Cleanroom / HVAC Validation

Why validate?
Air quality in clean rooms and clean air devices is critical in many areas of work including the process and manufacture of pharmaceutical products, operating theatres and sterile services departments.  When a clean room has just been built it must be tested to ensure that it is working correctly. The quantity and quality of air supplied, the air movement between and within clean rooms and the particle (and where necessary microbiological) counts in the clean room should be shown to be correct. 


Cleanroom Validation
We, Aimtech Solutions, provide value added quality services of Cleanroom validation. We carries out onsite Cleanroom Validation in all states as stated by BS EN ISO14644 & EUGMP.
We work regularly in Pharmaceutical Companies, Operation Theatres, Pathology Laboratories, research and production facilities and Cleanroom facilities available in other industries.
We offer extremely competitive rates and regularly work out of hours, at weekends and during shut down periods so as to provide a minimal disturbance service to customers.
Our engineers have a wealth of experience across numerous industries and record data that are re-produced in our clear, concise and comprehensive Cleanroom Validation Reports. Our reports contain all of the relevant information and data as expected by customers and regulatory authorities, including:

  • Clear, defined scope of works
  • Careful summary of the Cleanroom validation visit
  • Detailed method statements explaining how each validation test is performed
  • Detailed records of measurements recorded during the validation visit
  • Detailed records of measurements recorded during the validation visit
  • Original print-outs from particle counters (where relevant)

We provide onsite certification including all tests reports.
Testing is carried out in accordance with relevant standards (ISO 14644, EU GMP/EC GMP, FS 209E, WHO 2002, USFDA, MHRA, Drug and Cosmetic Act of India, 2005).

Equipment used in our Validation Services

  • VelociCalc Rotating Vane Anemometer
  • Aerosol Photometer
  • Hot wire Anemometer
  • DI Water Base Fogger
  • Accubalance Air Capture Hood
  • Aerosol Generator
  • Particle Counter

We carried out following test:

Cleanroom Laminar Airflow Unit Validation
  • Air Velocity Test and air changes rate calculation
  • Air Balancing and Airflow Measurement by using Air Capture Hood
  • Pressure Balancing Test
  • HEPA Filter Integrity Test (DOP/PAO Test)
  • Non - Viable Particle Count Test
  • Sweep off Time Test
  • Recovery Test
  • Air Flow Pattern Test by using Distilled Water/ Water for injection
  • Safe Zone Defining Test for LAFU, Dispensing Booth, Sampling Booth
  • Temperature/ RH Measurement
  • Noise Level Measurement
  • Light Intensity Measurement
  • Active Microbial Air Sampling Test
Laminar Airflow Unit Validation
  • Air Velocity Test and air changes rate calculation
  • Air Balancing and Airflow Measurement by using Air Capture Hood
  • HEPA Filter Integrity Test (DOP/PAO Test)
  • Non - Viable Particle Count Test
  • Recovery Test
  • Air Flow Pattern Test by using Distilled Water/ Water for injection
  • Safe Zone Defining Test for LAFU, Dispensing Booth, Sampling Booth
  • Noise Level Measurement
  • Light Intensity Measurement
  • Active Microbial Air Sampling Test
Operation Theater Validation
  • Air Velocity Test
  • Air Balancing and Airflow Measurement by using Air Capture Hood
  • Pressure Balancing Test
  • HEPA Filter Integrity Test (DOP/PAO Test)
  • Non - Viable Particle Count Test
  • Temperature/ RH Measurement
  • Noise Level Measurement
  • Light Intensity Measurement
  • Active Microbial Air Sampling Test
Bio-Safety Cabinet Testing
  • Air Velocity Test and air changes rate calculation
  • Air Balancing and Airflow Measurement by using Air Capture Hood
  • Pressure Balancing Test
  • Active Microbial Air Sampling Test
Vial Tunnel Validation
  • Air Velocity Test
  • HEPA Filter Integrity Test by DOP/PAO Aerosol Test
  • Air Flow Pattern Test
  • Non – viable Air Borne Particle Count Test
  • Active Microbial Air Sampling Test
Paint Booth Validation
  • Air Velocity Test
  • HEPA Filter Integrity Test by DOP/PAO Aerosol Test
  • Non – viable Air Borne Particle Count Test