Aseptic is defined as being “free from contamination caused by harmful bacteria, viruses, or other microorganisms.”
In pharmaceutical industry, we see cleanrooms as an aseptic environment. Cleanrooms are carefully maintained and monitored to keep out contamination. They are also carefully calibrated to keep certain temperatures, air pressures, humidity, and more.
Aseptic environments serve an important purpose: keeping the space clean for whatever is being conducted in that room. Cleanrooms are used for research, manufacturing, and more in a number of industries. From pharmaceuticals to tech, cleanrooms are an important environment that protect the contents. When referring to it as an “aseptic environment,” we are usually referring to the medical or pharmaceutical industries, In these industries, contamination does not only pose a threat to the product, but also to the end user. That is why it is so important to monitor the rooms. Not only are we monitoring for contamination, but also to prevent contaminants from growing.
1. Nonviable Particles
Nonviable particles are non-living particulate matter. This includes dust, skin cells, clothing particles, pollen, and more. This type of contamination does not grow or spread; however, it still poses a serious threat to an aseptic environment.
1.1. Nonviable Particle Monitoring
Traditional particle monitoring automatically detects nonviable particles. Particle monitors use a technique called light scattering to detect the number and size of particles in a space. A particle passes through a laser beam, and a photodetector is used to detect the change in the light. Basically, the particle casts a shadow, and the particle counter uses that shadow to determine the size and number of particles.
2. Viable Particles
So how exactly are viable particles different from nonviable particles?
Viable particles are live microorganisms. These can include yeast, bacteria, mold, fungi, and more. Not only are these contaminants dangerous to an aseptic environment because they are general contamination, but they have the potential to grow.
2.1. Viable Particle Monitoring
Viable particles are more difficult to monitor than nonviable particles because you have to determine if they will grow. This can take extra time and effort. In addition to a particle counter, you will need to use an air sampler as air well or Micro bio.
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