Aseptic Manufacturing

Albuzzano – 12 Novembre 2015
Do engineers and microbiologists speak a common language in order to achieve the drug excellence goal?

Looking into the future of aseptic manufacturing: need and expectations
M. Davies

  • Regulatory challenge
  • Microbiological Control in Context
  • Current System design deficiens
  • Way forward

QbD, ICH Q9 and ICH 10 requirements relevant to a sterile production
G. Dalmaso

  • ICHQ8: overview and important considerations
  • ICHQ9: Quality Risk Management
  • Risk Assessment and Risk Control
  • The new paradigm

The new relationship, coexistence and intersection of Non-viable (engineers) and viable (microbiologists) contamination control in aseptic manufacture
C. Murray

  • Aseptic manufacturing standard and guidance 
  • Challenges in aseptic Manufacturing Cleanrooms
  • Contamination Control Fundamentals
  • A microbiologist Perspective
  • Viable and not-viable (engineering & Microbiologists)
  • Evolution not revolution in Aseptic Manufacturing

Building, utilities, process integration and timelines are the essentials to face critical projects for sterile productions
P.A. Galligani

  • Backgroud
  • Integrazione progettuale e QbD
  • BIM
  • CFD

RABS vs Isolators: discussion of the engineering and microbiological challenges
P. Muscas – M. Zavaglia

  • Sesto Production Area: origins & evolution
  • Isolators vs RABS: characteristics
  • Discussion of the engineering and microbiological changelles
  • Continous improvement example

The use of robotics within process automation leads to lower risk of personnel induced contamination
S. Mauri

  • Pharma outlook trends and the aseptic manufacturing challenges
  • Advanced aseptic manufacturing including GMP robotics
  • 2020 years pharma manufacturing challenges
  • Class A continuity
  • Containment, SAL, nested glassware and closure integration
  • GMP robotics for fill/finish aseptic operation

A pratical example of Rapid Microbiological Methods (RRM) for controlling material transfer into a RABS
R. Soffiantini

  • PercheĆ© RMM
  • Tecnologia scelta
  • Applicazione su una linea di produzione
  • Conclusioni