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Pharma Template Live Demo

MERIDIAN BIOSCIENCES · FILL-FINISH FACILITY · BLDG 4

Environmental Monitoring

EM RUN · ACTIVE
SUITE
BATCH
AHU 54.1°F
--:--:--
FACILITY STATE IN SPEC
11/ 12 rooms
1 excursion · Airlock AL-2
GRADE B SUITE
64.6°F
RH 42.3% · limit 35–55%
DP CASCADE
+45Pa
Core → corridor holding
PARTICLES 0.5µm
2,140/m³
ISO 7 limit 352,000 · 0.6%
AIR CHANGES
32ACH
Design ≥ 30 · AHU-2 · 74% VFD
SUITE 2 — ROOM MAP GRADE B/C/DDP CASCADE
PARTICLE COUNTS — FILL ROOM 201 · LIVE 0.5 µm5.0 µm
STABILITY CHAMBERS ICH Q1A
ACTIVE EXCURSION
AUDIT TRAIL 21 CFR PART 11
ROOM AHU-2 · HEPA H14 · 32 ACH
CONTINUOUS MONITORING — LIMITS & ACTUALS GRADE B
INSTRUMENTATION
ROOM ACTIVITY
Occupancy limit 6 · viable EM settle plates on schedule
DOOR EVENTS — TODAY
ΔP — LIVE FILL ROOM 201
VIABLE EM — LATEST RESULTS
CHAMBERS ONLINE
4/ 4
All conditions in spec
ALARM-FREE STREAK
214days
Since last temp excursion
DOOR EVENTS TODAY
1
SC2 · 41 s · within SOP
NEXT MAPPING
SC1
Requalification due 2027-03
CHAMBER VIEW ALL CHAMBERS DETAIL
PROBE CALIBRATION & MAPPING STATUS
AIR HANDLER Serves Suite 2 · 8 rooms
AHU-2 SUPPLY
54.1°F
Setpoint 54.0 · dehumid lead
SUPPLY FAN VFD
74%
Static 2.4 in.w.c. · SP 2.3
RETURN AIR
66.8°F
RH 44.6% · from Suite 2
CHW VALVE
62%
Coil ΔT 11.2°F
OA FRACTION
18%
Min OA damper · 2,400 CFM
AHU-2 AIRSIDE — SUITE 2 RUNNING
PRE-FILTERMERV 8 · 0.32 in CHW COIL62% · dT 11.2°FLAT 54.1°F SUPPLY FANVFD 74% · 18.4 kW12,400 CFM HEPA H14BANK 2A · 0.98 in62% loaded→ SUITE 2 RA + OA
SEQUENCE OF OPERATION
Dehumidification lead: CHW valve modulates to hold 54.0°F leaving-air, reheat trims space to 64.6°F. Supply fan VFD holds duct static 2.3 in.w.c. with cascade trim from Suite 2 ΔP controller. On DP-low in any Grade B/C room, EF-2 tracking bias reduces 4% and the affected room damper drives open; HEPA scan ports remain isolated. AHU-2 failure alarms route to on-call QA and facilities simultaneously per SOP-HV-021.
FILTER LOADING
AIR HANDLERS
DAMPERS & VALVES
OA-D2Outside air damper · min position18%
RA-D2Return air damper · tracking82%
CHW-V2Cooling coil valve · modulating62%
RH-V2Reheat valve · trim12%
ISO-2AHEPA bank isolation · open100%
ACTIVE
1
DP low · Airlock AL-2
CRITICAL
0
No product-impact alarms
TODAY
3
2 cleared · 1 active
MEAN TIME TO ACK
2.4min
Trailing 30 d
ALARM QUEUE 6 shown
PRIORITY ALL HIGH WARN INFO STATE ANY ACTIVE UNACKED CLEARED
TOP SOURCES — TRAILING 30 D
Doors18
DP9
RH6
Comms4
ESCALATION & ROUTING
L1Control room console + operator mobileIMMEDIATE
L2On-call QA · SMS if unacked5 MIN
L3Facilities manager · voice call
AUTOAction-limit breach drafts deviation recordENABLED
ENTRIES TODAY
47
Across 6 categories
E-SIGNATURES
12verified
0 failed verifications
CONFIG CHANGES
3
All under change control
CHAIN INTEGRITY
VALID
SHA-256 verified 02:00
CATEGORY ALL EM ALARMS CONFIG EVENTS REPORTS USER 21 CFR PART 11 · IMMUTABLE
ENVIRONMENTAL LIMITS — BY GRADE
SHOW ALL GRADES GRADE B GRADE C GRADE D UNITS
EM SAMPLING SCHEDULE
Sample Location Frequency Next
Settle plates Fill 201 · 6 positions Per session · 4 h max 11:30
Active air 1 m³ Fill 201 · 2 positions Per session 12:00
Contact plates Gowning 204 Each exit
Compressed gas Point-of-use N₂ Weekly Mon
USERS & ROLES
User Role Permissions Last Seen
rkaul QA · EM Program lead ACK + APPROVE now
jortiz EM technician SAMPLE + ACK 28 m
mchen Facilities engineer CONFIG WRITE 1 h
auditsvc Machine account
ALARM ROUTING
SMS to on-call QA
Escalate unacked HIGH after 5 min
Auto-draft deviation on action-limit
Daily EM digest email
STATION
VersionNiagara 4.13.2
HostJACE-9000 · QNX
Uptime212 d 04:18
BackupToday 02:00 · OK
Audit DBSHA-256 chained
Time syncNTP · ±12 ms
ABOUT THIS DEMO

Live demo of the lab & pharma environmental monitoring kit for Niagara N4 by Niagara UI Marketplace. Values are simulated — try acknowledging the DP alarm, closing the airlock door on the home page, and watching the cascade recover on the Trends page. The full kit ships as Px views, widgets and a station palette ready to bind to your points.