2019 PDA EUROPE Parenteral Packaging
38
19-20 MARCH 2019 VENICE, ITALY EXHIBITION: 19-20 MARCH TRAINING: 21-22 MARCH IG MEETING: 21 MARCH 2019 PDA EUROPE Parenteral Packaging Interaction of Product, Package, and Process
Transcript of 2019 PDA EUROPE Parenteral Packaging
19-20 MARCH 2019 VENICE, ITALY
EXHIBITION: 19-20 MARCHTRAINING: 21-22 MARCHIG MEETING: 21 MARCH
2019 PDA EUROPE
Parenteral PackagingInteraction of Product, Package, and Process
2 #pdapackaging
WELCOME FROM THE CHAIRS
Dear Colleagues,
PDA Europe is pleased to welcome you to the 9th Parenteral Packaging Conference, returning to Venice for the second time. This conference has become highly regarded 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 for patients.
Biopharmaceuticals are a standard therapeutic modality to treat severe diseases; however, they require special considerations for processing and packaging.
Developments in packaging materials such as innovations in glass 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.
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.
Welcome to amazing Venice!
Sincerely, The Chairs
Roger Asselta, Conference Chair, Genesis Packaging Technologies
Roman Mathaes, PhD, Conference Chair, Lonza
SCIENTIFIC PROGRAM PLANNING COMMITTEE
Roger Asselta, Chair, Genesis Packaging TechnologiesRoman Mathaes, Chair, LonzaBettine Boltres, WestWilliam Dierick, TerumoDerek Duncan, LIGHTHOUSENicola Favaro, Stazione Sperimentale del VetroClaudia Heinl, Schott Renaud Janssen, DatwylerRobert Ovadia, GenentechGalen Huaiqiu Shi, Eli LillyMichael Spallek, Rommelag ENGINEERINGDaniel Wagner, SanofiKlaus Wuchner, Janssen J&JDaniele Zuccato, Nuova OMPI – Stevanato GroupJoerg Zuercher, BayerBrandon Zurawlow, Containsure SolutionsKerstin Wilken, PDA EuropeTeresa Schubach, PDA Europe, Manager Programs & Events
WELCOME TOVENICE
S C H E D U L E A T A G L A N C E
19 March 9:00 – 18:00 Parenteral Packaging Conference, Exhibition
19 March 19:00 – 21:30 Networking Event
20 March 9:00 – 16:30 Parenteral Packaging Conference, Exhibition
21 March 10:00 – 17:00 Packaging Science Interest Group Meeting
21 March 9:00 – 17:00 Container Closure Development Training Course
21 March22 March
9:00 – 18:009:00 – 15:30 Test-Methods for Pre-filled Syringe Systems Training Course
21 March22 March
9:00 – 17:308:30 – 16:30 Container Closure Integrity Testing Workshop
21 March22 March
9:00 – 18:009:00 – 16:30 Extractables & Leachables Training Course
Join @PDA_Europe on Twitter and post pictures and highlights of this meeting! #pdapackagingFollow us on LinkedIn linkedin.com/company/pda
HEADLINEPDA IS PROUD TO INVITE YOU TO A VERY SPECIAL NETWORKING EVENT
Date & Time:19 March 2019, 18:50
Meeting Point: Hotel Lobby, Hilton Molino Stucky
Boat Depature:19:00
21:30 Return to the Hilton Hotel Molino Stucky
Dress Code: CasualPlease confirm your attendance at the PDA registration desk.
5#pdapackaging
CONFERENCE AGENDA
Tuesday, 19 March 2019
9:00 Welcome and Introduction Kerstin Wilken, PDA EuropeRoger Asselta, Genesis Packaging TechnologiesRoman Mathaes, Lonza
OPENING PLENARY
9:15 Keynote: The Evolution of Parenteral Drug Substance and Drug Product Primary Containers
Karthik Vaideeswaran, Eli LillyGalen Shi, Eli Lilly
Session 1: Packaging Considerations for Cold Storage Moderator: Derek Duncan, LIGHTHOUSE
Products in the viral vaccine and cell & gene therapy areas can require deep cold storage ranging from -80 ℃ to cryo-tem-peratures. These low temperatures pose challenges to traditional pharmaceutical primary packaging solutions. This session will explore modeling approaches for gaining insights into potential container solutions. A case study will also describe an industry implementation.
9:45 Primary Container Design for Drug Substance at Cryo- and Cold Temperatures
Ronald Iacocca, Eli Lilly
10:15 Q&A, Discussion
10:45 Coffee Break, Poster Session & Exhibition
11:15 Nonlinear Finite Element Simulation of Frozen Container Closure Systems
Holger Roehl, RocheMartin Zueger, PinPlus
11:45 Case Study: Ensuring Container Closure Integrity of a Gene Therapy Cancer Vaccine in Need of Deep Cold Storage
Josine Wilmer, LIGHTHOUSE
12:15 Q&A, Discussion
12:45 Lunch Break, Poster Session & Exhibition
PAR ALLEL TR ACKS
Session 2: TR ACK A TR ACK B
GlassModerator: Claudia Heinl, SCHOTT
Manufacturing in the Digital AgeModerator: Bettine Boltres, WEST
This session it is all about glass as a primary packaging material for parenterals: Despite it being one of the oldest materials known many recent innovations in primary packaging are related to glass. Issues of concern such as breakage or glass particles will be addressed by the speakers. The respective case studies including possible solu-tions are either based on alternative glass types or achieved by optimization of glass production pro-cesses. Furthermore, the results of the round robin work within the Technical Committee TC12 ‘Pharma Packaging’ on glass delamination will also be part of this session.
This session is all about using digital options to prove the integrity of the chosen Container Closure System and to further optimize the manufacturing process. Starting with the assessment of the cho-sen vial, stopper and seal combination using com-puter simulation for stack-up analysis and integ-rity calculations, the theory can be proven using micro-computed tomography. Once the system is decided on, keeping its integrity can be supported by calculating crack initiation and propagation using FE and XFE methods and a by on-line data collec-tion for an optimized set-up of the manufacturing line.
14:00 Delamination in Glass Containers for Pharmaceu-tical Application: The International Commission
on Glass (ICG) Technical Committee TC12Massimo Guglielmi, University of Padova
Identification and Quantification: Multisensor Drone Technology
Fabian Thygs, Janssen J&J
6 #pdapackaging6
CONFERENCE AGENDA
14:20 Next Generation of Primary Packaging Glass
Robert Hayes, Gerresheimer
Comprehensive Container Closure System (CCS) Stack-up Simulation and Optimization in the
Digital AgeAnthony Bucci, WEST
14:40 A Case Study for Mitigation of Visual Particulate in Glass Ready-to-Use Vials
Anthony Vico, Stevanato GroupElizabeth Jane Pavlik, MSD
Testing and Computational Modelling in the Study of Cartridge Failure
Daniela P. Boso, University of Padova
15:00 New Parenteral Glass Packaging Option May Lead to Reduction in Particulates and Ultimately
Drug ShortagesKyle Hoff, Corning
Quantifying the Vial Capping Process Using Micro-Computed Tomography
Robert Ovadia, Genentech
15:20 Q&A, Discussion Q&A, Discussion
15:40 Coffee Break, Poster Session & Exhibition
Session 3: TR ACK A TR ACK B
Considerations on Container Closure Integrity
Moderator: Roger Asselta, Genesis Packaging Technologies
Interactions of Drug Product and Primary Packaging
Moderator: Galen Shi, Eli Lilly
Critical to maintaining drug product safety and quality, Container Closure Integrity remains a hot topic in parenteral packaging. This session will review some important and recent work in the area, including new looks at utilizing different test methods such as helium leak rate, laser headspace analysis and the consideration of package aesthet-ics relative to seal tightness.
This session will cover the important topic of compatibility between parenteral drug product and container closure systems. Three presentations will describe the leachables and surface coating (e.g., silicone oil) coming from parenteral con-tainers, which may lead to physical or chemical interactions with the drug molecules (impact to drug) or functionality deterioration of the container closure (impact to container).
