Procedure for Environmental Monitoring in Cleanrooms

1) Purpose

The purpose of this SOP is to outline the procedure for conducting environmental monitoring in cleanrooms to assess air quality and microbial contamination levels.

2) Scope

This SOP applies to all cleanrooms within the facility where pharmaceutical products are manufactured, requiring routine environmental monitoring to maintain compliance with regulatory standards and internal specifications.

3) Responsibilities

Quality Assurance (QA) Department: Responsible for overseeing environmental monitoring activities.
Environmental Monitoring Team: Responsible for conducting sampling and analysis according to this SOP.

4) Procedure

4.1 Monitoring Points Selection:
    4.1.1 Identify critical monitoring points (e.g., active air sampling, surface sampling) based on cleanroom classification and risk assessment.
    4.1.2 Ensure sampling points represent different zones within the cleanroom (e.g., critical, controlled, support).

4.2 Sampling Methods:
    4.2.1 Prepare sampling equipment, including agar plates, air samplers, and swabs, following sterilization and calibration procedures.
    4.2.2 Perform active air sampling using calibrated equipment at predetermined flow rates and durations.
    4.2.3 Conduct surface sampling by swabbing predefined areas using validated techniques and media.

4.3 Sample Collection:
    4.3.1 Execute sampling activities in aseptic conditions to avoid contamination.
    4.3.2 Record environmental conditions (e.g., temperature, humidity) at the time of sampling.
    4.3.3 Label samples with unique identifiers, including location, date, and