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Certified Third-Party Testing

Cleanroom &
HVAC Services
You Can Trust

Pioneer in third-party cleanroom validation and HVAC compliance. We certify, test, and commission controlled environments across Greece and Europe.

15+
Years Experience
ISO
14644 Certified
GMP
EU Compliant
Our Latest News

News & Updates

ISO 14644
2015

ISO 14644 Standard Update — Part 1 and Part 2

ISO 14644 Part 1 and Part 2 have been revised as new Final Draft International Standards. The updates cover classification of air cleanliness by particle concentration and monitoring to provide evidence of cleanroom performance.

Airflow Visualization
Video

A Sample Video of Airflow Visualization Test

Clevair presents you a sample video of Airflow Visualization Test from various projects in cleanrooms… Enjoy!!!

Gallery

Project Gallery

Air Velocity
HEPA Test
Particle Count
Smoke Test
Air Volumes
Recovery Test
Clean Bench
Ductwork
About Clevair

Who We Are

Pioneer in the field of third-party cleanroom validation services, serving pharmaceutical, biotech and industrial clients across Europe.

Our Company

Clevair is a pioneer in the field of third-party cleanroom validation services. We are an independent company focused on providing high-quality testing, certification, and compliance services for cleanrooms and controlled environments.

Our team consists of highly qualified engineers and specialists with extensive experience in the cleanroom and HVAC industry. We operate in accordance with the latest international standards and guidelines, including ISO 14644, EU GMP, WHO, and ISPE recommendations.

We serve a wide range of industries including pharmaceutical manufacturing, biotechnology, medical devices, semiconductor fabrication, food processing, and hospital operating theatres.

Our Mission

Our mission is to provide our clients with reliable, independent, and accurate testing and certification services that ensure their facilities comply with all applicable regulatory requirements.

ISO 14644 EU GMP Annex 1 WHO Guidelines ISPE Member FDA Compliant
HEPA Testing
Particle Count
About Clevair

Quality Policy

Our commitment to quality is the foundation of everything we do.

Our Commitment to Quality

Clevair is committed to providing services that consistently meet client requirements and applicable statutory and regulatory requirements. We aim to continually improve the effectiveness of our quality management system.

Quality Objectives

  • Deliver accurate, reproducible test results that meet international standards
  • Maintain independence and impartiality in all our assessments
  • Continuously train and develop our technical staff
  • Use calibrated, certified equipment for all measurements
  • Provide timely, clear, and comprehensive reports to our clients
  • Respond promptly to client feedback and continuously improve our services

Standards We Follow

ISO 14644-1
Classification of air cleanliness by particle concentration
ISO 14644-2
Monitoring to provide evidence of cleanroom performance
EU GMP Annex 1
Manufacture of sterile medicinal products
EN 12237
Ductwork strength and leakage testing
ASHRAE 110
Method of testing performance of fume hoods
EN 12469
Performance criteria for microbiological safety cabinets
ISO
Air Velocity Testing
What We Do

Our Services

Comprehensive cleanroom and HVAC testing and certification services, delivering precision and compliance.

🧪
Cleanroom

Cleanroom Certification

Independent ISO 14644 classification and performance testing for pharmaceutical, biotech, and electronics cleanrooms.

  • Particle Count
  • Airflow Tests
  • Pressure Differential
🔬
Cleanroom

Clean Bench Testing

Full performance validation of laminar airflow benches and biological safety cabinets to international standards.

  • HEPA Integrity
  • Airflow Uniformity
  • Containment Test
🌬️
HVAC

Testing, Adjusting & Balancing

Complete TAB services ensuring your HVAC systems perform exactly as designed. We verify airflow, hydronic systems, and overall system performance — documented for regulatory compliance.

  • Air Balancing
  • Hydronic Balancing
  • Report Generation
  • Commissioning Support
💧
HVAC

Ductwork Leakage Test

Pressurisation testing of HVAC ductwork to EN 12237 and EN 15727 standards for maximum energy efficiency.

  • EN 12237
  • Class A–D
📋
Other

Project Management

End-to-end project management for cleanroom construction and HVAC installation projects.

  • Design Review
  • Site Supervision
Cleanroom Services

Cleanroom Certification

Independent, third-party classification and performance testing of cleanrooms and controlled environments.

About the Service

Cleanroom certification is the process of formally verifying that a cleanroom or controlled environment meets the requirements of the applicable classification standard, typically ISO 14644-1. Clevair provides independent, third-party certification services to ensure objectivity and regulatory acceptance.

