High-Efficiency Particulate Air (HEPA) filters play a crucial role in maintaining contamination-free environments in cleanrooms, laboratories, and controlled areas. HEPA Filter Validation ensures that these filters effectively remove airborne particles, preventing microbial contamination and maintaining air purity.
At Prism Calibration, we provide comprehensive HEPA Filter Validation services, ensuring compliance with industry regulations and quality standards. Our testing and validation processes help industries achieve the highest level of air filtration efficiency.
– Airborne Contamination Control: HEPA filters remove 99.97% of particles as small as 0.3 microns, ensuring a clean environment.
– Regulatory Compliance: HEPA filters in pharmaceuticals, biotechnology, and healthcare must meet stringent ISO, GMP, and FDA standards.
– Protects Product Integrity: Essential for preventing contamination in sterile drug manufacturing, semiconductor fabrication, and medical research.
– Ensures Personnel Safety: Reduces exposure to harmful airborne contaminants in biosafety labs and hospitals.
– Critical for Controlled Environments: Used in cleanrooms, operating rooms, laminar airflow cabinets, and fume hoods to maintain sterility.
– Pharmaceutical & Biotechnology: Used in cleanrooms, isolators, and sterile drug manufacturing to maintain strict contamination control.
– Healthcare & Hospitals: Installed in operating theaters, intensive care units (ICUs), and isolation wards to prevent infection spread.
– Aerospace Industry: Ensures clean air in satellite assembly, spacecraft manufacturing, and high-precision laboratories.
– Electronics & Semiconductor Manufacturing: Protects delicate electronic components from microscopic dust particles.
– Food Processing & Packaging: Maintains a sterile environment to prevent contamination in food production facilities.
– Airflow Velocity Testing: Measures airflow uniformity across the HEPA filter to ensure proper air distribution.
– Integrity Testing (DOP/PAO Testing): Detects filter leaks using Dispersed Oil Particulate (DOP) or Poly Alpha Olefin (PAO) aerosol tests.
– Particle Count Testing: Uses laser particle counters to measure airborne particulate levels and confirm filter efficiency.
– Pressure Drop Testing: Evaluates filter resistance to airflow, ensuring optimal performance without excessive energy consumption.
– Smoke Visualization Testing: Uses safe fog generators to verify air movement patterns and identify any bypass areas.
– Filter Housing Inspection: Checks the sealing integrity of filter housings to prevent unfiltered air leakage.
– ISO 14644-3: Defines testing and validation requirements for HEPA filters in cleanrooms.
– Good Manufacturing Practice (GMP): Ensures pharmaceutical HEPA filters meet regulatory sterility requirements.
– FDA 21 CFR Part 211: Specifies air quality and contamination control for drug manufacturing facilities.
– EU GMP Annex 1: Regulates HEPA filter use in sterile pharmaceutical production.
– WHO GMP Guidelines: Defines HEPA validation protocols for global pharmaceutical compliance.
– Aerosol Generators: Produce DOP/PAO particles for HEPA integrity testing.
– Laser Particle Counters: Measure airborne particle concentration to verify filter efficiency.
– Manometers & Differential Pressure Gauges: Monitor pressure drop across HEPA filters.
– Air Velocity Meters: Measure airflow rates to ensure uniform air distribution.
– Fog Generators: Used for airflow visualization tests in cleanrooms and biosafety cabinets.
– Validation Protocol & Report: Includes test results, compliance data, and recommendations for corrective actions.
– Certificate of Compliance: Official documentation proving adherence to ISO and GMP standards.
– Airflow & Particle Count Reports: Detailed analysis of air quality before and after HEPA filtration.
– Audit-Ready Documentation: Ensures all regulatory bodies have the required validation records.
– Corrective Action Reports: Identifies filter performance issues and suggests improvements.
– Established Expertise – Over 20 years of experience in validation services.
– Comprehensive Solutions – SCADA validation, laboratory instrument validation, HEPA filter validation, software validation, and more.
– ISO/IEC 17025-Accredited Lab – Ensuring globally recognized quality and compliance.
-Regulatory Compliance – Meeting FDA, WHO, GMP, and NABL standards.
– Cutting-Edge Technology – Advanced instruments and latest validation techniques.
– Industry-Specific Validation – Tailored services for pharmaceuticals, healthcare, food, and manufacturing.
– Certified Professionals – Skilled engineers ensuring precision and reliability.
– Fast & Cost-Effective Services – Quick turnaround with detailed, audit-ready reports.
Choose Prism Calibration for reliable and compliant validation services backed by expertise and innovation.
Airflow testing, DOP/PAO integrity testing, particle count measurement, pressure drop analysis, and airflow visualization are key validation tests.
It detects filter leaks by introducing aerosolized oil particles and measuring penetration levels to ensure proper filtration.
The air change rate varies depending on cleanroom classification, typically ranging from 20 to 600 air changes per hour (ACH).
Yes, we provide a detailed validation report and compliance certification for regulatory approval.
We follow ISO 14644, GMP, FDA 21 CFR, and EU GMP Annex 1 standards for HEPA filter testing and validation.
