The Challenges Facing Disposable Technology and Their Solutions

Session 105
Manufacturing Operations Track

Single use components are an integral part of pharmaceutical manufacturing processes with the potential for impacting product quality, patient safety and plant operation. To address the inherent risks associated with reliance on single use components necessitates establishing and maintaining a secure supply chain management between supplier and the end-user.

Session Description

Discuss the new challenges and requirements of the Biotech Industry to improve quality, product integrity, assurance of supply and validation for extractable and toxicity assessment in single use systems. The first part of this session will examine typical materials of construction and the role of the supplier’s suppliers that provide base resins for the manufacture of single-use components. The second part of this session will focus on the adoption of Single Use Systems in all downstream processing steps of commercial production.

At the conclusion of this session, participants will be able to:

Understand regulations and best practices for single use component supply chain integrity
Describe the latest single use technology advances
Analyze the shift to product standardization and technology integration

Leaders

Speakers

Jeff Campie, USA
Richard Forsyth, Senior Consultant, Hyde Engineering + Consulting, USA
Nigel Hamilton, Global Quality, Strategy and Process Excellence, Sanofi Aventis, United Kingdom
Aisling Horan, Validation Scientist, Alkermes Plc, Ireland
Edwin Melendez, Principle Consultant, Parexel, USA
Mark O'Reilly, Director Engineering, Alkermes Pharma Ireland Ltd, Ireland
Kimberly Ray, A. Director Project Mgmt, Oso Biopharmaceuticals Mfg LLC, USA
Julian Wilkins, Vice President, PharmaConsult US Inc, USA
Paul Wreglesworth, Independent Consultant, United Kingdom

Who Should Attend

Manufacturing / Operations
Service Providers
Suppliers
Regulators

Communities of Practice Members that will Benefit

API
Biotechnologyg
C&Q
Containment
Disposables
Investigational Products
Operations Management
Oral Solid Dosage
Packaging
PQLI^®
Process Analytical Technology
Process/Product Development
Project Management
Sterile Products Processing
Sustainable Facilities

More information on ISPE's Communities of Practice