HVAC System, LAFs & Clean Room Validation
CALITECH provides comprehensive HVAC system validations adhering to a range of international standards and guidelines, including ISO 14644, EU cGMP, US Federal Standard 209E, WHO, USFDA, TGA (Australia), European standards (EMEA), and MHRA (European Countries). Our validation processes ensure that HVAC systems meet the stringent requirements for various room classifications, guaranteeing optimal performance and compliance with regulatory standards.
Utilizing cutting-edge technology and 21 CFR compliance, we conduct a series of rigorous tests to ensure the integrity and efficiency of HVAC systems. Our services include Filter Integrity Leak Tests using POLY ALFA OLIFINE (PAO), Air Flow Visualization Tests (Smoke Tests), and Air Velocity Measurements. These tests are essential for verifying that air filtration systems are functioning correctly and that air flow is adequate for maintaining clean room standards.
In addition to filter and air flow assessments, we also perform Light Intensity Measurements, Sound Level Measurements, and Airborne Particle Count Tests. These evaluations help to ensure that environmental conditions within clean rooms and controlled areas are within specified limits, contributing to a controlled and contaminant-free environment.
HVAC System Validation
- Filter Integrity Leak Test Using POLY ALFA OLIFINE (PAO)
- Air Flow Visualization Test (Smoke Test)
- Air Velocity Measurement
- Air Changes Per Hour Measurement
LAFs & Clean Room Validation
- Light Intensity Measurement
- Sound Level Measurement
- Airborne Particle Count Test
- Compliance with ISO 14644, EU cGMP, US Federal Standard 209E, WHO, USFDA, TGA, EMEA, and MHRA guidelines