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Parenteral Packaging

Feb 25 - Feb 26, 2020
Basel, Switzerland

  • Conference
  • Europe

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Program Highlights

Join us in Basel, Switzerland on 25-26 February 2020 hear all about the Interaction of Product, Package, and Process!

Now confirmed! TÜV Süd Germany will share the Notified Body perspective on EU MDR Article 117 and its impact on combination products!

 

Overview

Dear Colleagues,

On behalf of the Scientific Program Planning Committee and PDA Europe, we are proud to present the 10th Parenteral Packaging Conference, to take place in Basel/Switzerland, a hot spot of pharmaceutical manufacture, on 25-26 February 2020!

This conference has become highly regarded for its content and quality, and this year’s edition will continue the series of exceptional presentations and discussions. Industry leaders and technical experts from pharma and supplier companies along with regulators will cover many aspects of the drug product-package interface.

Primary packaging of a parenteral pharmaceutical drug product should be designed, processed and manufactured, to ensure efficacy and safety of the patients.  In particular, biopharmaceuticals require special considerations for processing and packaging.

Developments in packaging materials such as innovations in glass and polymer, and their characteristics regarding interactions with the drug product formulation and end-user preferences will be discussed. Case studies of the implementation of new guidelines, for example Annex 1 of the European GMP Guideline and USP 800 along with some of the latest developments in packaging materials & components and the role of Container Closure Integrity (CCI) in product-package development, assembly and processing will be presented.  Low temperature storage of biopharmaceuticals for cell and gene therapy poses new challenges to packaging materials.

The conference program is intended to initiate and support discussion and professional exchange through a diversity of scientific presentations, workshops, interest group meetings, training courses, joint dinners and networking events.

We look forward to you joining us in beautiful Basel to celebrate the 10th anniversary with us!

Agenda

  • Day 1
  • Day 2
  • Tuesday, 25 February 2020

    9:00
    Welcome and Introduction

    Falk Klar, PDA Europe
    Roman Mathaes, LONZA, Conference Chair
    Galen Shi, Eli Lilly & Company, Conference Chair

    KEYNOTE: Patient Centric Parenteral Delivery Ecosystem
    Karthik Vaideeswaran, Eli Lilly & Company

    Opening Plenary: Regulatory Updates
    Moderator: Renaud Janssen,
    Datwyler

    The Regulatory Update session of this conference has contributions on 2 topics that are of high interest to the parenteral industry. The first contribution is on the new EU Medical Device Regulation that will be implemented in the course of May 2020 and of which the impact on Combination Products will be discussed by a Notified Body presenter. The second contribution discusses the opinion of the Chinese Pharmacopoeia on packaging materials, that, unlike in Europe and in the US, have no separate pharmacopoeial chapters yet.

    09:50
    Notified Body Perspective on EU MDR Article 117 and its Impact on Combination Products

    Stephanie Goebel, TÜV Süd Germany

    10:20
    The New Chinese Pharmacopoeia and It’s Relation to Packaging Materials
    Songping Liao,
    Baxter
    - Remote Presentation-

    10:50
    Q&A, Discussion

    11:15 - 11:45
    Coffee Break, Poster Session & Exhibition

    Transition to Parallel Tracks

    Session 1A: Packaging Consideration for Deep Cold and Cryogenic Storage
    Moderator: Derek Duncan,
    LIGHTHOUSE

    The manufacture of cell- and gene-based therapies faces unique challenges one of which is the effects on the packaging during deep cold storage (from -80° C down to cryo temperatures). The topic of container closure integrity during cold storage for these products will become more critical as GMP production of these products scale up. In addition, new container solutions for these products should be investigated. This session will explore these current topics.

    11:45
    Overcoming Challenges of Storage and Distribution of Cell and Gene Therapy Products

    Sean Werner, Sexton Biotechnologies

    12:10
    Packaging Solution for Cryogenic Storage of Cell and Gene Therapy Products
    Luce Sohier, SCHOTT
    Mr. Pascal Sircoulomb, ARaymondLife

    13:00
    Q&A, Discussion

    Session 1B: Closed System Transfer Devices
    Moderator: Bettine Boltres,
    WEST

    The USP <800> general chapter is scheduled has come into effect in December 2019. This standard is aimed at limiting occupational exposure when handling hazardous drugs (HDs). The goal is to protect patients, health care personnel, and the environment. It stipulates the use of closed system transfer devices (CSTDs) during HD compounding and administration. Hospitals, pharmacies and healthcare organizations are making efforts to implement this regulation. However, the ambiguity of USP<800> has been challenging for the industry. Within this session we will explore the industry’s challenges and efforts so far and discuss possible solutions and options for moving forward.

