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Workshop: CONTINUOUS MANUFACTURING IN PHARMA: A forward looking approach for the production of oral solid dosage forms. 1 – 3 March 2016 NEW
Workshop:
CONTINUOUS MANUFACTURING IN PHARMA: A forward looking approach for the production of oral solid dosage forms. 1 – 3 March 2016
NEW
WHY PARTICIPATE ?
Since more than 10 years an intensive discussion about the broad introduction of continuous manufacturing into the pharma industry has been going on. Originally raised by the regulatory authorities many pharmaceutical manufacturers now increase their focus on utilizing continuous tech-nologies in OSD (oral solid dosing), very well known and practiced in related industries such as the chemical and nutritional for many years.
Practical benefits are witnessed e.g. in(i) speeding up development processes by the possibility to scale-up only in one size of equipment, (ii) more efficient production processes by increasing equipment efficiency with lower consumption of ressources, (iii) increased product and process quality making use of up-to-date solutions for process automation in combination with appropriate PAT
With this newly designed workshop we introduce this topic to our at-tendees, combining high level expertise from the academic field, from industry and also from Glatt’s own knowledge base.
We offer an overview of technological and regulatory basics and trends, show practical experiences and introduce to late stage PAT-methods.
Besides lectures we also use hands-on demonstrations in the lab.
WHO MAY ATTEND?
We kindly invite all interested employees from pharmaceutical and related industries and academic institutions, who are interested in gaining know-how and also practical insight into continuous OSD manufacturing.
Typically, staff from quality, operating and research will get most out of the workshop.
PROGRAM
TUESDAY, 1 MARCH 201611:45 Transfer from hotel to TTC
12:00 Reception and registration
12:50 Introduction. Torsten Ziegler
13:00 Continuous manufacturing in pharmaceutical industry: an overview on different concepts, philosophies and practices. Introducing to continuous drug product manufacture with similarities and differences between batch and continuous manufacture. Describing important concepts in continuous processing including residence time distributions and closed loop process control. Wet granulation will be used as a case study to highlight differences in product attributes and operation between batch and continuous processing. James Donald Litster
14:00 Recent developments in the field of continuous manufacturing. Giving an insight into latest developments in continuous manufacturing with focus on pharma industry. Highlights recent trends in academia and industry regarding equipment, processing and technology. Includes an overview of regulatory topics. Johannes Khinast
15:00 Coffee break
15:30 Granulation processes for oral solid dosage forms – mechanism and impact on the quality of the resulting tablets. Comparing different granulation approaches and processes and discussing the resulting tablet characteristics. Norbert Pöllinger
16:15 Basic approaches to continuous manufacturing. Introducing to specific processing and equipment considerations: „batch goes conti“ - a major difference or a minor change? Includes residence time considerations and their impact on product traceability. Jochen Thies
17:00 Transfer to hotel
19:30 Workshop dinner
WEDNESDAY, 2 MARCH 201608:40 Transfer from hotel to TTC
09:00 Modern modelling and simulation tools for design of continuous fluidized bed granulation. Discussing key principles like growth models, population balance modeling, DEM/CFD simulation of the fluid and particle dynamics as well as flowsheet simulation and shortcut-methods for the continuous operation. Stefan Heinrich
10:00 From powders to coated tablets: possibilities to end up with an automated process. Highlights the important processing steps in continuous manufacturing. Introduces to a modular equipment approach with real continuous granulate drying. Raoul Pila
10:45 Coffee break
