Procedure for Particle Count Testing in Cleanrooms
1) Purpose
The purpose of this SOP is to outline the procedure for conducting particle count testing in cleanrooms to monitor airborne particulate levels and ensure compliance with specified cleanliness standards.
2) Scope
This SOP applies to all cleanrooms and controlled environments within the facility, requiring periodic particle count testing to maintain cleanliness classification and meet regulatory requirements.
3) Responsibilities
Quality Control (QC) Department: Responsible for performing particle count testing.
Facility Engineering: Responsible for ensuring cleanroom systems are operational and conducive to accurate testing.
Quality Assurance (QA) Department: Responsible for review and approval of testing procedures and results.
4) Procedure
4.1 Pre-Test Preparation:
4.1.1 Verify cleanliness classification and operational status of the cleanroom.
4.1.2 Calibrate particle counters according to manufacturer specifications and facility procedures.
4.2 Sampling Method:
4.2.1 Determine sampling locations based on cleanroom layout and classification requirements.
4.2.2 Use a validated sampling plan to ensure representative sampling of critical areas and zones.
4.3 Particle Count Testing:
4.3.1 Power on and validate particle counters before sampling begins.
4.3.2 Conduct particle count sampling at designated locations and time intervals as per procedure.
4.3.3 Record environmental conditions (e.g., temperature, relative humidity) during testing.
4.4 Data Analysis:
4.4.1 Compile particle count data from each sampling point and time interval.
4.4.2 Compare measured particle counts against cleanliness classification limits specified in ISO standards or facility specifications.
4.4.3 Evaluate trends and deviations to identify potential sources of particle contamination.
4.5 Reporting:
4.5.1 Prepare a Particle Count Test Report summarizing test objectives, methodology, results, and conclusions.
4.5.2 Submit the report to QA for review and approval.
4.5.3 Maintain records of all particle count testing documentation in accordance with facility procedures and regulatory requirements.
5) Abbreviations, if any
QC: Quality Control
QA: Quality Assurance
ISO: International Organization for Standardization
6) Documents, if any
Particle Count Test Report
Particle Counter Calibration Records
7) Reference, if any
ISO 14644-1 – Cleanrooms and associated controlled environments (Part 1: Classification of air cleanliness)
FDA Guidance for Industry – Sterile Drug Products Produced by Aseptic Processing
8) SOP Version
Version 1.0
