HVAC Validation

Relationship Between Filter Life, Pressure Drop, and Airflow

Relationship Between Filter Life, Pressure Drop, and Airflow Relationship Between Filter Life, Pressure Drop, and Airflow The pharmaceutical industry relies heavily on effective HVAC systems to maintain product quality and compliance with regulatory standards. Understanding the interconnectedness of filter life,…

Calibration of HVAC Sensors for Velocity, Temperature, and RH

Calibration of HVAC Sensors for Velocity, Temperature, and RH Calibration of HVAC Sensors for Velocity, Temperature, and RH Ensuring the environmental conditions in pharmaceutical manufacturing facilities is critical to maintaining product integrity and compliance. The calibration of HVAC sensors for…

Interlock Testing Between Doors and HVAC Control

Interlock Testing Between Doors and HVAC Control Interlock Testing Between Doors and HVAC Control The pharmaceutical industry operates under stringent regulations that demand high standards of quality and compliance. This article provides a comprehensive step-by-step tutorial on conducting interlock testing…

Airflow Requalification After Major Equipment Change

Airflow Requalification After Major Equipment Change Airflow Requalification After Major Equipment Change In the highly regulated pharmaceutical industry, maintaining the integrity of environmental controls is paramount. Airflow in controlled environments must be precisely managed, particularly after major equipment changes. This…

SOP for Performing and Reviewing Smoke Studies

SOP for Performing and Reviewing Smoke Studies SOP for Performing and Reviewing Smoke Studies This article serves as a comprehensive guide for pharmaceutical professionals engaged in the execution and evaluation of smoke studies. It emphasizes the importance of computer system…

How to Capture Smoke Study Results for Regulatory Audits

How to Capture Smoke Study Results for Regulatory Audits How to Capture Smoke Study Results for Regulatory Audits Effective smoke study validation is vital for ensuring compliance and demonstrating that air filtration systems function as intended in regulated environments. This…

Role of Airflow Mapping in Detecting Design Flaws

Role of Airflow Mapping in Detecting Design Flaws Role of Airflow Mapping in Detecting Design Flaws Airflow mapping plays a crucial role in the validation lifecycle of pharmaceutical manufacturing environments. This guide aims to provide a comprehensive, step-by-step tutorial tailored…

FDA HVAC Validation Expectations During GMP Audits

FDA HVAC Validation Expectations During GMP Audits FDA HVAC Validation Expectations During GMP Audits As the pharmaceutical industry continues to evolve, regulatory expectations surrounding equipment and system validation have become increasingly stringent. A critical aspect of this is the validation…

EMA Annex 1 and HVAC Design for Aseptic Processing Areas

EMA Annex 1 and HVAC Design for Aseptic Processing Areas EMA Annex 1 and HVAC Design for Aseptic Processing Areas In the pharmaceutical industry, compliance with regulatory requirements is paramount in ensuring the safety and efficacy of medicinal products. One…

WHO HVAC Guidelines for Non-Sterile and Sterile Facilities

WHO HVAC Guidelines for Non-Sterile and Sterile Facilities WHO HVAC Guidelines for Non-Sterile and Sterile Facilities The validation of HVAC systems is critical in maintaining the quality and integrity of pharmaceutical products. This article provides a comprehensive step-by-step guide on…