Lab glossary
Grade A (cleanroom)
The cleanest zone in the EU GMP Annex 1 grading system, used for high-risk aseptic operations. Particles ≥0.5 µm are limited to 3,520 per m³ and no viable microorganisms are expected.
- Also: Grade A
- Also: ISO 5
- Also: critical zone
Where you will meet this term
- InstrumentLaminar air flow unit (LAF)
- InstrumentMicrobial air sampler (active air sampler)
- InstrumentAirborne particle counter
- InstrumentMembrane filtration unit
- Test methodEnvironmental Monitoring of Clean Areas (Viable)
- CalibrationLAF: HEPA filter integrity
- CalibrationLAF: Non-viable particle count
- CalibrationParticle counter: Flow rate and sizing calibration