Pharmaceutical Freeze Drying Roadshow

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SP Industries Inc. has announced the first dates for its 2010 Roadshow ’Freeze Drying of Pharmaceuticals: Principles and Practice’.

Drawing upon speakers from the internationally acknowledged Freeze Drying Group at the University of Erlangen, Germany - SP Industries has organised a comprehensive 1-day program of seminars and discussions. The talks have been designed to enable people involved with pharmaceutical freeze drying and lyophilisation, at all levels of experience, to gain considerable benefit.

Seminar topics include: Introduction to Freeze Drying: putting principles into practice ; Formulation: understanding the physical properties of materials ; Overcoming the challenge of formulating colloidal materials ; Freeze Drying Microscopy: introduction and relevance to process design and optimisation ; A review of PAT tools for freeze drying ; An introduction to MTM and SMART freeze dryer technology ; Heat & Mass transfer in freeze drying and Scale-Up: Fundamental Concepts.

For further information or to reserve a place at the free Roadshow seminars in Boston, MA (April 12th), New Brunswick, NJ (April 13th) or San Francisco, CA (April 15th) please contact SP Industries on +1-845-687-5303 or email leslie.mather@spindustries.com

SP Industries is a leading manufacturer of laboratory to production scale freeze dryers / lyophilizers, centrifugal evaporators and concentrators, environmental control chambers, thermal control system, glassware washers and dryers. The company sells its products under well-known brands including Hotpack®, VirTis®, FTS™ and Genevac®. SP Industries has ISO 9001:2000 registered production facilities in the USA and Europe. The company continues to invest heavily in validation and commissioning competencies. With the ongoing requirements of 21 CFR Part 11 and the emergence of GAMP 4, SP Industries is uniquely positioned as a leader in compliance and GAMP 4 commitment.

SP Industries ( USA ) & the Freeze Drying Focus Group, University of Erlangen ( Germany )
Freeze-Drying of Pharmaceuticals:
Principles and Practice
ROAD SHOW 2010

Dates and Locations	Monday, April 12th: BOSTON , MA Tuesday, April 13th: NEW BRUNSWICK , NJ Thursday, April 15th: SAN FRANCISCO , CA
--- S E M I N A R A G E N D A ---
09:00 – 09:15	Welcome Address and Opening Remarks	Mark Shon SP Industries
09:15 – 10:00	Introduction to Freeze-Drying: Putting Principles into Practice The concept of freeze-drying; fundamental physics behind lyo-philization; overview: areas of application; detailed discussion of the freezing, primary and secondary drying step; primary packing materials for pharmaceutical freeze-drying; product temperature and pressure measurement; etc.	Jakob Beirowski LPT, University of Erlangen
10:00 – 10:30	Formulation I: Physical Properties of Materials Differences between crystalline and amorphous systems and associated critical temperatures; formulation principles of pro-teins and small molecules; interrelation between formulation and process; possible formulation issues and how to solve them; etc.	Henning Gieseler LPT, University of Erlangen
10:30 – 10:45	Coffee Break
10:45 – 11:15	Formulation II: The Challenge of Formulating Colloidal Systems Introduction to rational formulation design for nano- and micro-particles, microemulsions and liposomes; potential challenges in the design of a freeze-drying cycle for such formulations; recent case studies and lessons learned; etc.	Jakob Beirowski LPT, University of Erlangen
11:15 – 12:00	Freeze-Dry Microscopy: Introduction and Rele-vance for Process Design and Optimization Equipment considerations; importance of methodology; experi-mental parameters which impact the collapse temperature result; FDM of protein formulations; a comparison: glass transitions vs. collapse temperatures for cycle design and optimization; transfer-ability of FDM data to actual freeze-drying cycles; etc.	Susanne Rutzinger LPT, University of Erlangen
12:00 – 01:30	Lunch Break
01:30 – 02:15	Process Design and Optimization I: A Survey of PAT Tools for Freeze-Drying PAT and QbD: definition and regulatory perspective; what does “advanced” PAT for freeze-drying mean? Overview of PAT for sin-gle vial monitoring and batch methods; traditional concepts versus latest technological innovations; etc.	Stefan Schneid LPT, University of Erlangen
02:15 – 02:45	Process Design and Optimization II: MTM and SMART Freeze Dryer Ô Technology Short introduction to MTM and the SMART Freeze Dryer Ô techno-logy; merits and demerits associated with MTM; review of recent case studies and performed research; etc.	Henning Gieseler LPT, University of Erlangen
02:45 – 03:00	Coffee Break
03:00 – 03:30	Heat and Mass Transfer in Freeze-Drying: Role of the Vial Molded vs. tubing vials; definition of the vial heat transfer coeffici-ent (Kv); proper methodology to evaluate Kv; importance of Kv for cycle design; new concepts for vials for freeze-drying; etc.	Susanne Rutzinger LPT, University of Erlangen
03:30 – 04:00	Fundamental Concepts about Scale-Up Differences between laboratory and production dryer; heat and mass transfer issues; matching product temperature profiles bet-ween laboratory and production scale equipment; minimum con-trollable pressure; design of robustness studies; etc.	Stefan Schneid LPT, University of Erlangen
04:00	Wrap-up (all speakers) and Closing Remarks

Worldwide Headquarters

SP Industries, Inc.
3538 Main Street
P.O Box 158
Stone Ridge
NY 12484
USA

Tel: +1.845.687.5315
e: remus.stefan@SPINDUSTRIES.com
www.spindustries.com

Europe / Asia

Genevac Ltd.
Farthing Road
Ipswich IP1 5AP
UK

tel. +44-1473-240000
email salesinfo@genevac.co.uk