One of Europe's most renowned Healthcare Packaging companies commissioned us to construct a new ISO 7 Cleanroom, alongside a fully-operational production facility in the north of Ireland.
The project had to be completed to be compliant with ISO 14644-1 Standard and involved the protection of live production facilities, which had to operate uninterrupted throughout the whole process.
ISO 14644-1 is an international standard that specifies the classification of air cleanliness in controlled environments such as cleanrooms and clean zones. It provides guidelines for determining the concentration of airborne particles of various sizes in the air.
The classification system helps define the level of cleanliness required for specific applications, ensuring that the air quality meets the necessary standards.
ISO 14644-1 defines particle size ranges and allowable particle concentrations for different cleanliness classes. These cleanliness classes are denoted by numbers, with lower numbers indicating cleaner environments.
The standard also outlines the sampling methods, counting procedures, and statistical considerations necessary for conducting particle measurements and determining the cleanliness classification.
Cleanrooms and controlled environments are used in various industries, including pharmaceuticals, electronics manufacturing, biotechnology, aerospace, and more, where even tiny airborne particles can impact product quality and safety.
It's worth noting that ISO 14644-1 is just one part of the ISO 14644 series, which consists of several standards covering different aspects of cleanrooms and controlled environments. Other parts of the series provide guidance on topics such as monitoring, test methods, and operations.
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