SOP for Compatibility Testing of Actuator and Formulation

1. Purpose

This Standard Operating Procedure (SOP) defines the process for conducting compatibility testing between actuators and formulations used in aerosol products. The objective is to ensure that the actuator, which controls the spray mechanism, is compatible with the formulation, maintaining product efficacy, safety, and stability. Compatibility testing ensures that the actuator does not degrade or interact negatively with the formulation, which could lead to product failure or suboptimal performance.

2. Scope

This SOP applies to all aerosol formulations and actuators used at [Company Name]. It covers the testing of actuator and formulation compatibility during the product development phase as well as periodic testing during production to ensure consistent quality and performance of aerosol products.

3. Responsibilities

• Production Team: Responsible for providing representative samples of the actuator and formulation to the QC team for testing and ensuring that the formulations are accurately prepared for testing.
• Quality Control (QC) Team: Responsible for conducting the compatibility tests, documenting results, and ensuring that both the actuator and formulation meet the required compatibility standards.
• Research and Development (R&D) Team: Involved in formulating new products and making adjustments to formulations or actuators based on compatibility testing results.
• Maintenance Team: Ensures that testing equipment is calibrated and in proper working condition before conducting the compatibility tests.

4. Accountability

The Manufacturing Manager is accountable for ensuring that compatibility testing is performed on all aerosol formulations and actuators. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Pre-Test Preparation

1. Ensure that the aerosol formulation is fully prepared and the actuator is sourced according to product specifications.
2. Gather the necessary equipment for compatibility testing, including:
   • Actuators (sample units to be tested)
   • Aerosol formulation (sample units to be tested)
   • Testing apparatus such as spray chambers or testing rigs
   • PPE, including gloves, goggles, and lab coats
3. Verify that the testing environment is clean, sterile, and free from contamination to avoid external factors influencing the results.

5.2. Conducting the Compatibility Test

1. Attach the actuator to the aerosol can filled with the formulation to simulate real-world usage conditions.
2. Perform the following compatibility tests:
   • Spray Pattern Test: Activate the actuator and observe the spray pattern. The spray should be consistent, uniform, and without clogging or sputtering.
   • Valve Performance Test: Ensure that the actuator does not cause leakage or malfunction. The valve should function correctly under pressure.
   • Stability Test: Check if the actuator’s performance is consistent over time when exposed to the formulation. The actuator should not corrode, degrade, or react adversely with the formulation.
   • Formulation Degradation Test: Monitor the formulation for any signs of degradation or chemical reactions, such as color change, separation, or reduced efficacy due to contact with the actuator.
3. Document the test observations, including the spray pattern, valve function, any degradation or reactions, and overall compatibility in the Compatibility Test Log (Annexure-1).

5.3. Post-Test Actions

1. If the actuator and formulation are compatible:
   • Proceed with the production process, ensuring that the formulation and actuator pairing meets all quality control standards.
   • Mark the tested actuator and formulation combination as approved in the Compatibility Test Log (Annexure-1).
2. If any incompatibility is found (e.g., leaking, degradation, poor spray performance), identify the root cause (e.g., improper formulation or actuator malfunction) and take corrective action:
   • Adjust the formulation or actuator design as needed.
   • Retest after making adjustments to ensure compatibility.
3. Notify the Quality Assurance (QA) team and relevant personnel about the incompatibility, and document any corrective actions taken in the Compatibility Test Log (Annexure-1).

5.4. Documentation and Record-Keeping

1. Document all compatibility test results in the Compatibility Test Log (Annexure-1), including the formulation ID, actuator model, test observations, and results.
2. Ensure that the results are reviewed and approved by the QC team and are available for future reference and audits.
3. Store all records in the document management system in accordance with the company’s document retention policy.

5.5. Calibration and Maintenance of Equipment

1. Ensure that all equipment used for compatibility testing (e.g., spray chambers, testing rigs) is calibrated regularly according to the manufacturer’s guidelines.
2. Perform routine maintenance on testing equipment, including cleaning and replacing any parts that may degrade or become damaged.
3. Document all calibration and maintenance activities in the Equipment Calibration Log (Annexure-2) and the Equipment Maintenance Log (Annexure-3).

5.6. Safety and Environmental Considerations

1. Ensure that all personnel conducting compatibility testing wear the appropriate PPE, including gloves, goggles, and lab coats, to prevent exposure to potentially harmful substances.
2. Conduct all testing in a well-ventilated area or fume hood to minimize exposure to aerosols and propellants.
3. Dispose of any waste generated during testing, including used formulations, actuators, or contaminated testing equipment, according to safety and environmental regulations.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• PPE: Personal Protective Equipment
• SOP: Standard Operating Procedure

7. Documents

1. Compatibility Test Log (Annexure-1)
2. Equipment Calibration Log (Annexure-2)
3. Equipment Maintenance Log (Annexure-3)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001:2015 – Quality Management Systems

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Compatibility Test Log

Annexure-2: Equipment Calibration Log

Annexure-3: Equipment Maintenance Log

12. Revision History:

SOP for Conducting Propellant Purity Tests

1. Purpose

This Standard Operating Procedure (SOP) defines the process for conducting propellant purity tests in aerosol products. The purpose of this SOP is to ensure that the propellants used in aerosol formulations are of the required purity and meet regulatory specifications. Propellant purity is critical for the safety, performance, and compliance of aerosol products. The testing verifies that the propellant does not contain impurities or contaminants that could compromise the quality of the product or its safety for consumers.

2. Scope

This SOP applies to the testing of propellants used in all aerosol products produced at [Company Name]. It includes the procedure for testing the purity of propellants before they are used in production to ensure that they meet required specifications for purity and do not contain harmful substances or contaminants.

3. Responsibilities

• Quality Control (QC) Team: Responsible for conducting propellant purity tests and ensuring that the propellant used in aerosol formulations meets the required purity standards. QC is also responsible for reviewing and approving test results.
• Production Team: Responsible for ensuring that the propellant used in the production process is from an approved source and that it is stored under proper conditions to avoid contamination.
• Health and Safety Officer: Ensures that safety protocols are followed during the testing process, particularly in relation to handling propellants, which may be pressurized or hazardous.
• Maintenance Team: Responsible for ensuring that testing equipment used for propellant purity tests is calibrated and properly maintained.

