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Validation

Cleanroom Validation in Kolkata, India

When it comes to Cleanroom Validation in Kolkata, India, Cadillac Project, a trusted name in designing, installing, and validating high-quality cleanroom environments.With 45 years of experience, we provide comprehensive validation services that ensure your facility, equipment, and processes meet stringent regulatory standards, including ISO 14644, GMP, and NABH guidelines. Our services cover particle count testing, air change calculations, temperature and humidity mapping, differential pressure monitoring, and HEPA filter integrity tests. Equipped with advanced tools like aerosol photometers, air capture hoods, particle counters, and anemometers, our professional team ensures precise and reliable validation. Committed to safety, hygiene, and efficiency, Cadillac Project delivers tailored solutions to maintain contamination-free, compliant, and fully optimized cleanroom environments for diverse industries across Kolkata.

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Why Cleanroom Validation is Important

Cleanroom validation is an essential process to ensure that the facility, equipment, and environment meet user requirements and perform according to regulatory standards such as ISO 14644-1:2015, GMP Annex 1, NABH, and CDC guidelines.

Purpose of Validation:

  • Assess cleanliness and air quality
  • Detect and prevent contamination from dust, microbes, and airborne particles
  • Ensure compliance with Good Manufacturing Practices (GMP)
  • Verify equipment and processes perform reliably

Why validation?

-To ensure that the design of the facility equipment, and environment meets User Requirement & is the best fit for its intended purpose.

- Cleanroom validation is provided by conducting a series of tests to qualify if a controlled environment is performing in accordance with process requirements and the applicable regulatory guidelines, such as ISO 14644-1:2015 or GMP Annex 1.

Validation parameters
  • 1. Particle Count Test.
  • 2. Air Change Per Hour (ACPH) calculation.
  • 3. Temperature mapping.
  • 4. Relative Humidity checking.
  • 5. Differential Pressure checking.
  • 6. Filter Integrity Test/ DOP Test/ PAO Test for HEPA Filters.

Tools & Equipment We Use

Aerosol Photometer – Detects filter leaks

Air Capture Hood – Measures airflow capacity

Airborne Particle Counter – Monitors cleanroom particle levels

Anemometer & Hygrometer – Measures airflow and humidity

Lux Meter & Digital Sound Level Meter – Checks lighting and noise levels

Vibration Meter – Ensures structural stability

Handheld Airborne Particle Counter – Quick field measurements

Expert Clean Room Validation in Kolkata
AEROSOL Photometer
Expert Clean Room Validation in Kolkata
AIR CAPACITY MEASUREMENT USEING AIR CAPTURE HOOD
Expert Clean Room Validation in Kolkata
AIRBONE PARTICLE COUNTER
Expert Clean Room Validation in Kolkata
ANEMOMETER
Expert Clean Room Validation in Kolkata
HANDLEND AIRBONE PARTICLE COUNTER
Expert Clean Room Validation in Kolkata
HYGROMETER
Expert Clean Room Validation in Kolkata
LUX METER
Expert Clean Room Validation in Kolkata
DIGITAL SOUND LEVEL METER
Expert Clean Room Validation in Kolkata
SET OF AIRBONE PARTICLE COUNTER
Expert Clean Room Validation in Kolkata
VIBRATION METER
Expert Clean Room Validation in Kolkata
Expert Clean Room Validation in Kolkata

Our Major Clients

Cadillac Project: Expert Clean Room Validation in Kolkata
Cadillac Project: Expert Clean Room Validation in Kolkata
Cadillac Project: Expert Clean Room Validation in Kolkata
Cadillac Project: Expert Clean Room Validation in Kolkata
Cadillac Project: Expert Clean Room Validation in Kolkata
Cadillac Project: Expert Clean Room Validation in Kolkata
Cadillac Project: Expert Clean Room Validation in Kolkata

STANDARDS TO-BE FOLLOWED :

  • 1. ISO 14644
  • 2. FEDERAL 209E
  • 3. GMP SCHEDULE- M
  • 4. NABH
  • 5. CDC

Our Experience

With 45 years of experience, Cadillac Project has successfully executed cleanroom validation and controlled environment projects across multiple industries:

  • Pharmaceutical manufacturing labs
  • Biotech research facilities
  • Academic and industrial R&D labs
  • Healthcare and diagnostic labs

We have successfully delivered hundreds of projects for reputed organizations such as Apollo Hospitals, Boroline, Narayana Hospital, Bengal Chemical and Pharmaceutical Ltd., and Indian Drugs and Pharmaceuticals Ltd., ensuring ISO-class compliance, precise environmental control, and seamless regulatory approvals.

FAQS

What is cleanroom validation?
Cleanroom validation is a documented process that confirms a cleanroom is designed, installed, and operating as per defined cleanliness and environmental standards. Cadillac Project performs validation to ensure the cleanroom meets ISO, GMP, and regulatory requirements.
Cleanroom validation is important to control dust, dirt, microbes, and contamination that can affect product quality and safety. It also helps organizations comply with regulatory authorities and Good Manufacturing Practices (GMP).
A cleanroom should typically be validated annually or whenever there is a major change in layout, HVAC system, equipment, or process. Cadillac Project follows predefined protocols to determine the correct validation frequency.
Cleanroom validation is essential for pharmaceutical companies, hospitals, biosafety labs, healthcare facilities, medical device manufacturers, and research laboratories where contamination control is critical.
Cadillac Project performs validation in compliance with ISO 14644, GMP Schedule M, Federal Standard 209E, NABH, and CDC guidelines, depending on the application and industry requirements.
Cleanroom validation includes particle count testing, air change per hour (ACPH) calculation, temperature mapping, relative humidity checks, differential pressure monitoring, and HEPA filter integrity testing.
Cadillac Project uses advanced instruments such as aerosol photometers, airborne particle counters, air capture hoods, anemometers, hygrometers, lux meters, sound level meters, and vibration meters for accurate validation results.
Yes, Cadillac Project conducts HEPA filter integrity tests using DOP or PAO methods to ensure there are no leaks and the filtration system performs as required.
Yes, Cadillac Project provides post-validation support and guidance to help maintain cleanroom performance, ensure compliance, and address any issues identified during validation.
With decades of experience, a professional technical team, advanced testing instruments, and a strong client base including leading hospitals and pharmaceutical companies, Cadillac Project is a trusted provider of Cleanroom Validation in Kolkata.

Our National and International Clients

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