Case Study

AI-Powered Smoke Study Validation Platform for Pharmaceutical Cleanrooms

Automating smoke study analysis using Computer Vision, AI, and cloud-native technologies to improve validation efficiency, operational visibility, and digital traceability.

Industry
Pharmaceutical Manufacturing
Solution Type
Enterprise SaaS Platform
Technologies
AI · Computer Vision · AWS
Deployment
Cloud Native

The Challenge

Traditional smoke study validation relies on manual video review, making the process time-intensive, subjective, and difficult to scale.

  • Extensive manual video review and high operational effort
  • Inconsistent interpretation of airflow behavior
  • Delayed validation reporting and compliance readiness
  • Fragmented evidence collection and audit challenges
  • Difficulty in detecting short-duration airflow disruptions
  • Scalability limitations across multiple facilities

Business Objectives

Reduce Manual Effort

Improve Validation Accuracy

Accelerate Validation Cycle

Strengthen Audit Readiness

Centralize Evidence

Enable Scalable Multi-Facility Deployment

Our AI-Powered Solution

An intelligent platform that automates the entire smoke study validation lifecycle — from secure video ingestion to AI-driven airflow analysis and audit-ready evidence.

  1. Smoke Study Video
  2. AI Video Processing
  3. Airflow Analysis
  4. Anomaly Detection
  5. Dashboards & Alerts
  6. Audit-Ready Evidence

AI-driven accuracy

Advanced models analyze every frame for precise, repeatable results.

Real-time alerts

Anomalies surface instantly with timestamped visual evidence.

Audit-ready

Structured records and evidence for complete traceability.

Enterprise-grade

Secure, scalable, and built for regulated environments.

AI Processing Workflow

1Upload Video
2Video Preprocessing
3Smoke Segmentation
4Optical Flow Analysis
5Airflow Validation
6AI Anomaly Detection
7Timestamped Alerts
8Dashboard Visualization
9Audit Repository

Solution Architecture

A cloud-native architecture on AWS, engineered for secure video processing, scalable AI inference, and end-to-end observability.

Experience Layer

  • Next.js Frontend
  • Web Application
  • Interactive Dashboards

API & Security

  • API Gateway
  • NestJS Backend
  • Microsoft Entra ID Authentication

Processing Layer

  • AWS Lambda
  • Amazon ECS
  • Event-Driven Pipelines

AI / ML Layer

  • AWS SageMaker
  • Computer Vision Models
  • Optical Flow Engines

Data & Messaging

  • Amazon S3 Storage
  • PostgreSQL Database
  • Amazon SNS · EventBridge

Monitoring & Delivery

  • Amazon CloudWatch
  • AWS CodePipeline · CodeBuild
  • GitHub CI/CD

Technology Stack

Frontend
Next.js
Backend
NestJS
AI / ML · Computer Vision
AWS SageMaker
Storage
Amazon S3
Database
PostgreSQL
Processing
AWS Lambda
Processing
Amazon ECS
Messaging
Amazon SNS
Messaging
Amazon EventBridge
Authentication
Microsoft Entra ID
Security
AWS IAM · KMS · TLS Encryption
Monitoring
Amazon CloudWatch
CI / CD
AWS CodePipeline
CI / CD
AWS CodeBuild
CI / CD
GitHub

Core Features

AI Smoke Detection

Airflow Behavior Analysis

Optical Flow Tracking

Anomaly Detection & Classification

Real-Time Alerting

Timestamped Evidence

Image-to-Alert Mapping

Interactive Dashboard

Audit Logging & Traceability

Secure User Access (SSO)

Business Benefits

  • Up to 70% reduction in manual review effort

  • Faster validation and reporting

  • Improved accuracy and consistency

  • Complete audit readiness

  • Centralized visibility across facilities and teams

  • Scalable and future-ready AI platform

Security & Compliance

  • End-to-End Encryption (TLS)
  • Role-Based Access Control
  • Microsoft Entra ID SSO
  • Audit Logs & Traceability
  • Secure Cloud — AWS Security Best Practices

Future-Ready Platform

  • Predictive Analytics
  • Multi-Facility Monitoring
  • Integration with Digital Systems

Ready to transform your validation workflows?

Let's build an intelligent, scalable, and AI-powered solution tailored to your needs.