Program
SYMPOSIUM ISCC2024 AGENDA - PROVISIONAL PROGRAM*
| 8.00 – 9.00 | Registration |
| 9.00 – 10.00 | ISCC2024 – Opening Ceremony |
| Plenary Session – Standards & Regulations | |
| 10.00 – 10.30 | Update and Progress on ISO/TC209 WG2 towards a new ISO 14644-20 Conor Murray (3 Dimension) |
| 10.30 – 11.00 | Impact of the Paradigm shift in GMP regulations on “Connecting the Dots” in Contamination Control James L. Drinkwater (PHSS) |
| 11.00 – 11.30 | Coffee Break & Ehibition |
| 11.30 – 12.00 | Cleanroom operations control program (New ISO 14644-5) Koos Agricola (Brookhuis/ICCS) |
| 12.00 – 12.30 | Beyond ISO TR 14644-21 – dealing with airbone particle sampling challenges in the field John Hargreaves (JHAC/ASPEC) |
| 12.30 – 13.00 | Standards & Regulation Q&A |
| 13.00 – 14.30 | Lunch & Exhibition |
| Parallel Clean Room Design, operation & maintentance | Parallel Barrier Technologies | Parallel Microelectronics and associated technologies | Parallel Healthcare | |
| 14.30 – 15.00 | Product Oriented Contamination Control Koos Agricola (Brookhuis/ICCS) |
Meeting the challenges of H2O2 biodecontamination with innovation in rapid validation methods Kate Marshall (Protak) |
Study – The semiconductor industry in the context of the European economy Udo Gommel (Fraunhofer) |
Environmental microbiological monitoring strategies Laura Boschi (ProPharma) |
| 15.00 – 15.30 | Ventilation efficiency: the impact of the temperature and velocity of the incoming air and internal heat loads Leonello Sabatini (Lesatec) |
Discover the power of Biological Indicators: Unveiling the science behind ensuring impeccable bio-decontamination in isolators Maria Luisa Bernuzzi (MesaLabs) – Federica Straforini (BSP Pharmaceuticals) |
Design essential for future ready Micro/nano cleanrooms Eric Stuiver (Deerns) |
Product safety and OOS (out of specifications) management Monica Gunetti (OPBG) |
| 15.30 – 16.00 | Use of CFD simulation to optimize ventilation effectiveness in cleanrooms – case study Lapo Galligani (Techniconsult) Toni Valente (Pierrel) |
Gloveless Robotic Filling. How to meet industry and regulatory requirements Robert Kibele (Groninger) |
A holistic approach for a large wafer Fab. An italian case study Angelo Colleoni (Global Wafers – MEMC) – Francesco Romano (Politecnico di Milano) |
Technical and Regulatory challenges of “Point of Care Manufacturing” Andrea Urciuolo (PQE Group) |
| 16.00- 16.30 | Coffee Break & Exhibition | Coffee Break & Exhibition | Coffee Break & Exhibition | Coffee Break & Exhibition |
| 16.30-17.00 | Ventilation effectiveness in practice Frans Saurwalt (Kropman) |
Design of isolators for aseptic fill-finish in extreme environmental and containment conditions Giacomo Guidi (IMA Life) |
Study of the regeneration method of cation exchange resin for treating trace level airborne molecular contaminats Wai Hoo Foong (Mayair) |
Automated compounding of non-hazardous drugs Giuseppe Zucca (Jaserv) |
| 17.00 – 17.30 | Experimental and computational Study of Upflow cleanrooms Takahiro Ishino (Tonets) |
Airflow Visualization Studies: the impact of Annex1 on sterility assurance Luca Calisi (Particle Measuring Systems) |
Contamination Control during construction of a large wafer Fab – phasing and strategies |
Updating the SIFO standars for galenics in oncology: reporting results from the SIFO-ASCCA collaborating group Costantino Jemos (ASST Nord Milano) |
| 17.30 – 18.30 | Panel Session | Panel Session | Panel Session | Panel Session |
| 8.00 – 8.30 | Registration |
| 8.30 – 9.00 | ISCC2024 – Day2 Opening |
| Plenary Session – Sustainability and Innovative Approaches | |
| 09.00 – 9.25 | Sustainability Ambition: Carbon net zero and net nature positive Chris Hayes (GSK) |
| 9.25 – 9.50 | Energy saving and decarbonization in a news biopharma manufacturing facility Pier Angelo Galligani – Giorgio Amato (Techniconsult) |
| 9.50 – 10.15 | Energy optimisation and Regulatory Aligment in GMP Cleanrooms – application of the new ISO 14644-16 to the new Annex1 Klemen Skrlec (Novartis) – Natasa Stirn (Klimer) – Conor Murray (3Dimension) |
| 10.15 – 10.40 | Advances in sustainable solutions at Life science Facilities Keith Beattie (EECO2) |
| 10.40 – 11.10 | Coffee Break & Ehibition |
