PDA Italy Chapter: Blow Fill Seal Technology  - State of the Art for the Aseptic Primary Packaging of Parenterals

Arzignano, Italy
Register Now
Ask a Question

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.

The conference will be held in the splendid setting of Villa Cordellina Lombardi, an Eighteenth-century palace that combines the Palladian elegance with Baroque forms. The presentations will be given under Tiepolo’s frescoes of the main hall and the coffee breaks will be held in the elegant garden of the villa. The workshop will be arranged at Brevetti Angela’s plant for all practical activities, where we will visit the production area and we will have the opportunity to see a BFS machine in operation.

This will also be a wonderful opportunity for exhibitors to present themselves and their product and service portfolio, as a dedicated time slot has been added to the agenda for this specific purpose.

Early bird discount: 10% discount for confirmation received by 20/05/2024.

Registration fee includes badge, program, admission to the scientific sessions, certificate of attendance, coffee breaks, lunches, networking dinner.

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 [email protected] 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)
[email protected]
Registration TypeRegistration 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 [email protected]

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 | The Risk Management of an aseptic filling process as a support to CCS, Marisa Pedretti, PTM Consulting

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.

18:00-19:00 | Aperitif / cocktail hour and networking

19:00-21:30 | Gala Dinner at the wonderful location of Villa Cordellina

21:30-22:15 | Transfer by bus to Hotel Crowne Plaza. Pickup and transfer to Hotel Crowne Plaza by bus provided by Brevetti Angela

NB: 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.

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 | Visual inspection and leak detection of Blow-Fill-Seal containers. Part I: Visual inspection for BFS containers - control strategy and lifecycle management considerations, Atanas Koulov, Clear Solutions Laboratories. Part II: Automatic Visual Inspection & Leak Detection for BFS containers, Matteo Falcone, 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

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.

Convention Hotel

Crowne Plaza Hotel

via Belgio 16, 37135 Verona

Reserve online: Crown Plaza Hotel