Lyophilization 2017 - Includes Workshop at GEA

Lyophilization 2017 - Includes Workshop at GEA

Cologne, Germany

Course No 15720


Costs

Non-ECA Members: EUR 2190,--
ECA Members: EUR 1990,--
EU GMP Inspectorates: EUR 1095,--
APIC Members (does not include ECA membership): EUR 2090,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Anthony Cannon, Samsung Biologics, Korea

Richard Denk, SKAN, Switzerland

Maik Guttzeit, GEA, Germany

Kristien Janssen, Pfizer, Belgium

Roland Koch, Wilco, Switzerland

Alexandra Stärk, Novartis, Switzerland

Prof Evangelos Tsotsas, University of Magdeburg, Germany

Markus Wahlen, GEA, Germany

Dr Andrea Weiland-Waibel, Explicat, Germany

Objectives

Take advantage of the opportunity to focus on freeze drying technologies and processes and get a first hand demonstration of solutions for diverse requirements. Further, benefit from the workshop where you can get a hands-on experience in freeze drying yourself. In small groups, you will learn how the freeze drying output is affected by different equipment, parameter changes, solvents, etc.

Background

Lyophilization (or freeze drying) is one of the most exciting technologies in the pharmaceutical industry, although it is a very old process for the preservation of unstable materials. Trends are growing towards using non-aqueous systems.

Additionally, Process Analytical Technology (PAT) systems for in-line process monitoring are used to control and determine critical processing parameters.

Modern development following ICH Q8, Q9 and Q10 is based on the objective to design a lyophilization cycle applying a systematic and scientific approach instead of trial and error. Sufficient process understanding is essential to achieve a robust production process and efficient handling of post-approval changes (life cycle management) of a freeze drying process.

There is an increasing trend in aseptically produced lyophilized products, including peptides and proteins. Owing to the nature of these biological products, the lyo-cycle is more complicated and, in most cases, even longer than for other medicinal products.

The utility of lyophilization goes far beyond the vial. Principles of low temperature, low pressure can be applied to stabilize substances ranging from high potent APIs, novel medical devices, biologics and nanomaterials, freeze drying offers multiple opportunities.

Target Group

This conference addresses specialists and executives working in the fields of pharmaceutical manufacture, research and development and quality control, as well as engineers, project/facility engineers, especially those involved in the implementation of new monitoring methods for controlled nucleation, risk-based scale-up models and process technology for freeze drying processes. The conference is also of interest for participants working in the areas of container development and manufacturing process/packaging.

Workshops on Thursday, 1 June 2017

On the third conference day, you will have the opportunity to take part in several parallel workshops. For that purpose, several lyophilizers will be available at GEA. Experienced GEA experts will lead you in small groups, providing an intensive experience and directly applicable know-how.

Target group of the Course
Process Engineers, Pharmaceutical Technologists, Pharmaceutical Formulation Scientists, Application Chemists, Drug Development Engineers, Particle Design Engineers.

Workshops

  • Fundamentals and operation of freeze dryers, details on system configuration
  • and basic controls
  • Cycle development and scale-up to pilot/commercial-scale freeze dryer
  • Fundamentals and operation of automated loading and unloading systems
  • Software development and simulation
  • New innovations in freeze drying applications, like silicone oil detection with mass spectroscopy, controlled nucleation, vial track-and-trace (for experts)

A shuttle bus will bring you to Cologne Central Station at approximately 15.15 h.
From Cologne Central Station, frequent airport connections are available.

It is highly recommended that you bring your own safety shoes, if available.

Programme

Fundamentals of freeze drying – basic concepts and processes

  • General advantages of freeze drying, product quality issues
  • Classification and comparison of freeze drying processes
  • Freeze drying in vials: Fundamentals of mass and heat transfer
  • Role and importance of freezing
  • Influence of process parameters, material properties, dryer design
  • Process optimization, monitoring and control
  • Freeze drying of frozen particles: Fundamentals of heat transfer, influence of mixing
Lyo-cycle development and PAT-based optimization
  • Critical quality attributes and critical process parameters: assessment of critical process parameters through robustness testing to establish the process boundaries as the basis for the transfer from lab to commercial scale
  • Freeze drying scale-up and validation: process qualification/validation in lyophilization strategies in relation to FDA/EMA modern process validation guidelines
  • Process control strategies: hot and cold spot determination to allow for process control by using a product temperature PAT device
Lyophilization of highly potent compounds
  • Freeze dryer equipped with isolator
  • An introduction to highly potent products
  • Which are the critical limits and how are they evaluated?
  • Correlation between critical limits and cleaning validation
  • Determination of critical process steps
  • Hardware solutions
  • Examples
Lyophilization technology - design requirements and technical solutions
  • Main components of a lyo (chamber, condenser, refrigeration skid,
  • vacuum skid, shelves, etc.)
  • Purpose of these components
  • Design criteria of these components (temperature homogeneity, cooling and heating capacity, sublimation capacity and gas flow, etc.)
Lyophilizer in aseptic production lines - challenges and opportunities
  • Loading and unloading of freeze dryers
  • Campaigning
  • Control of sterility
  • Changeover times
  • Vacuum and silicone oil leak tests
  • Maintenance
Media Fill
  • Media Fill Design
  • Worst-case parameters for Media Fills
  • Validation of lyophilization processes with Media Fills
  • Requirements for Media Fills
  • Actual trend with regards to Media Fills
How to organize a GMP-compliant lyophilization project
  • Effective customer/supplier relation
  • Definition of scope of supply (URS vs. supplier standard)
  • Managing project organization and set up of controls
  • Risk based life cycle approach in accordance with GAMP 5
Lyophilization cycle improvement and control by using mass spectroscopy
  • Application of GEA LYOPLUS™ for verification of freeze drying batches
  • Online data acquisition for monitoring the solution concentration in the
  • freeze drying chamber
  • Verification of freeze drying end points for primary and secondary drying
  • Investigation of opportunity to use LYOPLUS™ as PAT tool during freeze drying cycles
Qualification/validation and the use of QbD for freeze drying
  • Risk assessment in the context of qualification and validation
  • QbD aspects for successful lyophilization projects
  • Tests during qualification and validation
  • Concepts for reduced testing approach
100 % Inspection
  •  % quality monitoring for continuous production process improvement illustrated with a lyo process application.
  • Different inspections: container closure integrity before and after the crimping process,
  • cake residual moisture evaluated by means of NIR spectroscopy, combined with product identification and cake defect detection, downstream inline laser coding is clearly identifying the vial as a container which fully complies to all quality requirements.

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