🧪

Cleanroom Monitoring System

Particle counting, environmental control, and ISO 14644 classification with production lot traceability.

Solution Overview

Particle counting, environmental control, and ISO 14644 classification with production lot traceability. This solution is part of our Environment category and can be deployed in 2-4 weeks using our proven tech stack.

Industries

This solution is particularly suited for:

Pharma Semiconductor Medical Device

The Need

Cleanroom environments are the lifeblood of pharmaceutical manufacturing, semiconductor fabrication, and medical device production. These controlled spaces prevent particle contamination that would render products non-sterile or electrically defective. Yet cleanroom management remains largely manual and reactive. Operators conduct periodic particle counts using handheld counters, recording data on clipboards that are transcribed into spreadsheets days or weeks later. Environmental parameters—temperature, humidity, pressure differentials—are monitored by separate systems with no integration. When a particle count exceeds ISO 14644 limits, the facility typically discovers this only during the next scheduled check, meaning out-of-spec products may have already been manufactured for hours or days. By then, entire production batches may be affected, triggering recalls that cascade through customer inventories.

The financial consequences are staggering. A single pharmaceutical batch recall can cost $2-10 million in lost product, remediation, and customer notification. A semiconductor fab contamination incident idling even one production line for 48 hours costs $500k-2M depending on fab size and process node. Regulatory agencies (FDA for pharma and medical devices, SEMI/ASTM standards for semiconductors) impose fines, import delays, and market access restrictions when cleanroom controls fail. Companies struggle to prove they maintained ISO classification throughout production because data is fragmented, timestamps are unreliable, and there's no audit trail connecting environmental data to specific production batches.

The root cause is lack of continuous, integrated monitoring with automatic compliance verification. Current approaches rely on sampling: taking particle counts at fixed intervals (hourly, daily, weekly) and hoping conditions remain stable between samples. This sampling approach misses transient contamination events—a brief equipment malfunction, an operator error, a loading dock door opened too long—that causes temporary particle spike and then recovers. By the time the next count is taken, the spike is gone, leaving no record. Pressure differential monitoring exists, but it's disconnected from particle counts, operating status, and production batch data. An operator wouldn't notice a pressure drop that coincides with a specific production hour without manual cross-referencing of three separate systems. Correlation between environmental excursions and product defects is nearly impossible because there's no timestamp-linked genealogy connecting environmental events to specific production batches.

Environmental data exists in isolation from manufacturing. A cleanroom loses pressure control, but the manufacturing system doesn't know when that occurred or which batches were produced during the excursion. During investigations, companies spend days manually correlating environmental logs with production records, asking questions like "Which lots were produced between 14:00-16:00 on November 15?" without a system that can answer it automatically. Compliance audits require companies to physically reconstruct this evidence, generating volumes of documentation that auditors must laboriously review.

The Idea

A Cleanroom Monitoring System transforms contamination control from reactive sampling to continuous, real-time monitoring with automatic regulatory compliance verification and production lot genealogy. The system integrates multiple environmental sensors—particle counters, temperature probes, humidity sensors, pressure differential transducers—into a single data collection platform with synchronized timestamps. Modern particle counters provide digital output via USB or Ethernet, eliminating manual transcription. The system continuously ingests this data, stores every measurement with millisecond precision, and performs real-time compliance analysis.

Particle count data flows continuously into the system. Rather than waiting for the next scheduled count, the system analyzes counts as they arrive and compares them against ISO 14644 classification thresholds. ISO 14644 defines specific particle limits by cleanliness class: Class 3 requires <35 particles ≥0.5μm per cubic meter; Class 4 requires <352 particles per cubic meter; Class 5 requires <3,520 particles per cubic meter. The system tracks cumulative particles measured, moving-average concentrations, and peak excursions. When a count exceeds the ISO limit for the declared classification, the system immediately alerts operations: "Cleanroom particle count exceeds Class 5 limit. Measured: 5,200 particles at 0.5μm. Class 5 limit: 3,520. Alert Time: 2024-11-15 14:23:07. Recommended Action: Verify equipment operation, check HVAC filter status, stop production until root cause identified."

Pressure differential monitoring runs continuously. The system tracks differential pressure across the cleanroom entry (should be inward to prevent contaminated external air from infiltrating), across different cleanroom zones if present, and across key equipment enclosures. Normal pressure differential is maintained at 0.02-0.05 inches of water column. The system alerts when differentials fall below threshold: "Cleanroom negative pressure dropping. Current: 0.015 inWC. Minimum: 0.020 inWC. HVAC system may require filter change. Production should pause until pressure restored to specification." This prevents operators from unknowingly producing material while the cleanroom is compromised.

Temperature and humidity monitoring integrates with environmental control systems. Most pharmaceutical and semiconductor processes require tightly controlled conditions: temperature ±1-2°C (e.g., 20°C ±1°C), humidity 35-65% RH. The system tracks both parameters continuously and alerts when excursions occur: "Temperature excursion detected. Current: 21.8°C. Specification: 20±1°C. Duration: 18 minutes. Affected production time: 18:00-18:18 on 2024-11-15." These temperature and humidity events are correlated with particle counts—high humidity can degrade HVAC filter performance, causing particle counts to rise—enabling operators to understand the relationship between parameters.

The critical innovation is automatic production lot traceability linking. Every production order executed in the facility is timestamped in the manufacturing system: "Production Order PO-2024-1847 ran from 14:15-15:42 on 2024-11-15 in Cleanroom Zone A." The Cleanroom Monitoring System automatically retrieves production schedules and correlates them with environmental monitoring data. When a batch is produced, the system automatically captures the environmental conditions during that exact timeframe: temperature range, humidity range, particle count trend, pressure differentials. This creates immutable genealogy: "Batch LOT-2024-11-847 (5,000 units) was produced 14:15-15:42. During manufacturing: Temperature 19.8-20.2°C (spec: 20±1). Humidity 42-48% (spec: 35-65). Particle count Class 5 maintained (peak 2,800 at 0.5μm). Pressure differential 0.034 inWC (spec: ≥0.020). Classification: Conforming. Risk Assessment: No environmental excursions detected."

If an environmental excursion occurs during production, the system automatically flags affected batches and initiates investigation workflow: "Particle count excursion detected during Batch LOT-2024-11-850 production. Peak count: 6,200 particles at 0.5μm (exceeds Class 5 limit of 3,520). Excursion duration: 8 minutes (14:51-14:59). Batch status: HOLD pending investigation. Recommended actions: (1) Investigate root cause of particle spike, (2) Determine if batch can be salvaged with rework/inspection, (3) Document investigation findings, (4) Notify quality and regulatory functions." This enables fast decision-making with full data context.

The system maintains a complete audit trail for regulatory compliance. Every measurement is immutable: timestamp, sensor ID, sensor calibration status, measurement value, quality flag. When a sensor reading seems questionable, the system automatically checks sensor calibration status: "Particle counter Serial #PC-0234 last calibrated 2024-10-15 (30 days ago). Recommended recalibration: 2024-11-15 based on age. Readings from this sensor may lack certification until recalibrated." This enables auditors to assess data reliability. For FDA inspections, the company can generate comprehensive reports: "ISO 14644 Compliance Report: January-November 2024. Particle count compliance: 99.7% of measurements within Class 5 specification. Excursions: 3 total (all during equipment maintenance windows with production paused). Temperature compliance: 100% within specification. Humidity compliance: 99.9%. Pressure differential compliance: 99.8%. All excursions documented with root cause and corrective actions."

Environmental data feeds into quality investigations. When a defective product is discovered, the quality team can instantly retrieve environmental conditions during manufacture: "Defective unit serial #MD-2024-1847-0347 from Batch LOT-2024-11-847 was manufactured 14:15-15:42 in Cleanroom Zone A. Environmental conditions during manufacture: All parameters within specification. Particle count trend stable. No environmental risk factors identified. Probable cause: Non-environmental (material defect, assembly error, or operator technique)." This eliminates environmental contamination as a cause when data proves environment was controlled, allowing investigations to focus on actual root causes.

For semiconductor fabs, the system provides real-time ISO 14644 classification verification. Semiconductor manufacturing operates in Class 1-3 cleanrooms with even tighter particle limits than pharma. The system can integrate with process monitoring systems to pause lithography equipment if particle counts drift above specification, preventing mask defects and wafer contamination. For pharmaceutical operations, the system generates 100% batch documentation automatically, eliminating manual data compilation. For medical device manufacturers, the system provides auditable evidence that manufacturing occurred in compliant environments, enabling claims about bioburden and sterility assurance levels.

How It Works

flowchart TD A["Environmental Sensors
(Particle, Temp, Humidity, Pressure)"] --> B["Edge Device
Data Collection"] B --> C["High-Frequency
Timestamped Data
Particle: 1-5 min
Temp/Humidity: 30-60 sec
Pressure: Continuous"] C --> D["Real-Time Compliance
Analysis"] D --> E{"Exceeds
ISO Limits?"} E -->|Yes| F["ALERT:
Stop Production
Notify Management"] E -->|No| G["Record Measurement
in SQLite"] F --> H["Investigation
Workflow"] H --> I["Root Cause
Analysis"] I --> J["Corrective Action
Document"] G --> K["Production Batch
Running: T1-T2"] K --> L["Auto-Capture
Environmental Data
During Batch"] L --> M["Create Batch
Genealogy"] M --> N["Environmental
Compliance Cert
Temp/Humidity/Particle
Pressure Status
Sensor Calibration"] N --> O["Batch Status:
Conforming or
Hold/Investigate"] O --> P["Archive with
Production
Records"] P --> Q["FDA/Regulatory
Audit Ready"] J --> R["Retest Environment
Resume Production"] R --> G

Continuous cleanroom monitoring system integrating particle counting, environmental control parameters, and automatic production batch genealogy to ensure ISO 14644 compliance and regulatory documentation.

The Technology

All solutions run on the IoTReady Operations Traceability Platform (OTP), designed to handle millions of data points per day with sub-second querying. The platform combines an integrated OLTP + OLAP database architecture for real-time transaction processing and powerful analytics.

