Cleanroom technology continues to evolve as industries face stricter regulatory requirements, higher product quality expectations, and increasing pressure to reduce contamination risks.
This blog explains what non-viable particle counters are, how they work, why they matter in cleanroom environments, and how organizations can choose the right technology for their contamination control strategy.
At the center of modern cleanroom monitoring are non-viable particle counters, which provide real-time measurement of airborne particles that can compromise product quality, process integrity, and compliance.
A non-viable particle counter is a monitoring instrument used to detect and count airborne particles in a controlled environment without determining whether those particles are living (microbial) or non-living, such as:
Unlike viable monitoring systems that are designed to detect living microorganisms, non-viable particle counters detect particles based on their size and quantity.
These systems are essential for ensuring compliance with cleanroom classifications such as:
Cleanrooms are designed to provide a controlled environment and minimize contamination. Even microscopic particles can:
Non-viable particle counters help facilities:
Real-time monitoring allows operators to respond immediately before contamination becomes a larger issue.
Most modern particle counters use laser-based optical particle counting technology.
The Process
The results are typically displayed as:
Common measured particle sizes include:
Key Technologies in Modern Cleanroom Particle Monitoring
1. Real-Time Continuous Monitoring for all production fillings
Modern cleanrooms increasingly rely on continuous monitoring systems instead of periodic manual sampling.
Benefits include:
Continuous systems are especially important in aseptic processing environments.
Applications of Non-Viable Particle Counters
Pharmaceutical Manufacturing
In sterile drug production, particle monitoring is essential for:
EU GMP Annex 1 emphasizes continuous non-viable monitoring in Grade A areas during critical operations and risk-based monitoring for Grade B, C and D areas.
BBG Advanced Therapies facilities use particle counters to protect our partners science including:
Sensitive biologic products require highly controlled environments.
Frequently Asked Questions
What is the difference between viable and non-viable particle monitoring?
Non-viable monitoring measures airborne particulate matter, while viable monitoring detects living microorganisms such as bacteria and fungi.
Why is continuous particle monitoring important?
Continuous monitoring provides real-time contamination detection, allowing facilities to respond quickly before product quality is affected.
BBG Advanced Therapies, subsidiary of BioBridge Global, has maintained a commitment to quality since opening in 2025. BBG Advanced Therapies leverages the BioBridge Global enterprise quality management and electronic batch records.
Having this access to expert quality teams advance programs from early development through clinical evaluation and toward commercialization.
Authors: Suvarchala Syamala, Quality Control Technician, Angelica Padilla Perez Manager, Quality & Compliance, and Brooklyn Wilkinson, Digital Experience Manager
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