On Demand

Airflow visualization studies on demand webinar

Following the entry into force of the new Annex 1, airflow visualization studies like Smoke Studies and Computational Fluid Dynamic (CFD) studies, have become one of the key aspects of a company’s contamination control strategy (CCS).

The importance of these studies is not only limited to the qualification of clean rooms and clean air equipment, but if properly executed they can also be used for other evaluations, such as the definition of the environmental monitoring plan, the training of personnel and the definition of the positions of biological and chemical indicators for the validation of the VHP cycle.

But what does “properly executed studies” mean? There are several requirements that must be met not only to comply with regulatory requirements, but also to generate a scientific-sound study that allows a careful examination of airflow patterns and any related risks.

In this webinar, all these aspects will be explored, with particular focus on the interpretation and use of the information generated by these studies in order to build a holistic and effective contamination control strategy (CCS).

What you’ll learn:

  • the role of smoke studies within a Contamination Control Strategy
  • how to document a flow visualization
  • the requirements for the proper execution of smoke studies
  • how to determine the frequency of smoke studies

Who should attend:

  • Quality Assurance
  • Quality Control
  • Compliance and Validation Specialists
  • Bioprocess Engineers
  • Regulatory Affairs Specialists
  • Manufacturing and Operations Managers
  • R&D Personnel
  • Pharmaceutical Researchers, Scientists and Consultants

 

Webinar Presented By:
Luca Calisi
Advisory Specialist

Luca is a Doctor in Biological Sciences with experience in pharmaceutical microbiology, currently he is an Advisory Specialist in the Global Sterility Assurance Team of Particle Measuring Systems. He started his career in the microbiological quality control laboratory, before moving into sterility assurance in later years. For several years, he has been involved in the risk management and validations of multiple production processes and new lines starting from the quality by design phase. He works on contamination control strategies, cleaning and disinfection strategies, developing risk assessments for environmental monitoring and other sterility assurance consultancy services.

Luca is currently involved in many trainings and speeches for ISPE (International Society for Pharmaceutical Engineering), AFI (Associazione Farmaceutici dell’Industria), PDA (Parental Drug Association) and with lectures in Italian universities since 2020 for the Master of 2 Level in “Industrial Pharmaceutical Methodologies” of the Sapienza University of Rome.

Christian Glosse
Associate Product Line Manager

As an Associated Product Line Manager for GMP Services, Mr. Glosse is responsible for managing the product line of GMP services offered by Particle Measuring Systems in Switzerland. Christian holds a degree in Mechatronics Engineering and has completed various GMP-related trainings, as well as being a Certified Product Line Manager. With over 15 years of experience in the GMP Services field, Christian has worked in various roles, starting as a PMS (formerly CAS) GMP Service Technician in 2007. In 2016, Christian transitioned to the Sales organization as Sales Manager for GMP Services in Switzerland and Austria. Since 2021, he has been part of the Product Line Management Team for GMP Services, where he focuses on compressed gases, smoke studies, and ISO 14644. Outside of work, Christian enjoys spending time with family and exploring the open roads on a motorbike.