Conference:
Track:
Leader:
Dates:
Location:
ISPE Aseptic Conference 2012
Barrier Isolation
Jack Lysfjord
26.03./27.03.2012
Radisson Blu Hotel Frankfurt, Germany
MONDAY 26 MARCH
Start End
Presentation Title
Time Time
9:00
10:30
11:15
12:30
13:30
13:35
14:15
15:00
15:40
16:15
10:30
11:15
12:30
13:30
13:35
14:15
15:00
15:40
16:15
17:00
17:00
17:00 18:30
Speaker
(Full Name)
Keynote Address(es)
Networking Break
Keynote Address(es)
Lunch
Welcome & Introductions
Jack Lysfjord
Twenty Years and Counting-Restricted Access Barrier Systems (RABS)
Paul Gold
Learnings from 10 Years of Aseptic Processing Under Isolators
Patrick Van Hecke
Networking Break
Sterile Baseline Guide for RABS and Isolators
Mark von Stwolinski
Powders Not Liquids, Large Batches Not Small, Sterile and Toxic Products-What Do I Do?? A Ewart Richardson
Process Overview
The presentation will be based on a real case studies and touches on other similar systems we have
put in both Europe and are working on in China. It is aimed to be an educational presentation so
that other people/companies can learn from our experiences.
The presentation will aim to Explain and Explore the following: The Type of Risks involved with Containment and Sterility and how to Assess that Risk and Why
Some of the challenges when dealing with Simultaneous Containment of API’s in a Sterile
Environment
Benefits and Reasons for a Risk Based Approach
Company
90
45
75
Lysfjord Consulting
Pfizer
GSK BIO
CRB
DEC Group
Session Adjourns
Welcome Reception in Exhibit Hall
TUESDAY 27 MARCH
Start End
Presentation Title
Time Time
Total
min.
5
40
45
30
45
45
0
Speaker
(Full Name)
Company
Total
min.
90
8:30 10:00
Stefanie Trudel
Startup and production concept of a multiproduct isolator filling and freeze- drying line.
The presentation will focus on three topics:
1. Project scope and timeline for the implementation of 2 high-speed filling lines in isolator
technology. Line 1 is a vial filling line for liquid and freeze dryed prodcts, line 2 is a combiline for
vials as well as double chamber cartridges. Both filling lines are linked to the same two freeze
dryers.
2. Mode of operation as a flexible multiproduct line. This includes layout, product and material flow,
microbiological monitoring, glove procedures and glove tracking, mediafill and aseptic handling in
the isolator.
3. Lessons learned
BI
10:00 10:30
10:30 11:15
Networking Break
Break
Use of Isolators for Fill Finish of Biological Products
Alan Kelly
In this case study, experiences with two high speed Isolated vial filling lines is presented. Innovative
design concepts integrated into the new line are discussed including freeze dryer loading systems,
filling systems, stopper processor concepts, approaches to isolator decontamination and freeze
dryer qualification and vision systems for process control. Summary and lessons learned so far.
30
Genzyme Ireland Ltd 45
11:15 12:00
Retrofit of a Closed RABS for Aseptic Cytotoxic Fill Operations at a CMO
The application of a cost effective solution to an existing aseptic filler to safely handle cytotoxic
products, providing employee and product protection with lower investment costs, faster
implementation and improved operator interface. Design concepts that differ from conventional
RABS that provide enhanced containment, while still providing the access flexibility for operator
interface and cleaning. Demonstrated containment levels and aspects required for 3rd party
certification for safe handling of cytotoxic aseptic materials.
Lunch
3 Discussion Groups lead by Subject Matter Experts
Networking Break
Discussion Group Presentations (3)
12:00
13:00
14:20
15:00
13:00
14:20
15:00
15:30
15:30 16:00
16:00 17:00
Regulatory perspectives on the use of RABS and Isolators via Videoconference
Regulatory Q&A via Videoconference
17:00
Session Adjourns
Jessica Sasser
Discussion Group
Leaders
Destry Sillivan
Rick Friedman, Tara
Gooen, Invited
DSM
45
60
80
40
30
FDA
FDA
30
60
0