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.
This SOP applies to all transfer systems used for handling nebulizer components, semi-finished products, and finished goods within the facility.
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.
4.1 Pre-Operation Checks
4.2 Starting the Transfer System
4.3 Operating the Transfer System
4.4 Post-Operation Activities
4.5 Handling System Malfunctions
4.6 Preventive Maintenance
4.7 Safety Precautions
The following documents should be maintained:
Relevant regulatory guidelines and references include:
Version: 1.0
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 |
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.
This SOP applies to all storage racks used for holding nebulizer components, finished products, and associated materials within the facility.
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.
4.1 Routine Inspection
4.2 Cleaning of Storage Racks
4.3 Preventive Maintenance
4.4 Corrective Maintenance
4.5 Safety Checks
4.6 Frequency of Maintenance
4.7 Safety Precautions
The following documents should be maintained:
Relevant regulatory guidelines and references include:
Version: 1.0
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 |
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.
This SOP applies to all particle counters used for monitoring and validating nebulizer solution and aerosol particle size in the facility.
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.
4.1 Pre-Calibration Checks
4.2 Calibration Setup
4.3 Calibration Procedure
4.4 Post-Calibration Activities
4.5 Frequency of Calibration
4.6 Handling Calibration Failures
4.7 Safety Precautions
The following documents should be maintained:
Relevant regulatory guidelines and references include:
Version: 1.0
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 |
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.
This SOP applies to all heat sealing machines used in the nebulizer production process within the facility.
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.
4.1 Pre-Operation Checks
4.2 Setup and Adjustment
4.3 Operating the Heat Sealing Machine
4.4 Post-Operation Activities
4.5 Handling Non-Conforming Products
4.6 Preventive Maintenance
4.7 Safety Precautions
The following documents should be maintained:
Relevant regulatory guidelines and references include:
Version: 1.0
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 |
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.
This SOP applies to all mixing tanks, agitators, pipelines, and associated equipment used for preparing nebulizer solutions within the facility.
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.
4.1 Pre-Cleaning Activities
4.2 Cleaning Steps
4.2.1 Cleaning the Mixing Tank
4.2.2 Cleaning the Agitator
4.2.3 Cleaning Pipelines and Valves
4.3 Post-Cleaning Activities
4.4 Frequency of Cleaning
4.5 Handling Cleaning Failures
4.6 Safety Precautions
The following documents should be maintained:
Relevant regulatory guidelines and references include:
Version: 1.0
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 |
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.
This SOP applies to all pressure relief valves used in nebulizer manufacturing systems within the facility.
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.
4.1 Pre-Calibration Checks
4.2 Calibration Setup
4.3 Calibration Procedure
4.4 Post-Calibration Activities
4.5 Frequency of Calibration
4.6 Handling Calibration Failures
4.7 Safety Precautions
The following documents should be maintained:
Relevant regulatory guidelines and references include:
Version: 1.0
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 |
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.
This SOP applies to all filling nozzles used in nebulizer manufacturing processes within the facility.
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.
4.1 Pre-Operation Checks
4.2 Setup and Adjustment
4.3 Operating the Filling Nozzles
4.4 Post-Operation Activities
4.5 Handling Non-Conforming Products
4.6 Preventive Maintenance
4.7 Safety Precautions
The following documents should be maintained:
Relevant regulatory guidelines and references include:
Version: 1.0
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 |
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.
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.
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.
4.1 Pre-Maintenance Activities
4.2 Routine Maintenance
4.3 Preventive Maintenance
4.4 Corrective Maintenance
4.5 Post-Maintenance Activities
4.6 Frequency of Maintenance
4.7 Safety Precautions
The following documents should be maintained:
Relevant regulatory guidelines and references include:
Version: 1.0
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 |
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.
This SOP applies to all nebulizer component sorting machines used in the manufacturing process within the facility.
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.
4.1 Pre-Operation Checks
4.2 Setting Up the Sorting Machine
4.3 Operating the Sorting Machine
4.4 Post-Operation Activities
4.5 Handling Non-Conforming Components
4.6 Preventive Maintenance
4.7 Safety Precautions
The following documents should be maintained:
Relevant regulatory guidelines and references include:
Version: 1.0
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 |
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.
This SOP applies to all tools and equipment used in the manufacturing, assembly, and maintenance of nebulizers within the facility.
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.
4.1 Pre-Cleaning Activities
4.2 Cleaning Procedure
4.3 Sterilization Procedure
4.4 Post-Sterilization Activities
4.5 Handling Non-Conforming Tools
4.6 Safety Precautions
The following documents should be maintained:
Relevant regulatory guidelines and references include:
Version: 1.0
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 | Comments |