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2019 Polymer Packaging

Modern Polymer Pharma Packaging

May 22 - May 23, 2019
Berlin, Germany

This 2-day training course enables participants to evaluate different packaging systems for liquids and semi-liquids based on formulation properties, market requirements and end-user acceptability.

  • Education
  • Europe

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Program Highlights
THIS COURSE IS COMBINED WITH A SITE VISIT AT BAUSCH + LOMB

Overview

One of the main challenges in the pharmaceutical industry is selecting the most appropriate primary container system options covering a wide range from traditional glass containers to modern polymer container closure systems. Market segment range from generics to biotech, dosage forms from oral liquids to parenterals. This 2-day training course enables participants to evaluate different packaging systems for liquids and semi-liquids based on formulation properties, market requirements and end-user acceptability. The course is focused on polymer packaging materials and will provide an extensive overview about materials and systems, advantages and limitations. A brief comparison of polymer materials with glass is included in the course, as well as a detailed introduction to blow-fill-seal-technology including container closure integrity testing. Also, the different manufacturing and processes related to the implementation of polymer packaging materials will be discussed. Last but not least, most recent requirements, future trends and innovations in polymer pharmaceutical packaging will be outlined. The course combines classroom lectures with interactive exercises and discussions with experts in this field. The course will be completed with a site visit at a pharma facility, offering a special insight into aseptic blow-fill-seal processing.

Agenda

  • Day 1
  • Day 2
  • Wednesday, 22 May 2019

    9:00
    Welcome & Introduction


    9:15
    Target Product Profile and Container Closure System – From Drug to Packaging and Usability

    • Formulation
      • Compendial compliance
      • Properties e.g. viscosity
    • Processability
      • Aseptic filling
      • Thermal sterilization
    • Usability
      • User needs
      • Administration routes
      • Application systems
      • Single/multidose
      • Environmental conditions

    9:55
    Primary Container Closure Systems, Part I: Bottles, Vials, Ampules, Cartridges, Syringes

    • Requirements
    • Advantages and disadvantages
    • Overview about available systems
      • Glass (bottle, ampoules, vials, cartridges, syringes)
      • Polymers (vials, syringes)

    10:15
    Primary Container Closure Systems, Part II: Blow-Fill-Seal Containers

    • Requirements
    • Advantages and disadvantages
    • Overview about available systems (external sources)
      • Bags
    • Overview about available systems (internal manufacturing)
      • Blow-fill-seal containers
      • Bottles

    10:35
    Coffee Break

    10:05
    Basics of Blow-Fill-Seal Technology

    • From polymer granulates to filled and sealed containers
    • Traditional BFS-process
    • Multilayer options

    11:35
    Interactive Exercise 1:
    Impact of drug formulation and application on primary packaging and container closure system


    12:30
    Lunch Break

    13:30
    Dosage Forms, Designs and Usability of BFS Containers

    • Ophthalmics
    • Inhalation
    • Parenterals
    • Terminal sterilization
    • User acceptance and usability
      • Optimized application of infusions
      • Easy empty containers

    14:00
    Recent Innovations in Blow-Fill-Seal

    • Cool-BFS for temperature sensitive formulations
    • Increased functions by inserted parts
    • Adapters/closures for minimizing administration errors and increasing safety

    14:30
    Coffee Break

    Interactive Session 2:
    Impact of drug formulation and application on selection of primary packaging and container closure system and on manufacturing of primary packaging


    16:30
    Summary Day 1 and Q & A


    17:00
    End of Day 1
  • Thursday, 23 May 2019

    9:00
    Primary Packaging Materials, Part I: Glass, Polymers

    • Glass
      • Glass types
      • Basic properties
      • Advantages, limitations
      • Novel compositions, trends
      • Manufacturing
        • Tubing
        • Converting
        • Molding
        • Surface treatment
    • Polymers
      • PE, PP, COP/COP
      • Basic properties
      • Advantages, limitations
      • Trends
      • Manufacturing
        • Molding
        • Surface treatment

    9:40
    Primary Packaging Materials, Part II: Elastomers

    • Elastomers
      • Butyl, halobutyl, synthetic polyisoprenes, SBRs
      • Basic properties
      • Advantages, limitations
      • Trends
      • Manufacturing
        • Surface treatment

    10:00
    Coffee Break

    10:30
    Practical Considerations During Development/Selection of Packaging System

    • Interaction of packaging materials with drug product
    • Closure system
    • Impact of storage/transportation temperatures
    • Container closure integrity test methods

    11:30
    Interactive Session 3:
    Risk Analysis of material selection (glass or COC/COP) for pre-filled syringes during development of new biopharmaceutical drug product


