Modern Polymer Pharma Packaging

Name: Modern Polymer Pharma Packaging
Start: 2019-05-22
End: 2019-05-23

May 22 - May 23, 2019

Berlin, Germany

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Overview
Agenda
Trainers
Additional Information
Travel
Registration Fees
Exhibit & Sponsorship
Contact

Program Highlights

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

Note In response to considerable demand, all participants will now be given access to electronic course notes, which may be printed once for use during the course approximately 1 – 2 weeks in advance. Hard copies of course notes will no longer be provided to participants.

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

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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

rommelag ENGINEERING

Bernd Zeiss

Gerresheimer Bünde GmbH

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
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.

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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

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.

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 this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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 immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

All prices in Euro (EUR), excluding VAT

For your credit card information safety: Please send your details by fax only

For an easier registration, please note the helpful hints on the registration form

Ways to Register

Online Registration
FAX: +49 30 436 55 08 66
[email protected]

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).
Please contact us if you are entiteld to receive a discount

Antje Petzholdt

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

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Modern Polymer Pharma Packaging

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Program Highlights

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Agenda

Wednesday, 22 May 2019

Thursday, 23 May 2019