Why Cleanroom Air Monitoring is Essential

A cleanroom is a highly controlled environment designed to minimize contaminants such as dust, airborne microbes, aerosol particles, and chemical vapors. In such sensitive environments, even the smallest fluctuation in air quality can compromise product integrity, research accuracy, or patient safety.

A clean environment is paramount when creating, testing or packaging medicines or other substances destined for human consumption or contact. Contamination can cause serious illness or even death. An environmental monitoring (EM) program must demonstrate control over both viable and non-viable particles in critical areas.

Understanding exactly what to clean and monitor, and where to focus these efforts, is the starting point to maintaining the integrity of your cleanroom. Both viable and non-viable particles can exist, and monitoring for both is important to understand the cleanliness – and thus safety – of your operation.

Non-viable particles that don’t contain living organisms can spread viable particles, so monitoring for these is critical to maintaining asepsis. Testing for viable particles includes methods for isolating bacteria, yeast and mould.

The air in the facility will be continuously controlled by HVAC systems. While parameters such as pressure, temperature and humidity may be continuously monitored, routine air sampling for both viable and non-viable particle counts will be conducted depending on the grade of room and operations. A selected volume of air will need to be sampled to identify any presence of such particles.

Cleanroom Air Monitoring Plays A Crucial Role In:

• Ensuring Compliance: Industries such as pharmaceuticals and biotechnology must meet rigorous standards set by regulatory bodies like the FDA, EMA, and ISO 14644-1 for cleanroom classifications. Our monitoring services ensure that your facility complies with these standards.
• Product Quality and Safety: Monitoring airborne particulates, microbial contamination, and airflow helps maintain sterile conditions, ensuring the safety and quality of products and research.
• Reducing Contamination Risk: By regularly monitoring air quality, you can identify potential contamination sources early, allowing for corrective actions before they impact your cleanroom environment.
• Assessing Cleaning Effectiveness: Microbiological monitoring is conducted to verify the effectiveness of cleaning and disinfection procedures, ensuring a controlled cleanroom environment.

The Importance of Cleanroom Air Monitoring Services

• Accurate and Reliable Results: With state-of-the-art equipment and well-trained personnel, we provide accurate and reliable data to help you maintain optimal cleanroom conditions.
• Compliance with International Standards: Our services are aligned with ISO 14644, ISO 14698 & USP 1116 standards, ensuring your facility meets the requirements for cleanroom classification and operational integrity.
• Tailored Monitoring Solutions: Every cleanroom is unique, and so are its monitoring needs. We offer customized monitoring plans to suit the specific requirements of your industry and facility.
• Timely and Detailed Reporting: Our team provides comprehensive reports with trend analysis, allowing you to identify any changes in air quality and take proactive steps to maintain cleanroom compliance.

Cleanroom Air Monitoring in BIOCHEM

At Biochem Laboratories, our cleanroom air monitoring services are designed to provide precise and reliable results, ensuring that your cleanroom environment meets the standards. Our services include:

1) Particle Count Testing

We use advanced particle counters to measure airborne particulate levels in compliance with ISO 14644-1 cleanroom classifications. This ensures that the particulate concentration meets your cleanroom requirements

2) Microbial Air Monitoring

Using air samplers, we assess the microbial load in the air to identify and quantify the presence of bacteria, fungi, and other microorganisms. This is particularly critical for industries with sterility requirements, such as pharmaceutical manufacturing.

There are two methods of Air sampling in a Cleanroom: –

i) Air Samplers (active air sampling) – Air samplers draw in predetermined volumes of air. The air is drawn over a sterile media plate, which is later incubated to reveal the number of viable organisms per cubic feet or liter. Currently agar impaction is the method of choice throughout the industries. Using a specially designed, and calibrated piece of equipment which holds the media plate under a perforated lid and draws in a known amount of air one can accurately measure the number of viable bacteria within the air.

ii) Settling plates (passive air sampling) – Petri dishes containing sterile growth media are exposed to the environment for a specific period of time, usually between 30-60 minutes but can be exposed up to four hours before compromising the integrity of the media itself. Viable microorganisms which settle onto the media surface will grow after the plates are incubated. However, passive air sampling is tending to be phased out because it does not reflect microbial contamination with an accurately measured volume of air.

3) Airflow and Pressure Differential Monitoring

Our team monitors the airflow patterns, air velocity, and pressure differentials between cleanroom zones to ensure positive pressure is maintained where required, preventing cross-contamination.

4) Temperature and Humidity Control

Maintaining precise temperature and humidity levels is vital for cleanroom environments. We provide monitoring services that ensure your cleanroom stays within the optimal range, preventing conditions that could lead to microbial growth or equipment malfunction.