5th International Conference on Lyophilization and Freeze Drying

Workshop Program

This workshop is mainly dedicated to those professionals from the Pharmaceutical Industry involved with the formulation, filling and lyophilization operations.

Workshop is divided in two sessions:

√       Session 1: Predicting the real variables of interest (product temperature and sublimation mass flow) in a lyophillization cycle

√       Session 2: Turning Freeze Drying from a batch process into a continuous process led by Jos Corver

Session 1 program: Predicting the real variables of interest (product temperature and sublimation mass flow) in a lyophillization cycle

Workshop topic:

Cycle development demystified

A lyophilization process is usually only specified in terms of a ‘recipe’ (shelf temperature and chamber pressure vs. time).  Two variables are key to monitoring the lyophilization process: sublimation interface temperature (during the whole of primary drying this has to be maintained below the collapse temperature) and sublimation mass flow (which has to be maximized to achieve the most cost effective cycle). The main problem is how to set them within a rationale approach rather than relying in a vague intuition (because cycle development is perceived mainly as an art only achievable after many years of experience), and without embracing in comprehensive set of cycle trials.

This workshop pretends giving the rationale approach to find a sound starting point of a cycle recipe. In the first section there will be an introductory lecture presenting the process analysis underlying theory and a complete calculation model to predict the Product Interface Temperature given the shelf temperature and the chamber pressure. In order to perform the calculation two parameters will need to be estimated: the heat transfer coefficient (Kv) and the dry product average resistance (Rp). An experimental method to find Rp is proposed as well as some ways to estimate both Kv and Rp. An Excel spreadsheet will be given to the attendees and fully explained to facilitate this calculation. This method allows choosing quasi an optimum of the lyophilization process conditions maximizing efficiency.

The next part of the workshop will consist in two consecutive “hands-on” exercises -real cases- presented to the audience. There will be available laboratory thermal test raw data (DSC graphs and freeze-drying microscope set of images) that, first, will have to be interpreted and used to decide which are the maximum process operating conditions, and then defining, using the explained calculation tools, the optimum parameters of the lyophilization cycle. Explanations to extract the required parameters from the laboratory thermal test results will also be provided and the attendees will need to perform data mining from publications to reasonably estimate some needed parameters. These exercises will train the audience to establish a compromise between sublimation speed and product temperature safety margin. Prediction of the primary drying time will be possible.

Lessons learned:

·       Traditional lyophilization cycle development process needs a serious qualitative step to gain process knowledge.

·       From simple steady state models, they open a window into the process assisting to assess important lyophilization parameters.

·       Process can be optimized from the initial R&D.

·       R&D stage of process development simplified (time saving).

·       Discover areas for potential process and operational optimization.

·       Predict the impact of different parameters in the process kinetics.

Workshop leader:

Miquel Galan is Director of Innovation + R&D of Telstar LYO, a branch of Telstar Technologies, in Spain. He has been with Telstar for over 25 years. He is an expert in pharmaceutical engineering, as well as vacuum technology and leak detection. He has held a position as a Process Engineering Manager, and has managed many large freeze-drying projects.

He holds degrees in Chemical Engineering from the Instituto Químico de Sarrià (IQS) and Industrial Engineering from the Universitat Ramon Llull.

He is an active member of ISPE (International Society of Pharmaceutical Engineering), PDA (Parenteral Drug Association), and ISL-FD (International Society of Lyophilization – Freeze Drying). He is also a member of  PHSS (The Pharmaceutical and Healthcare Sciences Society –formerly Parenteral Society), and AAPS (American Association of Pharmaceutical Scientists).

He has chaired several freeze drying conferences, and lectured on many freeze drying courses, conferences and workshops, as well as in other topics about vacuum related subjects over the past twenty years.

Workshop schedule:

Session 2 program: Turning Freeze Drying from a batch process into a continuous process

Workshop topic:

The current implementation of Freeze Drying is largely implemented as a batch process. The physical constraints of the underlying processes dictate the current realization. In this workshop an interactive approach will be taken to discover and compare processes. Jointly the pros and cons of alternatives will be explored and projected upon Lyophilization. Besides this focus, it is intended to have the audience experience new creative insights and the application of some fundamental creative techniques like TRIZ.

