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2019 FD

Development of a Freeze Drying Process

Sep 26 - Sep 27, 2019
Berlin, Germany

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.

  • Education
  • Europe

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Program Highlights
Bring your own samples for discussion.

Overview

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.

Agenda

  • Day 1
  • Day 2
  • Thursday, 26 September 2019

    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 (with Parallel Hands-on)

    • Scientific Basics
    • Freezing Process
    • Sensors & PAT

    11:00
    Coffee Break

    11:30
    Nucleation (Cont.)

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

    12:45
    Lunch Break

    13:45
    Sublimation

    • Scientific Basics
    • Drying Process
    • Sensors & PAT
    • Hands-on: Ice-temperature calculation based on manometric temperature measurement

    16:00
    Coffee Break

    16:30
    Desorption

    • Scientific Basics
    • Residual Moisture
    • Sensors & PAT
    • Hands-on: Preparation and start of a lyo-process

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


    18:30
    End of Day 1

  • Friday, 27 September 2019

    TECHNOLOGIES & PRACTICE

    8:30
    Repetition of Previous Day Theory


    9:00
    Hands-On: Recipe Development


    11:00
    Coffee Break

    11:30
    Process Design
    Derive design requirements from process requirements

    • Process requirements
    • Process steps of Lyo-cycle
    • Auxiliary processes for parenteral production

    12:30
    Lunch Break

    13:30
    Design of a Lyophilizer - From Engineering to Qualification

    • Vessel system
      • Shelf system
      • Chamber system
      • Condenser system)
    • CIP / SIP-Equipment
    • Qualification procedures
      • CIP-Process
      • SIP-Process
      • Leak Test

    15:30
    Auxiliary Systems of a Lyophilzer

    • Aeration System with Filter test
    • Sensor Equipment / PAT Methods
    • Vacuum System
    • Heat Transfer System

    15:00
    Coffee Break

    16:30
    Hands-on:

    • Evaluation of the Lyo experiment & samples of collapsed probe

    17:00
    End of Training Course

Trainers

Georg  Frinke
Georg Frinke
Bayer Pharma

Additional Information

  • Learning Objectives

    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
  • Who Should Attend

    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
  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    PDA # / ACPE # / CEUs:
    Type of Activity: Not Applicable

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.
    Continuing Education for Professional Engineers
    New Jersey

    PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

    The credit value of this course is CPC credits.
    North Carolina

    PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDH) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

    The credit value of this course is PDH credits.

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Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Berlin Marriott Hotel

Inge-Beisheim Platz 1
Berlin, Germany
Phone: +49-30-220000

Make a Reservation
Berlin Marriott Hotel
  • Accommodations
    Hotel Website

    Showcasing spacious, impeccably appointed guest rooms and suites, a host of first-class amenities, and an unbeatable location in the heart of the city centre, the Berlin Marriott Hotel offers a seamless blend of comfort, style and convenience for your visit to Germany's capital city.

    Unwind in the well-appointed hotel rooms, each of which boasts deluxe bedding, a flat-screen TV, an ergonomic workspace and a mini-bar. You'll enjoy the wide variety of outstanding on-site resources, such as a state-of-the-art fitness center and indoor pool, an authentic steakhouse and a sleek, inviting hotel bar.

    Guests looking to host a successful meeting or wedding here in Germany will be thrilled with the 18,277 square feet of sophisticated event space, the expert planning and catering teams and the accessible location in Berlin city centre. The hotel is situated two blocks from Potsdamer Platz, and near the Brandenburg Gate and the Gendarmenmarkt. Allow the Berlin Marriott Hotel to redefine the meaning of contemporary elegance.

    PDA Europe has reserved a limited number of rooms until the 23rd August 2019.
    Book Your Room for the PDA Group Rate

    Single Room € 195 per night*
    Double Room € 215 per night*

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

    • Buffet Breakfast in the restaurant<
    • Wireless Internet Connection (WI-FI)
    • VAT, Taxes and Service Charge will apply
  • Amenities

How to Get Here

By Air

Nearest Airports:

Berlin-Tegel Airport - TXL
Airport Phone: +49 30 60911150
5.6 mi (9 km), 18 min by car
Alternate transportation: Limousinen Service; fee: 100 EUR (one way); reservation required
Estimated taxi fare: 25 EUR (one way)
Bus service, fee: 2.8 EUR (one way)
Subway service, fee: 2.8 EUR (one way)
Take the Bus X9 and get off at Zoologischer Garden, then take the subway U2 towards Pankow and get off at Potsdamer Platz.

OR

Berlin-Schoenefeld International Airport - SXF
Airport Phone: +49 30 60911150
12.7 mi (20.4 km), 25 min by car
Alternate transportation: Limousinen Service; fee: 130 EUR (one way); reservation required
Estimated taxi fare: 45 EUR (one way)
Bus service, fee: 3.6 EUR (one way)
Subway service, fee: 3.6 EUR (one way)
Take the train S45 to S-Bahnhof Suedkreuz. Then change to the S-train S2 and get off at Potsdamer Platz.

By Car

The Berlin Marriott Hotel is located at Inge-Beisheim Platz 1.

Other Options

Berlin Central Station: 2.3 mi from hotel.

Train Station Berlin Friedrichstrasse: 1.1 mi from hotel.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €1595

* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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Contact

Program Inquiries
Exhibition Inquiries
Training Course Inquiries

Tel: +1 (301) 656-5900
[email protected]

Tel: +49 (0) 30 43 655 08-10

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Tel: +1 (301) 656-5900 ext. 115
[email protected]

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