Cleanroom commissioning and qualification are critical processes that ensure the integrity and functionality of controlled environments. These processes involve thorough planning, testing, and documentation to…

What is a Cleanroom? A cleanroom is a controlled environment to maintain shallow particulate contamination. It is typically used in manufacturing and scientific research environments…

Cleanroom Environmental Monitoring Performance Qualification (EMPQ) Overview: The Cleanroom Environmental Monitoring Performance Qualification (EMPQ) is a critical part of the validation process to ensure that…

Cleanroom behaviors refer to the practices and protocols followed in environments where cleanliness and contamination control are critical, such as in cleanrooms used in industries…

Cleaning Methodology and Validation Best Practices This blog outlines essential validation requirements for cleaning procedures in GMP-regulated pharmaceutical facilities, following EU GMP Annex 15 and…

Building monitoring systems (BMS) are essential tools for managing and optimizing the performance of building infrastructure. They offer numerous benefits and help ensure compliance with…

Building Monitoring System (BMS) A Building Monitoring System (BMS) is an automated control system that monitors and manages a facility’s mechanical, electrical, and electromechanical services…

Biologics manufacturing presents several challenges due to the complex nature of biological products. These challenges encompass various stages of production, from cell line development to…

Biologics intermediates are life-saving products that can vastly improve patients’ quality of life. As such, regulatory agencies must ensure their quality, safety, and efficacy. The…