Filter Integrity & Airflow Validation

HEPA Filter Integrity Testing: DOP/PAO Method Explained

HEPA Filter Integrity Testing: DOP/PAO Method Explained HEPA Filter Integrity Testing: DOP/PAO Method Explained In the pharmaceutical and biotechnology industries, ensuring the integrity of HEPA filters is critical for maintaining aseptic environments. The DOP (di-octyl phthalate) and PAO (polyalphaolefin) methods…

Smoke Study for Airflow Visualization and Laminarity

Smoke Study for Airflow Visualization and Laminarity Smoke Study for Airflow Visualization and Laminarity In the pharmaceutical industry, the validation of environmental control systems is indispensable for ensuring product quality and regulatory compliance. A critical aspect of this validation process…

Velocity and Uniformity Testing in Laminar Airflow Units

Velocity and Uniformity Testing in Laminar Airflow Units Velocity and Uniformity Testing in Laminar Airflow Units This article provides a detailed, step-by-step validation tutorial on velocity and uniformity testing in laminar airflow units, focusing on kneat validation, and ensuring compliance…

Airflow Directionality Testing: Qualitative and Quantitative Methods

Airflow Directionality Testing: Qualitative and Quantitative Methods Airflow Directionality Testing: Qualitative and Quantitative Methods In the pharmaceutical and biotechnology industries, the validation of systems employed in cleanrooms and controlled environments is a critical aspect of ensuring product quality and compliance…

Acceptance Criteria for Air Velocity and Flow Patterns

Acceptance Criteria for Air Velocity and Flow Patterns Acceptance Criteria for Air Velocity and Flow Patterns This article presents a comprehensive step-by-step tutorial on establishing acceptance criteria for air velocity and flow patterns within pharmaceutical environments, in line with GxP…

Filter Installation Leak Test (ILT): Procedure and Documentation

Filter Installation Leak Test (ILT): Procedure and Documentation Filter Installation Leak Test (ILT): Procedure and Documentation The Filter Installation Leak Test (ILT) is a critical component of HVAC system validation in the pharmaceutical industry. This procedure ensures that filters are…

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…

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…

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).…

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,…