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