Ardmac Pharma Solutions Bi-Monthly Newsletter Sept …

What makes a cleanroom ‘clean’? A key part of a cleanroom is the air filter that is used to trap particles and enable the circulation of clean air within the room.

Personnel undertake extensive training in the protective measures that are determined for each controlled area. This may vary depending on the level of contamination permissible. This could include things like airlock entry and exit protocols, air showers and specialist personal protective equipment designed to trap contaminants that come from the body. The higher the classification of cleanroom, the more restrictions you have in place to ensure adequate control of contamination.

There are two main filter types used within a cleanroom; High Efficiency Particulate Air (HEPA) filters, which should remove particles 0.3µm in diameter and above and Ultra Low Particulate Air (ULPA) filters, which should remove particles as small as 0.1µm in diameter. Other factors that affect the cleanliness within a cleanroom are the things that are introduced into the environment. For example, process equipment or personnel. Each introduction must be carefully considered, and risk managed from a point of view of becoming a potential source of contamination.

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