Difference between viable and non viable particles – In the pharmaceutical industry, the demands for quality control and quality assurance have been driven by the aspiration to provide high-quality as well as safe products to the end-users. The standards that are designed to meet the goal are exorbitant and strictly controlled both internally and externally.
Cleanroom environments are an important section when it comes to manufacturing pharmaceutical products. Clean rooms are controlled and maintained by following proper protocols and guidelines by organizations such as the FDA and ISO.
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Quality control and quality assurance within this section have become a science in itself. The controlling and monitoring verify that the clean room is operating within the specific classifications. Let’s take a deep dive into the way the clean room environment is monitored when it comes to verifying the existence or nonexistence of both viable and non-viable particles.
What is a Viable Particle?
It is a particle that contains one or more living microorganisms. These microorganisms can affect the sterility of the pharmaceutical products. They usually range from ~0.2µm to ~30µm in size.
How to Monitor?
They can be monitored by capturing, colonizing, and counting them. There are two technologies used, including settled plates and air samplers.
Settled plates: They can be used to measure the number of microorganisms settling from the air onto a surface area over a specific time frame. These settled plates can be easily placed in positions of interest around the clean room, collected after specific hours based on the area of the surface on which they were collected to the specific time the sample was taken.
Air Samplers: They can be used to sample microorganisms in the air. The volume sampled can be defined as 1 m3 or CFU/m3.
What is a non-viable particle?
It is a particle that does not involve living microorganisms, but as transportation for viable particles.
How to monitor?
They can be monitored using particle counters that do not distinguish between viable and non-viable particles, but they are much more technically advanced as compared to air samplers. Viable and Non-viable particle counters were developed by the U.S. Military in the year 1960 for use in the aerospace industry. Later on, they were developed for use in the semiconductor and pharmaceutical industries. They include dark chamber, or sensor, that involves a discrete laser which uses mirrors as well as optics to view the particle, and a pump to pull the specific sample via the sensor.
The logic behind the detection, as well as the sizing of particles, is easy and simple. The vacuum pump pulls the particle via the sensor and the laser beam. Here, it deflects the light from the laser onto mirrors, which can be focused onto a photo detector. This reflected light is transformed into an electrical pulse by the photo detector. These pulses are counted and sized by the electronics within the particle counter. If the particle is bigger, it reflects more light; hence, the bigger the electrical pulse converted by the photo detector.
The particles can be sampled with the help of a selected volume of air. As they were first developed and manufactured in the United States, the first standards developed were magnificent, and a sample volume of 1 cubic foot become accepted globally as the standard volume, as it generally tool 1 minute to complete. There are several countries that have developed their own standards, and countries in Europe used metric volumes, so the one cubic meter samples came about. Depending on standards, the sample can be taken, and the concentration of particles per volume can be displayed on the screen of the particle counter.
