Cleanroom Particle Count and Microbial Sample (FDA Table)
Cleanest ISO class a 0.5 µm particle count meets in FDA's aseptic processing table (ISO 5 to 8).
Open the tool → Runs in your browser. Data leaves only if you deliberately send a problem report from the interactive tool.
Example
- Particle count unit
- Particles per m³
- Particle count at 0.5 µm and larger
- 2900
- Intended ISO class of the area
- ISO 5 (Class 100)
- Active air sample
- 0 cfu/m³
Result: The particle count meets ISO 5 (Class 100), within the intended ISO 5 (Class 100); active air under the action level.
The tool opens with these values already filled in. Replace them with your own.
What you enter
- Particle count unit: per cubic meter (m3) or per cubic foot (ft3)
- Particle count at 0.5 µm and larger
- Intended ISO class of the area: 5, 6, 7 or 8 (needed for a microbial sample)
- Active air sample (optional)
- 90 mm settling plate, cfu per 4 hours (optional)
How this is calculated
Citation
FDA, Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing, Current Good Manufacturing Practice (September 2004), Table 1: ISO 5 to 8 particle limits and recommended microbial action levels. Read the source ↗
A reference and educational tool. Not medical, legal, or financial advice, and not a substitute for clinician judgment.