4. Accountability

The Manufacturing Manager is accountable for ensuring that propellant purity tests are conducted as part of the quality control process. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Pre-Test Preparation

1. Ensure that the propellant sample to be tested is representative of the batch to be used in production.
2. Prepare the necessary laboratory equipment for testing, including:
   • Gas chromatograph (GC) or other suitable analytical instruments
   • Sample containers, syringes, and transfer tools
   • Standards for calibration
   • PPE, including gloves, goggles, and lab coats
3. Ensure that the testing area is clean, free of contamination, and that the equipment is calibrated according to the manufacturer’s guidelines.

5.2. Conducting the Propellant Purity Test

1. Take a representative sample of the propellant from the storage tank or canister using a sterile, clean sampling tool.
2. For testing with a gas chromatograph (GC):
   • Inject the propellant sample into the GC system, which will separate the components of the sample based on their chemical properties.
   • Monitor the chromatogram to identify the peaks corresponding to various components in the propellant.
   • Compare the identified peaks with the known purity standards for the propellant to determine the presence and concentration of any impurities.
3. For other testing methods (e.g., infrared spectroscopy, mass spectrometry):
   • Follow the specific procedures for each test, ensuring that the sample is analyzed accurately.
   • Ensure that all required reagents and standards are used for accurate testing.
4. Record all observations, including the type and concentration of any impurities detected, and compare the results with regulatory and internal purity specifications.

5.3. Post-Test Actions

1. If the propellant passes the purity test, proceed with its use in the production process.
2. If the propellant fails the purity test, remove it from the production process and label it as “non-conforming.” Investigate the source of contamination or impurity and determine the corrective actions required (e.g., return to supplier, further filtration, or treatment).
3. Document the test results, including the test date, sample ID, impurities detected, and any corrective actions taken, in the Propellant Purity Test Log (Annexure-1).

5.4. Calibration and Maintenance of Equipment

1. Calibrate testing equipment such as gas chromatographs, mass spectrometers, and infrared analyzers according to the manufacturer’s recommendations and the company’s standard operating procedures.
2. Ensure that the equipment is maintained regularly, including cleaning and replacing any parts that may degrade or become damaged.
3. Document all calibration and maintenance activities in the Equipment Calibration Log (Annexure-2) and the Equipment Maintenance Log (Annexure-3).

5.5. Documentation and Record-Keeping

1. Document all propellant purity test results, including the test date, sample details, operator name, impurities detected, and corrective actions taken, in the Propellant Purity Test Log (Annexure-1).
2. Ensure that test records are reviewed and approved by the QC team to confirm that the propellant meets the required purity specifications.
3. Store all purity testing records in the document management system, ensuring that they are available for future reference and audits.

5.6. Safety and Environmental Considerations

1. Ensure that all personnel involved in the testing process wear appropriate PPE, including gloves, goggles, and lab coats, to prevent exposure to propellants and chemicals.
2. Conduct all testing in a well-ventilated area, preferably in a fume hood, to minimize the risk of exposure to harmful vapors or gases.
3. Ensure proper disposal of any waste materials, such as used propellant samples, contaminated containers, and chemicals, according to the company’s waste disposal procedures and environmental regulations.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• PPE: Personal Protective Equipment
• SOP: Standard Operating Procedure

7. Documents

1. Propellant Purity Test Log (Annexure-1)
2. Equipment Calibration Log (Annexure-2)
3. Equipment Maintenance Log (Annexure-3)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001:2015 – Quality Management Systems

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Propellant Purity Test Log

Annexure-2: Equipment Calibration Log

Annexure-3: Equipment Maintenance Log

12. Revision History:

SOP for Conducting Microbial Limit Testing of Aerosol Products

1. Purpose

This Standard Operating Procedure (SOP) outlines the process for conducting microbial limit testing of aerosol products. The objective is to ensure that aerosol products meet microbial limits specified by regulatory authorities, ensuring the safety and quality of the product. Microbial contamination can affect product safety and efficacy, so regular testing is necessary to confirm compliance with safety standards and protect consumers.

2. Scope

This SOP applies to all aerosol products produced at [Company Name]. It covers the procedure for performing microbial limit testing on aerosol products, including testing for microbial contamination such as bacteria, yeasts, molds, and other microorganisms that could affect the product’s integrity and safety.

3. Responsibilities

• Quality Control (QC) Team: Responsible for conducting microbial limit tests, ensuring compliance with this SOP, and maintaining records of test results. The QC team is also responsible for initiating corrective actions if microbial contamination is found.
• Production Team: Responsible for ensuring that the aerosol products to be tested are properly prepared, representative of the production batch, and in the required condition for microbial testing.
• Health and Safety Officer: Ensures that safety protocols are followed during the testing process, especially in relation to handling microbial cultures and testing materials.
• Laboratory Personnel: Responsible for carrying out the microbial limit tests using appropriate techniques and equipment, and ensuring that the test conditions are controlled and documented.

4. Accountability

The Manufacturing Manager is accountable for ensuring that microbial limit tests are performed as part of the quality control process. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Pre-Test Preparation

1. Ensure that the aerosol products are fully prepared for testing, including proper sealing and labeling for identification.
2. Prepare the necessary laboratory equipment and materials, including:
   • Agar plates or broth media for microbial growth
   • Incubators set to the appropriate temperature for microbial growth
   • Appropriate sampling tools, such as sterile swabs or pipettes
   • PPE, including gloves, lab coats, and goggles, to ensure safety during testing
3. Ensure that the laboratory environment is sterile and free from contamination. Clean and disinfect the testing area and all equipment before use.
4. Ensure that microbial testing media are prepared and sterilized according to the manufacturer’s guidelines.

5.2. Conducting the Microbial Limit Test

1. Collect the sample from the aerosol product using sterile tools to avoid contamination during the sampling process.
2. For each sample, transfer an appropriate volume or mass of the aerosol product to the prepared agar plates or into the test broth media. The specific volume or weight will depend on the type of test being conducted (e.g., for total aerobic count or yeast and mold count).
3. For the microbial growth test:
   • Place the inoculated agar plates or broth in the incubator at the specified temperature for the recommended duration (e.g., 48–72 hours for bacterial growth).
   • Monitor the samples periodically to check for microbial growth.
   • After incubation, observe the samples for visible colonies. Record the number of colonies and the type of microorganisms (e.g., bacteria, yeast, mold) based on colony morphology, color, and shape.
4. For the absence test:
   • After the specified incubation period, check for the absence of microbial growth. If no growth is observed, the product passes the microbial limit test.
   • If microbial growth is detected, the sample fails the test and corrective actions must be taken.
5. Record the results of the test, including the number of colonies, the type of microorganism, and any deviations or issues observed during the test.

5.3. Post-Test Actions

1. If microbial contamination is detected, identify the source of contamination and investigate potential causes (e.g., inadequate cleaning, improper storage conditions).
2. Remove the contaminated products from the production line, and take corrective actions such as re-cleaning, reprocessing, or adjusting formulation components as necessary.
3. Notify the Quality Assurance (QA) Manager and relevant personnel of the test failure and the corrective actions taken to resolve the issue.
4. Document the test results, including the type of microorganisms detected, the actions taken, and any additional testing conducted, in the Microbial Limit Testing Log (Annexure-1).

5.4. Calibration and Maintenance of Equipment

1. Ensure that all equipment used for microbial testing, such as incubators and testing media, is calibrated and maintained according to the manufacturer’s specifications.
2. Regularly inspect and clean laboratory equipment, such as pipettes, inoculating loops, and incubation chambers, to ensure accurate testing and prevent cross-contamination.
3. Document all calibration and maintenance activities in the Equipment Calibration Log (Annexure-2) and the Equipment Maintenance Log (Annexure-3).

5.5. Documentation and Record-Keeping

1. Document all microbial limit testing activities, including the test results, sample details, operator name, and any corrective actions taken, in the Microbial Limit Testing Log (Annexure-1).
2. Ensure that all test records are reviewed and approved by the QC team to confirm that the aerosol product meets the required microbial limits.
3. Store all microbial testing records in the document management system for future reference and audits.

5.6. Safety and Environmental Considerations

1. Ensure that all personnel involved in microbial testing are trained in the proper handling of microbiological materials, including the use of PPE, safe handling of contaminated samples, and proper disposal of waste.
2. Conduct all testing in a controlled laboratory environment to minimize the risk of contamination.
3. Dispose of any contaminated materials, such as petri dishes, used sampling tools, or waste media, in accordance with safety and environmental regulations.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• PPE: Personal Protective Equipment
• SOP: Standard Operating Procedure

7. Documents

1. Microbial Limit Testing Log (Annexure-1)
2. Equipment Calibration Log (Annexure-2)
3. Equipment Maintenance Log (Annexure-3)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001:2015 – Quality Management Systems

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Microbial Limit Testing Log

Annexure-2: Equipment Calibration Log

Annexure-3: Equipment Maintenance Log

12. Revision History:

SOP for Conducting Valve Functionality Tests

1. Purpose

This Standard Operating Procedure (SOP) outlines the process for conducting valve functionality tests on aerosol products. The objective is to ensure that the aerosol valves are functioning properly, allowing for consistent spray delivery without leakage or malfunction. The proper functioning of the valve is crucial to achieving the desired performance, safety, and quality of aerosol products. Regular valve testing helps to maintain product integrity and comply with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all aerosol valves used in the production of aerosol products at [Company Name]. It covers the procedure for testing the functionality of aerosol valves during production and before final packaging to ensure they are working as intended.

3. Responsibilities

• Production Team: Responsible for conducting valve functionality tests and ensuring that any defective valves are identified and replaced before the product moves forward in the production process.
• Quality Control (QC) Team: Responsible for overseeing the valve functionality testing process, ensuring compliance with this SOP, and reviewing the test results to verify that valves meet the required specifications.
• Maintenance Team: Responsible for ensuring that testing equipment used for valve functionality checks is calibrated, maintained, and functioning properly.
• Health and Safety Officer: Ensures that safety protocols are followed during the valve testing process, especially regarding the handling of pressurized cans and propellants.

4. Accountability

The Manufacturing Manager is accountable for ensuring that this SOP is followed and that aerosol valves are tested for functionality before final packaging. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Pre-Test Preparation

1. Ensure that the aerosol cans are fully filled and sealed before testing the valve functionality.
2. Prepare the necessary testing equipment, including:
   • Valve functionality testing apparatus (e.g., spray test rig or manual spray test device)
   • Stopwatch or timer for measuring spray duration
   • Compressed air or propellant gas for pressurizing the aerosol can
   • PPE, including gloves and goggles, for safety during testing
3. Inspect the valve testing apparatus to ensure it is clean, calibrated, and properly assembled for the tests.
4. Ensure that the testing area is clear of any obstructions or contamination that may affect the test results.

5.2. Conducting the Valve Functionality Test

1. Position the aerosol can securely in the valve testing apparatus, ensuring that the valve is aligned correctly for testing.
2. Apply pressure to the aerosol can using compressed air or propellant, depending on the test method. This will activate the valve and simulate normal operation.
3. For the spray test:
   • Press the valve for a set time (e.g., 5 seconds) and observe the spray pattern.
   • Ensure that the spray is consistent, without sputtering, blockage, or leakage around the valve area.
   • Measure the spray volume or weight dispensed within the specified time frame and compare it to the product specifications.
4. For the leak test:
   • Hold the aerosol can in an upright position and observe the valve area for any signs of leakage or hissing sounds when the can is activated.
   • Ensure that there is no leakage from the valve, both during activation and while the can is stationary.
5. Repeat the valve functionality test for a sample of aerosol cans to ensure consistent performance across multiple units.

5.3. Post-Test Actions

1. For cans that pass the test, proceed with the next steps in the production process, ensuring that all valves are functioning properly and meeting product specifications.
2. If any can fails the valve functionality test (e.g., spray pattern is inconsistent, leakage detected), remove the defective can from the production line for further inspection or disposal.
3. Document the results of the valve functionality tests, including the test date, can ID, operator name, test results, and any corrective actions taken, in the Valve Functionality Test Log (Annexure-1).

5.4. Calibration and Maintenance of Equipment

1. Regularly calibrate the valve functionality testing apparatus according to the manufacturer’s guidelines to ensure accurate measurements.
2. Perform routine maintenance on the testing equipment, including cleaning, checking for wear, and replacing parts that may affect the accuracy of the test.
3. Document all calibration and maintenance activities in the Equipment Calibration Log (Annexure-2) and the Equipment Maintenance Log (Annexure-3).

5.5. Documentation and Record-Keeping

1. Document all valve functionality test results in the Valve Functionality Test Log (Annexure-1), including details such as the can ID, test date, operator name, and any deviations or issues found during testing.
2. Ensure that the results are reviewed and approved by the QC team to confirm that the aerosol product meets the required valve performance specifications.
3. Maintain records of valve functionality testing according to the company’s document retention policy, ensuring that they are available for future reference and audits.

5.6. Safety and Environmental Considerations

1. Ensure that all personnel involved in valve functionality testing wear the appropriate PPE, including gloves, goggles, and protective aprons, to prevent exposure to propellants or other chemicals.
2. Perform all testing in a well-ventilated area or fume hood to prevent the buildup of propellant vapors or other potentially hazardous fumes.
3. Dispose of any waste materials, such as defective cans or contaminated equipment, according to the company’s waste disposal procedures and environmental regulations.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• PPE: Personal Protective Equipment
• SOP: Standard Operating Procedure

7. Documents

1. Valve Functionality Test Log (Annexure-1)
2. Equipment Calibration Log (Annexure-2)
3. Equipment Maintenance Log (Annexure-3)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001:2015 – Quality Management Systems

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Valve Functionality Test Log

Annexure-2: Equipment Calibration Log

Annexure-3: Equipment Maintenance Log

12. Revision History:

SOP for Testing Particle Size Distribution

1. Purpose

This Standard Operating Procedure (SOP) defines the process for testing the particle size distribution of aerosol products. The objective is to determine the size of the particles in aerosol formulations to ensure uniformity and consistency in the spray delivery. Proper particle size distribution is essential for achieving the desired performance characteristics of aerosol products, such as spray pattern, consistency, and dispersion, and is a critical parameter in product quality control.

2. Scope

This SOP applies to all aerosol products produced at [Company Name]. It includes the procedure for testing the particle size distribution of the aerosol formulations, which is crucial for ensuring that the product performs as intended. This SOP covers both manual and automated methods for particle size testing, using instruments such as laser diffraction analyzers or cascade impactors.

3. Responsibilities

• Production Team: Responsible for collecting the samples of aerosol products for particle size testing according to this SOP and ensuring that the samples are representative of the entire batch.
• Quality Control (QC) Team: Responsible for conducting the particle size distribution tests, interpreting the results, and ensuring that the product meets the required specifications for particle size.
• Health and Safety Officer: Ensures that all safety protocols are followed during particle size testing, especially in relation to handling aerosols and the testing equipment.
• Maintenance Team: Responsible for ensuring that the particle size testing equipment is properly maintained, calibrated, and functioning as intended.

4. Accountability

The Manufacturing Manager is accountable for ensuring that this SOP is followed and that aerosol products meet the required particle size distribution specifications. Compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Pre-Test Preparation

1. Ensure that the aerosol product to be tested is representative of the batch and is fully prepared for testing (i.e., the product has been filled and sealed in the appropriate container).
2. Prepare the particle size testing equipment according to the manufacturer’s instructions. This may include calibration, checking the settings, and verifying the correct sample holders or accessories are in place.
3. Ensure that the testing environment is free from contamination and that all instruments are clean and in good working condition.
4. Gather the necessary tools, including sample collection equipment, personal protective equipment (PPE), and the appropriate testing apparatus (e.g., laser diffraction analyzer or cascade impactor).

5.2. Conducting the Particle Size Test

1. For laser diffraction analysis:
   • Place a representative sample of the aerosol product in the sample chamber of the analyzer.
   • Activate the aerosol can and collect the sample using the appropriate sampling device, such as a vacuum or aspiration system, to ensure a consistent sample is collected.
   • The laser diffraction analyzer will measure the particle size distribution by analyzing the diffraction pattern produced by the aerosol particles.
   • Ensure that the sample is adequately dispersed to avoid aggregation of particles, as this could affect the accuracy of the results.

5.3. Post-Test Actions

1. After testing, ensure that the particle size analyzer or cascade impactor is cleaned and calibrated, as required by the manufacturer’s instructions, to maintain the accuracy of future tests.
2. Analyze the data from the particle size test to determine if the aerosol product meets the required specifications. The data should include parameters such as the median particle size (D50), particle size distribution range, and the percentage of particles within the required size range.
3. If the results fall within the acceptable range, proceed with the next steps in the production process. If the particle size distribution is out of specification, investigate potential causes and take corrective actions, such as adjusting the formulation or valve specifications.

5.4. Documentation and Record-Keeping

1. Document all particle size testing results in the Particle Size Distribution Log (Annexure-1), including the test date, operator name, sample ID, and particle size data (e.g., D50, size range, and percentage distribution).
2. Ensure that the results are reviewed by the QC team and that any deviations are addressed and documented in the Deviation Log (Annexure-2).
3. Maintain records of particle size testing for each batch according to the company’s document retention policy for future reference and audits.

5.5. Calibration and Maintenance of Equipment

1. Calibrate the particle size testing equipment at regular intervals according to the manufacturer’s guidelines or company procedures.
2. Ensure that the particle size testing equipment is checked for proper functioning before and after each test and that any malfunctions or inaccuracies are addressed by the Maintenance Team.
3. Document calibration and maintenance activities in the Equipment Calibration Log (Annexure-3) and the Equipment Maintenance Log (Annexure-4).

