Environmental Monitoring for Pharmaceutical
Monitor cleanroom humidity, differential pressure, and temperature conditions in real time. Maintain continuous GMP compliance records across all controlled zones.
The Problem
Where Things Break Down
A humidity excursion in a Grade B cleanroom triggers a deviation investigation
GMP requires documented environmental control in production areas. When humidity drifts outside specification, the deviation investigation alone can cost $15,000-$50,000 before any product impact is assessed.
Pressure differential drops between zones compromise containment
Controlled areas rely on pressure cascades to prevent cross-contamination. A pressure differential that drops below specification may not trigger an alarm on the BMS, but it creates a compliance gap that regulators will find.
Environmental monitoring records have gaps that regulators flag
Data logger downloads fail, calibration records go missing, and paper logs have illegible entries. Every gap in the environmental record is a potential audit finding that requires a corrective action.
Our Approach
What Sandhed Does Differently
Sandhed connects to Shelly H&T sensors for temperature and humidity, and accepts additional environmental data from Kepware gateways and the REST Telemetry API for metrics like air pressure and particulate counts. Every reading is mapped to the sensor's physical location on your 3D floor plan. You see multi-sensor overlays showing temperature, humidity, and other parameters as color-coded zones. Thresholds are set per sensor and per metric, so each cleanroom class or controlled area has its own acceptable ranges. When conditions drift, alerts are created with automatic severity calculation and routed to the right team via email. All readings are stored in time-series format for compliance documentation.
Multi-Sensor Environmental Overlays
View temperature, humidity, and additional environmental parameters as layered color-coded overlays on your 3D floor plan. Switch between metrics to see which zones are in range and which need attention.
Zone-Specific Threshold Configuration
Set independent high and low thresholds for each sensor and each metric. A cleanroom can have humidity limits of 30-65% while an adjacent storage area has different requirements. Each zone enforces its own rules.
Severity-Based Alert Routing
Small drifts generate warnings sent to facilities teams. Readings 20% or more beyond a threshold trigger critical alerts routed to quality management. Each team member controls which severity levels they receive.
Continuous Compliance Records
Every environmental reading stored with a timestamp in time-series format. Alert lifecycle data, including creation, acknowledgment, and resolution, provides a complete audit trail. Pull records for any zone over any time period.
Expected Outcomes
Results You Can Measure
Fewer undetected environmental excursions
Reduction in missed environmental drift events
Less time spent on compliance documentation
Reduction in audit preparation hours
Alert to first response
Average time from threshold breach to action
Setup time
From floor plan to live environmental monitoring
Based on platform capabilities and industry benchmarks. Results vary by facility.
FAQ
Common Questions
Related Solutions
Temperature Monitoring
A 2-degree drift in a freezer or pasteurizer can destroy product, trigger recalls, and halt production. Sandhed maps live temperature data from Shelly sensors onto your 3D floor plan so you see every cold chain risk the moment it starts.
View SolutionCompliance & Audit Trails
Most facilities piece together audit documentation from spreadsheets, paper logs, and disconnected systems. Sandhed records every action, threshold breach, and maintenance event automatically, so your compliance evidence is ready before anyone asks for it.
View SolutionSee Your Controlled Zones on a Live Floor Plan
We will model your actual facility and show you how Sandhed monitors your specific environmental zones. No generic demo.