Validate Your Systems with Confidence
Partner with Pharma Integrity for reliable, fully compliant validation services.
Years Of Experience
Pharma Integrity Validations & Services is a trusted provider of specialized validation solutions for pharmaceutical, healthcare, and life sciences facilities. With over two decades of technical expertise, we offer end-to-end HVAC and cleanroom testing services across domestic and international markets, keeping your facility fully compliant with global health standards.
Validating your cleanrooms and air-handling systems proves that your controlled environments operate reliably, protecting product integrity and patient safety.
Design Verification: Confirming that your physical facility aligns with its original engineering intent. URS Compliance: Ensuring all equipment meets your specific User Requirement Specifications. Global Regulatory Alignment: Meeting strict international benchmarks including ISO, EU GMP, and WHO guidelines. Seamless System Integration: Guaranteeing that facility infrastructure, air handling, and environmental equipment function harmoniously.
Years Of Roofing
Experience
We execute all HVAC and cleanroom testing procedures in strict compliance with current global guidelines:
ISO 14644 (Parts 1, 2 & 3): Global standards for cleanroom classification, monitoring, and test execution. EU GMP / EC Annex 1: European Good Manufacturing Practices for sterile medicinal products. WHO Technical Report Series (TRS 937 / 961): World Health Organization standards for pharmaceutical air handling. Schedule M (CDSCO Guidelines): Indian statutory requirements for pharmaceutical manufacturing quality.
We certify clean environments to your required cleanliness class as defined by ISO 14644-1. Our team tailors the testing process based on your operational setup and specific regulatory targets.
Maintaining compliance requires continuous oversight after initial setup. We help implement Statistical Process Control (SPC) protocols to track critical cleanroom metrics over time as recommended by ISO 14644-2.
All tests are performed in accordance with ISO 14644-3 methodologies:
Measuring airflow speeds and volume distribution to calculate precise Air Changes Per Hour (ACPH) across all clean zones.
Performing aerosol leak detection using Poly Alpha Olefin (PAO) or DOP to confirm complete filter system integrity.
Classifying air cleanliness levels by measuring particulate concentration across As-Built, At-Rest, and Operational states.
Evaluating how quickly your cleanroom purges airborne contaminants back to its baseline cleanliness class after exposure.
Using specialized fog generators to record and analyze laminar airflow patterns, identifying potential dead zones or turbulence.
Validating positive/negative air pressure differentials between adjacent areas to stop cross-contamination.
Verifying that physical barriers and air curtains prevent external pollutants from penetrating clean areas.
Mapping thermal and moisture levels across critical zones to maintain process stability and operator comfort.
Checking light levels across work surfaces to ensure they meet required Lux standards for safe precision work.
Measuring decibel levels within cleanrooms to ensure operational machinery stays within comfortable decibel limits for staff safety.
Partner with Pharma Integrity for reliable, fully compliant validation services.
Pharma Integrity Validations & Services is your trusted partner for pharmaceutical and healthcare validation