✓Real-time Connectors: OPC-UA, MQTT, REST API, Modbus TCP
✓Trend Analysis: 90-day
✓Alerts: Email, SMS, WhatsApp, Teams
✓Multi-site Aggregation
📈 Real-time Chart
metric:sterilization_temperature
unit:°C
timeframe:real-time
chart type:line
min threshold:121
max threshold:135
target:134
update interval ms:5000
data source:OPC-UA
topic:sterilization/autoclave/temperature
📈 Real-time Chart
metric:sterilization_pressure
unit:bar
timeframe:real-time
chart type:line
min threshold:1
max threshold:2.5
target:2.1
update interval ms:5000
data source:OPC-UA
topic:sterilization/autoclave/pressure
📊 KPI Card
metric:sterilization_log_reduction
label:Log Reduction (LRV)
format:decimal_1
target:12
critical low:6
description:Minimum 12 LRV for sterile products per EU GMP Annex 1
📊 KPI Card
metric:d_value
label:D-Value (min)
format:decimal_2
target:1
range:[0.5,2]
description:Time to achieve 90% reduction of biological indicator
📊 KPI Card
metric:f0_value
label:F₀ Value (min)
format:decimal_1
target:15
critical low:8
description:Lethality equivalent at 121°C — minimum F₀ ≥ 8 min
📉 Trend Analysis
metrics:["sterilization_temperature","sterilization_pressure","f0_value"]
periods:[7,30,90]
chart type:multi_line
show control limits:true
show cppk:true
export format:["pdf","csv","xlsx"]
📋 Data Table
title:Sterilization Batches
columns:[{"key":"batch_id","label":"Batch ID","sortable":true},{"key":"product","label":"Product","sortable":true},{"key":"start_time","label":"Start Time","sortable":true,"type":"datetime"},{"key":"duration","label":"Duration (min)","sortable":true,"type":"number"},{"key":"max_temp","label":"Max Temp (°C)","sortable":true,"type":"number"},{"key":"f0","label":"F₀ (min)","sortable":true,"type":"number"},{"key":"lrv","label":"LRV","sortable":true,"type":"number"},{"key":"status","label":"Status","type":"badge","badges":{"pass":"green","fail":"red","pending":"yellow"}},{"key":"operator","label":"Operator"}]
sort by:start_time
sort order:desc
filters:["product","status","date_range"]
pagination:25
📄 Compliance Report
standards:["EU GMP Annex 1","FDA 21 CFR Part 211"]
report types:["batch_record","trend_analysis","deviation_summary","audit_trail"]
frequency:per_batch
auto generate:true
pdf template:pharma_sterilization_compliance
include signature block:true
retention days:365
🔔 Alert Engine
rules:[{"name":"Temperature Below Minimum","metric":"sterilization_temperature","condition":"below","threshold":121,"severity":"critical","message":"Autoclave temperature dropped below 121°C — batch may be compromised","channels":["email","sms","whatsapp"],"escalate_after_min":5},{"name":"F₀ Below Critical","metric":"f0_value","condition":"below","threshold":8,"severity":"critical","message":"F₀ lethality value below 8 min — sterilization cycle incomplete","channels":["email","sms","whatsapp"]},{"name":"LRV Below Target","metric":"sterilization_log_reduction","condition":"below","threshold":12,"severity":"warning","message":"Log reduction value below target — investigate biological indicator","channels":["email","whatsapp"]},{"name":"Cycle Deviation","metric":"sterilization_pressure","condition":"outside_range","range":[1.5,2.5],"severity":"warning","message":"Pressure deviation detected — cycle parameters out of specification","channels":["email"]}]
channels:{"email":{"enabled":true,"recipients":["qa_manager","production_manager"]},"sms":{"enabled":true,"recipients":["qa_manager"]},"whatsapp":{"enabled":true,"group":"sterilization_alerts"}}
🏭 Site Aggregator
max sites:3
metrics:["batch_pass_rate","avg_f0","avg_cycle_time","deviation_count"]
comparison mode:side_by_side
ranking metric:batch_pass_rate
Compliance Standards
EU GMP Annex 1 (2022 revision)FDA 21 CFR Part 211ISO 11607 (Packaging)WHO TRS 961 Annex 6
Supported Data Connectors
OPC-UA
● Connected
MQTT
● Connected
REST API
● Connected
Modbus TCP
● Connected