Viable Particles: Fungi , bacteria , virus , spores. Nonviable Particles: Dust, mist, fogs, fumes, and tiny wastes. Viable particles are microorganisms while nonviable particles are small organic particles in the air. Viable particles affect the sterility of the product. Nonviable particles serve as carriers of viable particles.
Different laboratory methods are involved in measuring both viable and nonviable particles. The main difference between viable and nonviable particles is the type, monitoring method, and the effect.
Kelly, Jason. Method of sedimentation. Figure 2: Cleanroom. Viable particles are not free floating they need a carrier to float from one area to another area. Non-Viable Particles Monitoring :. Good manufacturing practices should be followed to control the particle contamination in aseptic area. Particle contamination depends upon the activity in aseptic area. If there is no activity in aseptic area then particle contamination would be low and if activity is in progress in aseptic area then particle contamination would be increased.
That's why guidelines has defined different limits for at rest and in operation conditions. This is very important tool to have great control over the aseptic area during production hours.
Below is the chart showing maximum number of permitted particles in different classes of area as per EU GMP guideline. They consist of a dark chamber, or sensor, containing a discrete laser which uses mirrors and optics to view the particle, and a pump to pull the required sample through the sensor.
The principal behind the detection and sizing of particles is simple; the vacuum pump sucks the particle through the sensor and the laser beam. At this stage it deflects the light from the laser onto mirrors which are focused onto a photo detector; this reflected light is then converted into an electrical pulse by the photo detector.
The pulses are counted and sized by the electronics within the particle counter. The bigger the particle the more light it reflects and therefore the bigger the electrical pulse converted by the photo detector. See Figure 2. The particles are sampled using a selected volume of air. Because particle counters were first developed and manufactured in the U.
However, a lot of countries developed their own standards and countries in Europe used metric volumes so the 1 cubic meter sample came about. Depending on what standard is followed, the sample is taken and the concentration of particles per volume is displayed on the screen of the particle counter. Normally the size of particle is shown with the corresponding number of particles.
This information is then recorded, printed or downloaded and the data interpreted based on the standards used. Since , ISO has been adopted as the international standard, so that all countries follow the same guidelines and use the same parameters.
This has pushed current technology. One manufacturer has responded by introducing a particle counter with a, higher than normal, flow rate of 1. See Figure 3. For continuous sampling, facility monitoring systems are usually used. These systems incorporate remote sensors situated near the point of fill or where production is taking place.
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