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Parenteral Drug Association Connecting People, Science and Regulation ®

Development of a Freeze Drying Process

Nov 29 - Nov 30, 2018 |
Nov 30, 2018 |
MELIÁ SEVILLA | Seville, Spain
  • Education
  • Europe
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This workshop will give a thorough introduction into the Physics and Thermodynamics of Freeze-Drying. It comes with an additional overview about technical aspects to be considered and gives an overview about current technologies available on the market. It is created to introduce all people who are professionally linked to Freeze-Drying and might be of special interest for cycle developers (R&D), upscale & transfer specialists, project managers & engineers, process & site engineers, qualification & validation specialists. Open problem examination allows you to bring in a current problem linked to Freeze-Drying. The group will discuss and evaluate possible approaches for troubleshooting.

Who Should Attend

This course is designed specifically for:

  • Cycle Developers (R&D)
  • Upscale & Transfer Specialists
  • Project Managers & Engineers
  • Process & Site Engineers
  • Qualification & Validation Specialists
  • Members of Parenteral Production Teams

Learning Objectives

Upon completion of this course participants will know the basic principles of all Freeze Drying aspects:
  • Physical / Thermodynamic Theory of Nucleation, Sublimation and Desorption
  • Technical & Technological Solutions to accomplish a standard process
  • Based on the prior theory, several hands-on-sessions provide practical knowledge to design a Freeze-Drying process
  • Basics of qualification of a freeze dryer

Instructor

Georg Frinke, Bayer Pharma
Georg holds a degree in Engineering from UAS, Cologne, Germany. He is Process Engineer at Bayer Pharma and responsible for the technical operation of the parenteral facility. Previously, he worked as Process Engineer for Optima (Klee) and GEA Lyophil / Steris. Among others, he is specialized in the development of customized Freeze-Drying processes (particularly upscaling with PAT) and in the qualification (FAT, SAT, IQ, OQ, PQ) of pharmaceutical freeze dryers.

Thursday, 29 November 2018

THEORY

9:00
Introduction

  • Introduction to Drying Technologies
  • Overview of the Freeze Drying Process
  • Properties of Water
  • Properties of Heat Transfer during Lyophilization

10:00
Nucleation

  • Scientific Basics
  • Freezing Process
  • Sensors & PAT
  • Hands-on

11:00
Coffee Break

11:30
Nucleation (Cont.)

  • Hands-on: Freezing of Sucrose in a Lyo with integrated thermo-resistant measurement

13:00
Lunch Break

14:00
Sublimation

  • Scientific Basics
  • Drying Process
  • Sensors & PAT
  • Hands-on

16:00
Coffee Break

16:30
Desorption

  • Scientific Basics
  • Residual Moisture
  • Sensors & PAT
  • Hands-on

Bring in your Questions: Real problems of Freeze Drying can be presented and will be discussed as a group


18:30
End of Day 1

Friday, 30 November 2018

TECHNOLOGIES & PRACTICE

8:30
Repetition of Previous Day Theory & Transfer of a Freeze Drying Cycle


9:00
Hands-On: Recipe Development


11:00
Coffee Break

11:30
Module Structure of a Freeze Dryer

  • Chamber & Shelf System
  • Condenser & Main Valve
  • Venting System / Filter Test
  • Refrigeration
  • Vacuum System
  • CIP / SIP Systems

12:30
Lunch Break

14:00
Module Structure of a Freeze Dryer (Cont.)

  • System Benchmarks
  • Performance Criteria
  • Installation vs. Process
  • Design Criteria & Engineering Aspects

15:00
Coffee Break

15:30
Hands-on:

  • Evaluation of the Lyo experiment & samples of collapsed probe

16:30
Qualification Validation Hints for the SAT
17:00
End of Training Course

3 Ways to register

Please remember to log in if you are a member of PDA already! 

If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

  • All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
  • All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.)
  • Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).
  • No PDA membership obtainable upon booking training course, workshop or other related event.

Registration Fees

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All Participants

1,495 Euro

All fees given in Euro and excluding VAT (21%)

Contact

Antje PetzholdtAntje Petzholdt
Manager Registration, Chapters & Membership
Tel: +49 (0) 30 43 655 08-10
Fax: +49 (0) 30 43 655 08-66
Email

Exterior

MELIÁ SEVILLA
Calle Dr. Pedro de Castro 1
41004 Sevilla
Spain
Tel: +34 912 76 47 47
Hotel Website

Located in the heart of Seville opposite the Parque de Maria Luisa and Plaza España and very close to the University (Old Tobacco Factory), the Alcazar, the Barrio de Santa Cruz district, the Cathedral and the Archive of the Indies, the new Meliá Sevilla is the perfect choice for your business and leisure trips, thanks to its excellent location in the city centre, its fully equipped and comfortable facilities and the quality of its services.

Completely refurbished, the hotel offers a stunning outdoor pool with views of Plaza España and a spectacular Congress and Convention Centre. All the rooms at the new Meliá Sevilla are outward facing, comfortable and bright.

The hotel’s Mosaico restaurant serves an international breakfast buffet. There is also a poolside snack bar and a chic cocktail lounge, Elyxr.

PDA Europe has reserved a limited number of rooms until the 26th September 2018

Book Your Room for the PDA Group Rate

Single Room € 95 per night; 10% VAT, additional taxes and service charges will apply *
Double Room € 106 per night; 10% VAT, additional taxes and service charges will apply*

*Rates are per room and night, including the following services and benefits free of charge:

  • Buffet Breakfast in the restaurant
  • Wireless Internet Connection (WI-FI)

How to Get There

Seville Airport– SVQ
Airport Phone: +34 954 44 90 00
Hotel Direction: 11.8 km
The airport shuttle service is upon request for €25 per vehicle one way.

Parking

Parking available upon request at the registration desk.

Photos

Sponsorship and Exhibit Opportunities are Available!

For more information about exhibit and sponsorship opportunities, please contact:

Nadjeschda Gomez-Stahl
Manager Exhibition & Sponsorship
Tel: +49 (0) 30 43 655 08-23
Fax: +49 (0) 30 43 655 08-66
Email

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=4493

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