Achieve a Safe Bioburden Level by Applying Best Alcohol Cleaning & Disinfection 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 cGMP 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. 

Date: April 18, 2019

Choose a time and register:

10:00am Central Eastern Time

11:00am Eastern Time

 

Speaker

Anna Campanella

Global Sterility Assurance & Advisor, Life Sciences Division

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.