PDA Italy Chapter: Sterilization: Hot Topics and Innovation in the Pharmaceutical Applications

San Martino Siccomario, Italy
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Program Highlights

General Information

 

Registration

For registration, general information, and payment enquiry, please visit www.pda-it.org the page dedicated to this event

Language

The official languages are Italian and English. No simultaneous translation is provided. The presentations (ppt slides) will be in English.

Organizing Committee
  • Mauro Giusti Lilly Italia - PDA Chapter President
  • Filippo Trionfera BSP Pharmaceuticals
  • Lucia Ceresa Charles River Microbial Solution
  • Gabriele Peron Stevanato Group
  • Mirko Gabriele PDA Italy Chapter President Elect
  • Carlo Marconi (Antares Vision Group)

PDA Events & Organizing Secretariat

CCI

Centro Congressi Internazionale S.r.l.

Via Guarino Guarini 4 – 10123 Turino

Tel. 011/2446925 – fax 011/2446950

e-mail: pda@pda-it.org web: www.pda-it.org

PDA Italy Chapter is pleased to announce, in collaboration with De Lama, the event “Sterilization: hot topics and innovation in the Pharmaceutical Applications”. The event will take place on October 26th and 27th 2023 at the De Lama Plant in San Martino Siccomario (PV). The event is focused on:

  • Sterilization Hot topics (such as equilibration time, load configuration, cycle development, sterilization packaging, presterilized containers, etc..)
  • Innovations aspects (such as new sterilization processes and automation of sterilization operations)
  • Tour of the De Lama Plant

Case studies will be presented by Industry experts with strong experience in sterilization and commented with all participants.

The agenda will also include a guided tour at De Lama facility dedicated to the production of sterilization and washing equipment.

Finally, attendees will have the opportunity to share their experiences and challenges with experts.

Standard Registration

Member Price

€ 366,00

Day 1

  • 12:00 - 12:30 | Arrival at Hotel Moderno (PV)
  • 12:30 - 12:45 | Bus Transfer from Hotel Moderno to De Lama Plant
  • 12:45 - 14:00 | Arrival at De Lama Plant and welcome buffet & registration
  • 14:00 - 14:15 | Opening remarks and proposed discussion topic: Mauro Giusti – President PDA Italy Chapter
  • 14:15 - 14:30 | Welcome and Introduction: Marco Bianchi - De Lama S.p.A.
  • 14:30 - 15:15 |Innovative sterilization approach: Hyper pure technology key aspects : Guido Rovera – De Lama S.p.A
  • 15:15 - 15:45 | Equilibration time: how to fill the gap: Saverio Paolini – Akkodis
  • 15:45 - 16:00 | Sponsors' Welcome
  • 16:00 - 16:15 | Coffee Break
  • 16:15 - 16:45 | Autoclave validation: the importance of load designing on validation and re-validation activities: Giovanna Cantoni – PQE
  • 16:45 - 17:15 | In-line sterilization: case study: Marco Alberio – Pharma Process
  • 17:15 - 18:00 | Panel discussion with all speakers, chairs: Fernanda Ferrazin, Life Science Consultant, former Senior GMP Inspector and Marisa Delbò, former Senior GMP Inspector & Closing
  • 18:00 - 18:15 | Wrap-up and final remarks from Day-1: Filippo Trionfera – BSP Pharmaceuticals
  • 18:15 - 19:00 | Happy Hour with the Sponsors
  • 19:00 - 19:30 | Transfer to Villa Botta
  • 19:30 - 21:45 | Networking Dinner at Restaurant: Villa Botta Adorno di Torre d'Isola.

NOTES: Participants are responsible for their own travel costs and accommodation. A suitable number of rooms have been reserved at discounted rate at the Hotel Moderno.

Transfers from/back to Hotel Moderno (close to the Pavia train Station) and De Lama facility as well as from De Lama to Villa Botta and from Villa Botta, to Hotel Moderno will be arranged by De Lama based on the scheduled timing.

Day 2

  • 08:45 - 09:15 | Bus Transfer from Hotel Moderno to De Lama Plant or arrive at De Lama Plant by car
  • 09:15 - 09:45 | SUS sterilization methodologies - Risk based approach and data comparison: Dario Bonanni - Merck
  • 09:45 - 10:15 | Sterilization management of ready to use primary components: available options and industrial implementation: Alice Bellini and Leonardo Furlan - Stevanato Group
  • 10:15 - 10:45 | Packaging Solution for Sterilization Processes: Massimo Mannini - AM Instruments
  • 10:45 - 11:00 | Coffee Break
  • 11:00 - 11:30 |Terminal sterilization: case study: Mladen Simunovic - Consultant
  • 11:30 - 12:00 | Robotic & automation: how to impact the sterilization process: A. Tanzini - Staubli
  • 12:00 - 13:00 | Lunch
  • 13:00 - 14:30 | Factory tour at De Lama Facility. Intro 5 minutes: Background info and Factory guidelines
  • 14:30 - 15:15 | Biological Validation for a Moist Heat Sterilization; an overivew fo the different approaches based on the load we have to treat: Luisa Bernuzzi - Mesa Labs
  • 15:15 - 15:30 | Coffee Break
  • 15:30 - 16:00 | Panel discussion with all speakers, chairs: Fernanda Ferrazin - Life Science Consultant, former Senior AIFA GMP Inspector andMarisa Delbò, former Senior GMP Inspector & Closing
  • 16:00 - 16:15 | Wrap up and closing remarks: Mauro Giusti - President, PDA Italy Chapter
  • 16:30 - 17:00 | Bus Transferfrom De Lama Plant to Hotel Moderno
Agenda is subject to change.

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Congress Venue

MANUFACTURING PLANT at De Lama site:

Via Piemonte, 21, 27028 San Martino Siccomario (PV) Italy

Day-2, October 27th, 2023 - 13:15 -14:30

Factory tour

DE LAMA

Convention Hotel

Hotel Moderno
Viale Vittorio Emanuele II, 41 – 27100 Pavia
www.hotelmoderno.it/
While booking, refer to: “PDA/DE LAMA Sterilization event”.

Hotel Moderno