The seminar will host some of the world leaders in single use systems (SUS): Sartorius-Stedim, Pall, Merck, Neumo-SUS.

A primer on basic SUS equipment and materials will kick start the day.

The seminar will introduce the subject of general fluid management using Single-Use Technology: mixing, transfer, storage, how to connect to next operating unit, standardization. How to balance SUS lead times with design flexibility and supply predictability.

A presentation will be given on the advantages of the SUS in regards to process efficiency, savings in facility clean rooms and utilities.
A session on extractables and the effective adoption of Single-Use Systems (SUS) will be given with instruction on how to select the solvent streams and extraction conditions to model the product and process steps complemented with the right analytical strategy.

Agenda:

08:30-09:00

Registration

09:00-09:15
Introduction
Shlomo Sackstein
Biopuremax
09:15-10:00 An Introduction to Single Use Systems
Introduction to SUS equipment

Jaume Urpí
Neumo-SUS

10:00-10:45 Efficency of Single Use Systems
How single use systems make the factory smaller, more efficient, cost effective. Analysis of utilties to be adapted to SUS, how clean rooms change when SUS is used

Sarel Chen Tov
Biopharmax

Shlomo Sackstein

Biopuremax

10:45-11:15
Coffee Break
11:15-12:00 How to Assure Performance, Robustness, and Sterility of Single Use Systems
Quality approach in manufacturing of single-use systems: single-use assembly validation, quality control, risk mitigation practices
Simone Biel
Merck
12:00-12:45 General Fluid Management Using Single-Use Technology
Mixing, transfer, storage (performance, points to consider, challenges), How to connect to next operating unit (aspetic connector, how to validate, where to use, etc), Standardization? How to balance SUS lead times with design flexibility and supply predictability

Claudia Gagliardini
Pall Biotech

Daniel Martinez
Ompi-Stevanato Group

12:45-13:45 Lunch
13:45-14:30 Container Closure Integrity
How to assure performance, robustness, and sterility of single use systems. Sterilization, validation and integrity
Luke Coxon
Sartorius-Stedim
14:30-15:15 Coffee
15:15-16:00 Extractables and the Effective Adoption of Single-Use Systems
The successful adoption of single-use technologies in a biopharmaceutical process largely relies on confidently selecting the right components for use in the fluid path of a product, within a specific process. An important step in choosing such components requires generating an extractables profile, which can be done by carefully selecting the solvent streams and extraction conditions to model the product and process steps complemented with the right analytical strategy
Simone Biel
Merck
16:00-16:30 Wrap up

Note: the program and speakers are tentative and subject to change without prior notice.


Claudia Gagliardini, Pall Biotech, Claudia is Business Development Manager @ Pall Corporation, Claudia is a Molecular Biologist with 10 years experience in the pharmaceutical field, focused on biotech process flow development. She helps customers design flexible single use platform suitable for regulatory and market needs. Daniel Martinez, Ompi-Stevanato Group Bachelor’s degree in Mecatronics Engineering from the Instituto Tecnologico y de Estudios Superiores de Monterrey. Mr Martinez has worked for the past 7 years for international companies dedicated in primary packaging for parenteral drugs. He has experience in different aspect and functions such as production, technical liaison, quality, project management and sales. He currently holds a position as Product Manager and Special projects in Stevanato Group, responsible for the development and market placing of different products offered in Ompi’s portfolio.

Luke Coxon
is the Field Marketing Manager for Fluid Management Technologies responsible for the, Asia Pacific region. Luke is responsible for the field-based marketing and technical support personnel in the geography and supports the application of Single-Use Technologies in biopharmaceutical production processes at a range of large biophama organisations.Luke holds a degree in Biomedical Science and has worked in the biopharmaceutical sector for 17 years and single-use technologies for over 10 years. Before joining Sartorius in 2010 he worked as a Project Manager aligned with the manufacturing operation for a blue-chip vaccine producer and has extensive working knowledge of upstream, downstream and fill/finish operations in a GMP environment. Luke also holds membership with the PDA and regularly attends events and seminars for this professional body as well as the ISPE and BPSA.

Simone Biel: European Field Marketing Specialist in Single Use Technology at Merck. Simone is a PhD in Microbiology and Protein Purification The job responsibility is to investigate the market needs in single-use systems, product performance, regulatory compliance, and quality.


Target Audience:

CEO’s of pharma production, Production Managers, QA, QC


Participation Fees:
PDA members - 650 NIS
Non members - 850 NIS 


Exhibitors

 

Interesting exhibiting at the seminar?
For exhibition information please contact Reut at: reutl@bioforum.co.il


Organized & Produced by
Bioforum - Applied Knowledge Center
Golda Meir 3, Weizmann Science Park
P.O.B. 4034 Ness Ziona, Israel, 70400
Tel: 08-9313070
Fax: 08-9313071
E-mail: bioforum@bioforum.co.il
site: www.bioforum.co.il