A Breakdown of Cleanroom Grades & Standards
Europe, Australia, and some Asian countries have a set of standards that cleanrooms used for the manufacture of sterile medicinal products should adhere to. The standards dictate that sterile products should be manufactured in clean areas with entry into the areas by personnel and materials through airlocks. Filters should efficiently clean the air passing into the area.
Still, it’s impossible to completely eliminate contamination in a cleanroom; these measures only mean it’s controlled to acceptable levels. That is done in the following ways:
Manufacturing operations are usually divided into those that are aseptically conducted and those that require the product to be sterilized. Sterile production requires certain characteristics to minimize the risk of contamination of the materials or products. For a cleanroom to meet in-operation conditions, it must first achieve specific levels of cleanliness in at-rest occupancy rates.
Cleanrooms are usually graded depending on the level of manufacturing for sterile products. The grades are as below:
The grades can be related to ISO classes. ISO classes are basically the level of cleanliness of a cleanroom based on the number of particles of a given size per cubic meter. ISO 8 is usually the base level. Cleanrooms used for sterile manufacturing processes need to achieve ISO 5 level of cleanliness. Only electronics manufacturing requires classes above ISO 5.
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