Maintain Controlled Environments with Dedicated Cleanroom Services

Cleanrooms are essential for maintaining the controlled environments that are susceptible to contamination. They ensure that these spaces meet the stringent conditions necessary for producing safe and effective products and complying with strict regulatory requirements. Work with Performance Validation (PV) to keep your cleanroom in compliance with industry standards, ensuring the safety of your products and the integrity of your operations.

What Happens If a Cleanroom Is Compromised?

Without properly maintained cleanrooms, critical products could become contaminated and lead to severe injury or death for patients. Additionally, manufacturing facilities risk facing serious regulatory actions, such as warning letters or site seizures, if sterile environments are not upheld. Therefore, cleanrooms play a vital role in safeguarding both public health and the operational integrity of manufacturing facilities.

Industries We Serve

Effective Cleanroom Services

Particle Count Testing

Particle count testing is an essential procedure involving particle counters to measure the concentration and size distribution of airborne particles within a cleanroom. Particle counters typically use light scattering or light obscuration techniques to detect particles. The data collected is reported in terms of particle counts per cubic meter of air, categorized by different size ranges such as >0.5 µm, >1 µm and >5 µm.

Cleanrooms must adhere to specific cleanliness standards defined by regulatory agencies or industry standards, such as ISO 14644, ensuring that particle counts remain within acceptable limits.

Room Recovery Testing and Clean-Up Period Validation

Room recovery testing is a critical process in cleanroom environments, ensuring air quality returns to specified conditions within an acceptable timeframe after contamination events, such as personnel entry or material transfers. Defined by ISO 14644-3, this test demonstrates the efficiency of the HVAC and filtration systems in controlling airborne particulates and ensuring the room meets its intended cleanliness classification. Using calibrated particle counters and aerosol generators, recovery times are measured and validated to guarantee compliance and maintain the integrity of operations in controlled environments.

The clean-up period, per EU GMP Annex 1, refers to the specific duration required for a room to recover from a state of increased particulate levels to baseline particulate levels. Documentation of the clean-up period is essential for maintaining product quality and regulatory compliance in sterile manufacturing. Proper validation of recovery times not only ensures operational efficiency but also supports risk mitigation, safeguarding processes from potential contamination risks.

Microbial Testing

Microbial testing involves collecting samples from surfaces, air, and water within the cleanroom to detect the presence of microorganisms. Surface swabs gather samples from critical areas, and air samplers collect airborne microorganisms onto agar plates or other growth media.

Testing methods include:

• Microbial enumeration
• Identifying specific pathogens
• Detecting contamination using culture-based or molecular techniques

Results are then compared against established microbial count limits and species specifications to ensure compliance with regulatory and industry guidelines.

Airflow Velocity & Direction Testing

Assessing airflow velocity and direction is required to verify the performance of a cleanroom’s HVAC system. Anemometers and airflow visualization techniques, such as smoke studies or visualization tubes, are used to measure the velocity and direction of airflow. Ensuring the maintenance of specified flow patterns is vital to preventing the spread of contaminants and maintaining cleanliness levels within the cleanroom.

Temperature & Humidity Monitoring

Temperature and humidity monitoring is a routine task in which sensors are strategically placed throughout the cleanroom to continuously track environmental conditions. These monitoring systems use calibrated sensors and data loggers to record temperature and humidity levels at regular intervals. The recorded data is compared against specified operating ranges to ensure that environmental conditions remain within acceptable limits, which is crucial for product stability and process control.

Pressure Differential Testing

Pressure differential testing is performed between cleanrooms and adjacent areas to ensure proper containment of contaminants. This testing can be conducted using handheld manometers or by analyzing data from installed differential pressure (DP) monitoring devices. Utilizing calibrated Magnehelic gauges and manometers, the results are compared against the required pressure differentials specified by regulations or industry guidelines to prevent cross-contamination and maintain cleanroom integrity.

Electrostatic Discharge (ESD) Testing

ESD testing evaluates the effectiveness of electrostatic discharge control measures such as conductive flooring, grounding systems and personnel grounding devices. This testing involves measuring electrostatic charge generation and dissipation using electrostatic field meters or surface resistance meters. Ensuring that ESD control measures are adequate is critical to preventing electrostatic discharge events, which can damage sensitive electronic components.

