Effectively Removing the Pain of Passive Air Monitoring from Critical Environments
The most universally applied method for cleanroom classification is the one suggested in 1963 by Federal Standard 209 of the USA. In this standard the number of particles equal to and greater than 0.5 µm is measured in one cubic foot of air. This count is then used to classify the room (1 particle = class 1; 10 particles = class 10…). In the same period, scientific publications concerning healthcare facilities suggested that airborne particles carrying micro-organisms associated with human disease were usually found in the 4-20 µm equivalent diameter range. This contamination can be detected by settle plates.
- Event Type:
- Sep. 24, 2019
Historically, cGMP guidelines highlighted their expectations concerning a microbiological continuous process monitoring in A and B grades (FDA guideline_2004 and Annex 1_2008) by referring to settle plates because no other technology was easily available. Unfortunately, settle plates is a non-validatable method as it is simply based on the physical principle of the downfall of a particle on a surface. We will discusses the utility of active air versus passive air settle plate monitoring in routine environmental monitoring on the basis of actual scientific knowledge.
EMEA Sterility Assurance / Microbiology Product Specialist, Particle Measuring Systems
Paola is currently part of the EMEA Sterility Assurance / Microbiology Product Specialist Team and the Advisory Team in Particle Measuring Systems. She is a subject matter expert in the field of cleaning and sanitization of Pharmaceutical Cleanrooms through constant dialogue with operators, quality officers, and financial and production teams. She has experience in examining and understanding contamination issues with specific focus on microbiological hazard, setting rational cleaning and sanitization of cleanroom and pharmaceutical manufacturing plants with relative drafting of VMP, and supporting pharma companies in the validation of sanitizing and decontaminating agents. Paola participates as a speaker at national and international conferences.
Global Sterility Assurance & Advisor, Particle Measuring Systems
Anna Campanella, PhD, is the Global Sterility Assurance Advisor for Particle Measuring Systems. In this role, she uses her industry experience to collaborate and consult with pharmaceutical companies to develop and implement science-based strategies, principles of monitoring, and controlling and improving the chemical, physical, and microbiological state of various production processes. Anna has a diverse background in the Pharmaceutical field including a PhD in Molecular Medicine, expertise in QA&QC processes, validation of chemical and microbiological methods, validation of sterile production processes and experience in microbiological aspects of aseptic production processes.