Deployment options include on-premise installation, deployment on your cloud (AWS, Azure, GCP), or fully managed IoTReady-hosted solutions. All deployment models include identical enterprise features.

OTP includes built-in backup and restore, AI-powered assistance for data analysis and anomaly detection, integrated business intelligence dashboards, and spreadsheet-style data exploration. Role-based access control ensures appropriate information visibility across your organization.

Frequently Asked Questions

How does continuous cleanroom monitoring improve ISO 14644 compliance? +
Traditional sampling-based monitoring misses contamination events between scheduled checks, potentially leaving non-compliant products undetected for hours or days. Continuous monitoring analyzes particle counts in real-time against ISO 14644 classification thresholds (Class 3 requires <35 particles ≥0.5μm per cubic meter; Class 5 requires <3,520 particles per cubic meter) and immediately alerts operations when limits are exceeded. This enables instant corrective action and prevents out-of-spec production, creating an auditable compliance trail that regulatory agencies and FDA inspections require.
What is production batch genealogy and why does it matter for compliance? +
Production batch genealogy automatically captures environmental conditions (temperature, humidity, particle counts, pressure differentials, sensor calibration status) during the exact timeframe a batch was manufactured, creating immutable records that link production orders to environmental data. During FDA audits or quality investigations, companies can instantly answer 'What were the cleanroom conditions when batch LOT-2024-11-847 was produced?' without manual cross-referencing of three separate systems. This eliminates days of manual data compilation and provides auditors with immediate evidence of controlled manufacturing environments.
How can cleanroom monitoring help prevent costly product recalls? +
A single pharmaceutical batch recall costs $2-10 million in lost product and customer notification; semiconductor fab contamination can idle production for $500k-2M per 48 hours. Continuous monitoring detects particle spikes, pressure differential drops, and temperature excursions immediately rather than during the next scheduled count, enabling production to pause before affected batches complete. Automatic batch genealogy also helps investigations determine whether environmental conditions caused a defect, eliminating environmental contamination as a cause when data proves the environment was controlled, allowing root cause analysis to focus on actual failure mechanisms.
Can cleanroom monitoring work with legacy equipment and sensors? +
Yes. The system supports both modern networked sensors (particle counters with Ethernet output, digital pressure transducers) and existing analog sensors (4-20mA current loops, pneumatic signals) through analog-to-digital conversion modules. This enables retrofitting existing facilities without requiring sensor replacement, making the system practical for manufacturers with established cleanroom infrastructure. Edge device buffering also handles brief network interruptions, ensuring data collection continues even if connectivity is temporarily lost.
How does temperature and humidity monitoring integrate with particle count analysis? +
The system continuously monitors temperature (typically ±1-2°C specification) and humidity (typically 35-65% RH specification) while correlating these parameters with particle count trends in real-time. High humidity can degrade HVAC filter performance, causing particle counts to rise; understanding this relationship helps operators identify whether particle excursions are caused by HVAC filter degradation or other factors. When environmental excursions occur, the system automatically flags affected batches and initiates investigation workflows, enabling data-driven decisions about product disposition.
What happens when a cleanroom exceeds particle count limits during production? +
The system immediately alerts operations with the specific limit exceeded (e.g., 'Cleanroom particle count exceeds Class 5 limit. Measured: 5,200 particles at 0.5μm. Class 5 limit: 3,520') and automatically holds the affected production batch pending investigation. Operations and quality teams receive the alert, recommended actions (verify equipment operation, check HVAC filter status, stop production until root cause identified), and the system initiates a formal investigation workflow including root cause analysis and corrective action documentation. This automated process replaces manual investigation and provides the documentation FDA and regulatory audits require.
How does the system help during regulatory audits and FDA inspections? +
The system maintains complete immutable audit trails with timestamps, sensor IDs, calibration status, measurement values, and quality flags. During FDA audits, companies can generate comprehensive compliance reports showing 'ISO 14644 Compliance Report: January-November 2024. Particle count compliance: 99.7% of measurements within Class 5 specification. Excursions: 3 total (all during equipment maintenance windows with production paused).' The system automatically checks sensor calibration status to assess data reliability, and batch genealogy documentation proves environmental conditions during manufacture, eliminating the days of manual evidence compilation traditional approaches require.

Deployment Model

Rapid Implementation

2-4 week implementation with our proven tech stack. Get up and running quickly with minimal disruption.

Your Infrastructure

Deploy on your servers with Docker containers. You own all your data with perpetual license - no vendor lock-in.

Related Solutions

🌡️

Environmental Monitoring Dashboard

Real-time temperature, humidity, and pressure monitoring with automated alerting and compliance documentation.
💧

Humidity Control Verification

Real-time humidity monitoring with out-of-range alerts. Correlate humidity excursions with product defect patterns.
💨

Pressure Differential Monitoring

Monitor pressure differentials across controlled areas with alerts for compliance drift. Ensure cleanroom classification maintained.

Related Articles

GMP Documentation Requirements Guide

Read Article →
View All Articles

Ready to Get Started?

Let's discuss how Cleanroom Monitoring System can transform your operations.

Schedule a Demo