What Is a Particle?

At the most basic level, a particle can be described as a fragment. These are microscopic particles suspended in the air.

Why Are Particles So Important?

Particles present in the environment can cause deterioration of product concentration, changes in purity, reduced safety, loss of stability, and as a result lead to “Financial Loss” and, even more valuable, “Loss of Time.”
In healthcare, space science, and electronic circuitry, environmental particles are extremely critical and may lead to irreversible errors.

What Is the Purpose and What Are the Rules in Biotechnology and Pharmaceutical Applications?

To think simply;
  • Red blood cells are approximately 5 µm in size,
  • Capillaries have a diameter of 5 to 10 µm,
  • Veins and arteries have diameters between 10–50 µm,
Accordingly, limits have been defined in ISO 14644-1 and EU GMP Annex 1 standards. If these limits are exceeded, individuals exposed may experience;
  • Increased risk of infection,
  • Increased allergic reactions,
  • Negative effects such as embolism caused by vascular blockages.
Maximum permitted number of particles per m3 equal to or greater than the tabulated size
EC GMP ISO At Rest In Operation
Grade Class 0.5 µm 5.0 µm 0.5 µm 5.0 µm
A 4.8 3,520 20 3,520 20
B 5 3,520 29 352,000 2,900
C 7 352,000 2,900 3,520,000 29,000
D 8 3,520,000 29,000 not defined not defined
ISO 14644-1:2015 CLASSIFICATION NUMBER (N) MAXIMUM CONCENTRATION LIMITS (PARTICLES/M3)
0.1 µm 0.2 µm 0.3 µm 0.5 µm 1.0 µm 5.0 µm
ISO Class 110-----
ISO Class 21002410---
ISO Class 31,00023710235--
ISO Class 410,0002,3701,02035283-
ISO Class 5100,00023,70010,2003,520820-
ISO Class 61,000,000237,000102,00035,2008,320298
ISO Class 7---352,00083,2002,930
ISO Class 8---3,520,000832,00029,300
ISO Class 9---35,200,0008,320,000293,000
To visualize particle sizes;
Particle size comparison chart
For example; if you look through a window on a sunny day and see dust sparkling in the sunlight, you are observing the principle behind a light-scattering sensor or a particle counter. The sunlight acts like a laser, your eyes function like a photodetector, and if you organize and count the particles in a flow individually, you essentially become a particle counter.

Methods Used in Particle Counting

  • Continuous particle monitoring systems: These systems are divided into two types—external pump and internal pump. They also require monitoring software, alarm indicators, and cabling. This method is suitable for Grade A and B areas.
  • Sequential monitoring: This method allows measurement at up to 32 points and is suitable for Grade C and D areas. Hose length can reach up to 30 m.
  • Handheld and portable particle counters: Used for periodic monitoring in clean areas.

Operating Principle of Particle Measurement Systems

Particle counting is performed using the light scattering method. Light-scattering sensors detect particles by scattering or reflecting light from the particle surface. Advanced optical systems collect scattered light and focus it on a detector, converting photonic energy into electrical energy proportional to particle size.

Our Particle Measurement System Solutions

1) External Pump Continuous Monitoring Device

The Beckman Coulter MET ONE 6000 series is used. These devices require an external vacuum pump. They are industry leaders and offer cost-effective, sustainable solutions aligned with SOP standards. Calibration is performed outside the cleanroom. Available options include 0.3 µm and 0.5 µm. LED indicators provide real-time status, and long-life laser diodes are used. Optional temperature and humidity sensors are available. Airflow options include 0.1 CFM (2.83 L/min) and 1.0 CFM (28.3 L/min). Communication options include Analog 4–20 mA, RS232, RS485 (ModBus RTU), and Ethernet (TCP/IP). Compliant with ISO 14644, FDA cGMP, and EU GMP Annex 1.

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