Aseptic Manufacturing: do engineers and microbiologists speak a common language?

3 April 2016

In order to obtain quality products in the pharmaceutical manufacturing, it is essential to have synergy (real and not just in words) between the main professionals involved in the production processes. However, this is not what always happen in the reality. Just think about aseptic processing where the departments of Quality Assurance and Engineering seem to speak two different languages.

This way, ASCCA have developed a seminar a little ‘out of its traditional schemes to serve as an opportunity to meet these two professionals (and perhaps even contrast their opinions). Organized at the headquarters of Fedegari in Albuzzano (Italy), this one-day seminar will have interventions by national leaders and international representatives from the pharmaceutical world, in addition to designers and equipment manufacturers. After the seminar, participants will have the chance to visit the Fedegari facilities and workshop.

 8.30     Registration
9.00 Welcome speech
9.15     Drug excellence – the universal language of engineers and microbiologists
Claudia Roth (Vetter Pharma, Germany)
9.55     QbD, ICH Q9 and Q10 requirements relevant to a sterile production.
Gilberto Dalmaso (Particle Measuring Systems)
10.35     Coffee Break
11.00 The new relationship, coexistence and intersection of Non-Viable (Engineers) and Viable (Microbiologists) contamination control in aseptic manufacture
Conor Murray (Contamination Control Expert, Ireland Convenor Biocontamination Working Group CEN 243 (WG-5)
11.40 Building, utilities, process integration and timelines are the essentials to face critical projects for sterile productions
Pier Angelo Galligani (Techniconsult)
Business Lunch
14.00 RABS vs. Isolators; discussion of the engineering and microbiological challenges
Mauro Giusti, Patrizia Muscas (Eli Lilly)
14.30 The use of robotics within process automation leads to lower risk of personnel induced contamination
Sergio Mauri (Fedegari Group)
15.00 A practical example of Rapid Microbiological Methods (RRM) for controlling material transfer into a RABS
Roberto Maglio / Soffiantini Roberto (IBSA Italia)

At the end of the seminar there will be a workshop tour that should be booked in advance.

The seminar will be held in Italian – For the presentations in English, translation will be available.

Registration form  o On-line registration

program in pdf

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