5.6. Safety and Environmental Considerations

1. Ensure that all personnel involved in particle size testing are trained in the proper use of PPE, including gloves, goggles, and lab coats, to prevent exposure to aerosol formulations.
2. Conduct all tests in a well-ventilated area or fume hood to prevent the buildup of propellant vapors and maintain safety during aerosol testing.
3. Dispose of any waste generated during particle size testing, such as used sampling equipment or product residues, according to the company’s waste disposal procedures and environmental regulations.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• PPE: Personal Protective Equipment
• SOP: Standard Operating Procedure
• D50: Median Particle Size

7. Documents

1. Particle Size Distribution Log (Annexure-1)
2. Deviation Log (Annexure-2)
3. Equipment Calibration Log (Annexure-3)
4. Equipment Maintenance Log (Annexure-4)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001:2015 – Quality Management Systems

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Particle Size Distribution Log

Annexure-2: Deviation Log

Annexure-3: Equipment Calibration Log

Annexure-4: Equipment Maintenance Log

12. Revision History:

SOP for Measuring Spray Rate of Aerosol Products

1. Purpose

This Standard Operating Procedure (SOP) outlines the procedure for measuring the spray rate of aerosol products to ensure consistency in product delivery and performance. The spray rate measurement is essential for verifying that the aerosol product dispenses at the intended rate and that the valve and actuator are functioning correctly. Accurate spray rate measurement helps maintain quality control and ensures that the product meets the required specifications for consumer use.

2. Scope

This SOP applies to the measurement of spray rates for all aerosol products produced at [Company Name]. It includes the steps for testing spray rate consistency for various aerosol formulations, ensuring that each batch of aerosol products meets the specified spray rate before packaging and distribution.

3. Responsibilities

• Production Team: Responsible for conducting spray rate measurements on aerosol cans and ensuring that all measurements are recorded accurately. They are also responsible for following the SOP during testing and notifying QC or maintenance if discrepancies are found.
• Quality Control (QC) Team: Responsible for overseeing the spray rate measurement process, ensuring compliance with this SOP, and reviewing results to confirm that aerosol products meet the required spray rate specifications.
• Maintenance Team: Ensures that the equipment used for spray rate testing, such as the spray rate apparatus, is properly calibrated and maintained in working condition.
• Health and Safety Officer: Ensures that all safety protocols are followed during the spray rate measurement process, particularly with respect to handling pressurized cans and ensuring the proper use of personal protective equipment (PPE).

4. Accountability

The Manufacturing Manager is accountable for ensuring that this SOP is followed, and that aerosol spray rates are accurately measured as part of the quality control process. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Pre-Test Preparation

1. Ensure that the aerosol can to be tested is fully filled, sealed, and crimped, and that it is representative of the product batch being produced.
2. Gather the necessary equipment for spray rate measurement, including:
   • Spray rate apparatus (e.g., spray rate testing machine or collection tray)
   • Stopwatch or timer for measuring spray duration
   • Measuring container or balance to record the collected amount of product
   • PPE, including gloves and goggles, to ensure safety during testing
3. Inspect the spray rate apparatus to ensure it is clean, calibrated, and functioning correctly.

5.2. Conducting the Spray Rate Test

1. Position the aerosol can in the spray rate apparatus, ensuring that the can is held securely and that the nozzle is properly aligned for testing.
2. Activate the aerosol can for a set time (e.g., 10 seconds) while measuring the amount of product dispensed. The amount dispensed should be collected in a pre-weighed container or recorded directly by the apparatus.
3. Repeat the test three times to ensure consistency in spray rate measurements. The results should fall within the acceptable range specified for the product.
4. If using a collection tray, ensure that the tray is large enough to collect the entire spray without overflow and that it is placed on a surface that will not be affected by the aerosol spray (e.g., a non-absorbent, level surface).

5.3. Post-Test Actions

1. Record the results of each spray rate test, including the amount of product dispensed, the duration of the spray, and any deviations from the expected spray rate in the Spray Rate Test Log (Annexure-1).
2. Analyze the results to confirm that the measured spray rate falls within the product specification range. If the spray rate falls outside the acceptable limits, investigate the cause of the discrepancy and take corrective action.
3. If the spray rate is out of specification, notify the QC Team or Maintenance Team to address any issues with the valve, actuator, or can pressure, and retest after any corrective action is taken.

5.4. Calibration and Maintenance of Equipment

1. Regularly calibrate the spray rate apparatus according to the manufacturer’s guidelines or company procedures. Ensure that calibration is performed at specified intervals or after any major maintenance.
2. Inspect the spray rate testing equipment before each test to ensure that it is functioning properly. If any malfunction is observed, report it to the Maintenance Team for repair.
3. Document all calibration activities in the Calibration Log (Annexure-2) to ensure that the equipment is consistently providing accurate results.

5.5. Documentation and Record-Keeping

1. Document the results of all spray rate measurements, including the can ID, test date, operator name, and measured spray rate, in the Spray Rate Test Log (Annexure-1).
2. Ensure that all records are reviewed and approved by the QC team to confirm that the aerosol product meets the required spray rate specifications.
3. Store all spray rate test logs and calibration records in the document management system in accordance with the company’s document retention policy for future reference and audits.

5.6. Safety and Environmental Considerations

1. Ensure that all personnel conducting spray rate tests wear appropriate PPE, including gloves and goggles, to protect against exposure to propellants and product formulations.
2. Perform all testing in a well-ventilated area to prevent the buildup of propellant vapors or other potentially hazardous fumes.
3. Dispose of any waste materials generated during the testing process, such as used testing containers or waste aerosol, in accordance with the company’s waste disposal procedures and environmental regulations.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• PPE: Personal Protective Equipment
• SOP: Standard Operating Procedure

7. Documents

1. Spray Rate Test Log (Annexure-1)
2. Calibration Log (Annexure-2)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001:2015 – Quality Management Systems

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Spray Rate Test Log

Annexure-2: Calibration Log

12. Revision History:

SOP for Leak Testing of Aerosol Cans

1. Purpose

This Standard Operating Procedure (SOP) defines the process for conducting leak testing on aerosol cans to ensure they are properly sealed and free from leaks. The purpose of this SOP is to prevent the release of propellants, contaminants, or formulations, ensuring that the aerosol products meet the required safety, quality, and performance standards. Leak testing is a critical step in the quality control process to guarantee product integrity and compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all aerosol cans used in the production of aerosol products at [Company Name]. It includes the procedure for testing aerosol cans for leaks during the production process, after filling, and before packaging. This SOP covers both manual and automated leak testing methods used to identify defects in can seals, valves, and other critical components.