    11:45
    Development of Guidance for the Interconnectibility between Vial Container Closure Systems and Vial Transfer Devices

    Cathy Zhao, WEST

    12:10
    Functionality of Closed System Transfer Devices Impacting Drug Administration
    Ahmed Besheer, LONZA

    12:35
    Considerations for Using Closed System Transfer Devices with Biological Drug Products

    Kunjal Oza, Genentech/Roche

    13:00
    Q&A, Discussion

    13:15 - 14:15
    Lunch Break, Poster Session & Exhibition

    Transition to Parallel Tracks

    Session 2A: Packaging Consideration for Deep Cold and Cryogenic Storage, con't
    Moderator: Derek Duncan,
    LIGHTHOUSE

    14:15
    Evaluation and Development of Seal Integrity for Cryogenic Container Closure Systems, Integrating Material and Mechanics First Principles
    Jeremy Hemingway, Stress Engineering Services

    14:40
    The Contribution of Rubber Adhesion to Sealability at Deep Freeze Temperature
    Cathy Zhao, WEST

    15:15
    Q&A, Discussion

    Session 2B: Closed System Transfer Devices, con't
    Moderator: Bettine Boltres
    , WEST

    14:15
    CSTDs: How to Apply USP in Combination Product Development
    Katharina Golly, Novartis

    14:40
    CSTD Selection for an Established Container Closure System - A Case Study
    Holger Roehl, F. Hoffmann - La Roche

    15:15
    Q&A, Discussion

    15:45 - 16:15
    Coffee Break, Poster Session & Exhibition

    Transition to Parallel Tracks

    Session 3A: Ensuring Container Closure Integrity
    Moderator: Roger Asselta,
    Genesis Packaging Technologie

    Container Closure Integrity is of the utmost importance for parenteral packaging development and production. In this session we will explore three different aspects of CCI. First, we will look at a relatively new packaging configuration that uses a press fit closure over nested containers. Risks and analytical methods for qualification will be discussed. Second, we will delve into some of the issues and risks of a traditional vial-stopper seal system evaluating the effects of certain component variation using micro-computer aided tomography. Finally we will be presented on an automated container closure integrity test method in the production of lyophilized parenteral products. Using laser head-space analysis in two specific examples of production throughput.

    16:15
    Characterization of Nested Press-Fit Caps and Container Closure Integrity
    Maury Mossman, Genentech/Roche

    16:40
    Determining the Reject Limit in Headspace Analysis Applications
    Wolfram Schindler, Syntegon

    17:05
    Quantifying the Vial Capping Process Using Micro-computed Tomograph
    Robert Ovadia, Genentech/Roche

    17:30
    Q&A, Discussion

    Session 3B: Glass
    Moderator: Robert Guidos,
    Corning

    This session will offer insight into the many risk factors pharmaceutical companies must consider as they evaluate and select a glass primary packaging for their products. We will hear a new perspective on corrosion mechanisms, including the response of glass vials to acidic, basic, and neutral pH environments and the impact of chelators and surface heterogeneities upon extractable and leachable concentrations; consider ways to reduce glass vial surface interaction as one way to address the risk posed by high extractables, pH shifts, and surface delamination; and, finally, learn about the potential benefits (e.g., damage-resistance, enhanced strength) of coatings applied to glass vials and one drug company’s efforts to assess a coated vial for potential future use.

    16:15
    Review of Corrosion Principles Determining Extractables and Leachables of Glass Containers
    Robert Schaut, Corning

    16:40
    Applied Technology and Glass Type Selection's Influence on Vial Interactions
    David Lisman, Nipro Pharma Packaging

    17:05
    Comparative Filling Line Tests with Next Generation Vials
    Holger Roehl, F. Hoffmann - La Roche
    Florence Buschke, SCHOTT

    17:30
    Q&A, Discussion

    18:00
    End of Day 1 & Networking Event

  • Wednesday, 26 February 2020

    9:00

    Parallel Tracks

    Session 4A: Drug Products and Their Interactions with Primary Packaging
    Moderator: Herve Soukiassian
    , BD

    Biologics are becoming dominant in the biopharmaceutical pipeline thanks to their success in treating chronic conditions. The parenteral route is now commonly used for administration of those sophisticated and evolving drugs using prefilled syringes (PFS). Glass remains the undisputed gold standard material for those containers. This session contributes to enrich the industry understanding and knowledge around drug/container interactions, combining chemical and mechanical performance on one hand, but also developing predicting tools to de-risk development with the intend of a creating a robust match between problem and solutions.