| 11.10 – 11.35 | Case study on reuse/recycle of rain water in a pharmaceutical facility Lilian Amaral (Novo Nordisk) |
| 11.35 – 12.00 | Critical issues of pharmaceutical waste management within the broader framework of achieving a net zero waste approach and embracing circularity principles Samah Ringa (Veolia) |
| 12.00 – 12.25 | A greener semiconductor industry challenges & opportunities Reinier Richters (Deerns) |
| 12.25- 13.00 | Sustainability and Innovative Approaches Q&A |
| 13.00 – 14.30 | Lunch & Exhibition |
| Parallel Clean Room Design, operation & maintentance | Parallel Life Science | Parallel Environmental Control and Monitoring | Parallel Healthcare | |
| 14.30 – 14.55 | Integrated approach of HVAC design and commissioning Carlo Magni (Wood) |
The closed processing advantage: optimizing biopharma facilities Sarah Le Merdy (Merck KGaA) |
Future QC Testing usign automation and robotics – automated environmental monitoring Anke Hossfeld (Merk Life Science) |
The development of ultraclean air operating rooms |
| 14.55 – 15.20 | The advances in Hepa filtration equipment to improve test & validation efficiency and accuracy on your site Michael Feldtmann (Camfil) |
How CFD can suppoto CCS in clean room design – case study Toni Valente (Pierrel) – Lapo Galligani (Techniconsult) |
Continous environmental monitoring according to the European GMP Annex1 – new requirments, next challenges and comparison with the previous regulation guideline Diego Bompadre (Rigel Life Sciences) |
Evaluation of source strenght in a dispersal chamber of three new generation clean air suits Berit Reinmuller (Chalmers University of Technology) |
| 15.20 – 15.45 | Bridging the gap between construction and operation & maintenancet Chris Delaney – Andre van Tongeren (Apleona / VCCN) |
Annex1: Contamination Control Strategy for material transfer. Best practice for packaging and surface disinfection Renee Buthe (Steris Life Sciences) |
Microbiological environmental monitoring: a comprehensive analysis and procedure analysis for continuous monitoring according to EU GMP Annex1 Miriam Magrì (CMA Srl) – Francesco Romano (Politecnico di Milano) |
Operating theaters are not all the same: can laminar air flow really make a difference? A correlation study between HVAC systems and surgical site infections Agnese Lucesoli (Ospedale Ancona) |
| 15.45 – 16.15 | Coffee Break & Exhibition & Handing over | Coffee Break & Exhibition & Handing over | Coffee Break & Exhibition & Handing over | Coffee Break & Exhibition & Handing over |
| Parallel Clean Room Design, operation & maintentance | Parallel Life Science | Parallel Environmental Control and Monitoring | Parallel Aerospace | |
| 16.15-16.40 | Maintenance strategies for cleanliness critical environments – Fast setups, high efficiency, cost-minimized Udo Gommel (Fraunhofer) |
How to harness robotics in contamination controlled applications Andrea Tanzini (Staubli Robotic) – Filippo Parini (Steriline) | Development of an environmental monitoring program for a cleanroom in the life science industry Lene Blicher Olesen (Niras) |
Containment of terrestrial contamination in space missions to Mars Diana Beatriz Margheritis (Thales Alenia) |
| 16.40 – 17.05 | Research on Humidity Control Using a Desiccant wheel inside EFEM (Equipment Front End Module) Seong Cheon kim (Shinsung E&G) |
Leveraging emerging technologies for hydrogen peroxide bio-decontamination: from novel process data to real process impact Martin Novak (Skan) |
Basics and beyond; How to Prepare Proper Contamination Control Strategy Document Hasim Solmaz (Lighthouse worldwide solutions) |
Evaluation of advanced cleaning processes for sensitive surfaces in optical instrumentation David Cheung (ECP) |
| 17.05-17.30 | High Potent OSD facility: Process Containment and Clean Room design Emilio Moia – Ilaria Beccio ( Jacobs) |
Potent OSD Global Supply Marco Annoni (IMA Active Division) |
Are all viable microorganisms culturable? Michel Thibaudon (ASPEC) |
Sailor MOON: Solar ultraviolet light collector for germicidal irradiation on the Moon Matteo Lombini (INAF) |
| 17.30 – 18.00 | Closure Session | Closure Session | Closure Session | Closure Session |
Patronage