Room Air Balance

Room air balance testing is important for evaluating airflow distribution within a cleanroom. Spot checks can be performed using uncalibrated testing hoods, while comprehensive testing involves measuring and adjusting airflow rates from supply vents and return grilles to maintain desired air change rates and pressure differentials. Differential pressure sensors, airflow meters and smoke studies assess airflow patterns and identify any areas of stagnant or turbulent airflow.

Compressed Air/Gas Sampling

Compressed air and gas sampling assesses the quality and purity of gases used in cleanroom processes, such as nitrogen, argon or compressed air. This sampling can be performed using gas samplers and Draeger tubes. Methods involve collecting gas samples at various points in the distribution system and analyzing them for contaminants, moisture or particulate matter. Techniques such as gas chromatography or moisture content analysis are commonly used to quantify impurities, ensuring compliance with purity requirements.

Lighting Testing

Lighting testing evaluates the performance of lighting systems within a cleanroom, ensuring they provide adequate illumination levels and uniformity. This straightforward test can be conducted using a calibrated meter. The testing involves measuring light intensity, color rendering and uniformity with light meters and spectrophotometers. Results are compared against industry standards and regulatory requirements to ensure that lighting systems meet specified criteria for visibility, safety and comfort.

Vibration Testing

Vibration testing assesses the levels of mechanical vibration within a cleanroom, which can impact sensitive equipment and processes. This testing involves installing vibration sensors or accelerometers at critical locations to monitor vibration levels over time. The results are analyzed to identify sources of vibration, such as HVAC equipment or nearby machinery, and to implement mitigation measures to reduce vibration levels. This helps to ensure the stability and proper functioning of cleanroom operations.

Follow Cleanroom Industry Standards

Our team understands and adheres to the industry standards for cleanrooms:

• ISO 14644 : An international standard that specifies the classification and requirements for air cleanliness in controlled environments, such as clean rooms, based on the concentration and size of airborne particles.
• USP 797/800: Guidelines for compounding sterile preparations (USP 797) and handling hazardous drugs in healthcare settings (USP 800) to ensure patient safety and protect healthcare workers.
• EU GMP Annex 1 : A guideline outlining the requirements for manufacturing sterile medicinal products to ensure product quality and patient safety.
• FDA 21 CFR Part 11 : The standards for accepting electronic records and signatures to ensure they are as reliable and valid as paper records.

Why PV?

Many cleanroom certifiers are just “testers”—they observe the cleanroom’s current state and report results. PV has experts who take testing a step further—they ask why the room is performing the way it is and what controls or engineering changes could be implemented to improve conditions. 

Our studies have repeatedly withstood client and regulatory scrutiny relative to critical airflow visualization. We combine state-of-the-art technology for conducting smoke studies with extensive system expertise to ensure a compliant system.

Our Cleanroom Process

At PV, our cleanroom process is built on a foundation of development and management excellence. We start by collaborating closely with clients to clearly define their needs and pain points and identify the specific solutions they are seeking. Our team takes full ownership of the project and works with clients to develop detailed protocols and study plans. We execute these plans meticulously, addressing and resolving any issues that arise along the way. Ultimately, we deliver a comprehensive compliance package that meets all stakeholder expectations.

No Cleanroom Challenge Is Too Big for Us to Solve

Our approach goes beyond testing; we provide in-depth explanations and actionable insights to ensure compliance. By leveraging our real-world expertise, we report findings and offer practical solutions to fix any deficiencies. If issues are identified, we explore different approaches to ensure your cleanroom operates at its best. Our commitment to ownership and proactive problem-solving sets us apart, ensuring that your cleanroom meets the highest standards of cleanliness and operational efficiency.

Certified Cleanroom Testers

When you choose PV for cleanroom testing, you work with engineers who have received the CETA Cleanroom Testing certification and training on the following domains:

• Non-viable particular testing
• Temperature and humidity mapping
• Pressure differential testing
• Microbial sampling
• Compressed gas sampling
• Lighting testing

“Thank you for being on top of everything, getting stuff done, and having great communication.”

Top 5 Global Pharmaceutical Company

Your Dedicated Partner for Cleanroom Services

Partner with PV for comprehensive, expert support tailored to your specific cleanroom needs. With our extensive experience and state-of-the-art equipment, we provide accurate particle count testing, microbial testing and various environmental monitoring services that meet regulatory standards. Our commitment to quality and compliance guarantees that your cleanroom environment will maintain the highest cleanliness and operational efficiency levels, safeguarding your products and processes.