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Our Rigorous Five-Phase Validation Process
We follow a systematic, phased methodology that ensures thorough validation whilst minimising disruption to your operations across all industries. Our approach has been refined through of successful cleanroom qualifications, incorporating best practices from pharmaceutical GMP, semiconductor SEMI standards, medical device ISO 13485, food safety FSSC 22000, and aerospace & defence industry requirements.
Each phase builds upon the previous, creating a comprehensive validation package that demonstrates your cleanroom performs reliably under all operational scenarios whilst meeting regulatory requirements for your specific industry sector.
Phase 1: Assessment & Planning
Industry-Specific User
Requirement Specifications
We begin with a detailed facility assessment, reviewing architectural drawings, HVAC specifications, and operational requirements specific to your industry. Understanding your manufacturing processes, product requirements, and regulatory environment guides protocol development.
Validation Master Plan Development
Our team develops customised validation master plans and risk-based testing protocols aligned with your cleanroom classification and manufacturing processes. The plan defines acceptance criteria, testing methodologies, and documentation requirements.
Regulatory Alignment
We ensure all protocols align with applicable regulatory standards including FDA, EMA, SEMI, FSSC 22000, ISO 13485,
and aerospace specifications relevant to your industry and target markets.
Phase 2: Installation Qualification (IQ)
Multi-Industry Standards Compliance
Documentation review confirms that cleanroom components are installed per industry specifications. We verify equipment calibration certificates, utility connections, control system configuration, and construction materials for pharmaceutical GMP, semiconductor SEMI standards, food safety requirements, and aerospace specifications.
Comprehensive IQ documentation includes equipment specifications, calibration records, construction material certificates, P&ID verification, and as-built drawings. This phase establishes the foundation for subsequent operational and performance qualification testing.
Phase 3: Operational Qualification (OQ)
Electronics Industry OQ
ESD monitoring protocols, vibration control verification, sub-micron particle tracking, temperature precision testing (±0.1°C), and humidity control validation (±1% RH)
Pharmaceutical OQ
Viable particle monitoring, cleaning validation protocols, sterility testing procedures, media fills, and environmental monitoring system qualification
Food Industry OQ
Allergen control verification, sanitary design assessment, CIP/SIP validation, microbial monitoring, and HACCP critical control point validation
Aerospace & Defence OQ
Outgassing testing protocols, thermal cycling validation, materials compatibility verification, and contamination
molecular analysis
Phase 4: Performance Qualification (PQ)
Real-World Manufacturing Validation
Performance qualification demonstrates sustained cleanroom performance under actual production conditions across different manufacturing processes and industry requirements. Testing occurs over extended periods (typically 2-4 weeks) to capture normal operational variations.
PQ protocols include worst-case scenario testing, maximum occupancy studies, shift-to-shift variability assessment, and process simulation under representative conditions. This phase proves your cleanroom maintains specified parameters during actual manufacturing operations.
Phase 4: Performance Qualification (PQ)
Data Compilation
All testing data, deviations, corrective actions, and acceptance criteria results are compiled into comprehensive validation reports
Quality Review
Multi-level review ensures all documentation meets regulatory requirements and industry standards for your specific sector
Certification Delivery
Final validation reports with industry- specific compliance statements support regulatory submissions and customer audits
Testing Methods Used During Validation
Our core testing methods include:
HEPA/ULPA Filter Integrity Testing – Detects leaks and verifies filter performance to meet ISO 14644 standards.
Airflow & Velocity Verification – Uses advanced smoke studies and anemometry to confirm uniform airflow and pressure balance.
Environmental Monitoring – Measures temperature, humidity, particle count, and differential pressure for complete compliance assurance.
Each test is performed using calibrated equipment and documented for audit readiness, ensuring your cleanroom maintains the highest compliance and performance levels.
Ready to Validate Your Cleanroom?
Partner with NCT Multi-Industry Cleanroom Validation Experts
Whether you're commissioning a new semiconductor fab, pharmaceutical facility, medical device cleanroom, battery manufacturing plant, food processing facility, or aerospace production area, Nordic Clean Tech delivers the validation expertise you need for success.
Our team is ready to discuss your cleanroom validation requirements across any industry and develop a customised approach that ensures regulatory compliance, operational excellence, and manufacturing confidence.