3. Responsibilities

• Production Team: Responsible for conducting leak tests on aerosol cans according to this SOP and for ensuring that any defective cans are removed from the production line.
• Quality Control (QC) Team: Responsible for overseeing the leak testing process, ensuring compliance with this SOP, and reviewing testing results to verify product quality.
• Maintenance Team: Ensures that the leak testing equipment is in proper working condition and performs routine maintenance and calibration of the testing devices.
• Health and Safety Officer: Ensures that leak testing procedures are conducted following safety guidelines and that the proper PPE is worn during testing.

4. Accountability

The Manufacturing Manager is accountable for ensuring that the leak testing procedure is followed and that aerosol cans are tested according to the specified criteria. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Pre-Testing Preparation

1. Before conducting leak tests, ensure that all aerosol cans are fully filled, crimped, and sealed according to the specified production standards.
2. Ensure that the leak testing equipment is properly calibrated and in good working condition. Check for any malfunctions or inaccuracies in the testing system.
3. Gather the necessary tools and equipment for testing, including the leak tester, air pressure system, and any required PPE such as gloves, goggles, and protective aprons.
4. Ensure that the testing area is clean and free of any obstructions to avoid contamination or interference during testing.

5.2. Conducting the Leak Test

1. Place the filled aerosol can into the leak testing machine according to the manufacturer’s instructions. If performing manual testing, ensure the correct positioning of the can for accurate results.
2. For pressure-based leak tests:
   • Apply a specified air pressure to the can using the testing system.
   • Monitor the can for any signs of pressure loss or hissing sounds indicating a leak in the can, valve, or seal.
   • For automated systems, ensure that the system records the pressure and any variations in pressure over a specified duration to detect leaks.
3. For bubble-based leak tests:
   • Submerge the sealed aerosol can in a water or liquid bath, applying pressure to the can.
   • Look for the presence of bubbles forming around the seal, valve, or other components of the can. The presence of bubbles indicates a leak.
4. If the can passes the test, proceed with the next step in the production process. If the can fails the test, it must be removed from the production line for further inspection and corrective action.

5.3. Post-Testing Actions

1. For failed cans, remove them from the production line immediately and tag them for further investigation or disposal.
2. Document the results of the leak tests, including the number of cans tested, the number of passed and failed tests, and the actions taken on failed cans in the Leak Testing Log (Annexure-1).
3. For automated testing systems, ensure that the results are automatically recorded and stored in the system for future reference and analysis.

5.4. Documentation and Record-Keeping

1. Document all leak testing activities in the Leak Testing Log (Annexure-1), including the date of testing, operator name, test results, and corrective actions taken for failed cans.
2. Ensure that the records are reviewed by the QC team and signed off for compliance verification.
3. Store all leak testing records in the document management system for future reference and audits.

5.5. Calibration and Maintenance of Leak Testing Equipment

1. Perform routine calibration of leak testing equipment to ensure accurate readings. Calibration should be done according to the manufacturer’s instructions and at regular intervals.
2. Conduct preventive maintenance on the leak testing equipment, including cleaning, replacing worn components, and checking for functionality, as outlined in the maintenance schedule.
3. Keep a record of all calibration and maintenance activities in the Equipment Maintenance Log (Annexure-2).

5.6. Safety and Environmental Considerations

1. Ensure that all personnel involved in the leak testing process wear the appropriate PPE, including gloves, goggles, and protective aprons, to prevent exposure to pressurized cans and potential chemicals.
2. Follow all safety protocols for handling pressurized containers and gas propellants, including proper disposal procedures for failed cans or those with potential safety hazards.
3. Dispose of any waste generated during the leak testing process, such as failed cans or cleaning materials, according to environmental and safety regulations.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• PPE: Personal Protective Equipment
• SOP: Standard Operating Procedure

7. Documents

1. Leak Testing Log (Annexure-1)
2. Equipment Maintenance Log (Annexure-2)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001:2015 – Quality Management Systems

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Leak Testing Log

Annexure-2: Equipment Maintenance Log

12. Revision History:

SOP for Preventive Maintenance of Cleaning Equipment

1. Purpose

This Standard Operating Procedure (SOP) defines the process for performing preventive maintenance on cleaning equipment used in aerosol manufacturing. The objective is to ensure that all cleaning equipment, including washers, brushes, and other cleaning systems, are functioning optimally to maintain the cleanliness of machines and equipment. Regular preventive maintenance minimizes equipment downtime, ensures consistent cleaning performance, and helps maintain compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all cleaning equipment used in aerosol manufacturing, including cleaning machines, scrubbers, and washing stations. It covers the routine maintenance tasks that need to be performed on cleaning equipment to prevent malfunctions, reduce wear and tear, and extend the life of the equipment. This SOP does not cover the cleaning process itself, which is addressed separately.

3. Responsibilities

• Maintenance Team: Responsible for performing the preventive maintenance tasks on cleaning equipment according to this SOP, including lubrication, parts inspection, and adjustments.
• Production Team: Responsible for notifying the Maintenance Team of any issues or malfunctions related to the cleaning equipment and for following the SOP during cleaning activities.
• Quality Control (QC) Team: Ensures that the preventive maintenance program is being followed correctly and that equipment performance meets the necessary standards for cleaning.
• Health and Safety Officer: Ensures that maintenance work is conducted following safety protocols and that proper PPE is used to prevent injury.

4. Accountability

The Manufacturing Manager is accountable for ensuring that preventive maintenance is conducted according to this SOP and that cleaning equipment is maintained in good working condition. Compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Maintenance Schedule

1. Develop and maintain a preventive maintenance schedule for all cleaning equipment. The schedule should be based on the manufacturer’s recommendations and the frequency of use of the equipment.
2. The schedule should include tasks such as equipment inspection, lubrication, calibration, and part replacement.
3. Review the schedule annually and update it as needed based on equipment usage, wear, or operational changes.
4. Ensure that the schedule is clearly communicated to the Maintenance and Production Teams, and ensure that all required tasks are performed on time.

