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Pharma Template Live Demo
MERIDIAN BIOSCIENCES · FILL-FINISH FACILITY · BLDG 4
Environmental Monitoring
EM RUN · ACTIVE
BATCH LN-26-0847
AHU-2 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
FILL ROOM 201GRADE BISO 7IN SPEC
AHU-2 · HEPA H14 · 32 ACH
CONTINUOUS MONITORING — LIMITS & ACTUALS
| Parameter | Current | 24h Min / Max | Alert Band | Action Limit | Status |
|---|---|---|---|---|---|
| Temperature | 64.6°F | 63.9 / 65.3 | 62.6–68.0 | 60.8–69.8 | SPEC |
| Relative humidity | 42.3% | 40.8 / 44.1 | 35–55 | 30–60 | SPEC |
| Differential pressure | +45 Pa | +42 / +47 | ≥ +35 | ≥ +30 | SPEC |
| Particles 0.5µm | 2,140 /m³ | 1,820 / 2,960 | ≤ 200k | ≤ 352k | SPEC |
| Particles 5.0µm | 218 /m³ | 180 / 340 | ≤ 1,800 | ≤ 2,930 | SPEC |
| Air changes | 32 ACH | 31 / 33 | ≥ 30 | ≥ 28 | SPEC |
INSTRUMENTATION
| Probe | Type | Reading | Cal Due | Status |
|---|---|---|---|---|
| P-201-T1 | RTD · temperature | 64.6°F | 128 d | OK |
| P-201-RH1 | Capacitive · humidity | 42.3% | 128 d | OK |
| P-201-DP1 | ΔP vs corridor | +45 Pa | 64 d | OK |
| PC-201-A | Particle counter · 28.3 L/min | 2,140 /m³ | 201 d | OK |
| PC-201-B | Particle counter · redundant | 2,205 /m³ | 201 d | STANDBY |
ROOM ACTIVITY
Occupancy limit 6 · viable EM settle plates on schedule
DOOR EVENTS — TODAY
ΔP — LIVE
VIABLE EM — LATEST RESULTS
| Sample | Position | CFU | Limit | |
|---|---|---|---|---|
| S-201-13 | Filling point L | 0 | ≤ 5 | PASS |
| A-201-05 | Active air · 1 m³ | 1 | ≤ 10 | PASS |
| C-204-08 | Gown contact | 2 | ≤ 5 | PASS |
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
PROBE CALIBRATION & MAPPING STATUS
| Chamber | Probe | Type | Last Cal | Due | Mapping | Status |
|---|---|---|---|---|---|---|
| SC1 | T-SC1-01 / RH-SC1-01 | RTD · capacitive | 2026-04-02 | 128 d | 2026-03 · 9 pt | CURRENT |
| SC2 | T-SC2-01 / RH-SC2-01 | RTD · capacitive | 2026-05-14 | 170 d | 2026-05 · 9 pt | CURRENT |
| SC3 | T-SC3-01 / RH-SC3-01 | RTD · capacitive | 2026-05-14 | 170 d | 2026-05 · 9 pt | CURRENT |
| CLD | T-CLD-01 / T-CLD-02 | Dual RTD · redundant | 2026-06-30 | 216 d | 2026-06 · 12 pt | CURRENT |
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
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
| Filter | ΔP | Loaded | Change |
|---|---|---|---|
| PRE-2A · MERV 8 | 0.32 in | 41% | ~ 84 d |
| HEPA-2A · H14 | 0.98 in | 62% | ~ 210 d |
| HEPA-2B · H14 | 1.02 in | 65% | ~ 195 d |
AIR HANDLERS
AHU-1Suite 1 · supply 54.3°F · VFD 68%RUN
AHU-2Suite 2 · supply 54.1°F · VFD 74%RUN
AHU-3Warehouse · setback scheduleSTANDBY
EF-2Suite 2 exhaust · tracking 92%RUN
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
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 call15 MIN
AUTOAction-limit breach drafts deviation recordENABLED
FILL ROOM 201AIRLOCK AL-2
TEMPERATURE / RH — FILL 201°F% RH
DIFFERENTIAL PRESSURE CASCADE201202AL-2
PARTICLES 0.5µm — FILL 201COUNT /m³
TEMP 24H BAND
63.9– 65.3°F
Held inside alert band
RH 24H BAND
40.8– 44.1%
No dehumid overshoot
ΔP MINIMUM
+9Pa · AL-2
10:28 door-held event
PARTICLE PEAK
2,960/m³
0.8% of ISO 7 limit
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
ALLEM
ALARMS
CONFIG
21 CFR PART 11 · RECORDS IMMUTABLE
ENVIRONMENTAL LIMITS — BY GRADE
| Grade | Temp Band | RH Band | ΔP Min | 0.5µm Limit | ACH Min |
|---|---|---|---|---|---|
| GRADE B | 62.6–68.0°F | 35–55% | +35 Pa | 352,000 | 30 |
| GRADE C | 62.6–69.8°F | 35–60% | +20 Pa | 3,520,000 | 20 |
| GRADE D | 62.6–71.6°F | 30–65% | +10 Pa | — | 12 |
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 | READ ONLY | — |
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.