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Grade A–D particle limits — alert vs action for environmental monitoring samples.
Compare environmental monitoring particle counts to EU GMP Grade A–D action and alert limits — screening for QA review.
Results
Status
In spec
Count / m³
1,200
Action limit
3,520
Alert limit
2,464
Grade B @ ≥0.5 µm: 1,200 particles/m³ (sample 1 m³). Within alert and action limits for Grade B. Continue routine EM program per approved protocol.
infoCompendial planning aid. Compendial planning aid only — not a substitute for your validated SOP, pharmacopeial edition in force, regulatory submission, or qualified-person release decision. Always verify sampling tables against the official USP-NF (or applicable pharmacopeia) and your quality system before testing or batch disposition.
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Particle counts in classified areas must be compared to grade-specific limits at the correct particle size — usually normalized to per cubic meter.
Alert levels warn you early; action levels trigger formal excursion handling and often batch impact review.
This calculator supports routine EM screening. Pharma Quality Studio is where deviation narratives and trending live.
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