11:15 Continuous granulation approaches: implementation of various technologies as modules to provide best granule quality for different formulations. (i) Introduces to the currently dominating method of twin screw granulation (high-shear), (ii) Comparing with alternative continuous granulation solutions with fluid bed (low shear) and continuous mixer (mid-shear). Dirk Leister, Lilia Sprich
12:15 Lunch
13:15 From micro to commercial scale - a look at real world equipment. Discovering the variety of state-of-the-art fluidized bed systems for dedicated applications, factory tour. Sales Team
14:00 Inline particle size monitoring by spatial filter technology (SFT). Showing possibilities of online particle measurement for monitoring of fluidized bed processes, presenting different measuring principles. Discussing as an exemple the method of fiber-optic spatial filter technology including detailed case studies. Stefan Dietrich
14:45 Coffee break
15:00 Practical demonstrations: – Granulation / drying with double screw extruder and continuous fluid bed technology (Glatt MODCOS system) – Transferring an oil into a granules using Glatt ProCell continuous fluid bed granulation technology – Manufacturing high drug loaded micropellets applying Glatt MicroPx continuous fluid bed pelletisation technology– Continuous high shear granulation with Glatt GCG continuous technologyStefan Dietrich, Detlef Ortlieb, Lilia Sprich
17:00 Transfer to hotel
19:30 Workshop dinner
THURSDAY, 3 MARCH 201608:40 Check-out from hotel and transfer to TTC
09:00 Advanced continuous fluidized bed technologies to produce pellets and micropellets. Presenting different continuous fluidized bed processes. Evaluation of options to achieve optimal product quality and optimized manufacturing cost. Norbert Pöllinger
09:45 Controlling and self-regulating a continuous process with PATs Inline particle size monitoring by 3D imaging technology. Practical considerations for implementing of non-product-contact direct imaging particle size measuring PAT-system for both continuous and batch operations including case studies. Mike Mulcahy
10:30 Coffee break
11:00 A case study of continuous granulation for pharma applications. Continuous spraygranulation of dispersions, solutions and melts to achieve specific characteristics of excipients and APIs. Gudrun Ding
11:45 Inline moisture measurement with microwave technology. Demonstrating the inline moisture measurement in fluid bed drying by microwave resonance technology. Gives a spotlight on other pharmaceutical applications of this technique. Knut Szemjonneck
12:30 Summary and snack buffet
13:00 Transfer to Basel, German Railway Station (Badischer Bahnhof), Swiss Railway Station (SBB) and EuroAirport
SPEAKERS
Stefan Dietrich Parsum GmbH, GermanyGudrun Ding IPC Process Centre GmbH & Co. KG, GermanyProf. Dr. Stefan Heinrich Technische Universität Hamburg-Harburg, GermanyProf. Johannes Khinast RCPE Universität Graz, AustriaDirk Leister ThermoFisher Scientific, GermanyProf. Dr. James Donald Litster Purdue University, USAMike Mulcahy Innopharma Labs, IrelandRaoul Pila Glatt GmbH, GermanyDr. Norbert Pöllinger Glatt GmbH, GermanyLilia Sprich Glatt GmbH, GermanyKnut Szemjonneck TEWS Elektronik GmbH & Co. KG , GermanyDr. Jochen Thies Glatt AG, Switzerland
MODERATION
Dr. Torsten Ziegler, Technology Training Center, Germany
DETAILS
>> The participation fee is € 1490,− (exclusive of VAT).
>> This fee includes participation, accompanying course notes, daytime catering and dinner. Any other expenses are to be borne by the attendee.
>> Free attendance granted to a limited number of students.
>> Participation is limited. Registrations will be confirmed on a first come first serve basis.
>> Courses taking place in Germany are subject to Value Added Tax (VAT).
>> Each participant will receive a certificate of attendance at the end of the course.
>> Registration deadline: 14 January 2016
REGISTRATION
Workshop:CONTINUOUS MANUFACTURING IN PHARMA1 – 3 March 2016
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ORGANIZATON AND LOCATION
TTC - Technology Training CenterRegina Bernstein / Bianca Nowak / Torsten ZieglerWerner-Glatt-Straße 1, 79589 Binzen, GermanyTel +49 7621 - 664 308Fax +49 7621 - 664 798E-mail [email protected]
For further information or online registration please visit us on
www.ttc-binzen.de
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