The format of the workshop is as follows. After a short introduction on an aspect of the continuous processing topic, the audience will be asked to work for a short time in small teams to solve a specific issue/question. The results will be collected and discussed shortly. In a series of cycles the continuous processing topic will be concentrated upon freeze drying, with two alternatives: in bulk and per dose. For each alternative the general pros and cons are explored. The final part of the workshop will concentrate on the technical realization and the practical and pharmaceutical constraints that have to be fulfilled.

While there is active participation of the audience, this voyage will provide insight in the practical and technical requirements that have to be met to achieve a potential breakthrough in this field. This workshop does not pretend to deliver final answers and a ready-to-go solution. The purpose is to feed a creative process that may develop solutions to a changing market.

Exploring continuous processes in general

·       Characteristics

·       Advantages/Issues to solve

·       Fundamental questions in the light of pharmaceutical manufacturing

Current applications in pharmaceutical manufacturing

·       Fabrication of API’s

·       Filling systems (can be considered continuous?)

·       PAT in continuous processes

Current application of continuous processes in freeze drying

·       Fundamental limitations

·       Dose control

·       Infrastructure

·       Limitations

Novel applications of continuous processing in freeze drying

·       Remove the bottle necks

·       Technical issues to solve

·       Explore new possibilities

·       Business case

·       Which bottlenecks to remove?

Lessons learned:

·       Implications of continuous processes on pharmaceutical applications

·       Assess the physics-driven limitations of current freeze drying and develop alternative routes.

·       Apply new technical-creativity techniques on engineering issues

Workshop leader:

Jos Corver and Ernesto Renzi will lead the second portion of the workshop.

Jos Corver holds a degree in applied physics initially in the field of magneto-hydrodynamics. Executing development and engineering work in various industries enriched his expertise in powder physics, vacuum depositions techniques, material science and NMR. Having had leading roles in industrialization processes he also improved his expertise in quality and statistical assessment including Design of Experiments and Multiple Regression and FMEA.

After 12 years within BOC Edwards / IMA Life, he started his own company since 2011, RheaVita. RheaVita strives for innovative improvements in pharmaceutical processing and specifically in freeze drying and the processes supporting this. In parallel he takes project management roles in semicon industry to support his desire to implement cross-over between different industrial fields.

Jos Corver has published in various areas like pharmaceutical, optical en business literature. He is author of a range of patents on the application of NMR, improvements in freeze drying and color printing.

Jos Corver is member of the Board of Directors of the ISL-FD.

Mr. Renzi began his work with Edwards High Vacuum International in 1973 at Edwards Alto Vuoto in Milan.  Mr. Renzi  transferred to the United States in 1985, where he started the North American facility.  His career has spanned 35+ years in the freeze drying business starting with freeze drying process development, moving through R & D of the freeze drying process to Production Manager at Edwards High Vacuum.  He served as the Director of Engineering for the Freeze Drying Group of Edwards High Vacuum International worldwide before moving to his current position of President for IMA Life inc.

Workshop schedule:

Fee:

√       Registration after January 27^th, 2012: € 650.00

What is included?

√       Attendance to the two sessions of workshop

√       Morning and afternoon coffee breaks

√       Lunch

√       Workshop materials containing a CD with slides of both presentations

To register for Workshop please go to Conference Registration Form

Important Registration Information

Accommodations: Attendees to the Workshop are responsible for making their own hotel reservations and travel arrangements.

Cancellations: A refund less 10% service fee will be honored for registration to the Workshop if written notice of the cancellation is received on or before February 28^st, 2012. After February 28^st, 2012 a refund will be made less 20% of the fees.

Substitutions: No substitutions will be permitted prior to the start of the Workshop or during the Workshop.

No Shows: The attendees who sign up for the Workshop and do not appear will NOT receive a refund of their fees.

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