16:10 Balancing Container Closure Integrity and Aesthetics for Robust Primary Packaging
Yusuf Oni, Bristol-Myers Squibb
The Advantages of Considering Primary Container Systems as an Excipient During
Formulation DevelopmentCathy Zhao, WEST
16:40 Container Closure Integrity Testing – Method Development for Freeze- Dried Products Using
Laser-based Headspace Oxygen AnalysisSøren Dahl, Novo Nordisk
Jonas Olsen Hede, Technical University of Denmark
Comparative Leachable Study for Glass Vials to Demonstrate the Impact of
Low Fill Volume
Volker Rupertus, SCHOTT
17:10 Interlaboratory Study of Container Closure Integrity He-leak Test Method - Comparison of
Different Types of Artificial LeaksKlaus Wuchner, Janssen J&J
Daniel Wagner, Sanofi
Interactions of Leachables with Proteins: Combined In-Silico and Experimental Model
to Monitor the Potential Impact on Quality and Safety of Therapeutic Proteins
Piet Christiaens, Nelson Labs
17:40 Q&A, Discussion Q&A, Discussion
18:00 End of Day 1 and Networking Event
CONFERENCE AGENDA
Wednesday, 20 March 2019
9:00 Keynote: Getting Ready for Annex1 and USP 800 Roman Mathaes, LonzaHanns-Christian Mahler, Lonza
Session 4 Regulatory Updates Moderator: Andrea Salmaso, Stevanato Group
Current regulatory guidelines and latest updates still confirm the importance of primary and secondary packaging for delivering safe and effective product to the patient. A member of the CNPPA will present on the recent updates of the Chinese regulatory landscape. USP expert panel members will present on the current changes of the USP on chapters relevant to parenteral packaging, including proposed significant revisions to the chapters covering glass and rubbers. Additionally, an update on the activities of the ISO TC 76 and ISO TC 84 together with the proposed revisions to the ISO standards on Pre-filled Syringes will be presented by the ISO TC 76 WG 2 Chairman.
9:30 Chinese Regulatory Update Yonghua Gao, CNPPA
10:00 USP Chapter Changes on Glass and Rubber Bettine Boltres, WEST
10:30 ISO Standard Series ISO 11040 on Pre-filled Syringes, Updates on ISO Technical Committees TC76 and TC84
Horst Koller, HK Packaging
11:00 Q&A, Discussion
11:30 Coffee Break, Poster Session & Exhibition
PAR ALLEL TR ACKS
Session 5: TR ACK A TR ACK B
Challenges in Development & ManufactureModerator: Brendan Zuralow, Containsure Solutions
Sterilization of PackagingModerator: Joerg Zuercher, Bayer
This session will discuss technical challenges in manufacturing or development of parenteral pack-aging materials. Hear presentations about a QbD approach to the manufacture of elastomers and which points must be considered in the develop-ment of IV bag film development.
The session will cover non-standard, innovative sterilization procedures for packaging components and/or assembled and packed products. You will learn about the benefits of vaporized hydrogene peroxide and the equipment qualification and pro-cess validation for a tray-packed pre-filled syringe. The sterilization of rubber components prior to use will be discussed. The procedures discussed are important additions to the well qualified compendial standard methods and fill gaps for products and/or components sensitive to temperature, ethylene oxide exposure or irradiation.
2019 PDA Europe
Parenteral PackagingCommittee and Speaker Biographies
https://goo.gl/ih9pdb
and many more....find them all online!
8 #pdapackaging8
CONFERENCE AGENDA
12:00 A Quality by Design Approach Toward Manufacturing of Elastomeric Components for
Parenteral Packaging ApplicationsRahul Thakar, Datwyler
Validation of VH2O2 Sterilization Process per ISO14937
Juha Mattila, STERIS
12:25 Multi-Chamber IV Bag Film Development
Silvio Gianoli, Sealed Air Corporation
Alternative Sterilization Techniques for Elastomeric Components for Primary Packaging
Bram Jongen, Datwyler
12:50 Q&A, Discussion Q&A, Discussion
13:00 Lunch Break, Poster Session & Exhibition
CLOSING PLENARY
Session 6 Primary Packaging Choices and Their Technical Impact Moderator: Roman Mathaes, Lonza
Pre-filled syringes and other innovative combination products are receiving increased attention as the container closure system of choice for injectable drug products. Every component of the primary packaging system needs to fulfill its func-tion to maintain the product quality. In this plenary session we will discuss the increasing complexity at the interface of drug formulation and packaging component materials.
14:00 Factors Influencing Quality of Biopharmaceuticals in Pre-filled Syringes
Susumu Uchiyama, Osaka University
14:30 Lyophilization in Pre-filled Syringes: Evaluating the Influence of Primary Container Material and Loading Device
Timothy Dutill, Lyophilization TechnologiesKevin Constable, Terumo
15:00 Coffee Break, Poster Session & Exhibition
15:30 Quality of Components & Containers – Design, Materials, New Technologies
Robert Hormes, Novartis
16:00 Q&A, Discussion
16:30 Conference Summary & Farewell Roger Asselta, Genesis Packaging TechnologiesRoman Mathaes, Lonza Kerstin Wilken, PDA Europe
Visit lonza.com/drugproduct USA +1 201 316 9200 Japan +81 (0)3 6264 0600 Europe +41 61 316 81 11 Email [email protected]© 2019 Lonza. All rights reserved.
Successful drug product development should integrate formulation, manufacturing process, primary packaging, device and delivery to the patient. Lonza’s Drug Product Services (DPS) offering delivers a holistic approach to DP development that anticipates and prevents problems early and ensures the result is a product that is fit for purpose.
DPS’s combination of unparalleled experience, a strong scientific track record, and a state-of-the-art instrumental infrastructure provides industry best practices to successfully advance your drug product to the next milestone.
the next milestone in drug product development...We’ll reach it together.
DPS_PDAConf_Ad_final.indd 1 3/5/19 9:10 PM
Visit lonza.com/drugproduct USA +1 201 316 9200 Japan +81 (0)3 6264 0600 Europe +41 61 316 81 11 Email [email protected]© 2019 Lonza. All rights reserved.
Successful drug product development should integrate formulation, manufacturing process, primary packaging, device and delivery to the patient. Lonza’s Drug Product Services (DPS) offering delivers a holistic approach to DP development that anticipates and prevents problems early and ensures the result is a product that is fit for purpose.
DPS’s combination of unparalleled experience, a strong scientific track record, and a state-of-the-art instrumental infrastructure provides industry best practices to successfully advance your drug product to the next milestone.
the next milestone in drug product development...We’ll reach it together.
DPS_PDAConf_Ad_final.indd 1 3/5/19 9:10 PM
10 #pdapackaging
FLOOR PLAN
PDA Registration
1236 5 4
8 30
7
11121314
15
10 9
16
19
21
24
25
28
27
26
29 31
23
22
20
18
17
DIST
CONFERENCE ROOM
Venetian Ballroom Salone Venetiano
TRACK B
Co�ee Station
PDA Registration & PDA Chapter Italy
Table Top 2 m x 2,8 m (5,6 m2)
Catering
Poster Session
11#pdapackaging
EXHIBITORS
Company Name Booth
Afton Scientific 28
Amri 20
Atec Pharmatechnik 29
Bausch + Ströbel 1
Brevetti Angela 25
Bonfiglioli Engineering Sponsor 9
Comecer 24
Corning Sponsor 30
Datwyler 2
Eurofins BioPharma Product Testing Sponsor 19
Eye-Tec 31
Genesis Packaging Technologies 10
Gerresheimer 18
IWATA LABEL Europe 22
Kisico 11
LIGHTHOUSE Instruments 6
Lonza Pharma & Biotech Sponsor 21
Nelson Labs Europe 3
Company Name Booth
OMPI - A Stevanato Group Brand Sponsor 13+14
OPTIMA 5
PTI Inspection Systems 16
Rommelag ENGINEERING 7
Schott 15
SiO2 Medical Products 26
Smart Skin Technologies 27
Smithers 8
Steelco 23
Steriline 4
TERUMO 12
West Pharmaceutical Services 17
Wilco 1
www.eurofins.com/BPT
Comprehensive CCIT Testing Services Your Competence Center
ITALY
THE NETHERLANDS
US
HVLDVacuum Decay Helium Leak DetectionPressure Decay Microbial Ingress TestOxygen Headspace Aerosol Microbial Test
Largest scope of global servicesSharpest focus on packaging testing
Delivering the most comprehensive global testingcapabilities and expertise, quality systems, and dataintegrity, we offer a complete range of services forPackaging Testing including QC testing (EP/USP/JP),Extractables & Leachables and CCIT. With over 15 years of experience we have developedsophisticated deterministic and probabilistic methodsto verify the safety of your container closure systemand meet the stringent regulatory framework. Since we are part of an international network oflaboratories and testing units with global reach,we can provide full support to determine the best CCIT method to meet the needs of your project.