5.2. Routine Maintenance Tasks

1. Inspect all cleaning equipment components for signs of wear or damage. Key components to inspect include:
   • Motors and electrical components
   • Pumps and hoses
   • Valves and seals
   • Filters and air systems
   • Brushes and cleaning heads
2. Clean equipment components to prevent buildup of dirt or debris that could affect performance.
3. Lubricate moving parts according to the manufacturer’s guidelines to reduce friction and wear.
4. Test equipment to ensure that it is operating within the required specifications, such as pressure, temperature, or flow rate.
5. Check and replace any worn or damaged parts, such as seals, hoses, or filters, and document the replacement in the maintenance log (Annexure-1).

5.3. Equipment Calibration

1. For equipment that requires calibration, follow the manufacturer’s instructions to verify that the equipment is within the specified operating range.
2. If calibration results are outside the acceptable range, adjust the equipment as necessary or replace any faulty components.
3. Document the calibration results and any adjustments made in the calibration log (Annexure-2).

5.4. Cleaning Equipment Testing

1. Test the cleaning equipment after maintenance to ensure that it is functioning properly. This includes:
   • Running the equipment through a cycle to check for leaks or malfunctions.
   • Verifying that cleaning solutions or water flow properly through the system and that all components are operating smoothly.
   • Checking for proper pressure or vacuum levels in the cleaning systems.
2. Ensure that any issues identified during testing are documented and addressed before the equipment is put back into service.

5.5. Documentation and Record-Keeping

1. Document all preventive maintenance activities in the Preventive Maintenance Log (Annexure-1), including the date, tasks performed, parts replaced, and any issues encountered.
2. Ensure that the Maintenance Team signs off on all completed tasks and that the records are reviewed by the Quality Control (QC) Team.
3. Maintain a copy of the maintenance log in the document management system for future reference and audits.

5.6. Safety and Environmental Considerations

1. Ensure that all maintenance work is performed following the company’s health and safety policies, including lockout/tagout procedures to prevent accidental equipment activation during maintenance.
2. Ensure that maintenance personnel are equipped with the appropriate Personal Protective Equipment (PPE), including gloves, goggles, and hearing protection, where necessary.
3. Dispose of any waste generated during maintenance (e.g., used lubricants, filters, parts) according to the company’s waste disposal procedures and environmental regulations.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• PPE: Personal Protective Equipment
• SOP: Standard Operating Procedure

7. Documents

1. Preventive Maintenance Log (Annexure-1)
2. Calibration Log (Annexure-2)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001:2015 – Quality Management Systems

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Preventive Maintenance Log

Annexure-2: Calibration Log

12. Revision History:

SOP for Visual Inspection of Cleaned Machines

1. Purpose

This Standard Operating Procedure (SOP) outlines the steps for conducting a visual inspection of cleaned machines used in aerosol manufacturing. The objective is to verify that all machines and equipment have been thoroughly cleaned, free from contaminants, residues, and cleaning agents, ensuring that they are ready for the next production run. This inspection is crucial to maintaining product quality and ensuring compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all machines used in aerosol production that require cleaning between production runs, including filling machines, crimping machines, and other related equipment. It covers the visual inspection process to ensure that machines are free of any product residues, cleaning agents, or contaminants before being used again in production.

3. Responsibilities

• Production Team: Responsible for conducting the visual inspection of cleaned machines according to this SOP and ensuring that any discrepancies or issues are addressed before the machine is used again.
• Quality Control (QC) Team: Responsible for overseeing the visual inspection process to ensure compliance with this SOP and ensuring that all machines meet cleanliness standards before production starts.
• Health and Safety Officer: Ensures that safety protocols are followed during the inspection process, particularly in relation to handling cleaning agents and potential residues.
• Maintenance Team: Assists in addressing any mechanical issues identified during the inspection and ensures the machine is in good working condition.

4. Accountability

The Manufacturing Manager is accountable for ensuring that this SOP is followed, and that machines are inspected thoroughly after each cleaning cycle. The overall compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Pre-Inspection Preparation

1. Ensure that all cleaning and sanitization of the machine have been completed before the visual inspection begins. The machine should be free of any cleaning agents, solvents, and product residues.
2. Gather necessary tools for inspection, including a flashlight, magnifying glass (if required), and any other tools needed to access hard-to-reach areas.
3. Wear the appropriate Personal Protective Equipment (PPE), including gloves and safety glasses, to prevent contamination and ensure safety during the inspection process.

5.2. Conducting the Visual Inspection

1. Start the inspection by visually examining all accessible surfaces of the machine, including the exterior, interior, and all moving parts. Pay close attention to areas that come into contact with product formulations or cleaning agents.
2. Inspect the machine for the following:
   • Visible product residues or foreign particles on machine surfaces
   • Residues of cleaning agents, including any streaks or stains that indicate incomplete cleaning
   • Any signs of rust, corrosion, or damage to critical parts
   • Presence of dust, dirt, or debris in the machine’s operational areas
   • Cleanliness of seals, valves, and other parts that might trap residues
3. Use a flashlight or magnifying glass for better visibility in hard-to-reach areas such as under equipment, inside tubing, or around moving parts.
4. Inspect the machine for any signs of wear or damage that could affect its performance or cleanliness.
5. If any contamination or damage is found, document the issue and notify the maintenance team or responsible personnel for corrective action.

5.3. Post-Inspection Actions

1. If the machine passes the visual inspection, verify that it is ready for use by confirming that all necessary parts are reassembled and securely fastened.
2. If the machine fails the inspection, isolate it from the production area and report the issue to the Maintenance Team. The machine should not be used until it is cleaned again or repaired as needed.
3. Document the inspection results, including any discrepancies, corrective actions taken, and the operator’s name and date of inspection in the Visual Inspection Log (Annexure-1).

