Lake Como 2|4 October 2011 - CHIMICA Oggi/Chemistry Today
Lake Como 2|4 October 2011 - CHIMICA Oggi/Chemistry Today Lake Como 2|4 October 2011 - CHIMICA Oggi/Chemistry Today
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 SPEAKER ABSTRACT BIOGRAPHY Steven Ferguson Steven Ferguson is a researcher in the fi nal year of his PhD at the Solid State Pharmaceutical Cluster, University College Dublin. He began in this role in 2008 and his research focuses on the application of continuous processing to pharmaceutical crystallization. His particular expertise lies in crystallization design and in process analytical technology. He is currently collaborating on the Solid State Pharmaceutical Cluster, Continuous Crystallization Platform Project. His background is in chemical and bioprocess engineering with a degree also from University College Dublin. PAT based design of continuous plug fl ow crystallizations Steven Ferguson, Gary Morris, Hongxun Hao, Mark Barrett, Brian Glennon Solid State Pharmaceutical Cluster, University College Dublin - Ireland This study presents the development of a plug fl ow crystallization (PFC) platform consisting of a vortex mixer combined with a tubular reactor. Process analytical technologies (FBRM, PVM, FT-IR) were applied in-situ in order to characterize and optimize crystallizations via the use of novel fl ow cells. In addition to this a new calibration free method for concentration monitoring was successfully utilized. These techniques permit signifi cant reductions in process development time and could also be applied to in situ monitoring and control of continuous industrial crystallizations. The results of this characterization indicate that plug fl ow crystallizers provide a robust and impressively productive crystallization methodology. Supersaturation was found to be depleted extremely rapidly within the reactor volume allowing for the maximum potential system yield to be obtained. This meant that despite the small size of the crystallizer (~40 ml) it was capable of producing approximately 50 kg of product per day. In addition to this, vortex type mixers have demonstrated the ability to maintain mixing effi ciency at unequal fl ow rate ratios. This presents obvious operational advantages when compared to conventional confi ned impinging jet (CIJ) (CIJ) mixers, allowing allowing larger anti-solvent additions relative to product feed. This facilitates facilitates the the generation of higher supersaturation and resulted in the the reduction in fi nal product particle size below 10 µm, highlighting the potential of such crystallizer confi confi gurations to eliminate the need for milling operations to reduce particle size. 11 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 SPEAKER ABSTRACT BIOGRAPHY Successful achievement of regulatory compliance and continuous processing Nigel A. Fletcher Foster Wheeler Energy Ltd - UK Nigel A. Fletcher Nigel graduated in 1975 from Imperial College, London with an Honours Degree in Chemical Engineering and joined Foster Wheeler. Following training as a process designer he developed skills related to high value product plant design and joined the Pharmaceutical Division. He then worked in pharmaceutical plant design for over 25 years on batch APIs, sterile APIs, biologics, Secondary pharmaceuticals and some specialist chemicals. In 2005 he became part of the team developing one of the fi rst continuous pharmaceutical plants and was involved throughout the design, construction and commissioning of the plant. Since then he has been involved in several other continuous pharmaceutical (and fi ne chemical) plants all involving the conversion of batch processes to continuous operation. He is now the Manager of the Pharmaceutical group in Foster Wheeler in the UK and is also a director of the Britest Organisation. The presentation starts by looking at the key regulatory issues facing the designer and the operator of a pharmaceutical continuous processing plant. It continues with a short review of the background to continuous processing and some of the recent output of the US FDA and other leading regulatory agencies to understand what challenges must be met. The lecture then moves on to a case study for a multiproduct continuous plant and reviews how the multiproduct aspect added new challenges to the design. The case study describes some of the features of the plant that the project team designed introduced to address instrumentation and control, cleaning and other ‘normal’ GMP issues together with all the ‘new’ regulatory concerns. Finally the presentation looks at some of the lessons learned, what has happened since the unit came into operation and how the owner is now using the plant. 12 Lake Como 2|4 October 2011
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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 SPEAKER<br />
ABSTRACT<br />
BIOGRAPHY<br />
Successful achievement of regulatory compliance and continuous processing<br />
Nigel A. Fletcher<br />
Foster Wheeler Energy Ltd - UK<br />
Nigel A. Fletcher<br />
Nigel graduated in 1975 from Imperial College, London with an Honours Degree in Chemical<br />
Engineering and joined Foster Wheeler. Following training as a process designer he developed<br />
skills related to high value product plant design and joined the Pharmaceutical Division. He<br />
then worked in pharmaceutical plant design for over 25 years on batch APIs, sterile APIs,<br />
biologics, Secondary pharmaceuticals and some specialist chemicals. In 2005 he became<br />
part of the team developing one of the fi rst continuous pharmaceutical plants and was<br />
involved throughout the design, construction and commissioning of the plant. Since then he<br />
has been involved in several other continuous pharmaceutical (and fi ne chemical)<br />
plants all involving the conversion of batch processes to continuous operation.<br />
He is now the Manager of the Pharmaceutical group in Foster Wheeler in the<br />
UK and is also a director of the Britest Organisation.<br />
The presentation starts by looking at the key regulatory issues facing the designer and the operator of a pharmaceutical continuous<br />
processing plant. It continues with a short review of the background to continuous processing and some of the recent output of<br />
the US FDA and other leading regulatory agencies to understand what challenges must be met. The lecture then moves on to a<br />
case study for a multiproduct continuous plant and reviews how the multiproduct aspect added new challenges to the design.<br />
The case study describes some of the features of the plant that the project team designed introduced to address instrumentation<br />
and control, cleaning and other ‘normal’ GMP issues together with all the ‘new’ regulatory concerns. Finally the presentation looks<br />
at some of the lessons learned, what has happened since the unit came into operation and how the owner is now using the plant.<br />
12<br />
<strong>Lake</strong> <strong>Como</strong><br />
<strong>2|4</strong> <strong>October</strong> <strong>2011</strong>
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