Grade A / Grade B
Cleanroom classifications for sterile manufacturing — Grade A is the critical filling zone, Grade B its immediate background — defined by particle counts at rest and in operation plus microbiological limits.
The numbers
Grade A permits no more than 3,520 particles ≥ 0.5 µm per cubic metre both at rest and in operation, with microbiological action limits effectively at zero growth. Grade B holds Grade A limits at rest and relaxes in operation.
Why monitoring is continuous
Annex 1 expects continuous non-viable monitoring in Grade A for the duration of critical processing, because a classification certificate from last quarter says nothing about this batch.
Related terms
Where this applies
General Injectables, Oncology Injectables
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