    09:00
    Impact of Drug Formulation on Subvisible Particle Formation and Break/Lose Glide Force
    Susanne Joerg, LONZA

    09:30
    Analytical Approaches to Increase the Confidence in Pre-filled Syringes Selection for Sensitive Biological Drug Formulations
    Claire Brunet, Becton Dickinson

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    Session 4B: Sterilization & Decontamination
    Moderator: Joerg Zuercher,
    Bayer

    The session will give an update on innovative approaches to sterilize packaging components and/or assembled and packed temperature sensitive products. A new technology to treat ready-to-use systems prior to the filling process based on pulsed light technology is discussed. And you will hear about advanced vaporized hydrogen peroxide procedures and their validation.

    09:00
    Case Study Project: Robotic Tub Decontamination System
    Christophe Riedel, Claranor

    09:30
    Case Study - Control and Monitoring of VH2O2 Sterilization Process Variables in Industrial Applications
    Juha Mattila, STERIS

    10:00
    Q&A, Discussion

    10:30 - 11:00
    Coffee Break, Poster Session & Exhibition

    Transition to Parallel Tracks

    Session 5A: Modern Plastics in Pharma
    Moderator: Yusuf Oni,
    Bristol-Meyers Squibb

    In this session, the Guideline on Medical Grade Plastics published by VDI in 2019 outlining requirements for materials that have not yet been clearly defined will be presented and discussed from a raw material suppliers’ perspective. The ongoing digitalization of the pharmaceutical industry will be exemplified by a blow-fill-seal machine and the GMP relevant advantages and the improvement of data integrity will be discussed.

    11:00
    Plastics in Healthcare - VDI 2017 Guideline on Medical Grade Plastics
    Anja Gottschalk, Borealis

    11:30
    Improving Blow Fill Seal Efficiency in the Pharma 4.0 Era
    Massimo Consolaro, Brevetti Angela

    12:00
    Q&A, Discussion

    Session 5B: Manufacturing & Processing
    Moderator: Roman Mathaes,
    LONZA

    Sterile pharmaceuticals require to be developed and manufactured using suitable container closure systems to ensure compatibility to the drug product formulation and to maintain sterility until product opening. Particles in parenteral drug products are an obligatory CQA. Silicone oil or particles on rubber components can contribute to the total particle counts of a drug product and should be monitored and controlled. This session will discuss current strategies and best practices to mitigate the risks of particle contaminations associated to packaging components.

    11:00
    Advantages & Disadvantages of Methods Used to Determine the Degree of Silicone Oil on Rubber Closures
    Simon Kervyn, Datwyler

    11:30
    PDA Update: Quantifying Loose Particles on Elastomeric Components
    Ravi Patel, WEST
    John Rech,<WEST

    12:00
    Q&A, Discussion

    12:20 - 13:20
    Lunch Break, Poster Session & Exhibition

    Session 6: Challenges in Pre-filled Syringes
    Moderator: Galen Shi,
    Eli Lilly and Company

    This session will describe two under-appreciated challenges in PFS in 1) silicone oil changes in empty or filled syringe barrel, and 2) the cavitation risk in solution inside syringe upon autoinjector activation.

    13:20
    Physics of Silicon layer in Pre-filled Syringes
    Jean-René Authelin, Sanofi Pasteur

    13:45
    Analysis of Cavitation in Syringes
    Javad Eshraghi, Purdue University

    14:10
    Q&A, Discussion

    14:40 - 15:10
    Coffee Break, Poster Session & Exhibition

    Closing Keynotes
    Moderators:
    Roman Mathaes, LONZA

    In this final keynote session, Donald Klein will present the latest regulatory strategies for primary packaging comparability protocols, followed by an interactive survey. The conference will be summarized together with an outlook on the 2021 PDA Packaging conference focus topic: Primary packaging for ocular products

    15:10
    Comparability Protocols: A Regulatory Advantage
    Donald N. Klein, DLK Consulting Services

    15:35
    Mentimeter Excercise

    15:45
    Challenges for Intravitreal Drug Products at the Interface of Primary Packaging and Application
    Roman Mathaes, LONZA
    Ahmad Sediq, LONZA

    16:10
    Conference Summaries by the Chairs
    Roman Mathaes, LONZA, Chair
    Galen Shi, Eli Lilly & Company, Chair

    16:30
    Closing Remarks & Farewell
    Falk Klar, PDA Europe

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

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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.

Congress Center Basel

Messepl. 21
Basel, Switzerland
Phone: +41 58 206 28 28

Congress Center Basel
  • Accommodations
    Hotels Nearby

    PDA Europe recommends the reservation at one of the following hotels.
    The general terms of business are valid at the event hotels.


    Pullman Basel Europe
    Clarastrasse 43
    4058 Basel
    Switzerland
    Tel: +41616908080

    The Pullman Basel Europe is a vibrant and outstanding upscale hotel within walking distance of the old town, the Rhine river and only 200 m from the Congress Center Basel (Messe). Apart from the fashionable and luxuriously appointed rooms, the modern Fit Lounge and a charming bistro with regional cuisine, it also boasts a green inner courtyard to relax.

    The Basel SBB Train Station is 2 km away and there is parking space available for free for guests. Guests benefit from free access to public transport in Basel with the complimentary Basel Card.

    PDA Europe has reserved a limited number of rooms until the 06th January 2020

    • Single Superior Room CHF 220 per night*
    • Double Superior Room CHF 240 per night*

    You can book your Hotel Accomodation here!

    *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

    Swissôtel Basel
    Messeplatz 25
    4005 Basel
    Switzerland
    Telephone : +41 61 555 3333
    [email protected]

    The Swissôtel Basel (4**** superior) offers elegant guest rooms and real Swiss hospitality for an authentic Alpine experience. The rooms boast hand-picked, unique furnishings and calming tones with splashes of vibrant yellow. In-room technology, WiFi, workspaces and entertainment centres are complemented with Italian coffee machines and quality en-suite amenities to help you get the most out of your stay.

    It is centrally located directly connected with the Congress Center Basel (Messe) and within walking distance of the old town, the Rhine River and numerous sight-seeing spots.

    The Basel SBB Train Station is 2 km away and there is parking space available for free for guests. Guests benefit from free access to public transport in Basel with the complimentary Basel Card.

    PDA Europe has reserved a limited number of rooms until the 06th January 2020

    • Single Superior Room CHF 255 per night*
    • Double Superior Room CHF 285 per night*

    You can book your Hotel Accomodation here!

    *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

Pullman Basel Europe:

Basel's Euro-airport Basel-Mulhouse-Freiburg (BSL) is situated approximately 8km from the hotel. A direct bus (Line Nr. 50) runs every 20 minutes A direct bus (Line Nr. 50) runs every 20 minutes taking you to the SBB train Station. A taxi takes approximately 10-20 minutes to the hotel.


Swissôtel Basel

Basel's Euro-airport Basel-Mulhouse-Freiburg (BSL) is situated approximately 8km from the hotel. A direct bus (Line Nr. 50) runs every 20 minutes taking you to the SBB train Station. A taxi takes approximately 10-20 minutes to the hotel.

By Car

Swissôtel Basel

Exit ‘Basel Nord/Kleinhüningen’ from Hwy A5 or exit ‘Badischer Bahnhof/Basel Ost’ from Hwy A35. Self-parking or valet parking is available at the car park of the fairgrounds (allowed maximum height of 2m).

Other Options

Pullman Basel Europe
Rail:

  • The main train station ‘SBB Basel’ is approximately 2km away: take the tram No. 16 Bhfeingang Gundeldingen to Clarastrasse (duration 15-17 minutes, departure every X minutes)
  • the train station ‘Basel Badischer Bahnhof’ is approximately 1km away: take the tram No. 6 or No. 16 to Clarastrasse (duration 4 minutes, departure every 8 minutes)

Swissôtel Basel
Rail:

  • The main train station ‘SBB Basel’ is approximately 2km away: take the tram Nr. 1 or Nr. 2 to Messeplatz Basel
  • the train station ‘Basel Badischer Bahnhof’ is approximately 1km away: take the tram Nr. 6 to Messeplatz Basel

Directions

Registration Fees

Early Registration
Registration Type Price by 27 December
Member €1.695
Non-member €1.995
Govern./Health Authority/Academic €650
Young Professional (Member) €650
All fees given in Euro and excluding VAT (7,7%)




Regular Registration
Registration Type Price after 27 December
Member €1.895
Non-member €2.195
Govern./Health Authority/Academic €850
Young Professional (Member) €850
All fees given in Euro and excluding VAT (7,7%)




* For this member type or discounted rate, online registration is not available and must be faxed in.

† You must be a member to receive this rate.

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.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

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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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