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

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Propellant Purity Test Log

Sample ID	Test Date	Impurities Detected	Operator Name	Corrective Action
PROP-12345	06/02/2025	None	Rajesh Patel	Test passed

Annexure-2: Equipment Calibration Log

Equipment ID	Calibration Date	Calibration Results	Operator Name	Remarks
GC-001	06/02/2025	Pass	Rajesh Patel	No adjustments required

Annexure-3: Equipment Maintenance Log

Equipment ID	Maintenance Date	Tasks Performed	Operator Name	Remarks
GC-001	06/02/2025	Cleaned and calibrated	Rajesh Patel	No issues found

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	V 1.0	Initial Release	First Issue	Anjali Sharma	Page 1	[Ref Point]	First Release
01/01/2025	V 2.0	Updated propellant purity testing procedure	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures