Lake Como 2|4 October 2011 - CHIMICA Oggi/Chemistry Today

More documents

Recommendations

Info

SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER ABSTRACT BIOGRAPHY Manufacturing solutions for microreactors and continuous fl ow chemistry Dirk Kirschneck Microinnova - Austria Dirk Kirschneck Dirk Kirschneck founded Microinnova in 2003 (Managing Director, Majority owner). He established Microinnova as key player for process design and manufacturing applications of microreactors, process intensifi cation as well as fl ow chemistry. Dirk Kirschneck has given 23 presentations and 9 invited lectures on scientifi c conferences and seminars in the fi eld of micro process engineering. He has written 3 book chapters as author and co-author and 1 review article. He is key researcher in 2 European Union FP7 research projects. The Austrian Chemistry Federation has nominated Kirschneck as Austrian Industry delegate for the working party “Process Intensifi cation” of the EFCE. Flow chemistry in combination with process intensifi cation tools as microreactors offers a lot of new possibilities in development and manufacturing of chemicals. Advantages as reactions in novel process windows, higher safety or better product quality are important drivers to switch from batch to continuous processing and to integrate intensifi cation technology. With this new approach also plant technology has to be reconsidered. Highly automated continuous microfl uidic systems displace fl asks in laboratory, fl ow mini-plants replace the conventional pilot plant systems and high effi cient and fl exible manufacturing systems are doing the manufacturing process instead of batch vessels. This change brings a lot of challenging tasks for plant technology and devices, as required pressure and temperature ranges are much higher and dimensions of the equipment often need to be much smaller. Flexibility is a key of successful design and the need of GMP-compliant design makes the topic even more diffi cult. Microinnova has worked out plant solutions which fi t in this new approach of development and manufacturing and meet perfectly the demand of effi ciency and fl exibility. For development and small scale production, Microinnova has developed a system called “fl ow mini-plant”. In contrast to the classic batch-technology-development, where a strict separation between the lab and pilot plant and respectively the lab and pilot phase is given, a certain merger of these two development phases during the development of continuous fl ow processes has been detected. This results in enormous time and cost savings by signifi cant shortening of the pilot phase. Some of the lab and pilot phases of a process development can even be operated on one and the same plant only with small modifi cations. Consequent the solutions for manufacturing: The “modular multipurpose plant’” platform designed by Microinnova delivers a performance of a continuous plant mixed with the fl exibility of a batch vessel. The “unit operation solution’” substitutes a specifi c process step, in a chain of most batchwise run operations, with an intensifi ed continuous plant, whereby the change in the total procedure is minimal, but the increase of performance of the overall process is high. Finally also a “dedicated plant” can be equipped with intensifi cation technologies which is interesting for all long-term production where no fl exibility for product change is needed. 17 Lake Como 2|4 October 2011
SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER SPEAKER ABSTRACT BIOGRAPHY Continuous manufacturing FDA perspective on submissions and implementation Christine Moore FDA - USA Christine Moore Christine Moore is the Deputy Director for Science and Policy of FDA’s Offi ce of New Drug Quality Assessment. She started at the agency in 2004 as the Branch Chief of the newly created Manufacturing Science group. Christine has been actively involved in FDA’s Quality by Design initiatives and was a member of the expert working group for ICH Q8(R). Prior to joining the FDA, she worked for 10 years in API process development and scale-up at Pfi zer and Searle/Pharmacia. Her background is in chemical and biochemical engineering, with degrees from Northwestern University and Massachusetts Institute of Technology. Continuous manufacturing is a technology actively being explored for pharmaceutical manufacturing, both by academia and industry. With its lower equipment size and higher throughput, continuous manufacturing has the potential to provide economic and safety benefi ts. From a quality perspective, the online monitoring and control used in continuous manufacturing can lead to increased product quality assurance and implementation of real-time real testing (RTRT) approaches. This presentation will discuss the regulatory implications of continuous manufacturing from a US FDA viewpoint. Both scientifi c and regulatory considerations will be provided for developing and implementing a continuous manufacturing process. 18 Lake Como 2|4 October 2011
Page 1 and 2: in partnership with Organised by La
Page 3 and 4: AGENDA TUESDAY TUESDAY TUESDAY TUES
Page 5 and 6: SPEAKER SPEAKER SPEAKER SPEAKER SPE
Page 17: SPEAKER SPEAKER SPEAKER SPEAKER SPE
Page 23 and 24: Lake Como 2|4 October 2011 POSTERS
Page 25 and 26: Process intensifi cation under high
Page 27 and 28: Continuous fl ow chemistry in multi
Page 29 and 30: Huisgen cycloaddition to rufi namid
Page 31: Production of Semiconductor Nanopar

Lake Como 2|4 October 2011 - CHIMICA Oggi/Chemistry Today

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?