PDA Italy Chapter: Blow Fill Seal Technology - State of the Art for the Aseptic Primary Packaging of Parenterals
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Individual Registration
Group Registration
PDA Italy Chapter is pleased to announce Blow Fill Seal Technology: State of the Art for the Aseptic Primary Packaging of Parenterals in association with Brevetti Angela. Two days fully dedicated to latest developments in the Blow-Fill-Seal technology and the manufacture of sterile pharmaceutical products with a deep focus on the impact of new regulations, on the challenges and advantages faced when filling pharmaceutical products in plastic, and on the possibilities given by such a process compared to traditional filling.
At this event, we will present and discuss new developments and expectations in BFS, which continues to be critical for the packaging of parenterals with high speed and reduced cost. This applies to small volumes for injectables, ophtalmics, sprays, but also to prefilled syringes and to large volumes like IV solutions. Starting from the regulatory scenario, which continues to evolve rapidly with new or revised guidance, we will see how Annex 1 new requirements are met within the Blow Fill Seal process with a case study about vaccine filling.
We will examine the differences between traditional filling in glass ampoules and BFS, understanding pros and cons directly from the voice of a pharmaceutical company who has been using this technology for more than a decade. We will also analyze the role of plastic in primary packaging, with special attention to medical grade granules and sustainability. Special attention will be given to the matter of extractables and leachables, and to the role of Container Closure Integrity Testing and Visual Inspection.
Organizing Committee
Andrea Simonetti, Consultant
Massimo Consolaro, Brevetti Angela
Rajeev Kabbur, Brevetti Angela
Filippo Trionfera, BSP Pharmaceuticals
Lucia Ceresa, Charles River
Mirko Gabriele, InfiniteVision
Gabriele Peron, Stevanato
How to Register
For registration, general information and payment enquiry, please visit PDA Italy Chapter at the page dedicated to the Event.
Sponsorship Opportunities
Exhibition and Sponsorship Opportunities are available. Exhibit at PDA events and let your company’s products or services become a valuable tool or resource for our attendees. Contact the Organizing Secretariat at pda@pda-it.org to learn more.
Language
The official languages are Italian and English. No simultaneous translation is provided. The presentations (ppt slides) will be in English.
Congress Venue
Villa Cordellina Lombardi
Via Lovara 36, 36075 Montecchio Maggiore (VI)
Manufacturing Plant Tour
Brevetti Angela SRL
Via Seconda Strada 48
Via Industria 99
Arzignano (VI)
info@brevettiangela.comEvent Location
Via Industria, 99, Arzignano, Italy 36071 Get DirectionsContact
Chapter Inquiries
Membership Services
| Registration Type | Registration Fee |
|---|---|
| University and Regulators | €122.00 |
| PDA Members | €366.00 |
| PDA Non-Members | € 549.00 |
| 2 Colleagues for the Conference at the Same Time | € 732.00 |
| 3 Colleagues for the Conference at the Same Time | € 1,038.00 |
Registration fee includes badge, program, admission to the scientific sessions, certificate of attendance, coffee breaks, lunches, networking dinner.
Method of Payment
Bank Transfer Beneficiary: Centro Congressi Internazionale srl
Bank: INTESA SANPAOLO SPA
Mandatory causal: C009/24 + Name/Surname of the participant and Company IBAN: IT08X0306901000100000067336
BIC SWIFT: BCITITMM
Copy of the bank transfer should be sent to the Organizing Secretariat at pda@pda-it.org
After receiving the payment, the Organizing Secretariat (Centro Congressi Internazionale srl) will issue a regular invoice.
Day 1
11:00 | First Meeting Point at Verona Porta Nuova Train Station and Transfer by Bus to Hotel Crowne Plaza
11:30-11:45 | Overall Meeting Point at Hotel Crowne Plaza Lobby and Transfer by Bus to Villa Cordellina
13:00-14:00 | Arrival, Registration & Welcome Buffet
14:00-14:15 | Opening Remarks and Proposed Discussion Topic, Mirko Gabriele, Consultant and PDA Italy Chapter President
14:15-14:30 | Welcome and Introduction, Rajeev Kabbur, Director of Sales and R&D, Brevetti Angela S.r.l.
14:30-15:00 | Overview of the Regulatory Aspects and Requirements Related to BFS – EU GMP Volume 4 Annex 1, PTC BFS IOA, PDA TR 79. Andrea Simonetti, Consultant
15:00-15:30 | Evolving your Fill and Finish Process to Blow Fill Seal , Lellos Argyris, Demo, Rajeev Kabbur, Director of Sales and R&D, Brevetti S.r.l.
15:30-16:00 | Design of an Aseptic Filling Line in Accordance with new Annex 1, Mattia Ricchini, Junior Sales Manager, CSV Life Science, Ajay Kabbur, Sales Department, Brevetti Angela S.r.l.
16:00-16:15 | News from the Sponsors
16:15-16:45 | Coffee Break at the Sponsors Area
16:45-17:30 | Points-to-Consider for the Qualification and Validation of BFS Processes, Claudio Puglisi, Managing Partner, Entourage
17:30-17:45 | Panel Discussion with all Speakers, Chairs: Fernanda Ferrazin, Life Science Consultant, former Senior AIFA GMP Inspector and Marisa Delbò, former AIFA Senior GMP Inspector
17:45-18:00 | Wrap-up and Closure of the First Day. Networking Dinner to Follow at the Hotel Crowne Plaza. Pickup and Transfer Provided by Brevetti Angela
Day 2
07:45 | Meeting Point at Hotel Crowne Plaza Lobby
08:00-9:30 | Transfer by Bus to Villa Cordellina
9:30-10:00 | Medical Grade Plastics and the Challenges of Sustainability, Anja Gottschalk, Borealis Group
10:00-10:30 | Extractables & Leachables Testing of BFS Ampoules, Iris Destoop, Nelson Labs
10:30-11:00 | Coffee Break at the Sponsors Area
11:00-11:30 | BFS Applications and New Developments: Squeezable Syringes, Massimo Consolaro, Brevetti Angela S.r.l.
11:30-12:00 | BFS Containers Automatic Visual Inspection & Leak Detection: Particle Identification, Characterization and Definition of Control Strategy, Matteo Falcone, Antares Vision and Atanas Koulov, Clear Solutions Laboratories
12:00-12:30 | Blow Fill Seal Technology – GMP Inspection prospective, Panel Discussion with all Speakers, Chairs: Fernanda Ferrazin, Life Science Consultant, former Senior AIFA GMP Inspector and Marisa Delbò, former AIFA Chief GMP Inspectorate
12:30-13:30 | Lunch
13:30-13:45 | Transfer to Brevetti Angela Plant
13:45-15:00 | Manufacturing Tour: Splitting into Groups of About 15 people and Visit of the BFS Machines In-Operation
15:00-15:15 | Transfer from Brevetti Angela Facility to Villa Cordellina
15:15-15:45 | Coffee Break
15:45-16:15 | Round Table Discussion
16:15-16:30 | Wrap Up and Closing Remarks
16:30-17:00 | Transfer to Hotel Crowne Plaza
Note: Transfers from Hotel Crowne Plaza to Facilities and back will be arranged by Brevetti Angela based on the scheduled timing. Participants are responsible for organizing and paying their own travel costs and accommodation to the Hotel
Thank You to Our Sponsors
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.