Impact of the Human Factor on the Contamination of Pharmaceutical Cleanrooms
Personnel are a major source of particles and microorganisms in pharmaceutical environments. According to GMP guidelines, proper attire, continuous training and disciplined behavior are essential to minimize the risk of contamination and protect product integrity.
Clean Room Air Renewals
The air renewal rate is an essential parameter for maintaining environmental cleanliness. In accordance with GMP requirements and cleanroom standards, this continuous flow of filtered air allows particulate control, ensures adequate recovery times and protects product integrity.
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.
Design and Qualification of SAS and Locks
Safe transfer of materials is key in clean rooms. We analyze the design, ventilation and qualification of SAS and airlocks according to GMP standards, with special focus on VHP decontamination technologies to ensure maximum sterility.
Advanced Filtration Technologies for Clean Rooms
Pharmaceutical cleanrooms demand the highest air quality control. In this article we explore how HEPA and ULPA filters ensure contaminant-free environments, detailing selection, installation and maintenance criteria to meet the most stringent industry regulations.
Environmental Monitoring in Clean Rooms
Did you know that environmental monitoring is key to ensuring drug quality? Discover how cleanroom monitoring ensures safe environments and complies with the most stringent regulations.
HVAC Systems in Clean Rooms
HVAC systems are essential to ensure clean air, stable conditions and avoid cross-contamination in critical environments. Discover their key components, good design practices and how adaptive control allows you to optimize energy consumption without compromising quality.
Cleanroom Design and Construction: An Overview
Planning, designing and maintaining a cleanroom requires compliance with regulations such as ISO 14644 and GMP. In this article we explain the essential steps, from defining objectives to validation and operation, to ensure quality and safety in critical environments.
The Science of Cleanrooms
Do you remember those hours studying physics, chemistry or biology… and wondering what it would all be for someday?
In Iguña we were amused to remember it by reviewing the science behind something as technical (and as important) as cleanrooms…