Achieve a Safe Bioburden Level by Applying Alcohol Cleaning & Disinfection Best Practices 4/18/2019

Alcohol is the most used disinfectant in GMP cleanrooms. Alcohol's most appreciated features, the almost total absence of residues and its detergent action, depend on its quick evaporation. This means that a short contact time should be considered as a effectiveness limiting factor. Even if GMP guidelines clearly request a specific detergent step before disinfection, IPA is widely used both as cleaner and disinfectant for critical surfaces in aseptic areas, too. What should be considered to define the surface bioburden safe level ? How can it be met? We discuss the benefits and limits of the most commonly used disinfectants in GMP critical surfaces routine decontamination procedures, with particular focus on alcohol. Then, we point out the importance of mechanical actions for detergency and how disinfectants validation studies critical parameters have to be defined.





Paola Lazzeri

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.


Francesco Cenci

Sterility Assurance Leader, Sanofi

Francesco Cenci is a Sterility Assurance Leader at Sanofi. He is an expert in microbiological quality control testing, sterility assurance, environmental monitoring, aseptic process simulation, and failure investigations with a microbiological focus.