Tests Performed

  • Airborne Particle Count — ISO classification testing
  • Airflow Volume and Velocity Measurements
  • Air Pressure Differential Testing
  • HEPA/ULPA Filter Integrity Testing (DOP/PAO)
  • Air Change Rate Calculation
  • Recovery Test
  • Temperature and Humidity Uniformity
  • Airflow Visualization (Smoke Test)

Applicable Standards

ISO 14644-1
Classification of air cleanliness by particle concentration
ISO 14644-2
Monitoring to provide evidence of cleanroom performance
EU GMP Annex 1
Grade A, B, C, D classification
WHO TRS 961
Good manufacturing practices for pharmaceutical products
Air Velocity and Uniformity
HEPA Filter Integrity
Particle Count Test
Airflow Visualization
Recovery Test
Cleanroom Services

Clean Bench Testing

Performance testing and certification of laminar flow workstations, clean benches, and biological safety cabinets.

About the Service

Clean benches and biological safety cabinets (BSCs) are critical pieces of equipment used in laboratories, pharmaceutical manufacturing, and research facilities. Regular performance testing is essential to ensure they continue to provide adequate protection for the product, the operator, and the environment.

Equipment Tested

  • Horizontal Laminar Airflow Clean Benches
  • Vertical Laminar Airflow Clean Benches
  • Class II Biological Safety Cabinets (Type A2, B1, B2)
  • Class III Biological Safety Cabinets (Gloveboxes)
  • Cytotoxic Drug Safety Cabinets
  • Compounding Aseptic Isolators (CAI)

Tests Performed

  • HEPA Filter Integrity Test (DOP/PAO Aerosol Challenge)
  • Airflow Velocity and Uniformity
  • Inflow Velocity Measurement (BSCs)
  • Containment Test / KI Discus Test
  • Vibration, Noise & Lighting Measurement
  • UV Lamp Intensity

Applicable Standards

EN 12469
Performance criteria for microbiological safety cabinets
NSF/ANSI 49
Biosafety cabinetry design, construction, performance
ISO 14644-3
Test methods for cleanrooms
IEST-RP-CC001
HEPA and ULPA filters
Clean Bench Types
HEPA Filter Integrity Test
HVAC Services

Ductwork Leakage Test

Pressurisation testing of HVAC ductwork systems to European standards, ensuring energy efficiency and compliance.

About the Service

Ductwork leakage testing is the process of measuring the air leakage from HVAC ductwork systems. Excessive duct leakage leads to energy waste, reduced system performance, and potential contamination issues in controlled environments.

Clevair performs ductwork leakage tests using calibrated equipment in accordance with EN 12237 and EN 15727 standards.

Why Test Ductwork?

  • Verify compliance with design specifications and standards
  • Reduce energy consumption from air leakage
  • Ensure correct airflow delivery to critical spaces
  • Prevent cross-contamination in cleanroom facilities
  • Required by EU GMP for pharmaceutical facilities
  • Documentation for LEED and BREEAM certifications

Leakage Classes

Class A
Low pressure ductwork — up to 500 Pa
Class B
Medium pressure — up to 1000 Pa
Class C
High pressure — up to 2000 Pa
Class D
Very high pressure — up to 2500 Pa
Ductwork Leakage Test Equipment
HVAC Services

Commissioning

Systematic verification that HVAC and cleanroom systems are installed and operating as intended by the design.

About the Service

Commissioning is a quality-focused process for achieving, verifying, and documenting that the performance of facilities, systems, and assemblies meets defined objectives and criteria. Clevair provides independent commissioning services for HVAC and cleanroom systems.

Commissioning Scope

  • Review of design documents and specifications
  • Witness and verification of Factory Acceptance Tests (FAT)
  • Inspection of installation quality
  • Site Acceptance Testing (SAT)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Training of operations and maintenance staff
  • Final commissioning report and documentation

Industries Served

  • Pharmaceutical and Biotechnology manufacturing
  • Hospital operating theatres and clean areas
  • Semiconductor and electronics facilities
  • Food and beverage production
  • Commercial and industrial HVAC systems
Air Volume Measurement
Air Velocity Measurement
HVAC Services

Testing, Adjusting & Balancing

Comprehensive TAB services to verify and document that HVAC systems deliver design airflow and meet performance specifications.