5.4. Documentation and Record-Keeping

1. Complete the Visual Inspection Log (Annexure-1) after each inspection, noting the condition of the machine, any issues found, and any corrective actions taken.
2. Ensure that all inspection records are signed and approved by the relevant personnel (Production, QC, QA) to verify that the machine is ready for the next production run.
3. Store inspection records according to the company’s document retention policy to ensure that they are available for audits and regulatory inspections.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• PPE: Personal Protective Equipment
• SOP: Standard Operating Procedure

7. Documents

1. Visual Inspection Log (Annexure-1)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001:2015 – Quality Management Systems

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Visual Inspection Log

12. Revision History:

SOP for Cleaning and Sanitizing Small Tools in Manufacturing

1. Purpose

This Standard Operating Procedure (SOP) outlines the process for cleaning and sanitizing small tools used in aerosol manufacturing. The objective is to ensure that tools are free from contaminants, product residues, and cleaning agents, which could affect the quality and safety of aerosol products. Regular cleaning and sanitization of small tools is essential to comply with Good Manufacturing Practices (GMP) and to maintain product integrity.

2. Scope

This SOP applies to all small tools used in aerosol manufacturing, including measuring devices, dispensers, spatulas, brushes, mixing utensils, and any other hand-held tools that come into direct contact with aerosol formulations. This SOP covers the procedures for cleaning, sanitizing, and inspecting small tools after each use, especially when changing between different products or formulations.

3. Responsibilities

• Production Team: Responsible for cleaning, sanitizing, and inspecting small tools after each use, and ensuring that all tools are in good condition before use in subsequent production runs.
• Quality Control (QC) Team: Ensures that the cleaning and sanitization processes meet GMP standards and that tools are properly sanitized before being used in production.
• Health and Safety Officer: Ensures that all safety protocols for handling cleaning agents and sanitizers are followed, and that personal protective equipment (PPE) is used during cleaning and sanitization.
• Maintenance Team: Inspects and repairs small tools if necessary and assists in ensuring that tools are in proper working condition after cleaning.

4. Accountability

The Manufacturing Manager is accountable for ensuring that this SOP is followed and that all small tools are cleaned and sanitized according to the prescribed procedure. The overall compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Pre-Cleaning Preparation

1. Before cleaning, remove any product residues from the small tools by gently scraping or wiping the tools to prevent contamination of the cleaning solution.
2. Ensure that all small tools are properly disassembled, if applicable, to ensure thorough cleaning (e.g., removing detachable parts from dispensers or mixing devices).
3. Gather the required cleaning materials, including:
   • Approved cleaning agents (non-toxic and compatible with aerosol formulations)
   • Sanitizers suitable for food-grade or pharmaceutical manufacturing
   • Water or appropriate rinsing solvent
   • Cleaning brushes, sponges, cloths, and disposable wipes
   • Personal Protective Equipment (PPE), including gloves, goggles, and aprons
4. Inspect all cleaning tools to ensure they are clean and in good working condition.
5. Ensure that the cleaning agents used are compatible with the tools and will not damage the surfaces of the tools.

5.2. Cleaning the Tools

1. Clean each small tool by scrubbing with an appropriate cleaning agent and brush to remove any product residues. Ensure all surfaces, including hard-to-reach areas, are thoroughly cleaned.
2. If necessary, soak the tools in an appropriate cleaning solution for a set period to loosen stubborn residues before scrubbing.
3. Rinse the cleaned tools thoroughly with clean water or another approved solvent to remove any cleaning agent residues.
4. For tools that come into contact with propellants or other hazardous chemicals, ensure that the cleaning process removes all traces of these materials before sanitization.

5.3. Sanitizing the Tools

1. After cleaning, sanitize the tools using an approved sanitizer that is suitable for use in aerosol manufacturing. Ensure that the sanitizer is applied to all surfaces of the tools, paying particular attention to any areas where contamination could remain.
2. If necessary, use a soaking method to ensure thorough sanitization, following the manufacturer’s instructions for the sanitizer’s concentration and contact time.
3. After sanitizing, rinse the tools with clean water or a suitable rinsing solution to remove any excess sanitizer. Ensure that no sanitizer residues remain on the tools.
4. Allow the tools to air dry or dry them using compressed air or clean, lint-free cloths to ensure no moisture remains.

5.4. Post-Cleaning Inspection

1. Once the tools are cleaned and sanitized, perform a visual inspection to ensure that there are no visible residues, dirt, or contaminants remaining on the tools.
2. Check for any signs of damage or wear during cleaning and sanitization. Report any issues to the Maintenance Team for repair or replacement.
3. Ensure that all tools are completely dry before being stored or used again in production, as moisture could lead to microbial growth or rust.
4. Document the inspection results in the Tool Inspection Log (Annexure-1), noting the condition of the tools, any problems found, and corrective actions taken.

5.5. Documentation and Record-Keeping

1. Document all cleaning and sanitization activities in the Cleaning and Sanitization Log (Annexure-2), including the date, operator name, cleaning agents used, sanitizers used, and any deviations or issues encountered.
2. Ensure that the Tool Inspection Log (Annexure-1) is completed after each cleaning cycle to record the condition of the tools and any repairs or replacements made.
3. Ensure that all records are reviewed by the QC team and signed off by the relevant personnel to ensure compliance with this SOP.
4. Store all cleaning and inspection records in accordance with the company’s document retention policy to ensure that they are available for audits and regulatory inspections.

5.6. Safety and Environmental Considerations

1. Ensure that all cleaning and sanitization activities are conducted in accordance with safety guidelines, particularly with regard to handling cleaning agents, sanitizers, and any waste materials.
2. Ensure that all personnel handling cleaning agents and sanitizers wear appropriate PPE to prevent exposure to hazardous chemicals.
3. Dispose of used cleaning materials, such as cleaning agents and contaminated wipes, according to the company’s waste disposal policies and environmental regulations.
4. Ensure that the cleaning and sanitization process does not create any safety or environmental risks, and take appropriate measures to mitigate any hazards identified during the process.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• PPE: Personal Protective Equipment
• SOP: Standard Operating Procedure

7. Documents

1. Cleaning and Sanitization Log (Annexure-2)
2. Tool Inspection Log (Annexure-1)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001:2015 – Quality Management Systems

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Tool Inspection Log

Annexure-2: Cleaning and Sanitization Log

12. Revision History: