Precision Medical Component
See exactly what the Cleanroom Risk Engine delivers. This example shows a complete risk assessment for a medical device component with strict contamination requirements.
Input parameters
Product specifications
| Product | Medical implant housing |
| Product area | 25 cm² |
| Exposure time | 30 minutes |
| Critical particle size | ≥ 5 µm |
| Max acceptable particles | 3 |
Monitoring setup
| Sensor | APMON II |
| Sample time | 4 minutes |
| Sample area | 50 cm² |
| Industry | Medical devices |
Analysis results
Overall contamination risk
HighHigh contamination risk. Immediate attention needed for cleanroom improvement.
Required ISO class
ISO 0
Recommended local air cleanlinessPDRL
0
Le (events)APMON II Alarm Limit
0 events
Per 4-minute sample (50 cm²)Detailed calculation results
| Parameter | Value | Description |
|---|---|---|
| PDR (particle deposition rate) | 2400 particles/m²/h | Maximum allowable deposition rate for ≥ 5 µm |
| PDRL (limit value) | 1200 | Normalized deposition rate limit |
| ISO class | ISO 5.0 | Required local air cleanliness classification |
| Sensor alarm limit | 1 events | Maximum events per APMON II sample period |
| R5 value | 2400 | Intermediate calculation for ISO class derivation |
| C5 concentration | 80 particles/m³ | Equivalent airborne concentration at 5 µm |
Recommendations
- Reduce exposure time to reduce particle deposition rate limit
- Improve Operational Control Programme's to decrease particle deposition rate:
- Improve cleaning program (method, execution, frequency)
- Optimize gowning and entree programme (garment selection, changing procedure)
- Enhance transfer of goods program
- Strengthen personnel training
- Review air handling and circulation system (air change rate and ventilation efficiency)
Run your own simulation
Get the same detailed analysis for your specific product. Enter your parameters and receive validated risk scores and recommended cleanroom requirements.