About the Service

Testing, Adjusting, and Balancing (TAB) is the process of checking and adjusting all the systems in a building that run on air and water to make sure they perform according to design specifications. TAB is a critical step in the commissioning of any HVAC system.

Air-Side Testing

  • Total air volume measurements at Air Handling Units (AHU)
  • Supply, return, and exhaust air measurements at all terminals
  • Fan performance verification (RPM, static pressure, power)
  • Room air change rate calculations
  • Pressure differential measurements between spaces
  • Outside air volume verification

Hydronic Testing

  • Flow measurements at pumps, coils, and terminals
  • Differential pressure measurements
  • Pump performance verification
  • Proportional balancing of distribution systems

Reporting

All TAB results are documented in a comprehensive report following ASHRAE and NEBB standards, including as-found and as-left data, equipment data sheets, and a summary of deficiencies.

Testing and Balancing
Air Volume Measurement
Other Services

Project Management

End-to-end project management for cleanroom construction and HVAC installation projects.

About the Service

Clevair offers project management services for cleanroom construction, renovation, and HVAC installation projects. Our project managers have deep technical expertise in cleanroom and HVAC systems, allowing them to effectively manage all aspects of the project from design review through final handover.

Services Included

  • Design review and technical specification development
  • Tender preparation and contractor evaluation
  • Site supervision and quality control
  • Progress monitoring and reporting
  • Factory Acceptance Test (FAT) witnessing
  • Commissioning management and oversight
  • Final documentation and handover management

Project Types

  • New cleanroom construction
  • Cleanroom renovation and upgrade
  • HVAC system installation and upgrade
  • Laboratory fit-out
  • Pharmaceutical facility qualification projects
Cleanroom Equipment
HVAC Testing
Latest Updates

Our News

Stay up to date with the latest developments in cleanroom standards, HVAC regulations, and Clevair news.

ISO 14644
2015

ISO 14644 Standard Update — Part 1 and Part 2

ISO 14644 Part 1 and Part 2 have been revised as new Final Draft International Standards (FDIS). ISO/FDIS 14644-1 covers classification of air cleanliness by particle concentration, while ISO/FDIS 14644-2 addresses monitoring to provide evidence of cleanroom performance. These updates bring significant changes to sampling plans, statistical methods, and classification procedures. All cleanrooms certified under the previous versions should be re-assessed to ensure continued compliance.

Airflow Visualization Test
Video

A Sample Video of Airflow Visualization Test

Clevair presents you a sample video of Airflow Visualization Test from various projects in cleanrooms… Enjoy!!!

Our Work

Projects & Clients

We have successfully completed projects across a wide range of industries throughout Greece and Europe.

💊

Pharmaceutical Manufacturing

Cleanroom certification and HVAC commissioning for GMP-compliant pharmaceutical production facilities.

ISO 14644 / EU GMP
🧬

Biotechnology Laboratories

Performance qualification of biosafety cabinets and cleanrooms for biotech R&D facilities.

BSL-2 / BSL-3
🏥

Hospital Operating Theatres

Certification and validation of ultra-clean ventilation systems in surgical environments.

HTM 03-01
🔬

Medical Device Manufacturing

Cleanroom validation for ISO 13485-compliant medical device production environments.

ISO 13485
💻

Electronics & Semiconductor

High-precision cleanroom testing for microelectronics and semiconductor fabrication facilities.

ISO Class 3–6
🍽️

Food & Beverage Production

HVAC testing and balancing for food-grade production environments requiring controlled conditions.

HACCP / IFS
🏭

Industrial HVAC Systems

Testing, adjusting and balancing of large-scale industrial HVAC installations across multiple sites.

TAB / ASHRAE
🧪

Research Laboratories

Commissioning and certification of controlled environment laboratories for academic and research institutions.

GLP Compliant
🏗️

New Facility Construction

Project management and commissioning for new cleanroom construction projects from design through handover.

Full PM Service
Project Gallery

Photos from Our Work

Air Velocity
HEPA Test
Particle Count
Smoke Test
Air Volumes
Recovery Test
Clean Bench
Ductwork
Get In Touch

Contact Us

Ready to certify your cleanroom or HVAC system? Reach out — we respond within 24 hours.

📞
(+30) 2221 083 079
(+30) 6977 071 604
✉️
info@clevair.gr
We reply within 24 hours
📍
17, Patriarhi Grigoriou E' str, 34132 Chalkida
Greece — Serving all of Europe
🌐
Useful Links
WHO · EU GMP · ISPE · FDA
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