ad_ccit_final.indd 1 25/02/19 14:52
www.eurofins.com/BPT
Comprehensive CCIT Testing Services Your Competence Center
ITALY
THE NETHERLANDS
US
HVLDVacuum Decay Helium Leak DetectionPressure Decay Microbial Ingress TestOxygen Headspace Aerosol Microbial Test
Largest scope of global servicesSharpest focus on packaging testing
Delivering the most comprehensive global testingcapabilities and expertise, quality systems, and dataintegrity, we offer a complete range of services forPackaging Testing including QC testing (EP/USP/JP),Extractables & Leachables and CCIT. With over 15 years of experience we have developedsophisticated deterministic and probabilistic methodsto verify the safety of your container closure systemand meet the stringent regulatory framework. Since we are part of an international network oflaboratories and testing units with global reach,we can provide full support to determine the best CCIT method to meet the needs of your project.
ad_ccit_final.indd 1 25/02/19 14:52
EXHIBITIOR ABSTRACTS
Afton Scientific 2020 Avon Ct. 22902 Charlottesville, VA, USA Tel. +1 434 979 3737 Fax. +1 434 979 3738 [email protected] www.aftonscientific.com
cGMP Processing of Sterile Products Afton Scientific
Afton is also the world premiere provider of pre-packaged empty sterile vials, stoppers and seals (Ready-to-Fill®) to companies worldwide for immediate use in cGMP aseptic filling operations. These components are used not only for small clinical fills, but also for approved marketed injecta-ble drugs. Afton (DBA AnovaFill) provides cGMP contract sterile filling services of investigative new drugs, biologics, and commercial injectable pharmaceuticals. Capabilities to batch, sterilize, fill, label, and package. We specialize in small batch clinical and commercial runs. AnovaFill is a part of Afton Scientific. Afton’s customers include small biotechs, multinational pharmaceutical companies and major re-search institutions. Afton ships worldwide.
AMRI 26 Corporate Circle 12212 Albany, United States Tel. +1 518 522 3453 [email protected] www.amriglobal.com
AMRI, a global contract research and manufacturing orga-nization, partners with the pharmaceutical and biotechno-logy industries to improve patient outcomes and quality of life. With locations in North America, Europe and Asia, AM-RI’s team combines scientific expertise and market-leading technology to provide a complete suite of solutions in Disco-very, Development, Analytical and Solid State Services, API Manufacturing and Drug Product.
Atec Pharmatechnik GmbH Schulstraße 48-50 24966 Sörup, Germany Tel.+49 (0) 4635 293220 Fax. +49 (0) 4635 293229 [email protected] www.atecgroup.de
Atec Pharmatechnik GmbH specializes in sterile processing technologies such as stopper processors, cleanroom lifts and transfer equipment, CIP/SIP stations, process vessels, bagging machinery and formulation systems. All equipment is manufactured in Soerup, Germany within specialized workshops. Our state-of-the-art FAT bay is furnished with cleanroom utilities for conducting factory acceptance tests. Our in-house laboratory was designed specifically for analy-zing quality standards such as particle reduction, endotoxin reduction, and temperature uniformity, among others. We offer full-service project management, from engineering to post-installation services and everything in between.
Bausch + Ströbel Maschinenfabrik Ilshofen GmbH & Co. KG Parkstr. 1, 74532 Ilshofen, Germany Tel. +49 7904 701 0 [email protected] www.bausch-stroebel.com
Design and construction of filling and packaging machines for the pharmaceutical and similar industries. Containers such as ampoules, vials, syringes and cartridges are pro-cessed from cleaning to labeling.
Bonfiglioli Engineering S.r.l. Via Vespucci 20 44124 Ferrara, Italy Tel. +39 0532 715631 [email protected] www. bonfiglioliengineering.com
Bonfiglioli Engineering is the world leader in the leak testing and inspection systems, offering a wide production range of laboratories as well as in-line machines with the aim of verifying, based on four complementary technologies: Container Closure Integrity Testing, Visual Inspection, Leak Testing, and Headspace Gas Analysis: - Presence of leaks - Headspace gas content - The existence of visible foreign materials. Superior Technology, reliability and high custo-mization are Bonfiglioli Engineering's primary goals when it comes to delivering solutions that support our customers in the final supply of high-quality products to the market. With over 5000 installations around the world, Bonfiglioli Engineering serves a truly global customer base, making a dramatic impact on the efficiency and the safety of the pa-ckaging industry worldwide.
Brevetti Angela S.r.l. Via dell'Industria 99 36071 Arzignano (VI), Italia Tel.+390444474200 Fax. +390444474222 [email protected] www.brevettiangela.com
BREVETTI ANGELA was set up in 1977 by Francesco Con-solaro, who was already working intensely in the field of pharmaceutical packaging from the 1960’s on. Since then BREVETTI ANGELA has closely collaborated with many in the pharmaceutical industry to address their needs for pri-mary packaging. The fruits of its intense effort at the cut-ting-edge of technology are realised in the latest generation of blow-fill-seal equipment series called SYFPAC® and LI-QUIDPAC. Simultaneously, other packaging equipment, viz. FLUIPAC, CYNOPAC, MECAS, BAGPAC and SACKPAC, have also been developed by Brevetti Angela, whereas SECURE-JECT® pre-filled syringes made on SYFPAC® machine are our latest development.
13#pdapackaging
© 2019 Corning Incorporated. All Rights Reserved.
Valor® Glass—It’s About Machinability. Enduring quality and reliability to help increase your e�ciency.
E�ciency is critical in drug manufacturing. Breaks, interventions and rejection rates put production volumes and supply chains at risk. Valor Glasssigni�cantly* reduces production downtime and enables increased speed and e�cient �lling on both old and new lines.
With so much riding on your throughput, isn’t it time to consider a more reliable option?
Make plans to attend Corning expert, Kyle Ho�’s, presentation on Tuesday, March 19th (Track A) or visit Corning (#30) to �nd out how Valor Glass may increase your capacity.
*Compared to conventional borosilicate
© 2019 Corning Incorporated. All Rights Reserved.
Valor® Glass—It’s About Machinability. Enduring quality and reliability to help increase your e�ciency.
E�ciency is critical in drug manufacturing. Breaks, interventions and rejection rates put production volumes and supply chains at risk. Valor Glasssigni�cantly* reduces production downtime and enables increased speed and e�cient �lling on both old and new lines.
With so much riding on your throughput, isn’t it time to consider a more reliable option?
Make plans to attend Corning expert, Kyle Ho�’s, presentation on Tuesday, March 19th (Track A) or visit Corning (#30) to �nd out how Valor Glass may increase your capacity.
*Compared to conventional borosilicate
EXHIBITIOR ABSTRACTS
COMECER S.p.A. Via Maestri del Lavoro, 90 48014 Castel Bolognese, Italy Tel. +39 0546 656375 Fax. +39 0546 656353 www.comecer.com
The COMECER GROUP is a developer and manufacturer of high-tech systems in the field of Aseptic Processing and Containment for the Pharmaceutical and Nuclear Medicine Industries, specialising in isolation technology solutions for regenerative medicine and tissue engineering. COMECER’s products are used worldwide in hospitals, universities, re-search institutes, pharma companies and large industrial groups.
Corning 1 Riverfront Plaza 14831 Corning, USA Tel. +1 607 974 9000 [email protected] www.corning.com/valor
Corning is a world-leading innovator in materials science. For over 165 years, we have applied our unparalleled exper-tise in glass science and precision process technologies to solve tough industry challenges and transform lives. Our innovations enhance quality and drive efficiencies in every industry that we serve. Learn more about Corning Pharma-ceutical Technologies’ solutions and services for the phar-maceutical industry.
