ISPE Yearly SIG Evaluation

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ISPE Yearly SIG Evaluation

• Brussels, May 13th 2004
• ISOLATOR TECHNOLOGY

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1. Group composition

• Alcon P. Vande Gucht
• Janssen M. Swinnen M. Verbrugghen R. Van
  Genechten
• Pfizer C. Gunther P. François A. De Sadeleer
• UCB J.M. Decock G. Folie (Sponsor)
• GSK J.B. Castaigne (Facilitator) D. Beco L.
  Martin
• Eli Lilly C. Stevens R. Scoyer
• Solvay (NL) J. Hillebrand B. Van den Bosch

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2. Meetings held so far

• 19/06/2003 GSK Organization agreements Plant
  tour (Wavre site)
• 09/10/2003 UCB Justification of Isolator
  Technology Plant tour (UCB-Bioproducts)
• 22/01/2004 Alcon Management of Isolator projects
  (suppliers, cost,
  leadtime..) Plant tour (Incorporation isolator
  sterility testing)

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3. Next meetings/topics

• Meeting foreseen on 22/04/2004 at Solvay (NL) to
  be re-scheduled ? Isolator design features
  (cleanroom classification, material
  compatibility, RTP transfer...)
• June 2004 (Pfizer) ? Isolator Validation (VHP
  cycle, BIs, CIs, mediafills, load pattern
  for VHP cycle...)
• October 2004 (Eli Lilly) ? Isolators in
  production (Environmental monitoring, leak
  testing, process monitoring, ...)

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4. Main learnings

• Besides from the technical aspects
• Heterogeneity in the group is possible, in terms
  of activity and knowledge
• Adding new people to the group was not an issue
• Substituting people for one meeting was not an
  issue
• Openness of all participants
• Plant tours remain the most attractive part