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PDA Italy Chapter Single Use and Innovation Technologies to Face New Regulatory Challenges Event

Nov 06, 2019
Rome,

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Overview

Single use technologies - technically defined as disposables - play a prominent role in continuous growth in the development of new products and processes. Companies offering pre-assembled systems that are radiated and ready to use more and more numerous: in fact, it has been widely demonstrated that pre-assembled disposable systems reduce the risk of contamination, improve production efficiency and the Overall Equipment Efficiency (OEE). And again, thanks to their flexibility, the process transfer times, both from site to site and in case of scale up, are considerably reduced.

Although these credentials lay the foundations for a growing popularity, there are still some latent doubts and unanswered questions.

- What are the parameters that allow you to determine whether the use of the disposable in a process is convenient?
- How to foresee the interaction between plastic materials and product?
- Is it more appropriate to use a leachables or extractables solution?
- How to make sure that the disposable is sterile?
- What minimum standards should suppliers of disposable technologies be required to use in sterile applications? And for products for parenteral use?
- Are there good practices in the design of assembled and ready-to-use systems?

"Single Use and Innovation Technologies to face new Regulatory Challenges" aims to deepen these discussion points among the various themes, sharing the experience of those companies that have already processed and addressed them, implementing the disposable technology in their own production process.

Plant Tour

Site visites will be organized at the Patheon and BSP plants and will be reserved for the first 40 members of the Congress. Participants will be able to visit only one of the two establishments. It will be possible to indicate, during the registration phase, your preference which will be taken into consideration unless the places available are exhausted.

Agenda

  • Day 1
  • Day 2
    • 08:30 Attendees registration
    • 09:00 Welcome: Opening Remarks & Introduction: Angela Molaschi, PDA Italy Chapter President
    • 09:15 Introduction on Disposable Technology: regulatory requests and quality challenges Michele Simone - Bracco Suisse SA
    • 09:45 Disposable Technology in a biotech process; case study and business case Vito Pisani - Thermofisher
    • 10:15 Coffee Break at the sponsor area
    • 10:45 Implementation of the Single Use Technology for conjugation processes: Paolo Brandi – BSP Pharmaceuticals and Concetta Paolella - BSP Pharmaceuticals
    • 11:15 Design of a single use system for a high-speed syringe filling line in isolator Sergio Chiuderi - Eli Lilly Italia
    • 11:45 Single-use components for automation - Zanotto Andrea – IMA
    • 12.15 Questions from the audience
    • 12:45 News & technical innovation from the sponsors
    • 13:15 Lunch break and visit to the sponsor area
    • 14:30 E&L assessment for biotech manufacturing materials Irene Cecchini - Merck Health Care
    • 15:00 Implementation of an aseptic manufacturing model based on SUS from small to large scale - Enrico Paroni – Adienne, Martina Largoni – Stevanato Group
    • 15:30 Final filtration and single use technology – design consideration with respect to Annex 1 Nicola Rutigliani, Merck Health Care and Francesco Esposito - Merck Life Science
    • 16:00 Coffee Break at the Sponsor Area
    • 16:30 Process Design using Single Use Technology for sterile injectable drugs Eleonora Magliochetti - Thermofisher
    • 17:00 Single use device, pharma production process and barrier technology: the synergy between URS and technologies - Simone Penazzi – Comecer
    • 17:30 Roundtable Panel Discussion
    • 18:30 Cocktail and visit at the sponsor area
    • 20:00 Networking Dinner
    • 08.30 Departure from the Hotel Mediterraneo to reach either Thermofisher or BSP Pharmaceuticals (chosen during the event registration at the CCI Secretariat portal)
    • 10.30 Manufacturing Sites Visit
    • 13.30 Lunch all together
    • 15.00 Conclusions

Travel

Hotel Mediterraneo

Via Cavour, 15
Rome,

Directions

Registration Fees

Regular Price
Registration Type Price (VAT 22% Included)
PDA Member €500,00
Non-Member €650,00
Discounted Rate with 2 Collegues Registering Together €900,00
Discounted Rate with 3 Collegues Registering Together €1200,00


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