HVAC Validation

HVAC Qualification in Pharma: Airflow, HEPA Filters & Environmental Control

HVAC Qualification in Pharma: Airflow, HEPA Filters & Environmental Control HVAC Qualification in Pharma: Airflow, HEPA Filters & Environmental Control The HVAC (Heating, Ventilation, and Air Conditioning) system in pharmaceutical manufacturing environments is critical to maintaining cleanroom standards, ensuring product…

Leak Testing and DOP Challenge: A Complete Guide

Leak Testing and DOP Challenge: A Complete Guide Complete Guide to HEPA Filter Leak Testing and DOP Challenge in Pharma High-Efficiency Particulate Air (HEPA) filters are a cornerstone of contamination control in pharmaceutical cleanrooms and sterile manufacturing areas. Ensuring their…

Smoke Studies for Unidirectional & Turbulent Flow

Smoke Studies for Unidirectional & Turbulent Flow How to Perform Smoke Studies for Unidirectional and Turbulent Airflow in Pharma Cleanrooms Smoke studies — also known as airflow visualization studies — are essential in pharmaceutical HVAC validation, particularly for sterile and…

Environmental Mapping & Monitoring for HVAC Qualification

Environmental Mapping & Monitoring for HVAC Qualification How to Conduct Environmental Mapping and Monitoring for HVAC Qualification in Pharma Environmental mapping and monitoring of temperature and relative humidity (RH) are critical components of HVAC qualification in pharmaceutical cleanrooms, warehouses, and…

ISO 14644, EU GMP Grade A–D Area Validation

ISO 14644, EU GMP Grade A–D Area Validation Comprehensive Validation of Cleanroom Grades A to D According to ISO 14644 and EU GMP Guidelines Validation of cleanroom areas classified as Grade A to D is a foundational requirement in pharmaceutical…

HVAC System Validation in Pharma: Step-by-Step Guide

HVAC System Validation in Pharma: Step-by-Step Guide HVAC System Validation in Pharma: Step-by-Step Guide In the pharmaceutical industry, the validation of Heating, Ventilation, and Air Conditioning (HVAC) systems is crucial to ensure that environmental conditions for manufacturing processes are controlled…

How to Perform Airflow Visualization (Smoke Study) for Cleanrooms

How to Perform Airflow Visualization (Smoke Study) for Cleanrooms How to Perform Airflow Visualization (Smoke Study) for Cleanrooms Airflow visualization, often referred to as a smoke study, is an essential component of process validation in the pharmaceutical industry, particularly in…

HEPA Filter Integrity Testing: DOP, PAO, and Beyond

HEPA Filter Integrity Testing: DOP, PAO, and Beyond HEPA Filter Integrity Testing: DOP, PAO, and Beyond HEPA filter integrity testing is a critical component in ensuring that cleanrooms and controlled environments in the pharmaceutical industry meet stringent regulatory standards. This…