PDA Italy Chapter: Managing Disinfection Within an Advanced CC

Limbiate, Italy
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Program Highlights


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

Organizing Committee

Mirko Gabriele / President PDA Italy Chapter

Mauro Giusti / Lilly Italia – PDA Italy Past Chapter President

Angela Molaschi / Pharmatex – Past-Past President PDA Italy Chapter

Filippo Trionfera / BSP Pharmaceuticals – President-elect PDA Italy Chapter

Gabriele Peron / Stevanato Group - PDA Italy Chapter Board

Claudio Puglisi / Entourage - PDA Italy Chapter Board

Lucia Ceresa / Charles River Microbial Solution - PDA Italy Chapter Steering

Francesco Boschi / Pfizer-AFI

Annex 1 indicates clear requirements for Cleaning and Disinfection which are key elements included in the Contamination Control Strategy (CCS) as a holistic and mandatory process for the manufacture of sterile products.

Based on the process understanding, appropriate risks assessment and mitigation measures should be applied considering potential impact on the quality of the final sterile product with the final goal to create a specific quality assurance-approved disinfection and monitoring program able to ensure the required compliance.

Materials utilized for the construction of the room and for items used within the cleanroom, should be selected to minimize particle generation and to allow the suitable use of the cleaning and disinfectant agents.

Several case studies will describe practical solutions for: glove management and materials handling, cleaning, sanitizing agents, disinfectants evaluation, materials compatibility, and frequency program and sanitization technologies.

Registration TypeRegistration Fee
University and Regulators€122.00
PDA and AFI members €366.00 (Friday only: € 219.00)
PDA and AFI NON-members€ 549.00 (Friday only: € 329)
2 Colleagues for the Conference at the Same Time€ 732.00
3 Colleagues for the Conference at the Same Time€ 1,038.00

Day 1

12:40-14:00 | Arrival, registration & Welcome buffet at AM Instruments Limbiate site

14:00-14:15 | Opening remarks and proposed discussion topic – PDA Italy Chapter / AFI

14:15-14:30 | Welcome and Introduction – Maria Adele Imro & Massimo Mannini, AM Instruments

14:30-15:00 | Clean rooms sanitizing technology – Emanuele Salmaso & Antonio Evangelista, Fresenius Kabi iPSUM

15:00-15:30 | Tim Sandle (confirmed)

15:30-16:00 | Managing residues - How can cleaning and disinfectant residues be a risk to product quality? What can be done to control them in a cleanroom environment? – David Keen, Ecolab

16:00-16:10 | Sponsors’ Welcome

16:10-16:45 | Coffee break

16:45-17:15 | Selection and rotation of disinfectants for DCS (Drug Containment Solution) – Greta Franzoso & Francesca Squizzato, Stevanato Group

17:15-17:45 | Hard to Kill Bugs: Identifying resistant Species – Duncan Barlow, Microbial Solutions, Charles River

17:45-18:15 | Rationalization of the cleaning and disinfection program - Valentina Farsetti, Consultant

18:15-18:45 | Panel discussion with all speakers. Chairs: Fernanda Ferrazin, Life Science Consultant, former Senior AIFA GMP Inspector and Marisa Delbò, former AIFA Chief GMP Inspectorate

18:45-19:00 | Wrap-up and final remarks from Day 1, PDA Italy Chapter/AFI

19:00-19:30 | Happy Hour with the Sponsors

19:45-22:00 | Networking dinner at Palazzo Borromeo (Cesano Moderno - MI)

Day 2

08:45-09:00 | Arrival & registration DAY-2 at AM Instruments Limbiate site

09:00-09:15 | Opening remarks and proposed discussion topic – PDA Italy Chapter

09:15-09:45 | Cleaning and disinfection within CCS program – Francesco Boschi, Pfizer/AFI

09:45-10:15 | Contamination control in aseptic production – Application of sterile packaging and protective solutions in the pharmaceutical industry– Juha-Pekka Pöyry, Dupont Tyvek® Healthcare Packaging

10:15-10:45 | Managing cleaning and disinfection for Isolator use – Massimiliano Frasca, BSP

10:45-11:15 | Coffee break

11:15-11:45 | Grade A continuity: contact parts management for transfer into isolator technology – Fabrizio Gelli, GSK Vaccines Rosia

11:45-12:15 | Control and qualification of Rapid Transfer Port – Lorenzo Mazzetti, Thermo Fisher Scientific / Monza

12:15-13:00 | Lunch

13:00-14:30 | AM Instruments Factories Tour

14:30-15:15 | AIFA Inspector (Invited)

15:30-15:45 | Panel discussion with all Speakers. Chairs: Fernanda Ferrazin, Life Science Consultant, former Senior AIFA GMP Inspector and Marisa Delbò, former AIFA Chief GMP Inspectorate

15:45-16:00 | Wrap-up and Closing Remarks, PDA Italy Chapter/AFI

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

AS Hotel Limbiate Fiera

When booking online, enter code: AMIN

Congress Venue

AM Instruments Via Isonzo, 1/c, 20812 Limbiate MB

Day 2, Friday March 15th, 2024: 13:00 -14:30:

Manufacturing Plants Tour at AM Instruments Plant in Limbiate and AM Instruments Plant in Cesano Maderno MB.

Transfer will be arranged by CCI/PDA Italy Secretariat - AM Instruments.