Filter Integrity & Airflow Validation

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…

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…

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…

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…

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…

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…

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,…

Cleanroom Recovery Rate Testing: Calculations and Parameters

Cleanroom Recovery Rate Testing: Calculations and Parameters Cleanroom Recovery Rate Testing: Calculations and Parameters Step 1: Understanding User Requirements Specification (URS) and Risk Assessment The foundation of effective cleanroom recovery rate testing begins with a comprehensive User Requirements Specification (URS).…

Case Study: Filter Integrity Failure and Remedial Actions

Case Study: Filter Integrity Failure and Remedial Actions Case Study: Filter Integrity Failure and Remedial Actions This article provides a comprehensive step-by-step tutorial on the validation lifecycle, focusing on case studies related to filter integrity failure within the framework of…

Terminal Filter Leak Testing in Critical Grade A and B Zones

Terminal Filter Leak Testing in Critical Grade A and B Zones Terminal Filter Leak Testing in Critical Grade A and B Zones This article provides a comprehensive, step-by-step validation tutorial focusing on terminal filter leak testing in critical Grade A…