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To adhere to strict sanitation standards involved with medical device production, there are specific ISO standards organizations must meet. Most medical devices are produced using ISO standards 5-8 for cleanroom manufacturing and assembly. Here are their main differences.
This cleanroom must have less than 3,520 particles >0.5 micron per cubic meter and 250-300 HEPA filtered air changes per hour. This is commonly used for safely filling pharmaceutical capsules and producing various medications. It is also utilized for medical devices requiring highly sterile production conditions.
Slightly less strict than ISO 5 cleanroom, this room must have less than 35,200 particles >0.5 micron per cubic meter and 180 HEPA filtered air changes per hour. This is another common standard used in highly sensitive medical device production and pharmaceutical compounding.
One of the most common classifications for medical device production, ISO 7 cleanrooms must have less than 352,000 particles >0.5 micron per cubic meter and 60HEPA filtered air changes per hour. It is also a common standard for pharmaceuticals and medical device packaging.
Commonly used for medical devices produced through the extrusion or injection molding process, this clean room must have less than 35,200,000 particles >0.5 micron per cubic meter and 20 HEPA filtered air changes per hour.
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