Datwyler Belgium Genny Fiore Industrieterrein Kolmen 1519 3570 Alken, Belgium Tel. + 39 3456685496 [email protected] http://sealing.datwyler.com/
Datwyler Sealing Solutions is a leading industrial supplier and a key player in the global health care world. Our state-of-the-art solutions for drug packaging and medical devices, build on over 100 years of experience. Within our health care offering and its three pillars Bio Care, Pharma Care and Med Care, we provide a unique range of products and services including the most advanced elastomer formulations, coa-tings, aluminum seals, and processing technologies. Part-nering up with the world’s top pharmaceutical and medical companies, we are a vital link and stand by our mission to ensure all patient’s safety and improve patients’ lives.
Eurofins BioPharma Product Testing Via Bruno Buozzi 2 20090 Milano, Italy Tel. +39 022 507 151 [email protected] https://www.eurofins.com/BPT
With an outstanding analytical expertise, highest standards of quality and state-of-the-art instrumentation, Eurofins Bio-Pharma Product Testing delivers the most complete range of services for Packaging Testing including QC testing (EP/USP/JP), E&L and CCIT. With focus on CCIT, we offer de-terministic and probabilistic methods such as HVLD, Vacu-um & Pressure Decay, Microbial Ingress Test and Aerosol Microbial Test to verify the safety of your container closure system and meet the stringent regulatory framework. Euro-fins BioPharma Product Testing sites in Italy and in The Net-herlands provide full support to determine which method is best for your packaging project needs.
Eye-Tec Ballaarstraat 72 2018 Antwerpen, Belgium Tel. +32 0497708607 [email protected] www.eye-tec.eu
Eye-Tec provides support in the domain of Visual Inspection to pharmaceutical companies around the globe. We are the ‘bridge’ between pharmaceutical manufacturers and inspection machine builders. We do this through our combined competence in both compliance and technology and our own past experience in parenterals manufacturing. Our projects can be on corporate strategies but just as well about hands-on vision process improvements or qualification. With the enhanced focus on Container Closure Integrity (CCIT) we provide Leak Test Samples with pinholes from 5µ onward. The client chooses pinhole location and diameter and provides us with his own empty containers.
Genesis Packaging Technologies 435 Creamery Way, Suite 100 19341 Exton PA, United States Tel. +1 800 552 9980 Fax. +1 610 458 4939 [email protected] www.gen-techno.com
Genesis Packaging Technologies is a worldwide leader in the science and technology of parenteral vial sealing and re-sidual seal force testing. We provide the best capping equip-ment in the world and we offer both the global service and technical support to back it up. Offering our customers the tools and knowledge to consistently achieve container clo-sure integrity remains our priority.
15#pdapackaging
2019 PDA Europe Conference
22-23 October 2019Gothenburg, Sweden
The Universe of Pre-filled Syringes & Injection Devices
EXHIBITIOR ABSTRACTS
Gerresheimer Klaus-Bungert-Str. 4 40468 Düsseldorf Germany Tel. +49 211 618 100 [email protected] www.gerresheimer.com
Gerresheimer is a leading global partner to the pharma and healthcare industry. With our specialty glass and plastic products, we contribute to health and well-being. We have worldwide operations and about 10,000 employees ma-nufacture our products in local markets, close to our cus-tomers. With our plants in Europe, North America, South America and Asia, we generate revenues of approximately EUR 1.4 billion. The comprehensive product portfolio inclu-des pharmaceutical packaging and products for the safe, simple administration of medicines: Insulin pens, inhalers, prefillable syringes, injection vials, ampoules, bottles and containers for liquid and solid medicines with closure and safety systems.
IWATA LABEL Europe Berliner Allee 59 40212 Düsseldorf, Germany Tel. +49 211 5403 9784 [email protected] www.iwatalabel.com
IWATA LABEL Europe GmbH is a specialty manufacturer of adhesive labels and labeling machines for pharmaceutical products. Our products add high value and multiple functi-ons to pharmaceutical labeling needs. The need for labeling solutions, which protect medical staff, greatly helps us fo-cus on innovation and develop new products and services.
KISICO GmbH Rieslingstr. 41 65375 Oestrich-Winkel, Germany Tel. +49 6723 99650 Fax. +49 6723 9965550 [email protected] www.kisico.de
KISICO is a German producer of screw caps, laboratory caps, 2 and 3 component caps, desiccant caps, child re-sistant caps, tamper evident caps and caps with brushes or spoons. The clients of these caps are mostly from the diagnostic and pharmaceutical industry. Our R&D depart-ment will help you with the realization of your customized solution, but you can also choose from the wide range of our standard program.
LIGHTHOUSE Instruments Science Park 408 1098 XH, Amsterdam, The Netherlands Tel. +31 6 4226 7380 [email protected] www.lighthouseinstruments.com
LIGHTHOUSE is the leading global provider of laser-based, non-destructive headspace inspection systems. LIGHT-HOUSE introduced the laser-based headspace method into the pharmaceutical industry in 2000 and offers a range of benchtop and in-line platforms with patented laser sensor technology commercialized with the help of funding from the Food and Drug Administration. In addition to delivering equipment, Measurement Services & Support are delivered from laboratory facilities in Amsterdam and Charlottesville, Virginia. A staff of Application Scientists supports custo-mers with outsourced testing services, scientific studies, and lease equipment projects.
Lonza Pharma & Biotech Hochbergerstrasse 60 A 4057 Basel Switzerland Tel. +41 61 316 8111 [email protected] lonza.com/drugproduct
As a leader for contract development and manufacturing, Lonza Pharma & Biotech is recognized for reliable, high-qua-lity services, global capacity, innovative technology plat-forms and extensive experience. Our broad capabilities span across biologics, small molecules, bioconjugates, and cell and gene therapies. We manage projects from pre-clinical stage through to commercialization and our expertise covers both drug substance and drug product. We believe that the best outcome – for you and your patients – can only come as a result of a successful collaboration. Together, we can solve the next challenge and bring your next medicine to life.
16 #pdapackaging
pda.org/EU/UPS2019
EXHIBITIOR ABSTRACTS
Nelson Labs Europe Piet Christiaens Romeinsestraat 12 3001 Heverlee, Belgium Tel. + 32 16 400484 [email protected] www.nelsonlabs.be
Nelson Labs Europe is an independent contract research or-ganization, specialized in providing premium Extractables & Leachables services to the pharmaceutical industry. Based in Belgium, Nelson Labs Europe supports pharmaceutical companies across the globe in developing worldwide com-pliance testing strategies to qualify Container/Closure Ap-plications and Pharmaceutical Production Equipment from an Extractables & Leachables perspective. Nelson Labs Europe supported over 200 submissions to the FDA and to the EMA. Nelson Labs Europe is ISO 17025 accredited and GLP-certified. Nelson Labs Europe has received a GMP ac-creditation from the European Authorities. In 2017, Nelson Labs Europe was successfully audited by the FDA.
OMPI - A Stevanato Group Brand Via Molinella, 17 35017 Piombino Dese, Italy Tel. +39 04 993 18611 Fax. +39 04 993 18611 [email protected] www.ompipharma.com/
OMPI is part of the Pharmaceutical Systems division of Stevanato Group and boasts a unique expertise in provi-ding superior pharmaceutical containers from glass tubing. With operations in Italy, Slovakia, Mexico and China, Ompi offers the widest range of glass primary packaging, from the traditional ones such as vials and ampoules, to the high value ones as syringes and cartridges for auto-injectors and pen-injectors. Vials, cartridges and syringes are available also sterile and ready to fill (Ompi EZ-fill®).
OPTIMA pharma GmbH Otto-Hahn-Str. 1 74523 Schwäbisch Hall, Germany Tel +49 791 9495 0 Fax. +49 791 9495 2610 [email protected] www.optima-packaging.com/pharma
For uncompromising pharmaceutical applications: Optima Pharma develops and manufactures filling, sealing and pro-cess technology for pharmaceuticals. Highly sophisticated, fully automated systems from Optima Pharma are used to process blood plasma products, vaccines, oncology and biotech products in prefilled syringes, vials, bottles and car-tridges. Non-sterile pharmaceuticals and diagnostics are further applications. The company’s extensive technology portfolio includes washing machines, sterilization tunnels, filling and sealing, robotic product handling and other functi-ons. Freeze drying systems and isolator technology are part of turnkey systems by Optima Pharma. The product range comprises machinery for laboratory filling up to high-speed systems. The division guarantees quick, professional ser-vice with 13 international locations.
