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 time of collection.
4.4 Analysis and Incubation:
4.4.1 Transport samples to the microbiology laboratory promptly for analysis.
4.4.2 Incubate agar plates and swabs according to specified conditions (e.g., temperature, duration) to promote microbial growth.
4.4.3 Monitor plates for colony formation and record observations regularly.
4.5 Data Interpretation:
4.5.1 Count and identify microbial colonies using validated methods and identification techniques.
4.5.2 Compare results against predefined alert and action limits for microbial contamination.
4.5.3 Investigate any deviations from acceptable limits and implement corrective actions.
4.6 Reporting:
4.6.1 Document all monitoring activities, including sampling procedures, results, and corrective actions, in the Environmental Monitoring Report.
4.6.2 Provide summary reports to QA for review and approval.
4.6.3 Archive all records according to facility procedures and regulatory requirements.
5) Abbreviations, if any
QA: Quality Assurance
6) Documents, if any
Environmental Monitoring Report
Calibration Records for Monitoring Equipment
Microbial Identification Records
7) Reference, if any
ISO 14644-1:2015 – Cleanrooms and associated controlled environments
FDA Guidance for Industry – Sterile Drug Products Produced by Aseptic Processing
8) SOP Version
Version 1.0