    12:30
    Lunch Break

    13:15
    Bus Transfer to Bausch + Lomb


    14:00
    Introduction to Facility Tour

    • "Virtual" tour through facility: what will be seen
    • Different type of BFS technology
    • CCIT
    • Inspection systems

    14:30
    Facility Tour at Bausch + Lomb

    • BFS machines types in production
    • CCIT in operation
    • Inspection systems in operation

    15:30
    Summary Day 1 & 2 and Q & A


    16:00
    Farewell Coffee


    16:30
    Transfer to Training Course Hotel


    17:00
    End of Training Course

Trainers

Michael Spallek
Michael Spallek
rommelag ENGINEERING
Bernd Zeiss
Bernd Zeiss
Gerresheimer Bünde GmbH
Jörg Zürcher
Jörg Zürcher
Bayer HealthCare

Additional Information

  • Learning Objectives

    Learning Objectives

    Upon completion of this course attendees will be able to

    • Develop target profiles for primary pharmaceutical packaging systems for liquids
    • Understand modern pharmaceutical packaging technologies, materials, applications and requirements
    • Compare different primary container systems with their advantages and limitations
    • Understand the specifics of polymer materials used for primary packaging
    • Evaluate the characteristics of manufacturing technologies for polymer packaging including blow-fill-seal technology
    • Select packaging systems based on the evaluation of market requirements and drug product properties
  • Who Should Attend

    Who Should Attend

    This course is designed for those involved in pharmaceutical development and manufacturing of drug products with responsibilities for selection of container closure systems:

    • CMC experts
    • Packaging development and engineering
    • Formulation scientists
    • Professionals in manufacturing and engineering

    Pre-requisite to attend the course is an understanding of pharmaceutical development including basic primary packaging aspects. Specific knowledge and expertise in polymers is not required.

  • Accreditation

    Accreditation

    NOTE   Continuing education credits are not available for this event.

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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.

Courtyard by Marriott Berlin City Center

Axel-Springer-Strasse 55
Berlin, Germany
Phone: +49-30-800 928 0

Courtyard by Marriott Berlin City Center
  • Accommodations

    Hotel Website

    The Courtyard Berlin City Center is situated in the heart of the action, placing you near landmarks like Checkpoint Charlie, Potsdamer Platz, Brandenburg Gate and Alexanderplatz. You'll find it easy to relax in your modern, well-appointed hotel lodging; all of the spacious rooms showcase free high-speed Wi-Fi access, luxurious bedding, an ergonomic desk, a mini-fridge and more. Fuel up for your morning in the Mitte district with a hot breakfast buffet at Oléo Pazzo, or end your day with a delicious Mediterranean meal.

    We also provide a fully equipped fitness center, a sauna and an on-site coffee house. Host a meeting or social event with us here in Berlin city center to make use of 8,342 square feet of versatile venue space, cutting-edge event technology and innovative planning and catering. Make the Courtyard Berlin City Center your destination of choice for your visit to the Mitte district.

    PDA Europe has reserved a limited number of rooms until the 08th April 2019.

    Book Your Room for the PDA Group Rate
    Single Room € 135 per night*
    Double Room € 150 per night*

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

    • Buffet Breakfast in the restaurant
    • usage of Wireless LAN
  • Amenities

How to Get Here

By Air

Nearest Airports:

Berlin-Tegel Airport - TXL
Airport Phone: +49 30 60911150
7.1 mi (11.42 km), 22 min by car
Estimated taxi fare: 28 EUR (one way)
Bus service, fee: 2.7 EUR (one way)
Subway service, fee: 2.7 EUR (one way)
Take the bus X9 and get off at the Zoological Garden. Change to the subway U2 towards Pankow and get off at Spittelmarkt. Cross Seydelstrasse and turn right. The hotel will be on the right.

OR

Berlin-Schoenefeld International Airport - SXF
Airport Phone: +49 30 60911150
11.7 mi (18.9 km), 23 min by car
Estimated taxi fare: 40 EUR (one way)
Bus service, fee: 3.3 EUR (one way)
Subway service, fee: 3.3 EUR (one way)
Take the bus SX1 to Südkreuz. Then change to bus 248 to S+U Bahnhof Alexanderplatz and get off at Lindenstrasse/Oranienstrasse. Turn right into Axel-Springer-Strasse, direction Axel-Springer building. The hotel is located at the very end of the street on the left hand side.

By Car

The Marriott Berlin City Center is located at Axel Springer Strasse 55.

Other Options

Bus station: Spittelmarkt, 0.1 miles.

Subway station: Spittelmarkt, 0.1 miles.

Train station: Hauptbahnhof, 3.1 miles.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €1.595

All fees given in Euro and excluding VAT

* 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).

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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

Registration Customer Care

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

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