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pda.org/EU/ParPack2020
2020 PDA EUROPE
Parenteral Packaging
Interaction of Product, Package, and Process
25-26 FEBRUARY 2020
BASEL, SWITZERLAND
EXHIBITION: 25-26 FEBRUARY
TRAINING: 27-28 FEBRUARY
IG MEETINGS: 24 + 27 FEBRUARY
WELCOME FROM THE CHAIRS
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 manufac-
tured, to ensure efficacy and safety of the patients. In particular, biopharmaceuticals require special consid-
erations for processing and packaging.
Developments in packaging materials such as innovations
SCIENTIFIC PROGRAM PLANNING COMMITTEE in glass and polymer, and their characteristics regarding
Roman Mathaes, LONZA, Chair interactions with the drug product formulation and end-user
Galen Shi, Eli Lilly & Company, Chair preferences will be discussed. Case studies of the imple-
Roger Asselta, Genesis Packaging Technologies
mentation of new guidelines, for example Annex 1 of the
Bettine Boltres, WEST
European GMP Guideline and USP 800 along with some
Derek Duncan, LIGHTHOUSE
of the latest developments in packaging materials & com-
Robert Guidos, Corning
ponents and the role of Container Closure Integrity (CCI) in
Renaud Janssen, Datwyler
product-package development, assembly and processing
Philippe Lauwers, Terumo
will be presented. Low temperature storage of biopharma-
Yusuf Oni, Bristol-Myers Squibb
ceuticals for cell and gene therapy poses new challenges
Robert Ovadia, Genentech
to packaging materials.
Herve Soukiassian, BD
Folker Steden, SCHOTT The conference program is intended to initiate and support
Joerg Zuercher, Bayer discussion and professional exchange through a diversity
Falk Klar, PDA Europe of scientific presentations, workshops, interest group
Janie Miller, PDA meetings, training courses, joint dinners and networking
Teresa Schubach, PDA Europe, Manager Programs & Events events.
We look forward to you joining us in beautiful Basel to celebrate the 10th anniversary with us!
Sincerely,
The Chairs
Roman Mathaes, PhD, Galen Shi, PhD,
Conference Chair, Conference Chair
LONZA Eli Lilly & Company
2 pda.org/EU/ParPack2020
HEADER HEADLINE
WELCOME TO
BASEL
SCHEDULE AT A GLANCE
24 February 10:00 – 16:30 Pre-filled Syringes Interest Group Meeting
25 February 9:00 – 18:00 Parenteral Packaging Conference, Exhibition
25 February 19:00 – 21:30 Networking Reception - with PDA Live Entertainment
26 February 9:00 – 16:30 Parenteral Packaging Conference, Exhibition
27 February 10:00 – 16:30 Packaging Science Interest Group Meeting
27 February 9:00 – 17:00 Container Closure Development Training Course
9:00 – 17:30 Container Closure Integrity Testing
27-28 February Training Course
8:30 – 16:30 - Basic Course -
9:00 – 18:00
27-28 February Extractables and Leachables Training Course
9:00 – 16:30
For latest information, please visit: pda.org/EU/ParPack2020
Photo by Abi-Binchley via unsplash.com pda.org/EU/ParPack2020 3
24 FEBRUARY – INTEREST GROUP MEETING
Pre-filled Syringes
2020 Focus Topic:
The Selection of Application Systems –
From Unique Systems to Platform
Dear Colleagues,
In today’s pharmaceutical market, devices like pen/autoinjector/safety devices have gained significance over the last
several years due to increased convenience for end-users. Pharmaceutical and biotechnology companies with a
drug product in application systems such as syringes/cartridges in clinical phases are usually focused on scale-up of
the product. Drug delivery devices to further improve end-user friendliness that not considered early on can have
a negative effect on further processability, variability in the forms of presentation, or cost and time-to-market. Therefore,
starting the discussion early regarding the packaging strategy can save you time and money.
The goal of the meeting is to discuss these issues with a primary focus on:
ꞏ When does one begin creating a strategy to introduce an end-user convenient device? What needs to be consid-
ered for development, assembly and reimbursement?
ꞏ What is the selection process for a pen/autoinjector, safety device, wearables and add-ons - customized versus platform?
ꞏ Learn from case studies from a pharma/biotech supplier using tools, selection process, platforms, process and
technology infrastructure and development strategies.
ꞏ What is the risk to implement a platform and the potential negative impact
Take advantage of the open forum design approach offered by this small Interest Group meeting. Hear presentations
from leading experts and interact and discuss your experiences with colleagues in “World Cafe” discussions. Receive
the latest information about activities of the Interest Group/Pre-filled Syringes.
Brigitte Reutter-Haerle, Vetter Pharma International GmbH, Interest Group Leader Europe
Brigitte Reutter-Haerle is the Vice President of Marketing / Corporate Communications for Vetter, a leading contract develop-
ment and manufacturing organization that serves the global pharma/biotech industry. She was called to this new position in
September 2014 and is responsible for the company’s international marketing activities, product and service management
as well as HR marketing and internal communication. Between 2004 and 2014, she held the position of Director Corporate
Marketing. In 2009, she led the communications program for Vetter’s U.S. expansion. Ms. Reutter-Haerle joined Vetter in
1996, serving in the company’s sales and marketing function, and transferred to corporate marketing three years later. She
began her career in 1983, holding various positions in the sales organizations of firms including Hilton International and TNT Express World-
wide. Ms. Reutter-Haerle earned a B.A. and a degree in Business Administration from Baden-Wuerttemberg Cooperative State University. She
has been leading the Pre-filled Syringe Interest Group/Europe of the Parenteral Drug Association since 2007.
4 pda.org/EU/IG-PFS2020INTEREST GROUP MEETING AGENDA
31 Jan. 2020
Monday, 24 February 2020
10:00 Welcome and Introduction Falk Klar, PDA Europe
Brigitte Reutter-Haerle, Vetter
Opening: Platform Technologies - Challenges and Opportunities Moderator: Brigitte Reutter-Haerle, Vetter
10:10 The Power of Platform Technologies: Flora Felsovalyi, Roche
Streamlining Combination Product Development
10:35 Challenges with Platform Technologies Axel Wagner, Optima pharma
11:00 Coffee Break
11:30 Bend the Platforms to Fit - Using Flexible and Scalable Solution Jens Schou Christensen,
SVM Automatik
12:00 Lunch Break
Interactive Session – From Unique Application Systems to Platform Moderator: Frank Bamberg, CSL Behring
After parting in 4 groups the participants will enter a structured conversational process regarding Pros and Cons of
Platform vs. Customized, Selection Process for Primary Packaging & Med. Devices, Challenges to Implement a Novel
Platform and How to Define a Platform in four rounds. Facilitated by a table moderator each group is introduced to the
topic and will have a set amount of time to discuss and gather key points on each topic. As each group will build on the
knowledge already gathered, each round will be shorter than the prior. Inspired by the method developed by Juanita Brown
und David Isaacs, this session will result in conclusive take home messages on each topic discussed.
13:00 Introduction Frank Bamberg, CSL Behring
Pros and Cons of Platform Selection Process Challenges to How to Define
vs. Customized for Primary Packaging & Implement a a Platform
Gabriele Peron, Med. Devices Novel Platform
Stevanato Group Brigitte Reutter-Haerle, Vetter Frank Bamberg, CSL Behring Ian Thompson, Ypsomed
13:15 Round 1
13:35 Round 2
13:50 Round 3
14:00 Round 4
14:10 Summary of the Interactive Session & Q&A
14:30 Coffee Break
Track & Trace Moderator: Gabriele Peron, Stevanato Group
15:00 RFID Connected Pre-Filled Syringes – Current and Future Applications Yves Steffen, Novartis
15:20 Q&A, Discussion
15:35 Update on the 2019 PDA Survey on Traceability of Gabriele Peron, Stevanato Group
Primary Packaging
15:50 Panel Discussion on the 2019 PDA Survey on Chi Yuen Liu, Johnson & Johnson
Traceability of Primary Packaging Diana Löber, SCHOTT
Tod Urquhart, Stevanato Group
Bernd Zeiss, Gerresheimer
16:20 Conclusion of Interest Group Meeting Brigitte Reutter-Haerle, Vetter
Activities of the Pre-filled Syringes Interest Group Frank Bamberg, CSL Behring
16:30 Farewell
pda.org/EU/IG-PFS2020 5CONFERENCE AGENDA
31 Jan 2020
Tuesday, 25 February 2020
9:00 Welcome and Introduction Falk Klar, PDA Europe
Roman Mathaes, LONZA, Chair
Galen Shi, Eli Lilly & Company, Chair
9:20 Keynote: Patient Centric Parenteral Delivery Ecosystem Karthik Vaideeswaran,
Eli Lilly & Company
Opening Plenary Regulatory Updates Moderator: Renaud Janssen, Datwyler
9:50 Notified Body Perspective on EU MDR Article 117 and its Stephanie Goebel, TÜV Süd
Impact on Combination Products Germany
10:20 The New Chinese Pharmacopoeia Songping Liao, Baxter
and Its Relation to Packaging Materials
10:50 Q&A, Discussion
11:15 Coffee Break, Poster Session & Exhibition
TRANSITION TO PARALLEL TRACKS
Session 1: TRACK A TRACK B
Closed System Transfer Devices Packaging Consideration for Deep Cold
and Cryogenic Storage
Moderator: Bettine Boltres, WEST Moderator: Derek Duncan, LIGHTHOUSE
11:45 Development of Guidance for the Overcoming Challenges
Interconnectibility between Vial Container of Storage and Distribution of
Closure Systems and Vial Transfer Devices Cell and Gene Therapy Products
Cathy Zhao, WEST Sean Werner, Sexton Biotechnologies
12:10 Functionality of Closed System Evaluation and Development of
Transfer Devices Impacting Seal Integrity for Cryogenic Container
Drug Administration Closure Systems, Integrating Material
and Mechanics First Principles
Ahmed Besheer, LONZA Jeremy Hemingway, Stress Engineering Services
12:35 Considerations for The Contribution of Rubber Adhesion to
Using Closed System Transfer Devices Sealability at Deep Freeze Temperature
with Biological Drug Products
Kunjal Oza, Genentech/Roche Cathy Zhao, WEST
13:00 Q&A, Discussion Q&A, Discussion
13:15 Lunch Break, Poster Session & Exhibition
Session 2: TRACK A TRACK B
Closed System Transfer Devices Packaging Consideration for Deep Cold and
continued Cryogenic Storage continued
Moderator: Bettine Boltres, WEST Moderator: Derek Duncan, LIGHTHOUSE
14:15 CSTDs: How to Apply USP Primary Containers for Cell Therapy Products
in Combination Product Development
Katharina Golly, Novartis Min Wei, AstraZeneca
6 pda.org/EU/ParPack2020CONFERENCE AGENDA
14:40 CSTD Selection for an Established Container Packaging Solution for Cryogenic Storage
Closure System - A Case Study of Cell and Gene Therapy Products
Luce Sohier, SCHOTT
Holger Roehl, F. Hoffmann - La Roche Pascal Sircoulomb, ARaymondLife
15:15 Q&A, Discussion Q&A, Discussion
15:45 Coffee Break, Poster Session & Exhibition
Session 3: TRACK A TRACK B
Ensuring Container Closure Integrity Glass
Moderator: Roger Asselta,
Genesis Packaging Technologies Moderator: Robert Guidos, Corning
16:15 Determining the Reject Limit in Headspace Review of Corrosion Principles
Analysis Applications Determining Extractables and Leachables
of Glass Containers
Wolfram Schindler, Syntegon Robert Schaut, Corning
16:40 Quantifying the Vial Capping Process Applied Technology and Glass Type
Using Micro-computed Tomograph Selection’s Influence on Vial Interactions
Robert Ovadia, Genentech/Roche David Lisman, Nipro Pharma Packaging
17:05 Characterization of Nested Press-Fit Caps Comparative Filling Line Tests with
and Container Closure Integrity Next Generation Vials
Holger Roehl, F. Hoffmann - La Roche
Maury Mossman, Genentech/Roche Florence Buschke, SCHOTT
17:30 Q&A, Discussion Q&A, Discussion
18:00 End of Day 1 and Networking Event
LET´S ROCK
THE
PARENTERALS
TUESDAY, 25 FEBRUARY 2020
19:00 - 21:30
BAR ROUGE | MESSEPLATZ 10
4058 BASEL, SWITZERLAND
LiveonStage ED BY
HE ADBA NGCONFERENCE AGENDA
Wednesday, 26 February 2020
Session 4: TRACK A TRACK B
Drug Products and their Interactions with Sterilization & Decontamination
Primary Packaging
Moderator: Herve Soukiassian, BD Moderator: Joerg Zuercher, Bayer
9:00 Impact of Drug Formulation on Subvisible Case Study Project:
Particle Formation and Break/lose Glide Force Robotic Tub Decontamination System
Susanne Joerg, LONZA Christophe Riedel, Claranor
9:30 Analytical Approaches to Increase the Case Study - Control and Monitoring of
Confidence in Prefilled Syringes Selection for VH2O2 Sterilization Process Variables in
Sensitive Biological Drug Formulations Industrial Applications
Filippo Conti, BD Juha Mattila, STERIS
10:00 Q&A, Discussion Q&A, Discussion
10:30 Coffee Break, Poster Session & Exhibition
Session 5: TRACK A TRACK B
New Technologies and Digitalization Manufacturing & Processing
Moderator: Yusuf Oni, Bristol-Meyers Squibb Moderator: Roman Mathaes, LONZA
11:00 Dynamic Sealing Performance Evaluation Advantages & Disadvantages of
and Modeling for Container Closure System Methods Used to Determine the Degree
at Low Temperature Cycles of Silicone Oil on Rubber Closures
Qingyu Zeng, WEST Simon Kervyn, Datwyler
11:30 Improving Blow Fill Seal Efficiency in PDA Update: Quantifying Loose Particles on
Pharma 4.0 Era Elastomeric Components
Ravi Patel, WEST
Massimo Consolaro, Brevetti Angela John Rech, WEST
12:00 Q&A, Discussion Q&A, Discussion
12:20 Lunch Break, Poster Session & Exhibition
Session 6: Challenges in Pre-Filled Syringes Moderator: Galen Shi,
Eli Lilly & Company
13:20 Physics of Silicon Layer in Pre-Filled Syringes Jean-René Authelin, Sanofi
13:45 Analysis of Cavitation in Syringes Javad Eshraghi,
Purdue University
14:10 Q&A, Discussion
14:40 Coffee Break, Poster Session & Exhibition
8 pda.org/EU/ParPack2020CONFERENCE AGENDA
Closing Keynotes Moderators: Galen Shi, Eli Lilly & Company
Roman Mathaes, LONZA
15:10 Comparability Protocols: A Regulatory Advantage Donald N. Klein,
DLK Consulting Services
15:35 Interactive Mentimeter Exercise: Survey on Comparability Protocols
15:45 Challenges for Intravitreal Drug Products at Roman Mathaes, LONZA
the Interface of Primary Packaging and Application 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
Agenda is subject to change without notice
PDA Scientific Poster Presentation
1 Sloshing Motion of Arezoo M. Ardekani,
Liquid Interface in Syringes Purdue University
2 Advanced Safety Syringe with Christoph Egloff,
Closed System Drug Transfer and Weibel CDS AG
Integrated Reconstitution/Compounding
3 Evaluate the Impact of Shrinking Process Akira Sumitani,
of Shrink Tack Labels on Antibody Iwata Label
Products in Glass Vials
4 Quantification and Mitigation of Sterilising Martin Novak,
Process Residuals Uptake into Aseptically SKAN AG
Processed (Bio)Pharmaceutical Products
pda.org/EU/ParPack2020 9SKANFOG® SPECTRA Sterility testing at a new spectrum Cutting-edge SKANFOG® technology = faster and more efficient H2O2 decontamination Short transfer time through the airlock and work chamber Fits into a standard cleanroom and is easy to integrate Integrated catalytic converter = exhaust air to room Easy to operate and to clean Ergonomic design Stainless steel construction and safety glass windows GMP cleanroom class A, ISO 5 Developed and documented according to GAMP Latest automation technology Short delivery times due to standardisation For more information visit www.skan.ch Together always one step ahead
Floor Plan
Room Singapore Room Sydney
1
2
3
24 Lift
12 16 17 18 19 20
15 21
4 25
11 14 22
5
26
13 23
6
27
7
28
8 29
34 33 32 31 30
9
10
Wardrobe
Terrace Registration & Information
Lager
Lift
TO EXHIBIT
PDA meetings and conferences are a great opportunity for your company to gain on-site exposure in front of
highly-qualified, upper-level professionals in the pharmaceutical and biopharmaceutical industry. Exhibition
and Sponsorship Opportunities are available. A basic exhibition package for this event is priced 1.995 Euro
net (table-top). For more information please contact expo-europe@pda.org
pda.org/EU/ParPack2020 1127 FEBRUARY – INTEREST GROUP MEETING
AT
LONZA
FACILITIES
Packaging Science
Focus Topic: Process of Packaging Development
Dear Colleagues,
Taking the opportunity to meet up in an exclusive environment at the LONZA facility in Basel,
Switzerland, our 2020 IG Meeting will focus on the process of packaging development!
Bringing together a group of packaging experts to share experiences will stimulate fruitful
discussions on a number of primary packaging topics.
In addition, hands-on sessions in the Lonza packaging development lab will look at some of the
devices used for ensuring packaging integrity and compliance with current regulations.
Please be invited to contribute to this open forum and discuss latest approaches, exchange
experiences, and share technology updates on primary packaging challenges. Hear
presentations from renowned international experts, interact and discuss your experiences with
colleagues in round table discussions and forums during the meeting.
Roger Asselta, Genesis Packaging Technologies
Roger Asselta is Vice President of Technical Affairs at Genesis Packaging Technologies. He has over 25 years of experience in
pharmaceutical packaging, working for firms producing glass containers, plastic containers and closures, elastomeric closures
and seals, and sealing technology equipment. This year, he is member of the Program Planning Committee of the PDA Paren-
teral Packaging conference.
Bettine Boltres, PhD, WEST
Bettine Boltres has 8 years’ experience in the primary packaging industry. As Technical Account Manager, Europe, for WEST
Pharmaceutical Systems she is supporting pharmaceutical companies in assessing the scientific challenges of elastomers
as primary packaging components, complementing her 7 years’ work as Product Manager for Schott Pharmaceutical Tubing,
where she provided scientific consulting for glass primary packaging. This year, she is member of the Program Planning Com-
mittee of the PDA Parenteral Packaging conference.
Susan M. Dounce, PhD, WEST
Susan is currently Director of Commercial Technology Development at West Pharmaceutical. Prior to joining West, Susan has
held various technical, commercial and academic roles in the Healthcare industry with Datwyler, W.L. Gore and as an Adjunct
Professor at Temple University. She also serves as Vice Chair for the PDA Packaging Science Interest Group. She holds a B.S.
in Chemistry from the University of Rochester and a Ph.D. in Physical Chemistry from the University of Pennsylvania.
Derek Duncan, PhD, LIGHTHOUSE
Derek Duncan, PhD, began his career as a Research Scientist at the Dutch Institute for Atomic & Molecular Physics in Amster-
dam. He then moved into industry holding various Product & Application Development positions. is responsible for developing
applications for pharmaceutical process monitoring and finished product inspection for Lighthouse Instruments. He is based in
Amsterdam. This year, he is member of the Program Planning Committee of the PDA Parenteral Packaging conference.
12 pda.org/EU/IG-PS2020INTEREST GROUP MEETING AGENDA
31 Jan. 2020
Thursday, 27 February 2020
10:00 Welcome: Opening Remarks & Introductions Bettine Boltres, WEST
Roger Asselta,
Genesis Packaging Technology
Derek Duncan, LIGHTHOUSE
Susan Dounce, WEST
10:05 PDA Updates Carol Flynn, Corning
Preparing the Development Process of Packaging
10:15 Selection of Packaging Systems and Components Katharina Golly, Novartis
• How the selection is made:
pros and cons of different packaging systems
• Gathering information
10:40 Quality by Design: A Robust Packaging Development Process Bettine Boltres, WEST
and Associated Technical Considerations
11:05 Utilizing Advanced Material Testing and Simulation to Robert States,
Characterize Critical Defect Size in a Vial Sealing System Stress Engineering Services
Michael Edey, Pfizer
11:30 Coffee Break
12:00 Positive Controls and a Discussion on Best Practices Derek Duncan, LIGHTHOUSE
12:25 Technologies in a Process Development Lab: a Case Study Roman Mathaes, LONZA
12:50 Q&A, Discussion
13:00 Lunch Break
Site Visit at LONZA Facilities
14:00 Participants Join a Guided Tour and Take a Deeper Look into Processes at the LONZA Facilities in Basel
15:00 Coffee Break
Interactive Session: Best Practices in Packaging Development
15:30 Brief Introduction to Best Practices in Packaging Development Derek Duncan, LIGHTHOUSE
Roger Asselta,
Genesis Packaging Technology
15:40 Group Discussion: Best Practices in Packaging Development
• CCIT in Annex
- How will requirements change in manufacturing?
- What data needs to be collected to make good choices in manufacture?
16:30 Conclusion and Farewell Bettine Boltres, WEST
Roger Asselta,
Genesis Packaging Technology
Derek Duncan, LIGHTHOUSE
Susan Dounce, WEST
pda.org/EU/IG-PS2020 1327 FEBRUARY – ONE-DAY TRAINING COURSE
Container Closure
Development
Overview
The course will give an overview on how to develop a container closure system for parenteral products.
Starting with setting up a product profile of the final product container, all aspects will be covered, like
selection of materials, assessment of container closure systems, specification and documentation of
components and entire systems. In addition, current hot topics such as glass delamination and container
closure integrity testing will be discussed.
For all topics of the agenda presentations will be given. The participants are invited to add own experience,
ask questions and offer issues to be discussed within the group and/or with the trainer. The intention is to
work in an open workshop-like atmosphere.
Who Should Attend
• Scientists in Drug Product Development
• Scientists/ Engineers in Packaging Development
• Regulatory Affairs Experts
Learning Objectives
• Set-up of a target product profile of a container closure system
• Select appropriate container closure materials, components, and systems
• Apply the appropriate regulations and standards to container closure systems for parenteral formulations
• Prepare a development plan of a container closure systems from the early development until market phase
• Specify container closure systems regarding technical aspects and regulatory requirements
• Understand compendial requirements and quality as well as technical standards regarding
• Container closure components and systems
Joerg Zuercher, PhD, Senior Scientist, Bayer
Juerg Zuercher is a pharmacist by education. After his studies and PhD thesis at the Free University in Berlin, he started his
career in the pharmaceutical industry 1990 with the former Schering AG. He is responsible for the development of container
closure systems and application devices at Bayer HealthCare and has more than 25 years’ experience in that field. His current
focus is the development of systems/devices for liquid and parenteral as well as ophthalmic dosage forms.
14 pda.org/EU/CCD2020TRAINING COURSE AGENDA
Thursday, 27 February 2020 9:00 – 17:00
09:00 Welcome and Introduction
09:30 Definitions
•Compendial definition
•Functional definition
•Components vs CCS
•Description of options
•Materials
09:45 • Regulatory Background
• Ph.Eur.
• USP
• JP
• FDA Guideline
• EU Directive
• Relevant eCTD sections
10:45 Coffee Break
11:15 • Development of Container Closure Systems
• Set-up of target profile
• Packaging materials
• Modification of materials
• Extractables & Leachables (E&L) testing
• Permeability
• Light transmission
• Processability
• Functional testing
• Container closure integrity (CCI)
• Shipping assessment
• Combination products
12:30 Lunch Break
13:30 Workshop: Develop Your CCS
15:00 Coffee Break
15:30 Presentation of Workshop Results
16:00 • Setting of Specifications / Submission Documentation
• Technical/ Quality specification
• Regulatory specification
• Technical drawing
• Regulatory drawing
• DMF for US submission
16:30 Wrap-up and Final Q&A
17:00 End of Course
pda.org/EU/CCD2020 1527-28 FEBRUARY – TWO-DAY-TRAINING COURSE
Container Closure Integrity Testing
- Basic Course -
Overview
This training course focuses on theoretical and practical fundamentals of various CCI testing technologies and pro-
vides a systematic approach to apply these testing methods for CCI verification throughout drug product lifecycle.
The training course will enable the participants to implement CCI testing strategies to ensure adequate drug product
protection and be compliant with relevant regulatory and compendia requirements. In this training course, participants
gain critical problem solving skills through:
• interactive discussions with a panel of cross-functional technical experts consisting of CCI testing laboratory
experts, testing instrument suppliers/manufacturers, and pharmaceutical packaging development engineers
• hands-on testing training on the newest innovations and state-of-the-art instruments
• real-world case studies
Who Should Attend
• Parenteral drug packaging engineers and formulation scientists Presentation of Technology,
Instruments Demo and Hands-on
• Laboratory scientific staff and managers
Training kindly supported by
• Parenteral manufacturing staff
several suppliers of Container
• Sterility Quality Assurance
Closure Integrity testing systems
• Regulatory affair scientists and services
• Pharmaceutical packaging component manufacturing staff
Learning Objectives
This training course utilizes lectures, case studies, and detection (e.g. helium leak detection), electrical
interactive hands-on training on testing instruments to conductivity and capacitance (HVLD), vacuum decay
provide insight into the latest developments of Container leak detection, laser-based gas headspace analysis,
Closure Integrity (CCI) Testing, with focus on achieving mass extraction leak test.
the following key objectives:
• Selecting and applying appropriate testing
• Understanding up-to-date regulatory and methods for both laboratory and in-process testing
pharmacopeia requirements on CCI. to formulate comprehensive package integrity
verification profiles.
• Defining CCI requirements for various container and
drug product types using a risk-based approach. • Defining CCI testing method development and
validation approach and best practices.
• Explaining working principles of various CCI testing
techniques and their practical applications, with focus • Avoiding common issues and pitfalls in CCI testing
on deterministic methods such as tracer gas applications.
Allison L. Dill, PhD, Eli Lilly and Company
Allison Dill, Ph.D. is a Senior Research Scientist in Delivery and Device Connected Solutions at Eli Lilly and Company,
Indianapolis, IN. She received a BS in Chemistry and Biology from Indiana University, and worked for 4 years as
an analytical chemist in Product Research and Development before attending graduate school. She received
her Ph.D. in Analytical Chemistry from Purdue University, studying imaging mass spectrometry for disease state
characterization. While at Lilly, she has been responsible for the analytical control strategy of many solid oral
and parenteral dosage forms and has contributed to several regulatory submissions. Her recent contributions have focused on
enabling the delivery of the early phase portfolio within a complex global network with responsibility for the analytical control
strategy of both the active pharmaceutical ingredient and the drug product. She is now focusing on the CCI strategy for multiple
molecules with a concentration in on-line high voltage leak detection for 100% inspection.
16 pda.org/EU/CCIT2020TRAINING COURSE AGENDA
Thursday, 27 February 2020 9:00 – 17:30 Friday, 28 February 2020 8:30 – 16:30
9:00 Welcome and Introduction 8:30 Application Case Studies – Part 2
9:15 Regulatory Requirements: • Vacuum and pressure decay
CCI introduction, regulatory requirements, and • Mass extraction
industry trends 9:10 Hands-on Training
10:00 Introduction 10:10 Coffee Break
• CCI assurance throughout product lifecycle
• Testing requirement definition – risk based 10:40 Application Case Studies – Part 3
approach • Headspace analysis
• CCI profile & testing strategy development • HVLD
10:30 Coffee Break 11:20 Hands-on Training
11:00 CCI Test Methods: Fundamentals 12:00 Lunch Break
• CCI defects and commonly used positive
controls 13:00 Development and Validation of
Integrity Test Methods
• Evolution of CCI testing technology: liquid
flow, gas flow, electron flow (electric current) • Method development best practices
• Method validation strategy
11:40 Methodologies for Sizing CCI Defects Using • Pitfalls and solutions
Gas Flow Dynamics • A Case study
12:00 Lunch Break 14:10 Approaches to CCI Testing Method Selection
Introduce group exercise:
13:00 CCI Test Methods: Overview
Product life cycle testing and method selection
• Deterministic vs probabilistic definitions
• Physicochemical methods vs microbiological 14:30 Coffee Break
methods: differences and correlations
• Microbial and dye ingress testing basics 15:00 Group Exercise - Breakout
14:00 CCI Testing Technologies 16:00 Group Exercise - Presentations & Discussion
• Vacuum and pressure decay
16:30 End of Workshop
• Mass Extraction
• Headspace analysis
• HVLD
• Tracer gas (helium leak detection)
• Seal quality testing (residual seal force)
15:00 Coffee Break
15:30 Current Topics: Industry Best-Practices and
Novel Technologies
• AMI optical emission spectroscopy for
CCI testing & demo
16:00 Application Case Studies – Part 1
• Tracer gas (helium leak detection)
• API container testing using helium leak
detection & video
17:30 End of Day 1
Brandon Zurawlow, Principal Consultant, Containsure
Brandon is a Principal Consultant working with life-science clients to develop and implement comprehensive
container testing strategies through Containsure, his consulting firm founded in 2018. Brandon leverages 8
years of cGMP experience at Whitehouse Laboratories applying compendial chapters such as USP ,
, and their EP counterparts; as well as the choice, development, and validation of CCI methods now
found in USP . Brandon is a contributor to industry documents and textbook chapters, and a speaker on
the topic of compendial container testing and CCI at client sites, training seminars, and conferences in the US, Europe, and Asia.
Brandon holds a B.S. in Biology from The College of New Jersey in the US.
pda.org/EU/CCIT2020 1727-28 FEBRUARY – TWO-DAY-TRAINING COURSE
Extractables & Leachables
Including: Important Regulatory Updates –
Case Study Section: Selection of the most interesting Case Studies,
presented over the last 10 years!
Overview
When making Parenteral Drug Products, pharmaceutical companies are faced with the need to further investigate
the materials that will be in contact with the drug product, either during manufacturing, intermediate storage, stor-
age in its final packaging, or during the delivery of the drug to the patient. While historically, the potential safety
issues were the main driver in these kinds of investigations, recently, also quality issues – i.e. for biopharmaceuticals
– have become an additional concern.
This workshop will look at “Extractables & Leachables” from many different angles: Definitions, Regulatory, Material
& Polymer Science, Analytical E/L Methodologies, Safety Assessments, Study Design for different parenteral pri-
mary packaging systems, as well as for injection devices.
Learning Objectives Who Should Attend
Upon completion of this workshop, you will be able to: • Pharmaceutical Packaging and Device Engineers
• Explain in detail the current regulatory requirements for • Production Engineers, using SU systems
container/closure qualification from an E/L perspective.
• Regulatory Affairs Officers
• Explain the upcoming changes in regulations, standards and
• Pharmaceutical R & D Managers
recommendations from PQRI, USP and BPOG and how these
changes could impact a future evaluation of a pharmaceutical C/C- • Analytical Chemists, working on E/L
system. • Quality Assurance Officers
• Understand the materials of construction – and their
composition – of container closure systems, and how they could
impact the safety and quality of a parenteral drug product.
• Put together an evaluation program (review of provided
documentation, analytical testing) of different types of parenteral
drug product container/closure systems.
• Perform a safety/risk assessment of analytical results,
obtained after completion of an E/L study.
Dennis Jenke, PhD, Chief Executive Scientist, Triad Scientific Solutions
Dennis Jenke is the Chief Executive Scientist for Triad Scientific Solutions, a provider of science-based solutions
to plastic/product compatibility challenges associated with packaging, manufacturing equipment and delivery
devices in the pharmaceutical, cosmetic, food and related industries. He was a Distinguished Scientist at Baxter
Healthcare Corporation where for more than three decades he lead a team whose primary responsibility includes
the assessment of material/product compatibility, specifically with respect to establishing the suitability for use
of packaging systems, manufacturing systems and administration devices for pharmaceutical products (for example, extractables/
leachables and product ingredient binding). He has published extensively in the areas of analytical chemistry, environmental
science and material/solution compatibility and serves as an expert reviewer for numerous pharmaceutical and analytical journals.
He is the author of the book Compatibility of Pharmaceutical Solutions and Contact Materials; Safety Considerations Associated
with Extractables and Leachables and a contributing author to the Leachables and Extractables Handbook. Dennis Jenke is a
member of numerous industry groups whose charter is to establish best demonstrated practices in the area of material/solution
compatibility.
18 pda.org/EU/EL2020TRAINING COURSE AGENDA
Thursday, 27 February 2020 9:00 – 18:00
Introduction on Extractables & Leachables (E/L)
▶ What is the importance of a good E/L-qualification
▶ Historical cases of leachables, impacting the quality or the safety of a drug product
▶ Regulatory requirements (FDA, EMA…) for primary packaging
Understanding the Materials, Used in the Manufacture of Pharmaceutical Containers & Closures
▶ Types of polymers – examples in medical/pharmaceutical use
▶ Understanding the composition of polymers
▶ The issues with glass in parenteral applications
FULL Session on Updates of E/L- Regulations, Standards and Recommendations
▶ Pharma Packaging:
▶ Preview of the final PQRI Parenteral Drug Product (DPD) & ODP Chemistry group
▶ Update on the most recent developments on the USP chapters
▶ Devices
▶ Chemical characterization of devices according to ISO 10993-18: What changes are coming up?
▶ Upcoming Revisions of the USP and USP : Where could it go to?
▶ (Bio)Pharmaceutical Manufacturing
▶ Where is USP with the update on the USP Plastic Manufacturing Components standard
How to Perform a Safety Evaluation – Risk Assessment on Extractables & Leachables
▶ Toxicology 101
▶ EMA Guideline on Genotoxic Impurities
▶ ICH M7 (DNA reactive Impurities) and its suggested staged approach
▶ The Threshold Concept of PQRI (OINDP and PDP/ODP)
▶ Examples
How to Look at Injection Devices from an E/L Perspective
▶ Medical device regulations versus pharma packaging
▶ Test selection process for devices: What to do?
▶ USP and ISO 10993 series for biocompatibility testing
▶ Case: Injection device
Piet Christiaens, PhD, Scientific Director, Nelson Labs
Piet Christiaens received his Ph.D. from the Analytical Chemistry Department of the University of Leuven (Bel-
gium) in 1991. From 1992 to 1997, he was Lab Manager in two Analytical Contract Laboratories. From 1997
to 2000, he worked as an independent consultant with Shell Chemical Company in Houston, Texas where he
conducted research on a new hydrogenation catalyst system for Hydrogenated Triblock Co-Polymers (Kraton
Polymers). Since 2001, Mr. Christiaens has been Scientific Director at Nelson Labs Europe (formerly Toxikon
Europe) where he develops analytical methods and protocols for both extractables and leachables studies for the Medical and
Pharmaceutical Industries. Mr. Christiaens oversees all laboratory operations at Nelson Labs Europe and supports the European
business development team.
pda.org/EU/EL2020 19TRAINING COURSE AGENDA
Friday, 28 February 2020 9:00 – 16:30
E/L Testing for Small Volume Parenteral Applications
▶ Glass Syringes: the issues with tungsten, glue residues and silicone oil and glass metals leaching
▶ The Issue with rubbers: the plunger, the needle shield or the tip cap: different approaches needed?
▶ The impact of secondary packaging – option or necessity?
▶ Setting up extractable & leachable studies for a pre-filled Syringe or a vial system
E/L Testing for Lyophilized Drug Products
▶ Primary packaging for the lyophilized drug product – modus of interaction with the DP
▶ Impact of the “21CFR Part 4” on combination products, used in the administration of a lyo DP
▶ Critical aspects when designing leachable studies for lyophilized DP
▶ Integration of the administration procedure (e.g. IV-set, pump system) in leachables evaluation
Large Volume Parenterals
▶ The challenge in E/L testing for LVP’s
▶ Primary packaging for LVP’s – critical materials and components
▶ Secondary packaging for LVP: critical points to consider
E/L Testing for Disposable and Single-Use Systems in Bioproduction
▶ How to classify the risk of different single-use systems in the bioproduction process
▶ Understanding BPSA & BPOG recommendations, and how they can be implemented in the study design
▶ Performing E/L studies on filters: potential approaches
Analytical Techniques and Methodologies in E/L Research
▶ Discussion of the Analytical Instrumentation used
▶ The Analytical Chromatographic Screening Process to Discover, Identify and Quantify Organic Extractables
▶ The Risk of Omissions with the Screening Process
▶ The Risk of Inexact Identifications in the Screening Process
▶ The Risk of Inaccurate Quantification when Sscreening
▶ A Risk Mitigation Strategy when Implementing a Screening Methodology
How to Set-up Extractables & Leachables Studies
▶ Selecting the right conditions for extraction
▶ How to select the right compounds to monitor in a leachable study
▶ Designing a leachable study
20 pda.org/EU/EL2020INFORMATION
VENUE CO N FE RE N C E REG ISTR ATIO N H OU RS
Congress Center Basel Monday, 24 February: 15:00 – 17:00
MCH Messe Schweiz (Basel) AG Tuesday, 25 February: 8:00 – 17:30
4005 Basel Wednesday, 26 February: 8:00 – 12:00
Switzerland
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Fax: +41 58 206 21 86 Thursday, 27 February: 8:00 – 16:30
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TO E X HI BIT:
DI RECTIO NS Exhibition and Sponsorship Opportunities are available.
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pda.org/EU/ParPack2020 21Parenteral Packaging Reg Form Page 1
24-28 February 2020 | Basel | Switzerland This PDF-file provides an automatic
fill-in function. Your signature,
however, is needed in writing.
Your registration is only complete upon filling in and submitting both pages of this form.
1 Registration
Late fee of 200€ applies after 21 February 2020
All fees given in Euro, excluding VAT (7,7 %)
24-28 February 2020 Conference Conference Fee
Parenteral Packaging 1895
PDA Member
¹Nonmember 2195
²Young Professionals 950
¹Regulatory/Academic 950
Poster Presenter please mark here (written approval required, conference fee applies)
24 February Interest Group Meeting Training Course Fee
IG Meeting Pre-filled Syringes All Participants 350
27 February Interest Group Meeting Training Course Fee
IG Meeting Packaging Science All Participants 350
27 February One-Day Training Course Training Course Fee
Container Closure Development All Participants 895
27-28 February Two-Day Training Course Training Course Fee
Container Closure Integrity Testing - Basic Course - All Participants 1595
27-28 February Two-Day Training Course Training Course Fee
Extractables and Leachables All Participants 1595
M
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22 pda.org/EU/ParPack2020Reg Form Page 2 Parenteral Packaging
This PDF-file provides an automatic
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24-28 February 2020 | Basel | Switzerland
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