CleanRooms

Determining particle composition: consider the path to the source; Raman spectroscopy can put a name on contamination and optimize the particle-counting process. (Particle Counting).

Quick identification of contamination sources in cleanroom environments are fundamental for a clean and smooth-running production process. Conclusions regarding contamination sources are perhaps best drawn from precise information collected from the material composition of particles.

Cleanroom users can quantitatively assess particles and classify them by size using classical monitoring systems, although qualitative assessments are not usually conducted on production lines. However, knowing a particle's composition can give insight into possible faults occurring during production. With the help of an exact chemical analysis of the particle, it is possible to identify its source and thereby eliminate the contamination in the future.

There are two ways to ensure that cleanroom-produced products are free of particles: checking the air in the room and sampling the product itself for particles.

The second method is more commonly chosen, especially when parenteral drug products are being produced. In fact, checking products such as ampoules for contamination is required under the U.S. Food and Drug Administration's (FDA) current good manufacturing practices (cGMPs) to protect the consumer.

Using Raman spectroscopy, Advance Particle Systems GmbH (APSys; Berlin, Germany) has developed two methods to identify airborne particles as well as contamination in highly purified fluids. Using these methods, most compounds, that are used during clean production, can be identified. …

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