ISPE Milan Conferences - Kereon AG

Sterile Product Processing for the 21 st Century -
28-29 November 2005
Conference Leaders
Gordon Farquharson, Bovis Lend Lease Technology, UK
Nunzio Genoni, Jacobs Italia SpA, Italy
Programme
6
Conference Description
This conference will first explore how FDA’s Aseptic
Guidance has bedded down, how it fits with the
anticipated changes in Annex 1 (expected mid 2005)
and the possible changes to the cleanroom standard
ISO 14644-1:1999. This standard is due for systematic
review in 2005.
Speakers will flesh out some of these requirements with
presentations of case studies and operational
experience to help illustrate how the industry is
interpreting the guidance, and the real cGMP
compliance issues. Available technologies including
blow-fill-seal, RABS, isolators and particle counting will
be explored. The seminar will provide the opportunity for
discussion of some key issues influencing operations in
the field of advanced aseptic processing and the impact
on the business.
Learning Objectives
At the conclusion of this seminar, delegates will be able to:
• Understand how the industry is dealing with the 2004
GMP changes
• Describe principles such as Grade A continuity
• Explain forthcoming changes to Annex 1, ISO 14644-1
and ISPE’s Sterile Manufacturing Facilities Baseline ®
Guide
• Apply state of the art environmental monitoring
• See how advanced aseptic techniques can influence
their business
Who Should Attend
• Practitioners looking for valuable insight into recent
and changing guidance and regulations
• Engineers, quality assurance, quality control and
production professionals
• Financial, operational and technical managers
• Suppliers
Agenda
Monday, 28 November
10.00 - 10.15 Welcome and Introduction
Gordon Farquharson, Bovis Lend Lease Technology, UK
Nunzio Genoni, Jacobs Italia SpA, Italy
10.15 - 11.00 FDA’s Aseptic Guidance (September 2004)
– Industry View: 12 Months on
Speaker to be advised
• Brief history of the development of the guidance
• Implementation as part of the “GMPs for the 21 st Century”
• Implementation issues so far
11.00 - 11.45 A European Regulatory Perspective on
Sterile Product Processing
Jean-Denis Mallet, France
• Critical sterile products issues from an EU regulatory perspective
• Status of the revision to Annex 1 of the EU GMP related to
airborne particles and media fill (process simulation)
• Sterile products inspection trends
11.45 - 12.15 Regulatory Discussion
12.15 - 13.30 Lunch
13.30 - 14.30 Restricted Access Barrier System (RABS) –
Presentation of ISPE / FDA Draft
Jack Lysfjord, Valicare Division, Bosch, USA
The USA FDA has become increasingly concerned that the
term RABS is being used too loosely by our industry. FDA
has sought ISPE’s support to develop a consensus about
this important advanced aseptic processing technology.
The aspects considered will be:
• What is a RABS?
• Which elements are essential to call it a RABS?
• RABS design basis
• Standard operating procedures required for rare interventions
• Initial high level disinfection with sporicidal agent
• The progress of the guidance note
14.30 - 15.30 Case Study: Innovative Solutions for Filling
and Freeze Drying of Biopharmaceuticals – RABS
Technology
Frank Küpler, Ferring, Germany
Freeze drying is an essential and growing technology
applied to many biological products. The product and
process is highly susceptible to contamination and the
industry is keen to find low-risk solutions.
• Automated freeze dryer loading/unloading system:
Comparison of alternatives, presentation of the selected
solutions with fully automated frame handling
• Application of RABS technology
• Environmental monitoring