Biopharmaceutical Cleanroom Design: Upstream and Downstream
General Principles of Cleanroom Design The main purpose of a cleanroom is to protect the product from contamination. According to EU-GMP or ISO 14644 standards, the classification of rooms is defined by the maximum number of particles and microorganisms in suspension. Air quality parameters (temperature, humidity, pressure) are maintained by specialized engineering constructions and dedicated […]
Integral Validation of Pharmaceutical Clean Rooms
Pharmaceutical cleanroom validation is key to ensuring product quality and process safety. In this article we review the essential steps of the process, from design to operation, under a risk-based approach aligned with GMP and ISO requirements.