Cleanroom & Environmental Monitoring (EM)
ISO 14644-1 Classification • EU GMP Annex 1 Viable/Non-Viable Telemetry • Positive Pressure AirlocksCleanroom Suites
4 Zones Qualified
Grade A
Grade B
Grade C
Grade D
Sampling Grid
18 Points
3 logged today •
100% scheduled coverage
Compliance Rate
100%
ISO 14644-1 Cleanliness Standard
Active Excursions
0 Action
Alert Level: 0 Excursions
GRADEA
Qualified
CR-ISO5-LAF01
Grade A Aseptic Laminar Flow Station LAF-01
ΔP Differential:
+22.5 Pa
Air Changes:
60 ACH
HVAC Climate:
20.2°C • 42.1%RH
Sampling Points:
4 Points
GRADEB
Qualified
CR-ISO7-STE01
Grade B Cleanroom Background Suite 101
ΔP Differential:
+16.2 Pa
Air Changes:
45 ACH
HVAC Climate:
20.6°C • 44.5%RH
Sampling Points:
6 Points
GRADEC
Qualified
CR-ISO8-PREP02
Grade C Formulation & Prep Hall 102
ΔP Differential:
+11.8 Pa
Air Changes:
30 ACH
HVAC Climate:
21.0°C • 46.8%RH
Sampling Points:
5 Points
GRADED
Qualified
CR-AIRL-WASH03
Grade D Material Air-Lock & Component Wash
ΔP Differential:
+6.4 Pa
Air Changes:
20 ACH
HVAC Climate:
21.5°C • 48.2%RH
Sampling Points:
3 Points
EU GMP Annex 1:2022 & ISO 14644-1 Airborne Particle & Viable Limits
Regulatory Baseline| Cleanroom Grade | At Rest Non-Viable Particles/m³ | In Operation Non-Viable Particles/m³ | Viable Microorganism Limits (In Operation) | ||||
|---|---|---|---|---|---|---|---|
| ≥ 0.5 μm | ≥ 5.0 μm | ≥ 0.5 μm | ≥ 5.0 μm | Air Sample (CFU/m³) | Settle Plate 90mm (CFU/4h) | Contact Plate 55mm (CFU/plate) | |
| Grade A (ISO 4.8 / 5) | 3,520 | 29 | 3,520 | 29 | < 1 | < 1 | < 1 |
| Grade B (ISO 7 in op) | 3,520 | 29 | 352,000 | 2,900 | 10 | 5 | 5 |
| Grade C (ISO 8 in op) | 352,000 | 2,900 | 3,520,000 | 29,000 | 100 | 50 | 25 |
| Grade D (ISO 8 at rest) | 3,520,000 | 29,000 | Not predetermined | Not predetermined | 200 | 100 | 50 |
Environmental Monitoring Sampling Records & Excursion Log
3 Records Logged| Sample # | Timestamp | Zone & Grade | Sampling Point | Sample Type | 0.5 μm / m³ | 5.0 μm / m³ | CFU | ΔP | Status & Evaluation |
|---|---|---|---|---|---|---|---|---|---|
| EM-2026-0083 | 2026-11-13 08:23 | CR-ISO7-STE01 GradeB |
SP-B01
Personnel Gowning Entry Threshold
|
ActiveAirSamplerViable | - | - | 3 CFU | - |
COMPLIANT
3 CFU/m3 detected (Within Grade B operational action limit 10 CFU/m3).
|
| EM-2026-0082 | 2026-11-13 07:23 | CR-ISO5-LAF01 GradeA |
SP-A02
Aseptic Fill Needles Work Surface
|
PassiveSettlePlate | - | - | 0 CFU | - |
COMPLIANT
0 CFU detected over 4 hours (Meets Grade A limit <1 CFU).
|
| EM-2026-0081 | 2026-11-13 06:23 | CR-ISO5-LAF01 GradeA |
SP-A01
LAF HEPA Diffuser Face Center
|
NonViableAirParticle | 420 | 2 | - | +22.5 Pa |
COMPLIANT
Within EU GMP Annex 1 Grade A limits (0.5um: 420 vs 3520 max; 5.0um: 2 vs 29 max).
|