Tag: HVAC validation

Writing an HVAC Qualification Protocol (IQ, OQ, PQ)

Writing an HVAC Qualification Protocol (IQ, OQ, PQ) Writing an HVAC Qualification Protocol (IQ, OQ, PQ) The HVAC system in pharmaceutical manufacturing is critical to maintaining the integrity of cleanroom environments. This comprehensive guide outlines the step-by-step process for developing…

HVAC Zoning and Pressure Cascade Validation in Controlled Environments

HVAC Zoning and Pressure Cascade Validation in Controlled Environments HVAC Zoning and Pressure Cascade Validation in Controlled Environments In the pharmaceutical industry, ensuring environmental integrity through proper HVAC (Heating, Ventilation, and Air Conditioning) zoning and pressure cascade validation is pivotal…

Air Change Rate and Recovery Time Calculations for HVAC Validation

Air Change Rate and Recovery Time Calculations for HVAC Validation Air Change Rate and Recovery Time Calculations for HVAC Validation In the pharmaceutical industry, ensuring high-quality production environments is critical to maintaining product integrity and compliance with regulatory standards. HVAC…

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…

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…

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…

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…

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…

Cleanroom Validation & Microbiological Risk Assessment: A GMP-Compliant Strategy

Cleanroom Validation & Microbiological Risk Assessment: A GMP-Compliant Strategy How to Validate Cleanrooms and Perform Microbiological Risk Assessment in Pharma Introduction Cleanroom validation and microbiological risk assessment are essential components of any GMP-compliant pharmaceutical facility. Cleanrooms support critical manufacturing environments…