Procedure for Clean Steam Quality Testing
1) Purpose
The purpose of this SOP is to outline the procedure for testing the quality of clean steam used in pharmaceutical manufacturing processes to ensure it meets specified standards for purity and suitability.
2) Scope
This SOP applies to all stages of clean steam generation, distribution, and usage within the facility, requiring regular testing to comply with pharmacopeial standards and internal specifications.
3) Responsibilities
Quality Control (QC) Department: Responsible for performing clean steam quality testing.
Quality Assurance (QA) Department: Responsible for oversight and review of testing procedures.
4) Procedure
4.1 Sampling Points Identification:
4.1.1 Identify critical sampling points where clean steam quality will be tested (e.g., point of use, distribution lines).
4.1.2 Ensure sampling points cover different areas and usage points within the facility.
4.2 Sampling and Testing:
4.2.1 Prepare sampling equipment, including validated sampling methods and sterile containers.
4.2.2 Collect clean steam samples according to aseptic sampling procedures, ensuring samples are representative of the source and usage points.
4.2.3 Test clean steam samples for key parameters such as purity (e.g., non-condensable gases), chemical impurities, and microbiological content (if applicable).
4.3 Analytical Testing:
4.3.1 Perform analytical tests using validated methods and equipment (e.g., gas chromatography, chemical analysis methods).
4.3.2 Follow pharmacopeial standards and facility specifications for sample preparation, testing conditions, and acceptance criteria.
4.3.3 Record environmental conditions (e.g., temperature, pressure) during sampling and testing.
4.4 Data Analysis:
4.4.1 Interpret test results and compare them against acceptance criteria for clean steam quality.
4.4.2 Evaluate trends over time to identify potential deviations or changes in clean steam parameters.
4.4.3 Investigate any out-of-specification results and implement corrective actions as necessary.
4.5 Reporting:
4.5.1 Document all testing activities, including sampling locations, methods, results, and actions taken, in the Clean Steam Quality Test Report.
4.5.2 Provide summary reports to QA for review and approval.
4.5.3 Maintain records of all testing documentation in accordance with facility procedures and regulatory requirements.
5) Abbreviations, if any
QC: Quality Control
QA: Quality Assurance
6) Documents, if any
Clean Steam Quality Test Report
Calibration Records for Testing Equipment
Analytical Method Validation Records
7) Reference, if any
ISO 14644-7 – Cleanrooms and associated controlled environments (Part 7: Separative devices)
FDA Guidance for Industry – Sterile Drug Products Produced by Aseptic Processing
8) SOP Version
Version 1.0
