products onto the transfer system in a secure and organized manner to prevent spillage or damage.
• Monitor the system continuously during operation to ensure smooth and consistent product movement.
• Inspect transferred products periodically to confirm they remain undamaged.
• Record operational details, including batch number and operator initials, in the Operation Log.

4.4 Post-Operation Activities

• Turn off the transfer system and disconnect it from the power supply.
• Clean the belts, rollers, and other components using approved cleaning agents.
• Inspect the system for any wear or damage and report findings to the maintenance team.
• Document post-operation activities in the Transfer System Log.

4.5 Handling System Malfunctions

• Stop the transfer system immediately if any malfunctions occur.
• Notify the maintenance team and document the issue in the System Malfunction Report.
• Resume operation only after the issue has been resolved and the system has been tested.

4.6 Preventive Maintenance

• Inspect belts, rollers, and motor components monthly and replace worn parts as necessary.
• Lubricate moving parts as per the manufacturer’s guidelines to ensure smooth operation.
• Calibrate the system quarterly to verify speed and load capacity settings.
• Document all maintenance activities in the Maintenance Log.

4.7 Safety Precautions

• Wear appropriate personal protective equipment (PPE), such as gloves and safety shoes, during operation and maintenance.
• Ensure no unauthorized personnel are near the system during operation.
• Keep hands and tools away from moving parts while the system is operational.
• Follow lockout/tagout procedures when performing maintenance activities.

5) Abbreviations

• QA: Quality Assurance
• PPE: Personal Protective Equipment

6) Documents

The following documents should be maintained:

• Transfer System Log
• Operation Log
• System Malfunction Report
• Maintenance Log

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: Transfer System Log

 
 
 
Date
 
System ID
 
Pre-Operation Check
 
Post-Operation Check
 
Operator Initials
 
Remarks
 
 
 
DD/MM/YYYY
 
System Identifier
 
Pass/Fail
 
Pass/Fail
 
Operator Name
 
Details of operation
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Annexure Title: System Malfunction Report

 
 
 
Date
 
System ID
 
Issue Identified
 
Corrective Action
 
Performed By
 
QA Approval
 
 
 
DD/MM/YYYY
 
System Identifier
 
Description of issue
 
Details of corrective action
 
Technician Name
 
QA Name
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Annexure Title: Maintenance Log

 
 
 
Date
 
System ID
 
Maintenance Type
 
Performed By
 
QA Approval
 
Remarks
 
 
 
DD/MM/YYYY
 
System Identifier
 
Routine/Corrective
 
Technician Name
 
QA Name
 
Details of activity
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Standard Operating Procedure for Maintaining Nebulizer Storage Racks

1) Purpose

The purpose of this SOP is to define the procedure for maintaining nebulizer storage racks to ensure they remain clean, functional, and compliant with safety and quality standards.

2) Scope

This SOP applies to all storage racks used for holding nebulizer components, finished products, and associated materials within the facility.

3) Responsibilities

Operators: Perform routine checks and cleaning of the storage racks.
Maintenance Team: Address any repairs or replacements required for damaged racks.
Quality Assurance (QA): Validate maintenance activities and approve maintenance records.
Supervisors: Ensure compliance with this SOP and monitor storage conditions.

4) Procedure

4.1 Routine Inspection

• Inspect storage racks weekly for cleanliness, structural integrity, and signs of wear or damage.
• Ensure racks are free of dust, debris, or spilled materials.
• Check for loose bolts, broken welds, or bent metal components.
• Verify that all racks are correctly labeled and meet weight capacity guidelines.
• Document inspection findings in the Storage Rack Inspection Log.

4.2 Cleaning of Storage Racks

• Remove all stored items from the racks before cleaning.
• Dust the surfaces using a clean, dry cloth or vacuum with a soft brush attachment.
• Wipe down the racks with a cloth dampened with an approved cleaning solution.
• Ensure that all cleaning agents are non-reactive and suitable for contact with stored materials.
• Allow racks to air dry before returning stored items.

4.3 Preventive Maintenance

• Tighten any loose bolts or fasteners during inspections.
• Lubricate sliding or moving parts, such as rack sliders or wheels, as needed.
• Replace worn or damaged components immediately to prevent accidents or product damage.
• Repaint or coat racks showing signs of rust or corrosion using approved materials.
• Maintain a record of preventive maintenance activities in the Maintenance Log.

4.4 Corrective Maintenance

• Isolate any racks that are damaged or unsafe for use.
• Repair structural damage, such as bent or broken metal components, as soon as possible.
• Replace racks that are beyond repair and dispose of them according to facility guidelines.
• Conduct a post-maintenance inspection to ensure repaired racks meet safety and functional requirements.
• Document corrective maintenance activities in the Maintenance Report.

4.5 Safety Checks

• Ensure racks are not overloaded and comply with specified weight limits.
• Verify that stored items are organized securely to prevent falls or spills.
• Ensure all racks are stable and properly anchored, especially those in high-traffic areas.

4.6 Frequency of Maintenance

• Routine Inspection: Weekly
• Cleaning: Monthly or as required
• Preventive Maintenance: Quarterly
• Corrective Maintenance: As needed

4.7 Safety Precautions

• Wear appropriate personal protective equipment (PPE), such as gloves and safety boots, during cleaning and maintenance activities.
• Ensure all stored items are handled carefully and returned to their designated locations after cleaning or maintenance.
• Follow lockout/tagout procedures when working on racks with electrical components, such as motorized units.

5) Abbreviations

• QA: Quality Assurance
• PPE: Personal Protective Equipment

6) Documents

The following documents should be maintained:

• Storage Rack Inspection Log
• Maintenance Log
• Maintenance Report

7) References

Relevant regulatory guidelines and references include:

• ISO 13485: Medical Devices Quality Management Systems
• Good Manufacturing Practices (GMP) Guidelines
• Facility Safety Standards

8) SOP Version

Version: 1.0

Annexure

Annexure Title: Storage Rack Inspection Log

 
 
 
Date
 
Rack ID
 
Condition
 
Inspected By
 
Remarks
 
 
 
DD/MM/YYYY
 
Rack Identifier
 
Good/Damaged
 
Inspector Name
 
Details of condition
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Annexure Title: Maintenance Log

 
 
 
Date
 
Rack ID
 
Maintenance Type
 
Performed By
 
QA Approval
 
Remarks
 
 
 
DD/MM/YYYY
 
Rack Identifier
 
Routine/Corrective
 
Technician Name
 
QA Name
 
Details of activity
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Annexure Title: Maintenance Report

 
 
 
Date
 
Rack ID
 
Issue Identified
 
Corrective Action
 
Performed By
 
QA Approval
 
 
 
DD/MM/YYYY
 
Rack Identifier
 
Description of issue
 
Details of corrective action
 
Technician Name
 
QA Name
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Standard Operating Procedure for Calibrating Nebulizer Particle Counters

1) Purpose

The purpose of this SOP is to define the standardized procedure for calibrating nebulizer particle counters to ensure accurate and reliable particle size measurement, which is critical for product quality and regulatory compliance.

2) Scope

This SOP applies to all particle counters used for monitoring and validating nebulizer solution and aerosol particle size in the facility.

3) Responsibilities

Operators: Assist with calibration setup and document activities.
Maintenance Team: Perform the calibration of particle counters and address any issues.
Quality Assurance (QA): Validate calibration results and approve calibration records.
Supervisors: Oversee calibration activities and ensure adherence to the SOP.

4) Procedure

4.1 Pre-Calibration Checks

• Ensure the particle counter is clean, free from any contamination, and powered off.
• Verify that the calibration equipment, such as standard particle generators, is within its calibration validity period.
• Review the equipment manual to identify specific calibration requirements.
• Document the particle counter details, such as model and serial number, in the Calibration Log.

4.2 Calibration Setup

• Connect the particle counter to the calibration test bench as per the manufacturer’s instructions.
• Prepare the particle size reference standards or calibration aerosols.
• Ensure that the testing environment meets the specified conditions, such as temperature and humidity.

4.3 Calibration Procedure

• Power on the particle counter and allow it to stabilize for the recommended warm-up period.
• Introduce the reference particles or calibration aerosols into the particle counter using a clean and sealed delivery system.
• Measure the particle size and concentration using the counter and compare the results with the known reference standards.
• Adjust the particle counter’s settings if deviations from the reference values are identified.
• Repeat the calibration process for multiple particle sizes within the instrument’s operational range.
• Record all readings and adjustments in the Calibration Report.

4.4 Post-Calibration Activities

• Disconnect the particle counter from the test bench and clean any components exposed to calibration aerosols.
• Label the particle counter with the calibration status, date, and next due date.
• Submit the calibration report to QA for validation and approval.
• Update the Calibration Log with the details of the activity.

4.5 Frequency of Calibration

• Routine Calibration: Annually or as specified by the manufacturer.
• Post-Maintenance Calibration: After repairs or replacement of critical components.

4.6 Handling Calibration Failures

• Isolate the particle counter if calibration fails and report the issue to the maintenance team.
• Document the failure details in the Calibration Failure Report.
• Repair or replace the faulty components and repeat the calibration process.

4.7 Safety Precautions

• Wear appropriate personal protective equipment (PPE), such as gloves and safety goggles, during calibration.
• Ensure that the calibration environment is free of dust or unintended aerosols that could affect results.
• Follow the equipment manual and safety guidelines for handling calibration aerosols and reference standards.

5) Abbreviations

• QA: Quality Assurance
• PPE: Personal Protective Equipment

6) Documents

The following documents should be maintained:

• Calibration Log
• Calibration Report
• Calibration Failure 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: Calibration Log

 
 
 
Date
 
Equipment ID
 
Calibration Type
 
Performed By
 
QA Approval
 
Remarks
 
 
 
DD/MM/YYYY
 
Equipment Identifier
 
Routine/Post-Maintenance
 
Technician Name
 
QA Name
 
Details of activity
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Annexure Title: Calibration Report

 
 
 
Date
 
Equipment ID
 
Reference Particle Size
 
Measured Particle Size
 
Performed By
 
QA Approval
 
 
 
DD/MM/YYYY
 
Equipment Identifier
 
Standard Value
 
Measured Value
 
Technician Name
 
QA Name
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Annexure Title: Calibration Failure Report

 
 
 
Date
 
Equipment ID
 
Issue Identified
 
Corrective Action
 
Performed By
 
QA Approval
 
 
 
DD/MM/YYYY
 
Equipment Identifier
 
Description of issue
 
Details of corrective action
 
Technician Name
 
QA Name
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Standard Operating Procedure for Operating Nebulizer Heat Sealing Machines

1) Purpose

The purpose of this SOP is to establish a standardized procedure for operating nebulizer heat sealing machines to ensure consistent, secure, and contamination-free sealing of nebulizer components.

2) Scope

This SOP applies to all heat sealing machines used in the nebulizer production process within the facility.

3) Responsibilities

Operators: Operate the heat sealing machines and monitor their performance.
Maintenance Team: Conduct regular inspections and resolve technical issues.
Quality Assurance (QA): Validate the sealing process and approve production records.
Supervisors: Ensure compliance with the SOP and oversee operations during production shifts.

4) Procedure

4.1 Pre-Operation Checks

• Inspect the heat sealing machine for cleanliness and ensure it is free of residues from previous operations.
• Check that the machine is connected to a stable power supply and verify its readiness for operation.
• Ensure that the temperature, pressure, and sealing time settings match the batch requirements.
• Inspect the sealing jaws for wear or damage and replace them if necessary.
• Document pre-operation checks in the Sealing Machine Log.

4.2 Setup and Adjustment

• Load the nebulizer components onto the conveyor or sealing station as per the operating guidelines.
• Set the required parameters, including temperature, sealing time, and pressure, using the machine’s control panel.
• Run a trial batch with a small number of components to confirm proper sealing quality.
• Adjust the parameters if necessary to achieve optimal performance.

4.3 Operating the Heat Sealing Machine

• Start the heat sealing process and monitor the machine to ensure smooth operation.
• Periodically inspect sealed components to verify that the seal is secure and meets quality standards.
• Address any misaligned or improperly sealed components immediately.
• Record operational details, including batch number and operator initials, in the Operation Log.

4.4 Post-Operation Activities

• Turn off the heat sealing machine and allow it to cool before cleaning.
• Clean the sealing jaws and other machine parts with a lint-free cloth and approved cleaning agents.
• Inspect the machine for any wear or damage and report findings to the maintenance team.
• Document post-operation activities in the Sealing Machine Log.

4.5 Handling Non-Conforming Products

• Segregate components with defective seals and label them as “Rejected.”
• Document the details of rejected components in the Defective Product Report.
• Investigate the root cause of sealing issues and recalibrate the machine if necessary.

4.6 Preventive Maintenance

• Inspect the heating elements, sealing jaws, and control systems weekly and replace any faulty parts as needed.
• Lubricate mechanical components as per the manufacturer’s recommendations.
• Calibrate the machine quarterly to ensure accuracy in temperature, time, and pressure settings.
• Document maintenance activities in the Maintenance Log.

4.7 Safety Precautions

• Wear appropriate personal protective equipment (PPE), such as heat-resistant gloves and safety goggles, during operation and cleaning.
• Ensure that the machine is powered off before performing any adjustments or cleaning activities.
• Keep hands and tools away from the sealing jaws during operation to prevent injuries.

5) Abbreviations

• QA: Quality Assurance
• PPE: Personal Protective Equipment

6) Documents

The following documents should be maintained:

• Sealing Machine Log
• Operation Log
• Defective Product Report
• Maintenance Log

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: Sealing Machine Log

 
 
 
Date
 
Machine ID
 
Pre-Operation Check
 
Post-Operation Check
 
Operator Initials
 
Remarks
 
 
 
DD/MM/YYYY
 
Machine Identifier
 
Pass/Fail
 
Pass/Fail
 
Operator Name
 
Details of operation
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Annexure Title: Defective Product Report

 
 
 
Date
 
Batch No.
 
Issue Identified
 
Quantity
 
Reported By
 
Remarks
 
 
 
DD/MM/YYYY
 
Batch Identifier
 
Description of issue
 
Number of units
 
Operator Name
 
Details of resolution
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Annexure Title: Maintenance Log

 
 
 
Date
 
Machine ID
 
Maintenance Type
 
Performed By
 
QA Approval
 
Remarks
 
 
 
DD/MM/YYYY
 
Machine Identifier
 
Routine/Corrective
 
Technician Name
 
QA Name
 
Details of activity
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Standard Operating Procedure for Cleaning Nebulizer Solution Mixing Equipment

1) Purpose

The purpose of this SOP is to define the process for cleaning nebulizer solution mixing equipment to ensure compliance with hygiene standards, avoid cross-contamination, and maintain product quality.

2) Scope

This SOP applies to all mixing tanks, agitators, pipelines, and associated equipment used for preparing nebulizer solutions within the facility.

3) Responsibilities

Operators: Perform routine cleaning activities as per the defined procedure.
Maintenance Team: Inspect and repair equipment if required during cleaning activities.
Quality Assurance (QA): Validate and approve cleaning records.
Supervisors: Ensure cleaning is conducted as per schedule and procedures.

4) Procedure

4.1 Pre-Cleaning Activities

• Ensure the mixing equipment is powered off and disconnected from any electrical supply.
• Verify that the equipment is empty of any residual solution or material.
• Wear appropriate personal protective equipment (PPE), including gloves, goggles, and aprons.
• Review cleaning requirements and gather necessary cleaning tools, detergents, and sanitizers.

4.2 Cleaning Steps

4.2.1 Cleaning the Mixing Tank

• Rinse the interior of the mixing tank with warm water to remove loose residues.
• Prepare a cleaning solution using an approved detergent at the recommended concentration.
• Scrub the tank’s inner surfaces, including corners and crevices, using soft brushes or cleaning pads.
• Rinse the tank thoroughly with deionized water to remove detergent residues.
• Conduct a final rinse with purified water and allow the tank to air dry or dry with filtered compressed air.

4.2.2 Cleaning the Agitator

• Disassemble removable parts of the agitator as per the equipment manual.
• Soak the components in the prepared cleaning solution for the recommended time.
• Scrub each component with a soft brush and rinse with purified water.
• Dry the parts thoroughly and reassemble them into the mixing tank.

4.2.3 Cleaning Pipelines and Valves

• Flush the pipelines and valves with warm water to remove any residual product.
• Circulate the cleaning solution through the pipelines for the prescribed duration.
• Rinse with deionized water until no traces of detergent are observed.
• Conduct a final rinse with purified water to ensure cleanliness.

4.3 Post-Cleaning Activities

• Inspect all cleaned equipment to ensure no visible residues or detergent traces remain.
• Label the equipment as “Cleaned” and log the cleaning details in the Cleaning Log.
• Store cleaning tools and materials in designated areas.
• Submit the cleaning record to QA for validation and approval.

4.4 Frequency of Cleaning

• Routine Cleaning: After every batch.
• Deep Cleaning: Weekly or as specified in the cleaning schedule.
• Cleaning After Maintenance: Post-repair or modification of equipment.

4.5 Handling Cleaning Failures

• Report any cleaning failures, such as visible residues or contamination, to the supervisor immediately.
• Document the issue in the Cleaning Failure Report.
• Repeat the cleaning process and escalate persistent issues to the maintenance team.

4.6 Safety Precautions

• Ensure proper ventilation in the cleaning area to avoid exposure to fumes from cleaning agents.
• Use only approved detergents and sanitizers to prevent equipment damage.
• Handle cleaning equipment carefully to avoid personal injury or equipment damage.

5) Abbreviations

• QA: Quality Assurance
• PPE: Personal Protective Equipment

6) Documents

The following documents should be maintained:

• Cleaning Log
• Cleaning Schedule
• Cleaning Failure 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: Cleaning Log

 
 
 
Date
 
Equipment ID
 
Cleaning Method
 
Performed By
 
QA Approval
 
Remarks
 
 
 
DD/MM/YYYY
 
Equipment Identifier
 
Details of cleaning
 
Technician Name
 
QA Name
 
Details of activity
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Annexure Title: Cleaning Schedule

 
 
 
Equipment ID
 
Cleaning Type
 
Frequency
 
Last Cleaned Date
 
Next Due Date
 
 
 
Equipment Identifier
 
Routine/Deep
 
Daily/Weekly
 
DD/MM/YYYY
 
DD/MM/YYYY
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Annexure Title: Cleaning Failure Report

 
 
 
Date
 
Equipment ID
 
Issue Identified
 
Corrective Action
 
Performed By
 
QA Approval
 
 
 
DD/MM/YYYY
 
Equipment Identifier
 
Description of issue
 
Details of corrective action
 
Technician Name
 
QA Name
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Standard Operating Procedure for Calibrating Nebulizer Pressure Relief Valves

1) Purpose

The purpose of this SOP is to define the procedure for calibrating pressure relief valves used in nebulizer systems to ensure their reliability, safety, and compliance with operational standards.

2) Scope

This SOP applies to all pressure relief valves used in nebulizer manufacturing systems within the facility.

3) Responsibilities

Operators: Assist in calibration setup and document readings.
Maintenance Team: Perform calibration and ensure proper functioning of the valves.
Quality Assurance (QA): Validate calibration results and approve calibration records.
Supervisors: Ensure compliance with this SOP and oversee calibration activities.

4) Procedure

4.1 Pre-Calibration Checks

• Ensure the calibration equipment, such as pressure gauges and reference valves, is within its calibration validity period.
• Inspect the pressure relief valve for physical damage, dirt, or wear.
• Verify that the valve is correctly installed in the system and isolated for calibration purposes.
• Document the valve details, such as model and serial number, in the Calibration Log.

4.2 Calibration Setup

• Connect the pressure relief valve to the calibration test bench or setup as specified in the manufacturer’s guidelines.
• Attach the pressure source to the valve inlet and the pressure gauge to monitor the applied pressure.
• Ensure all connections are secure and free of leaks.

4.3 Calibration Procedure

• Gradually increase the pressure using the test setup until the valve begins to release pressure (the set-point).
• Record the pressure at which the valve opens and compare it with the manufacturer’s specifications.
• Adjust the valve set-point if it deviates from the acceptable range using the adjustment mechanism provided by the manufacturer.
• Repeat the process three times to confirm consistent performance.
• Document the results of each trial in the Calibration Report.

4.4 Post-Calibration Activities

• Reinstall the calibrated pressure relief valve onto the nebulizer system.
• Label the valve with the calibration status, date, and next due date.
• Submit the calibration records to QA for validation and approval.
• Document the calibration activity in the Calibration Log.

4.5 Frequency of Calibration

• Routine Calibration: Annually or as per the manufacturer’s recommendations.
• Post-Maintenance Calibration: After repairs, replacements, or major adjustments.

4.6 Handling Calibration Failures

• Isolate the valve and report the issue to the maintenance team if calibration fails.
• Document the failure details in the Calibration Failure Report and notify QA.
• Replace or repair faulty valves and repeat the calibration process.

4.7 Safety Precautions

• Wear appropriate personal protective equipment (PPE), including gloves and safety goggles, during calibration activities.
• Handle pressurized systems carefully to avoid accidents or equipment damage.
• Ensure proper grounding and follow lockout/tagout procedures where necessary.

5) Abbreviations

• QA: Quality Assurance
• PPE: Personal Protective Equipment

6) Documents

The following documents should be maintained:

• Calibration Log
• Calibration Report
• Calibration Failure 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: Calibration Log

 
 
 
Date
 
Valve ID
 
Set-Point Pressure
 
Measured Pressure
 
Performed By
 
Remarks
 
 
 
DD/MM/YYYY
 
Valve Identifier
 
Specified Value
 
Measured Value
 
Technician Name
 
Details of calibration
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Annexure Title: Calibration Report

 
 
 
Date
 
Valve ID
 
Pre-Calibration Reading
 
Post-Calibration Reading
 
Performed By
 
QA Approval
 
 
 
DD/MM/YYYY
 
Valve Identifier
 
Pre-Calibration Value
 
Post-Calibration Value
 
Technician Name
 
QA Name
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Annexure Title: Calibration Failure Report

 
 
 
Date
 
Valve ID
 
Issue Identified
 
Corrective Action
 
Performed By
 
QA Approval
 
 
 
DD/MM/YYYY
 
Valve Identifier
 
Details of issue
 
Details of corrective action
 
Technician Name
 
QA Name
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Standard Operating Procedure for Operating Nebulizer Filling Nozzles

1) Purpose

The purpose of this SOP is to define the procedure for the operation of nebulizer filling nozzles to ensure accurate, consistent, and contamination-free filling during production.

2) Scope

This SOP applies to all filling nozzles used in nebulizer manufacturing processes within the facility.

3) Responsibilities

Operators: Operate filling nozzles and monitor their performance during production.
Maintenance Team: Conduct regular checks and address nozzle-related issues.
Quality Assurance (QA): Validate the filling process and approve batch records.
Supervisors: Ensure compliance with the SOP and oversee operations during production shifts.

4) Procedure

4.1 Pre-Operation Checks

• Inspect filling nozzles for cleanliness and ensure they are free of residues from previous operations.
• Verify that the nozzles are properly aligned and securely attached to the filling machine.
• Check for any physical damage or wear on the nozzles.
• Ensure the filling machine and nozzles are calibrated for the required filling volume.
• Document pre-operation inspection details in the Filling Nozzle Log.

4.2 Setup and Adjustment

• Connect the nozzles to the filling machine and ensure all fittings are secure.
• Set the filling parameters, such as volume, speed, and cycle time, according to the batch requirements.
• Run a trial filling with a small number of containers to verify nozzle performance and accuracy.
• Adjust the nozzles if necessary to achieve optimal performance.

4.3 Operating the Filling Nozzles

• Start the filling process and monitor the operation to ensure consistent and accurate filling.
• Inspect filled containers periodically to confirm proper volume and absence of spills or overfills.
• Maintain a steady supply of containers to avoid interruptions in the filling process.
• Record operational details, including batch number and operator initials, in the Operation Log.

4.4 Post-Operation Activities

• Stop the filling process and disconnect the nozzles from the machine.
• Clean the nozzles thoroughly according to the cleaning SOP to prevent cross-contamination.
• Inspect the nozzles for any wear or damage and report findings to the maintenance team.
• Document post-operation activities in the Filling Nozzle Log.

4.5 Handling Non-Conforming Products

• Segregate containers with incorrect fill volumes or visible defects and label them as “Rejected.”
• Document the details of rejected containers in the Defective Product Report.
• Investigate the root cause and implement corrective actions before resuming production.

4.6 Preventive Maintenance

• Inspect the nozzles for wear or damage monthly and replace any faulty parts as necessary.
• Calibrate the filling nozzles quarterly to ensure accuracy.
• Lubricate any moving parts associated with the nozzles according to the manufacturer’s recommendations.
• Document maintenance activities in the Maintenance Log.

4.7 Safety Precautions

• Wear appropriate personal protective equipment (PPE), such as gloves and safety glasses, during operation and cleaning.
• Ensure the filling machine is powered off before attaching, detaching, or cleaning the nozzles.
• Handle nozzles carefully to prevent damage or misalignment.

5) Abbreviations

• QA: Quality Assurance
• PPE: Personal Protective Equipment

6) Documents

The following documents should be maintained:

• Filling Nozzle Log
• Operation Log
• Defective Product Report
• Maintenance Log

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: Filling Nozzle Log

 
 
 
Date
 
Nozzle ID
 
Pre-Operation Check
 
Post-Operation Check
 
Operator Initials
 
Remarks
 
 
 
DD/MM/YYYY
 
Nozzle Identifier
 
Pass/Fail
 
Pass/Fail
 
Operator Name
 
Details of operation
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Annexure Title: Defective Product Report

 
 
 
Date
 
Batch No.
 
Issue Identified
 
Quantity
 
Reported By
 
Remarks
 
 
 
DD/MM/YYYY
 
Batch Identifier
 
Description of issue
 
Number of units
 
Operator Name
 
Details of resolution
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Annexure Title: Maintenance Log

 
 
 
Date
 
Nozzle ID
 
Maintenance Type
 
Performed By
 
QA Approval
 
Remarks
 
 
 
DD/MM/YYYY
 
Nozzle Identifier
 
Routine/Corrective
 
Technician Name
 
QA Name
 
Details of activity
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Standard Operating Procedure for Maintaining Nebulizer Quality Control Equipment

1) Purpose

The purpose of this SOP is to provide guidelines for the maintenance of nebulizer quality control (QC) equipment to ensure its accuracy, reliability, and operational efficiency.

2) Scope

This SOP applies to all QC equipment used in the testing and inspection of nebulizers, including particle size analyzers, flow meters, and pressure testers, within the facility.

3) Responsibilities

Operators: Perform basic cleaning and report any malfunctions.
Maintenance Team: Conduct routine, preventive, and corrective maintenance of QC equipment.
Quality Assurance (QA): Validate maintenance activities and approve maintenance records.
Supervisors: Oversee adherence to maintenance schedules and procedures.

4) Procedure

4.1 Pre-Maintenance Activities

• Verify the equipment maintenance schedule and prepare the necessary tools and materials.
• Ensure the equipment is powered off and disconnected from the power supply.
• Review the equipment’s manual to identify specific maintenance requirements.
• Document the equipment details, such as model and serial number, in the Maintenance Log.

4.2 Routine Maintenance

• Clean the external surfaces of the equipment using a lint-free cloth and an approved cleaning agent.
• Inspect all visible parts, such as probes, sensors, and connectors, for wear or damage.
• Check and replace consumables, such as filters and seals, as per the manufacturer’s guidelines.
• Verify the calibration status of the equipment and recalibrate if necessary.
• Lubricate moving parts with appropriate lubricants to reduce wear and tear.

4.3 Preventive Maintenance

• Conduct a detailed inspection of the internal components, such as circuit boards and wiring, quarterly.
• Test the accuracy of sensors and replace them if they are beyond calibration limits.
• Inspect and clean air vents, fans, or cooling systems to prevent overheating.
• Update the equipment software or firmware as recommended by the manufacturer.

4.4 Corrective Maintenance

• Diagnose and repair any malfunctions or performance issues reported by operators.
• Replace damaged components, such as sensors, probes, or cables, as required.
• Test the equipment post-repair to ensure it meets operational specifications.
• Document the corrective actions taken in the Maintenance Report and submit it to QA.

4.5 Post-Maintenance Activities

• Power on the equipment and perform functional tests to verify its performance.
• Label the equipment with the maintenance status, date, and next due date.
• Clean the maintenance area and properly dispose of used materials, such as cleaning cloths and filters.
• Update the Maintenance Log with details of the activities performed.

4.6 Frequency of Maintenance

• Routine Maintenance: Monthly or as per the manufacturer’s guidelines.
• Preventive Maintenance: Quarterly or semi-annually based on the equipment’s usage.
• Corrective Maintenance: As required in case of malfunctions.

4.7 Safety Precautions

• Wear personal protective equipment (PPE), such as gloves and safety glasses, during maintenance activities.
• Ensure tools and materials used are compatible with the equipment.
• Follow lockout/tagout procedures to prevent accidental start-up during maintenance.

5) Abbreviations

• QA: Quality Assurance
• QC: Quality Control
• PPE: Personal Protective Equipment

6) Documents

The following documents should be maintained:

• Maintenance Log
• Calibration Records
• Maintenance 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: Maintenance Log

 
 
 
Date
 
Equipment ID
 
Maintenance Type
 
Performed By
 
QA Approval
 
Remarks
 
 
 
DD/MM/YYYY
 
Equipment Identifier
 
Routine/Preventive/Corrective
 
Technician Name
 
QA Name
 
Details of activity
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Annexure Title: Calibration Records

 
 
 
Date
 
Equipment ID
 
Pre-Calibration Reading
 
Post-Calibration Reading
 
Performed By
 
QA Approval
 
 
 
DD/MM/YYYY
 
Equipment Identifier
 
Pre-Calibration Values
 
Post-Calibration Values
 
Technician Name
 
QA Name
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Annexure Title: Maintenance Report

 
 
 
Date
 
Equipment ID
 
Issue Identified
 
Action Taken
 
Performed By
 
QA Approval
 
 
 
DD/MM/YYYY
 
Equipment Identifier
 
Description of issue
 
Details of corrective action
 
Technician Name
 
QA Name
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Standard Operating Procedure for Operating Nebulizer Component Sorting Machines

1) Purpose

The purpose of this SOP is to establish a standardized procedure for operating nebulizer component sorting machines to ensure the accurate and efficient sorting of components as per production requirements.

2) Scope

This SOP applies to all nebulizer component sorting machines used in the manufacturing process within the facility.

3) Responsibilities

Operators: Operate sorting machines and ensure proper sorting of components.
Maintenance Team: Perform regular maintenance and troubleshoot any issues with the machines.
Quality Assurance (QA): Validate the sorting process and approve related documentation.
Supervisors: Oversee the sorting process and ensure compliance with this SOP.

4) Procedure

4.1 Pre-Operation Checks

• Ensure the sorting machine is clean and free from any debris or previous batch residues.
• Verify the machine is connected to the power supply and is in working condition.
• Inspect the machine for any physical damage or misalignment of components.
• Confirm that the required component specifications are loaded into the machine’s program.
• Record the pre-operation inspection details in the Machine Inspection Log.

4.2 Setting Up the Sorting Machine

• Load the hopper or input section of the sorting machine with the nebulizer components.
• Set the sorting parameters, such as size, shape, or weight, based on the batch requirements.
• Run a trial batch to confirm proper sorting functionality and make adjustments if needed.

4.3 Operating the Sorting Machine

• Start the sorting process using the machine’s control panel.
• Monitor the operation to ensure components are being sorted accurately.
• Regularly check the output bins to verify that sorted components meet the specified criteria.
• Document the operation details, including batch number and operator initials, in the Operation Log.

4.4 Post-Operation Activities

• Turn off the sorting machine and disconnect it from the power supply.
• Clean the machine thoroughly to remove any remaining components or debris.
• Inspect the machine for wear or damage and report any findings to the maintenance team.
• Record the completion of the operation in the Machine Operation Log.

4.5 Handling Non-Conforming Components

• Segregate components that do not meet sorting criteria and label them as “Rejected.”
• Document the details of rejected components in the Rejected Component Log.
• Investigate the root cause of sorting errors and recalibrate the machine if necessary.

4.6 Preventive Maintenance

• Inspect and clean the sorting machine’s internal parts, such as sensors and conveyors, weekly.
• Lubricate moving parts as per the manufacturer’s recommendations.
• Perform a full calibration of the machine quarterly to ensure sorting accuracy.
• Document maintenance activities in the Maintenance Log and submit them to QA.

4.7 Safety Precautions

• Wear appropriate personal protective equipment (PPE), such as gloves and safety goggles, during operation and maintenance.
• Ensure hands and tools are kept away from moving parts during machine operation.
• Follow the manufacturer’s safety guidelines for handling sorting machines.

5) Abbreviations

• QA: Quality Assurance
• PPE: Personal Protective Equipment

6) Documents

The following documents should be maintained:

• Machine Inspection Log
• Operation Log
• Rejected Component Log
• Maintenance Log

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: Machine Inspection Log

 
 
 
Date
 
Machine ID
 
Pre-Operation Check
 
Post-Operation Check
 
Inspected By
 
Remarks
 
 
 
DD/MM/YYYY
 
Machine Identifier
 
Pass/Fail
 
Pass/Fail
 
Inspector Name
 
Details of inspection
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Annexure Title: Rejected Component Log

 
 
 
Date
 
Batch No.
 
Component Type
 
Reason for Rejection
 
Quantity
 
Inspected By
 
 
 
DD/MM/YYYY
 
Batch Identifier
 
Component Details
 
Reason for rejection
 
Number of units
 
Inspector Name
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Annexure Title: Maintenance Log

 
 
 
Date
 
Machine ID
 
Maintenance Type
 
Performed By
 
QA Approval
 
Remarks
 
 
 
DD/MM/YYYY
 
Machine Identifier
 
Routine/Corrective
 
Technician Name
 
QA Name
 
Details of activity
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Standard Operating Procedure for Cleaning and Sterilizing Nebulizer Production Tools

1) Purpose

The purpose of this SOP is to outline a standardized procedure for cleaning and sterilizing tools used in nebulizer production to ensure product quality and prevent contamination.

2) Scope

This SOP applies to all tools and equipment used in the manufacturing, assembly, and maintenance of nebulizers within the facility.

3) Responsibilities

Operators: Perform routine cleaning and report any abnormalities.
Maintenance Team: Sterilize tools and ensure they are properly maintained.
Quality Assurance (QA): Validate cleaning and sterilization activities and approve records.
Supervisors: Oversee adherence to cleaning and sterilization schedules.

4) Procedure

4.1 Pre-Cleaning Activities

• Inspect all tools for visible contamination, wear, or damage before cleaning.
• Segregate tools based on their material and cleaning requirements.
• Prepare the cleaning area, ensuring all necessary cleaning agents and equipment are available.
• Wear appropriate personal protective equipment (PPE), including gloves and safety goggles.

4.2 Cleaning Procedure

• Rinse tools under warm running water to remove loose debris and residue.
• Prepare a cleaning solution using an approved detergent in a designated cleaning tank.
• Submerge the tools in the cleaning solution and allow them to soak for the recommended duration.
• Use brushes or cleaning swabs to scrub surfaces, focusing on crevices and intricate parts.
• Rinse the tools thoroughly with deionized water to remove all detergent residues.
• Inspect tools visually to ensure cleanliness before proceeding to sterilization.

4.3 Sterilization Procedure

• Place cleaned tools in sterilization pouches or trays, ensuring they are not overcrowded.
• Load the sterilization equipment, such as an autoclave or dry heat sterilizer, according to the manufacturer’s guidelines.
• Set the sterilizer parameters (e.g., temperature, pressure, and time) based on the tool material and sterilization requirements:
  • Autoclave: Typically 121°C at 15 psi for 15–20 minutes.
  • Dry Heat Sterilizer: Typically 160°C for 2 hours.
• Run the sterilization cycle and monitor equipment readings to ensure compliance with the set parameters.
• Allow tools to cool down before removing them from the sterilizer.

4.4 Post-Sterilization Activities

• Inspect sterilized tools for any signs of damage or incomplete sterilization.
• Label sterilized tools with the sterilization date and expiration date, if applicable.
• Store tools in a clean, designated area to maintain sterility until use.
• Document cleaning and sterilization activities in the Sterilization Log and submit it to QA for approval.

4.5 Handling Non-Conforming Tools

• Segregate tools that fail cleaning or sterilization and label them as “Rejected.”
• Document the details in the Non-Conformance Report.
• Repair or replace damaged tools before reintroducing them into the production process.

4.6 Safety Precautions

• Wear appropriate PPE during cleaning and sterilization activities to protect against chemical and thermal hazards.
• Handle hot tools and sterilization equipment carefully to prevent burns.
• Ensure proper ventilation in the cleaning and sterilization areas to avoid exposure to fumes.

5) Abbreviations

• QA: Quality Assurance
• PPE: Personal Protective Equipment

6) Documents

The following documents should be maintained:

• Cleaning and Sterilization Log
• Non-Conformance Report
• Tool Inspection Checklist

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: Cleaning and Sterilization Log

 
 
 
Date
 
Tool ID
 
Cleaning Method
 
Sterilization Method
 
Performed By
 
QA Approval
 
 
 
DD/MM/YYYY
 
Tool Identifier
 
Details of cleaning
 
Details of sterilization
 
Technician Name
 
QA Name
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Annexure Title: Non-Conformance Report

 
 
 
Date
 
Tool ID
 
Issue Identified
 
Corrective Action
 
Performed By
 
QA Approval
 
 
 
DD/MM/YYYY
 
Tool Identifier
 
Description of issue
 
Details of corrective action
 
Technician Name
 
QA Name
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Annexure Title: Tool Inspection Checklist

 
 
 
Date
 
Tool ID
 
Condition
 
Inspected By
 
Remarks
 
 
 
DD/MM/YYYY
 
Tool Identifier
 
Good/Damaged
 
Inspector Name
 
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