Abstract
Ensuring air quality in aseptic cleanrooms is critical in biotechnology, pharmaceuticals, and stem cell research to maintain product integrity. Air sampling, particularly at working height, is essential for continuous, non-invasive monitoring of microbiological air quality, in line with GMP regulations. This article explores the technical, regulatory, and health-related aspects of air sampling, emphasizing its importance for GMP compliance and best practices.
Key regulatory frameworks, including ISO 14644, Annex 1:2022, VDI 2083, and FDA cGMP, highlight the need for precise air sampling methods at specified heights to ensure sterility. Air quality is defined by particle concentration and microbiological monitoring, with maximum permissible particle counts outlined to prevent contamination.
The concept of “working height” is critical, often defined as the height where most production activities occur, typically around 1 meter. This height is vital for accurate air quality monitoring, considering the breathing zone of personnel and proximity to products.
The article discusses the technical perspective of air velocity measurement, the microbiological perspective of contamination risks from personnel, and the occupational safety perspective of assessing particle exposure. These aspects underscore the need for air sampling at working height to ensure product and personnel safety. Finally, best practices for passive air sampling are addressed for upholding product integrity and the health and safety of cleanroom personnel.
Download the German version here: German version of Article “Air Sampling at Working Height in Aseptic Cleanrooms: GMP Compliance and Best Practices”
