Advanced Aseptic Processing Utilizing RABS and Isolators

Session 509
Technology Track

The use of RABS and Isolators is current state-of-the-art and the cGMP for Aseptic Processing fill finish applications. FDA is putting industry on notice that conventional aseptic processing lines not employing isolators or restricted access barrier systems (RABS) will get heightened scrutiny from agency investigators and that a convincing justification will have to be provided for their ability to consistently produce sterile product.

Session Description

Case studies will be used to learn new innovations and better understand the “c” in cGMP related to the use of RABS or Isolators for aseptic processing. Interact with current users of RABS and Isolators during the question and answer session.

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

Better understand the “c” in cGMP
Evaluate case studies from user companies
Interact and establish network with current users of RABS and Isoloators

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/ Engineering/Validation/ Regulatory/ Project Management Personnel involved in Aseptic Processing
Equipment Suppliers
Regulators

Communities of Practice Members that will Benefit

Biotechnology
C&Q
Containment
Disposables
Engineering Standards Benchmarking
GAMP^®
HVAC
Investigational Products
Operations Management
PQLI^®
Process/Product Development
Project Management
Sterile Products Processing
Sustainable Facilities

More information on ISPE's Communities of Practice