Cleanroom Industries We Serve
Comprehensive cleanroom validation and testing across all critical manufacturing sectors, from pharmaceuticals to aerospace.
GMP Annex 1 Compliance & Sterile Production
Pharmaceutical cleanrooms require stringent GMP validation to ensure patient safety and regulatory compliance. Nordic Clean Tech provides comprehensive validation services aligned with global pharmaceutical standards, including FDA 21 CFR Part 211, EU GMP Annex 1, ICH Q7, and WHO guidelines.
Our pharmaceutical validation expertise covers sterile drug manufacturing (injectable products, ophthalmic preparations, inhalation products), biotechnology facilities (cell culture, fermentation, biologics manufacturing), hospital pharmacy cleanrooms (cytotoxic preparation, sterile compounding), API manufacturing, and clinical manufacturing for trials.
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GMP Grade Classifications
Grade A: ISO Class 5
Aseptic filling and high-risk operations requiring maximum environmental control with continuous particle monitoring
Grade B: ISO Class 5-7
Background areas for sterile preparation with appropriate particle limits for at-rest and in-operation conditions
Grade C: ISO Class 7
Less critical pharmaceutical processes including formulation, filling preparation, and equipment cleaning areas
Grade D: ISO Class 8
General pharmaceutical production areas with lower cleanliness requirements but controlled environments
High-Tech Electronics & Semiconductor Validation
Ultra-High Purity Manufacturing ISO Class 1-5
The semiconductor industry demands the most stringent cleanroom conditions, where a single particle can render expensive wafers useless. Our expertise covers semiconductor fabrication facilities, MEMS and microsystems manufacturing, photonics and optics production, and nanotechnology applications.
Critical Requirements
• ISO Class 1-3: ≤10 particles/m³ (≥0.1μm) for advanced chip
manufacturing
• Temperature control: ±0.1°C precision for lithography processesHumidity control: ±1% • RH for static discharge prevention
• ESD protection: ≤100V static discharge limits
• Vibration control: ≤1μm movement for precision equipment
Medical Device Manufacturing Validation
ISO 13485 Compliant Validation
Medical device manufacturing requires risk-based cleanroom approaches aligned with device classification and patient contact levels. Our validation services ensure compliance with ISO 13485, FDA 21 CFR Part 820, and EU Medical Device Regulation (MDR 2017/745) standards.
We specialise in validating environments for implantable devices (cardiovascular implants, orthopaedic devices, neurostimulators), diagnostic equipment (in-vitro diagnostic devices, laboratory analysers), surgical instruments (precision cleaning, sterile packaging), and combination products (drug-device combinations, biologic-device combinations).
Advanced Battery Manufacturing Validation
0.3g
Moisture Level
Water per kilogramme of air maintained at dew point -35°C to -60°C for lithium-ion battery manufacturing
0.5°C
Temperature Control
Precision environmental control ensures chemical stability throughout electrode manufacturing and cell assembly processes
6-8
Audit-Ready Documentation
Two decades dedicated exclusively to cleanroom validation across pharmaceutical, electronics, medical device, food, aerospace, and emerging industries
Food Industry Cleanroom Validation
FDA cGMP & FSSC 22000 Compliance
Food processing cleanrooms ensure product safety and extend shelf life without preservatives, meeting FDA cGMP regulations under 21 CFR Part 110 and FSSC 22000 standards. Our validation services cover sterile packaging operations, functional foods and nutraceuticals production, allergen control zones, and clean label product manufacturing.
Validation protocols address microbial contamination control, allergen cross-contamination prevention, cleaning validation (CIP/SIP systems), environmental monitoring for pathogens, and HACCP critical control point verification. Documentation supports BRC, SQF, and GFSI certification requirements.
Cannabis Cleanroom Validation
FDA cGMP & FSSC 22000 Compliance
Cannabis processing cleanrooms ensure product safety and extend shelf life without preservatives, meeting FDA cGMP regulations under 21 CFR Part 110 and FSSC 22000 standards. Our validation services cover sterile packaging operations, functional foods and nutraceuticals production, allergen control zones, and clean label product manufacturing.
Validation protocols address microbial contamination control, allergen cross-contamination prevention, cleaning validation (CIP/SIP systems), environmental monitoring for pathogens, and HACCP critical control point verification. Documentation supports BRC, SQF, and GFSI certification requirements.
Aerospace & Space Industries Validation
Critical Component Manufacturing
Space industry applications require specialised cleanroom validation for mission-critical components where failure is not an option. Our stringent protocols cover satellite component assembly and testing, spacecraft integration facilities, optical systems manufacturing, and propulsion component production.
Aerospace validation addresses unique requirements including molecular contamination control, outgassing prevention for space environments, materials compatibility testing, thermal cycling validation (-180°C to +150°C), and electrostatic discharge protection. Contamination control must meet NASA cleanliness levels and European Cooperation for Space Standardization (ECSS) requirements.