PTI Inspection Systems 145 Main Street, 10707 Tuckahoe, USA Tel. +1 914 337 2005 Fax. +1 914 337 8519 [email protected] www.ptiusa.com
PTI is a global leader in package testing equipment. We manufacture non-destructive solutions for package integri-ty testing, leak detection, container closure integrity (CCI), and seal integrity testing. PTI's inspection technologies are deterministic test methods that produce reliable quantitati-ve test data. Our technologies conform to ASTM, USP 1207 and other regulatory standards. We specialize in offering our customers comprehensive solutions including test method development. Applications include testing parenteral pro-ducts: vials, ampoules, auto-injectors, cartridges, pre-filled syringes as well as pouches and flexible packaging, bottles & other rigid containers.
Rommelag ENGINEERING Mayenner Strasse 18-20 71332 Waiblingen, Germany Tel. +49 7151 958 11-0 [email protected] www.rommelag.com
Rommelag ENGINERING is the inventor and worldwide lea-der of Blow-Fill-Seal technology (BFS) which has a wide range of economic and technological advantages for the aseptic filling and packaging of parenterals. Container pro-duction, aseptic filling and closure of the container in one operation under controlled conditions. Additionally, we offer leak detectors, cap welding machines, particle and vial in-spection machines for BFS containers.
17#pdapackaging
2019 PDA Europe Workshop
22-23 May 2019Berlin | Germany
Modern Polymer Pharmaceutical Packaging
EXHIBITIOR ABSTRACTS
SCHOTT AG Hattenbergstr. 10 55122 Mainz, Germany Tel. +49 6131 66 1589 Fax. +49 3641/28888-9408 [email protected] www.schott.com/pharma
SCHOTT Pharmaceutical Systems is a leading supplier of primary pharma packaging and analytical lab services. We provide quality solutions while meeting the highest de-mands. Our product portfolio includes ampoules, syringes, cartridges and vials as well as various polymer solutions. Furthermore, we are constantly improving our products and offer individual customer solutions to remain on top of the market’s needs. Our lab analytics experts offer a wide va-riety of lab services for pharmaceutical packaging to our customers in finding solutions to their most challenging packaging requirements. Our production facilities and pro-ducts comply with the highest international standards for pharmaceutical needs.
SiO2 Medical Products, Inc. 350 Enterprise Drive 36832 Auburn, AL, USA Tel. 334-321-5000 Fax. 334-321-5005 [email protected] www.sio2med.com
SiO2 Medical Products manufactures precision-molded pri-mary containers molded from medical grade engineered po-lymer, such as cyclic olefin polymer (COP). SiO2’s products incorporate a silicon-based barrier coating system that com-bines the durability, pH stability, and dimensional consisten-cy of plastic with the barrier properties and low extractables of silica glass (i.e., quartz). The containers have unique fea-tures not found in any containers on the market today and are ideally suited for sensitive, biopharmaceutical drugs. On-line inspection systems deliver containers meeting a six-sigma quality level for critical defects and each container has a unique ID for unparalleled track and trace capabilities.
Smart Skin Technologies 527 Queen St. Suite 210 E3B1B8 Fredericton Canada Tel. +1 506 206 8778 [email protected] www.smartskintech.com
At Smart Skin, we believe the first step in management is measurement. We market a smart-sensor based quality as-surance platform that enables customers to measure and manage previously unmeasurable adverse forces experien-ced by containers throughout their operations and supply chain. Smart Skin’s patented QuantifeelTM platform utili-zes wireless smart sensor vials to simultaneously stream production and quality information pertaining to pressure, shock, rotation, tilt, and precise line location to a tablet PC running our award-winning visualization software.
Smithers Shrewsbury Road SY4 4NR Shawbury, United Kingdom Tel. +44 1939 250383 [email protected] www.smithersrapra.com
Smithers offers a range of testing services for the medical and pharmaceutical industries, supporting you at every part of your path to market. Our services help clients demonstra-te compliance to regulatory guidance or specifications set out by the FDA, EMA, USP, ASTM and ISO: Pharmaceutical and Medical Device Chemical Analysis, Drug Delivery Device and Accessories Testing, Healthcare Product and Packa-ging Validation, Support Demonstrating Regulatory Compli-ance, Materials Selection, Characterisation and Testing
18 #pdapackaging
EXHIBITIOR ABSTRACTS
Steelco S.p.a. Riese Pio X (TV) Italy Tel. +39 042 375 61 [email protected] www.steelcospa.com
Steelco Pharma | Solutions for the pharmaceuticals and biotechnology companies Based close to Venice (Italy) Steelco Group has been at the forefront of the washers and sterilizers production for over 30 years with a strong global customer base. Steelco, through its branch offices for sa-les and after sales based in Hungary, Malaysia, Denmark, Germany, India, USA and thanks to its worldwide partners provides its products in more than 100 countries. Steelco Pharma division is specialized in design and manufacturing of: • cGMP washers; • cGMP sterilizers; • cGMP for terminal sterilization; • Ethylene Oxide low temperature sterilization; • cGMP Closure processor to wash and sterilize rubber stop-per and aluminum caps; • Class 100 Depyrogenization oven and Granulate Dryer (ATEX 94/9/EC compliance). With a comprehensive range of pharmaceutical equipment, Steel-co has set a new standard in the automated cleaning pro-cess equipment. Modular design and excellent quality are at the heart of these products. Steelco’ s GMP washers are designed, manufactured, validated and documented accor-ding to the latest global practices and standards to facilita-te customer compliance with current Good Manufacturing Practices (cGMP's). The design of the GMP range ensures self-cleaning of the machine chamber and pipework at each process stage, to prevent avoiding the risk of cross conta-mination.
Steriline Srl Via Tentorio, 30 22100 Como, Italy Tel.+39-031-592064 [email protected] www.steriline.it
We are an expanding European manufacturer founded in the Lake Como area in 1989, highly specialized in the production of complete lines for the aseptic processing of injectable products, supplying pharmaceutical companies worldwi-de. We are focused on the development and production of highly technological and distinct solutions based on advan-ced engineering, providing tangible added value to custo-mers looking for strong specificity combined to consistent quality. Our approach is based on building a close partner-ship with our customers, where dialogue is frequent, open and ongoing at all stages of product lifecycle, to provide the most effective responses to clients’ needs and the highest reliability in the long term.
TERUMO Interleuvenlaan 40 3001 Leuven, Belgium Tel. +32 16 38 12 11 [email protected] www.terumo-ps.com
Terumo Pharmaceutical Solutions Carefully Crafted We de-velop alliances with pharmaceutical companies on a global scale, using Terumo technology to develop, manufacture and supply carefully crafted solutions to their injectable drug delivery challenges. We pride ourselves on offering a full portfolio of products and services for the pharmaceutical industry, backed by unrivalled scientific expertise and know-how. By anticipating new trends and maintaining a constant dialogue, we provide a first class customer experience.
West Pharmaceutical Services Deutschland, GmbH & Co. KG Stolberger Straße 21-41 52249 Eschweiler, Germany Tel. +49 24037960 West.Pharmaceutical.Services @westpharma.com www.westpharma.com
West Pharmaceutical Services, Inc. is a leading manufactu-rer of packaging components and delivery systems for in-jectable drugs and healthcare products. Working by the side of its customers from concept to patient, West creates pro-ducts that promote the efficiency, reliability and safety of the world's pharmaceutical drug supply. West is headquartered in Exton, Pennsylvania, and supports its customers from lo-cations in North and South America, Europe, Asia and Aus-tralia. West's 2015 sales of $1.4 billion reflect the daily use of approximately 110 million of its components and devices, which are designed to improve the delivery of healthcare to patients around the world.
WILCO AG Rigackerstrasse 11 5610 Wohlen, Switzerland Tel. +41 566 184 343 Fax. +41 566 184 344 [email protected] www.wilco.com
WILCO AG provides in-line, off-line and laboratory machi-nes with non-destructive testing methods for monitoring the oxygen content and container closure integrity simul-taneously. Our patented leak detection methods based on the process analytical technologies (PAT) offers the oppor-tunity for monitoring the finishing processes as well. We have newly implemented Visual Inspection technologies in our portfolio. With CCIT and Visual Inspection WILCO AG now covers all inspection expectations for pharmaceutical products and our customers benefit from WILCO AG’s vast experience in quality inspection.
19#pdapackaging
20 #pdapackaging
POSTER SESSION
stevanatogroup.com
Come to visitOmpi atbooths13 & 14!
Specialty Plastics
Assembling, Packaging& Serialization
Glass PrimaryPackaging
Our DrugDelivery Systems
Portfolio
AnalyticalServices
YourIntegratedSolutionProvider
Wearables RespiratoryPen InjectorsAuto Injectors
SG_DDS_PDA_Venice_2019_FullPage_A4.pdf 1 25/02/2019 14:16
Parenteral Packaging: Testing and Inspection for Quality Assurance
Giovanni Golinelli, Bonfiglioli Engineering 1
Practical Approaches of Container Closure IntegrityTesting (CCIT) – a Comparability Study at a cGMP ContractLaboratory
Lisa-Antje Sünnemann, Labor LS 4
Valor Glass Extract-ables Confirm Uniform Surface Chemistry and Suitability for Parenteral Packaging
Carol Flynn, Corning 2
Characterization of Ocular Transfer Syringes
Sarah Peláez, Lonza 5
Needle Shield/Tip Cap compound selection for Glass or COP syringe barrels
Tine Hardemann, Datwyler 3
Particle Detection in Printed IV-Bags Using Symbol Verification
Dietmar Karepin, Vitronic 6
stevanatogroup.com
Come to visitOmpi atbooths13 & 14!
Specialty Plastics
Assembling, Packaging& Serialization
Glass PrimaryPackaging
Our DrugDelivery Systems
Portfolio
AnalyticalServices
YourIntegratedSolutionProvider
Wearables RespiratoryPen InjectorsAuto Injectors
SG_DDS_PDA_Venice_2019_FullPage_A4.pdf 1 25/02/2019 14:16
22 #pdapackaging
Packaging ScienceFocus Topic: CCI at Deep Cold Temperatures
Dear Colleagues,
Based on feedback from industry and the many open questions, our focus topic for 2019 will be CCI at Deep Cold Temperatures.
Please be invited to contribute to this open forum and discuss latest approaches, exchange experience, and share technology updates on primary packaging challenges related to:
· Cell and Gene Therapy Market
· CAR-T Therapy
· Regulatory challenges for CCI at cold temperatures
· Challenges for different materials at cold temperatures
· Measurement techniques
We will have experts to the mentioned topics and would like to highlight this topic from many different angles.
Take advantage of the open forum design offered by the small Interest Group meeting approach. 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 TechnologiesRoger 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 co-chair of the PDA Parenteral Packaging conference.
Bettine Boltres, PhD, WESTBettine 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.
Derek Duncan, PhD, LIGHTHOUSEDerek 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.
21 MARCH – INTEREST GROUP MEETING
23#pdapackaging
Thursday, 21 March 2019 10:00-17:00
10:00 Welcome: Opening Remarks & Introductions Kerstin Wilken, PDA EuropeBettine Boltres, WESTDerek Duncan, LIGHTHOUSERoger Asselta, Genesis Packaging Technologies
10:10 Cell & Gene Therapy – Production, Storage and Transport: Current Challenges and Solutions
Richard Zajicek, GSK
10:40 Introduction to the Chemical and Physical Properties of Different Packaging Materials
Bettine Boltres, WESTOtto Schubert, Rommelag
Packaging Solutions for Cell & Gene Therapies Moderator: Derek Duncan, LIGHTHOUSE
One of the areas in which there is a push for new packaging options is in the area of cell and gene therapies. These products require deep cold storage ranging from -80 ̊ C to cryogenic temperatures. Initial studies have shown that these low tempera-tures pose challenges to the traditional package for injectables—the rubber-stoppered glass vial. This can introduce some risk to container closure integrity. Current solutions and the future outlook will be discussed in this session.
11:10 An Introduction of the International Society of Cell and Gene Therapies – A Current Update
Jean-Sebastien Parisse, Aseptic Technologies
11:30 Current Packaging Solutions and the Reactions of Materials in Deep Cold Temperatures – A Supplier Update
Nicolas Brandes, WEST
11:50 Coffee Break, Poster Session & Exhibition
12:20 Polymer Container System for Storage of Cell Therapy Products at Cryogenic Temperature
Robert Sassa, WL GoreJean-Sebastien Parisse, Aseptic Technologies
12:45 Group Discussion - Challenges in Packaging:• What requirements need to be met when packaging and storing cell and gene therapeutics?• What solutions are currently available and how do different container react in deep cold temperatures?• Which challenges still need to be overcome?
13:30 Lunch Break, Poster Session & Exhibition
Pharma Packaging Solution Requirements for Deep Cold Storage Moderator: Bettine Boltres, WEST
In order to understand why and how different materials behave differently under different temperature conditions, the ses-sion will start with an in-depth dive into the relevant physical and chemical properties of glass, rubber and plastics. Further on we will get inside information from industry into the challenges that they are facing. We will discuss different approaches and especially identify those areas that still need to be addressed
14:30 Vial Solutions: Challenges for Glass and Stoppers in Deep Cold Temperatures
Chris Folta, Janssen J&J
Container Closure Systems at Deep Cold Storage Holger Roehl, Roche
15:10 Group Discussion – Current Materials Used in Deep Cold Temperatures, the Challenges and a Future Outlook:• Interactions of Drug Products and Primary Packaging Materials at Deep Cold Temperatures• Available Solutions and Associated Challenges
15:30 Coffee Break, Poster Session & Exhibition
16:00 Group Discussion – Current Materials Used in Deep Cold Temperatures, the Challenges and a Future Outlook:(contin’d)
16:30 Discussion on Hot Topics from the Conference
17:00 Conclusion and Farewell Bettine Boltres, WESTDerek Duncan, LIGHTHOUSERoger Asselta, Genesis Packaging TechnologiesKerstin Wilken, PDA Europe
INTEREST GROUP MEETING AGENDA
24
Joerg Zuercher, PhD, Senior Scientist, BayerJuerg 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.
#pdapackaging
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
Who Should Attend
• Scientists in Drug Product Development
• Scientists/ Engineers in Packaging Development
• Regulatory Affairs Experts
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.
21 MARCH – ONE-DAY TRAINING COURSE
Container Closure Development
25
TRAINING COURSE AGENDA
Thursday, 21 March 2019 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
#pdapackaging
TWO-DAY TRAINING COURSE
26 #pdapackaging
Learning Objectives
• Materials used for PFS Systems• Luer Cone and Luer Lock Compliance Testing• Requirements for the empty sterile sub-assembled syringe ready for filling• Test Methods for Drug Product Filled Syringes• PFS used in Delivery Systems
Who Should Attend • The course is designed specifically for those who are
involved or interested in the development, manufacturing and QC-testing of a Pre-filled Syringe System
• Engineers and Managers in Device Development and all other technical functions surrounding syringe systems
• Quality Personal / Regulatory Personal• Clinical and commercial Drug Product Manufacturing
Test-Methods forPre-filled Syringe Systems
Overview
The course will be an interactive lecture around Pre-filled Syringe Systems including ISO compliance testing. The participants will benefit from first hand information of both lecture leaders based on practical experience. The lec-ture includes the life cycle of a PFS from the idea to finished marketed product.
Horst Koller, CEO, HK Packaging ConsultingPrior to becoming a consultant, Horst worked for Abbott Diagnostic and SCHOTT Pharmaceutical Packaging with a total of more than 20 years industry experience. His consulting company is focusing on Technical, Regulatory and QM-Support around Primary and Secondary Packaging Systems including Medical Devices. He is an active member within the technical ISO Committees TC76 and TC84 as well as an active speaker on international conferences. He holds an Engineering degree in Biotechnology from the University of Applied Sciences in Mannheim / Germany.
Faculty
27#pdapackaging
TRAINING COURSE AGENDA
Thursday, 21 March 2019 9:00 – 18:00
9:00 Welcome
9:15 Introduction of Pre-filled Syringes and Materials Used to Manufacture Syringes
10.30 Coffee Break
11:00 Luer cone and Luer lock Compliance Testing for Glass and Polymer Syringes
Requirements for the Empty Sterile Sub- assembled Syringes Ready for Filling- Part 1)• Cone Breakage / Flange Breakage
12:30 Lunch Break
13:30 Requirements for the Empty Sterile Sub- assembled Syringes Ready for Filling- Part 1 (cont.)• Closure Testing
15:30 Coffee Break
16:00 Requirements for the Empty Sterile Sub- assembled Syringes Ready for Filling- Part 2• Break Loose and Gliding Force / Needle
Testing / Particulate Matter
17:30 Wrap-up of Day 1
18:00 End of Day 1
Friday, 22 March 2019 9:00 – 15:30
9:00 Regulatory Requirements of Finished Pre-filled Syringes – Part 1• System Characterization / Physical
Characterization
10:15 Coffee Break
10:45 Regulatory Requirements of Finished Pre-filled Syringes – Part 2• Pharmaceutical Characterization
11:45 Challenges of Syringe Systems and Components• Parenterals and Ophthalmics
12:30 Lunch Break
13:30 Challenges of Syringe Systems and Components (cont.)• Parenterals and Ophthalmics
14:15 Additional Testing for Use in Delivery Devices
15:15 Wrap-up of Day 2
15:30 End of Training Course
28 #pdapackaging
21-22 MARCH – TWO-DAY WORKSHOP
Container Closure Integrity TestingOverviewThis workshop focuses on theoretical and practical fundamentals of various CCI testing technologies and provides a systematic approach to apply these testing methods for CCI verification throughout drug product lifecycle. The Workshop 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 Workshop, 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
Lei Li, Ph.D, Associate Engineer Advisor Delivery and Device R&D, Eli Lilly
Lei Li currently serves as an engineer advisor at Delivery and Device R&D, Eli Lilly and Company. Lei has 9 years of experience in pharmaceutical and medical device industry, with focus on developing API and drug prod-uct packaging in support of clinical development and product commercialization, and establishing cold-chain distribution for biologic products. His current responsibilities include developing package integrity verification profiles for Lilly’s diverse pipeline portfolio, developing and validating CCI testing methods, and supporting
commercial control strategy development for CCI verification throughout drug product and device life cycle. He is a frequent speaker at PDA conferences and author of peer-reviewed articles and book chapters on CCI test methods. Lei Li received his Ph. D. in Analytical Chemistry from West Virginia University; prior to joining Eli Lilly, he worked at GE Plastics as an analytical and material scientist.
Learning Objectives This workshop utilizes lectures, case studies, and interactive hands-on training on testing instruments to provide insight into the latest developments of Container Closure Integrity (CCI) Testing, with focus on achieving the following key objectives:
• Understanding up-to-date regulatory and pharmacopeia requirements on CCI.
• Defining CCI requirements for various container and drug product types using a risk-based approach.
• Explaining working principles of various CCI testing techniques and their practical applications, with focus on deterministic methods such as tracer gas
detection (e.g. helium leak detection), electrical conductivity and capacitance (HVLD), vacuum decay leak detection, laser-based gas headspace analysis, mass extraction leak test.
• Selecting and applying appropriate testing methods for both laboratory and in-process testing to formulate comprehensive package integrity verification profiles.
• Defining CCI testing method development and validation approach and best practices.
• Avoiding common issues and pitfalls in CCI testing applications.
Who Should Attend• Parenteral drug packaging engineers and formulation scientists• Laboratory scientific staff and managers • Parenteral manufacturing staff• Sterility Quality Assurance• Regulatory affair scientists• Pharmaceutical packaging component manufacturing staff
Presentation of Technology, Instruments Demo and Hands-on Training kindly supported by
Eurofins, Genesis Packaging Technology, Lenox Laser, Lighthouse, Pfeiffer Vacuum, pti, Sartorius Stedim, Wilco
29#pdapackaging
WORKSHOP AGENDA
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.
Thursday, 21 March 2019 9:00 – 17:309:00 Welcome and Introduction
9:15 Regulatory Requirements: CCI introduction, regulatory requirements, and industry trends
10:00 Introduction• CCI assurance throughout product lifecycle • Testing requirement definition – risk based
approach• CCI profile & testing strategy development
10:30 Coffee Break
11:00 CCI Test Methods: Fundamentals • CCI defects and commonly used positive
controls • Evolution of CCI testing technology: liquid
flow, gas flow, electron flow (electric current)
11:40 Methodologies for Sizing CCI Defects Using Gas Flow Dynamics
12:00 Lunch Break
13:00 CCI Test Methods: Overview • Deterministic vs probabilistic definitions • Physicochemical methods vs microbiological
methods: differences and correlations• Microbial and dye ingress testing basics
14:00 CCI Testing Technologies • Vacuum and pressure decay • 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
Friday, 22 March 2019 8:30 – 16:308:30 Application Case Studies – Part 2
• Vacuum and pressure decay• Mass extraction
9:10 Hands-on Training
10:10 Coffee Break
10:40 Application Case Studies – Part 3• Headspace analysis• HVLD
11:20 Hands-on Training
12:00 Lunch Break
13:00 Development and Validation of Integrity Test Methods• Method development best practices• Method validation strategy• Pitfalls and solutions• A Case study
14:10 Approaches to CCI Testing Method Selection
Introduce group exercise: Product life cycle testing and method selection
14:30 Coffee Break
15:00 Group Exercise - Breakout
16:00 Group Exercise - Presentations & Discussion
16:30 End of Workshop
30 #pdapackaging
21-22 MARCH – TWO-DAY TRAINING COURSE
Extractables & LeachablesIncluding: 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.
Who Should Attend• Pharmaceutical Packaging and Device Engineers• Production Engineers, using SU systems• Regulatory Affairs Officers• Pharmaceutical R & D Managers• Analytical Chemists, working on E/L• Quality Assurance Officers
Learning Objectives Upon completion of this workshop, you will be able to:• Explain in detail the current regulatory requirements for
container/closure qualification from an E/L perspective.• Explain the upcoming changes in regulations, standards and
recommendations from PQRI, USP and BPOG and how these changes could impact a future evaluation of a pharmaceutical C/C-system.
• 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.
31#pdapackaging
TRAINING COURSE AGENDA
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.
Thursday, 21 March 2019 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 <661> chapters
▶ Devices
▶ Chemical characterization of devices according to ISO 10993-18: What changes are coming up?
▶ Upcoming Revisions of the USP <87> and USP <88>: Where could it go to?
▶ (Bio)Pharmaceutical Manufacturing
▶ Where is USP with the update on the USP <661.3> 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
32
TRAINING COURSE AGENDA
Friday, 22 March 2019 9:00 – 16:30
John Iannone, Principal Consultant, iCG Solutions
John Iannone has a background in Biomedical Engineering from Boston University. Since joining the Biotech/Medtech Industry 15 years ago, John has assisted multiple pharmaceutical & medical device companies with the development of their product safety evaluation strategies. Currently he is a Principal Consultant for iCG, LLC. His areas of expertise include Material Qualification & Biocompatibility, Extractables & Leachables, Chemical Characterization, and attainment of Biological or Toxicological risk assessments for medical devices,
pharmaceutical container systems, bioprocessing systems, and combination products. John has given numerous technical presentations and has led many workshops on Extractable & Leachable Considerations, Biocompatibility, Microbiology, and Regulatory Testing Requirements. He also participates in the development of both industry groups’ recommendations and regulatory guidelines through Expert Panel membership, global Technical Committees, and industry collaborations.
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
#pdapackaging
pda.org/calendar
2019 PDA EUROPE
PDA Exchange SeriesMeet, Exchange and Connect with Professionals from Related Fields and Expand you Knowledge!
24-25 SEPTEMBER 2019 BERLIN, GERMANY
EXHIBITION: 24-25 SEPTEMBER 2019EDUCATION & TRAINING: 26-27 SEPTEMBER 2019
REGISTER BEFORE 28 JULY AND SAVE UP TO €200!
PharmaceuticalFreeze DryingTechnology
Particles in Injectables
INFORMATION
35#pdapackaging
VENUEHilton Molino Stucky VeniceGiudecca, 81030133 Venice, ItalyTel. + 39 041 272 3311https://goo.gl/r1dN9L
CONTACT INFORMATIONConference InquiriesMelanie DeckerDirector Events & [email protected] Program InquiriesTeresa [email protected] Customer CareTel: + 49 30 436 55 [email protected] Program InquiriesElke von [email protected]/Sponsorship Inquiries Melanie [email protected]
GENERAL ADDRESSPDA Europe gGmbHAm Borsigturm 6013507 Berlin, GermanyTel: + 49 30 436 55 08-0Fax: + 49 30 436 55 08-66
CONFERENCE REGISTRATION HOURSTuesday, 19 March: 8:00 – 17:30Wednesday, 20 March: 8:00 – 13:00
COURSE REGISTRATION HOURSThursday, 21 March: 8:00 – 16:30Friday, 22 March: 8:00 – 12:00
SPECIAL REQUIREMENTSIf you require special accommodations to fully participate, please attach a written description of your
needs with your registration form. Specific questions can be directed to [email protected].
PDA Europe supports the children's hospice „Sonnenhof”
The Sonnenhof Hospice, located near PDA’s office in Berlin, offers support and assistance to families with children suf-fering from incurable and/or debilitating diseases. At Sonnenhof, children, together with their families, can spend the time they have left as they wish and find some relief from their suffering. Instead of purchasing expensive gifts for the conference speakers, PDA has decided to donate this amount to the Sonnenhof Hospice. You can also con-tribute and help us increase the amount, it is easy: buy a package of chewing gums at the
registration desk. THANK YOU!
To know more about the Sonnenhof Hospice, please visit www.bjoern-schulz-stiftung.de
pda.org/calendar
2019 PDA EUROPE
PDA Exchange SeriesMeet, Exchange and Connect with Professionals from Related Fields and Expand you Knowledge!
24-25 SEPTEMBER 2019 BERLIN, GERMANY
EXHIBITION: 24-25 SEPTEMBER 2019EDUCATION & TRAINING: 26-27 SEPTEMBER 2019
REGISTER BEFORE 28 JULY AND SAVE UP TO €200!
PharmaceuticalFreeze DryingTechnology
Particles in Injectables
36
1 Registration
Your registration is only complete upon filling in and submitting both pages of this form.
A 200€ late fee will apply for conference registrations after 16 March 2019
All fees given in Euro, excluding VAT (22 %)
Reg Form Page 1
18-22 March 2019 | Venice | Italy
Parenteral Packaging
pda.org/EU/ParPack2019
Please mark here if your company is an exhibitor to this event and you will receive the conference ticket at the special price of 1195 € per ticket. No further discounts are applicable with this option (as PDA Membership Discount or Group Ticket discount).
Discount for Exhibiting Companies
Group Registration Discount Register 5 colleagues for the conference at the same time and receive the 5th registration free. For more information on group discounts please contact Antje Petzholdt at [email protected]. Other discounts cannot be applied.
The fee includes event documentation as well as mid-session refreshments and lunch. Excellent networking opportunities with snacks and drinks will be given. The fee does not include the hotel accommodation. PDA Europe has secured a limited number of rooms at a special group rate.
Registration fee includes a one-year PDA membership if no further special discount is granted. If you do not wish to join PDA and receive the benefits of membership, please check here (same rate applies).
Your consent is important. We manage your personal data responsibly. For more information, please visit pda.org/privacy-policy
RESPONSE REQUIRED – By checking the box(es) below, I consent to: My contact information (name, company, job title, city, state, country) being printed on the attendee
list distributed at the event. PDA sending me promotional information via email.
PDA recording and/or photographing me and using those recordings and/or photographs in future PDA promotional and marketing materials.
PDA sending me promotional information via post
All fees given in Euro, excluding VAT (22 %)
18 March Interest Group Meeting Meeting Fee
Pre-filled Syringes All Participants 350
21 March Interest Group Meeting Meeting Fee
Packaging Science All Participants 350
21 March One-Day Training Course Training Course Fee
Container Closure Development All Participants 895
21-22 March Two-Day Training Course Training Course Fee
Extractables & Leachables All Participants 1595
21-22 March Two-Day Workshop Workshop Fee
Container Closure Integrity Testing All Participants 1595
21-22 March Two-Day Workshop Training Course Fee
Test-Methods for Pre-filled Syringe Systems All Participants 1595
19-20 March Conference only Conference Fee
Parenteral Packaging PDA Member 1695Nonmember 1995
Early Bird 750 € Regulatory/Academic 850 Poster Presenter please mark here (written approval required, conference fee applies)
This PDF-file provides an automatic fill-in function. Your signature, however, is needed in writing.
This PDF-file provides an automatic fill-in function. Your signature, however, is needed in writing.
Date Mandatory Signature
Your registration is only complete upon filling in and submitting both pages of this form.
Billing Address: Same as contact information address above. If not, please send your billing address to: [email protected]
Purchase Order
Purchase Order Number
Job Title
Mailing Address
Substituting for(Check only if you are substituting for a previously enrolled colleague; a nonmember substituting for member must pay the membership fee.)
PDA MemberName (Last, First, MI)
ID Number
Email Country
FaxBusiness Phone
DepartmentCompany
Postal CodeCity
Mr. Ms. Dr. Nonmember
3 WAYS TO REGISTER
online: pda.org/EU/ParPack2019FAX: +49 30 4365508-66Email: [email protected]
1
2
3
Reg Form Page 2
18-22 March 2019 | Venice | Italy
If this form is an update to a previously submitted form, please check here.I want to become a PDA Member. Please send me a subsription form
Parenteral Packaging
2 Your Contact Information
3 Information about Visa Matters • 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).
4Payment Options
By Bank Transfer Beneficiary: PDA Europe gGmbHIBAN: DE73 1007 0024 0922 8735 00 BIC (SWIFT-Code): DEUTDEDBBERBank Address: Deutsche Bank, Welfenallee 3-7, D-13465 Berlin, Germany
By Credit Card
American Express MasterCard VISAFor your credit card information safety:Please send your details by fax only (+49 30 4365508-66) or register online.
Your Company VAT I.D.:
This number starts by your country code with two characters (example: PDA Europe’s country code starts with: DE | followed by the number)
PDA Europe VAT I.D.: DE254459362
37
CONFIRMATION: Transmitting your filled-in registration form constitutes a binding application for the specific event. PDA Europe will send you a confirmation including payment details. A legally binding contract is concluded once PDA Europe has sent a written invoice by mail to you. A letter of confirmation will be sent to you within one week once payment has been received. You must have this written confirmation to be considered enrolled for this PDA event. PDA Europe reserves the right to deny access to anyone unable to provide written confirmation that all dues have been fully set-tled. SUBSTITUTIONS: If you are unable to attend, substitutions are welcome and can be made at any time, including on site at the prevailing rate. If you are registering as a substitute attendee, please indicate this on the registration form. Changes are free of charge until 2 weeks prior to the start of the event. After this two-weeks period, there will be a charge of € 100 excl. VAT per name change. REFUNDS: Refund requests must be sent to PDA Europe. If your written request is received on or before 29 January 2019 you will receive a full refund minus a 150 € excl. VAT handling fee. After that time, no refund or credit requests will be approved. If you are an unpaid registrant and do not attend the event, you are responsible for paying the registration fee. On-site registrants are not guaranteed to receive conference materials until all advanced registered attendees receive them. PDA Europe works PCI-Compliant. EVENT CANCELLATION: PDA reserves the right to modify the material or speakers/instructors without notice, or to cancel an event. If an event must be canceled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at [email protected] or fax to +49 30 4365508-66.
pda.org/EU/ParPack2019
This PDF-file provides an automatic fill-in function. Your signature,
however, is needed in writing.
Save the DateParenteral Packaging
25 - 26 February 2020Basel | Switzerland
