Three days fully dedicated to every sterilization aspect, from basic principles to validation activities. Starting from an overview of all sterilization methods, participants will have the opportunity to discover the
secrets of moist-heat sterilization. Not only theoretical sessions, but also hands-on training with process
machines for increasing your practical knowledge.
The course will be held at Fedegari’s Tech Center, where participants will be able to discuss real-life problems while using Fedegari equipment to apply their new knowledge and capabilities. Finally, attendees will have the opportunity to share their experiences and challenges with experts in sterilization and contamination control.
Attendees will learn how to
- Create the perfect cycle for liquid and porous loads
- Run biological and thermal validation
Who Should Attend
- Manufacturing Supervisors and Operators
- QA Managers
- QC Managers
- Facility Managers/Technicians
- Validation/Qualification Personnel
- Equipment Manufacturers
- Head of Production
- Process Engineers
- Process Developers
Learning Objectives
The participants:
- Have understood concepts of decontamination, disinfection and sterilization
- Have understood the principles of moist heat/dry heat sterilization
- Have an overview of other sterilization methods (gamma irradiation, E-Beam, EtO)
- Can calculate F and D values
- Have understood the different cycle requirements for various load types (solid, porous, liquid)
- Have understood approaches for qualification of equipment
- Have understood challenges and solutions for biological and chemical indicators
Instructors
Maria Luisa Bernuzzi, Manager R&D, Fedegari Group
Graduated from University (Chemistry and Pharmaceutical Technology) at the University of Pavia, Maria Luisa started her career dealing with environmental analyses, and then moved to Chemical - Pharmaceutical industry. Being R&D manager and QC manager, in 2010, she also attended a Master degree about “Evaluation and control of the toxicological risk from environmental pollutants - legislation REACH, CLP - chemical risk assessment”. Since 2011, Maria Luisa is R & D manager at Fedegari group: new technologies, a multidisciplinary approach at the Innovations, development of validation strategies ad assessment of process efficacy, also with microbiological tests, are her main tasks. Specialties: Validation of equipment, Sterilization processes, Isolation technology in aseptic and containment applications, Decontamination.
Darren Beckett, Technical Director, Steritech Ltd
Darren Beckett is the Technical Director for SteriTech Ltd. SteriTech are the partner company for Fedegari and Masco Groups in the UK and Ireland. Darren heads the technical team responsible for support, training and consultancy focused on washing, sterilisation and associated aseptic processes including cycle development and validation activities. Darren has over 20 years’ hands-on industrial experience in the Biotech and Pharmaceutical industry focusing on commissioning and validation of moist and dry heat sterilisers and critical utility systems. Since 2013, he has managed the technical centre which includes client product R&D and process development/validation projects and acts as the principle technical and process trainer both at our technical centre and at customer’s sites across Europe and the US.
Annick Gillet, Technical Director EO Pharma, Sterigenics
Annick Gillet has a biochemistry background and began her career at Sterigenics up to 10 years ago as Quality Manager for one of the biggest EO Sterigenics plant located in Belgium. She acted as the main contact during customers and regulatory inspections (FDA, European Authorities …etc.). Annick also gained ten years of experience in Medical Device industry (wound dressings) in R&D, Quality, and consultancy. She also worked for about two years as SME in sterilization at Allergan (Pharmaceutical industry) in a site manufacturing terminally sterilized hormonal Intra Uterine device. As a Technical Director for 3 years, Annick currently leads ethylene oxide sterilization projects in different Sterigenics plants and is supporting the plants as technical expert with pharmaceutical project responsibilities.