Interaction of Product, Package, and Process

2019 PDA EUROPE Parenteral Packaging Interaction of Product, Package, and Process

19-20 MARCH 2019 VENICE, ITALY EXHIBITION: 19-20 MARCH TRAINING: 21-22 MARCH IG MEETING: 21 MARCH 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 SCIENTIFIC PROGRAM PLANNING COMMITTEE to treat severe diseases; however, they require special Roger Asselta, Chair, Genesis Packaging Technologies considerations for processing and packaging. Roman Mathaes, Chair, Lonza Developments in packaging materials such as Bettine Boltres, West innovations in glass and their characteristics regarding William Dierick, Terumo interactions with the drug product formulation and end- Derek Duncan, LIGHTHOUSE user preferences will be discussed. Case studies of the Nicola Favaro, Stazione Sperimentale del Vetro implementation of new guidelines, for example Annex Claudia Heinl, Schott Renaud Janssen, Datwyler 1 of the European GMP Guideline and USP 800 along Robert Ovadia, Genentech with some of the latest developments in packaging Galen Huaiqiu Shi, Eli Lilly materials & components and the role of Container Michael Spallek, Rommelag ENGINEERING Closure Integrity (CCI) in product-package development, Daniel Wagner, Sanofi assembly and processing will be presented. Klaus Wuchner, Janssen J&J The conference program is intended to initiate and Daniele Zuccato, Nuova OMPI – Stevanato Group support discussion and professional exchange through a Joerg Zuercher, Bayer Brandon Zurawlow, Containsure Solutions diversity of scientific presentations, workshops, interest Kerstin Wilken, PDA Europe group meetings, training courses, joint dinners and Teresa Schubach, PDA Europe, Manager Programs & Events networking events. Welcome to amazing Venice!

Sincerely, The Chairs

Roger Asselta, Roman Mathaes, PhD, Conference Chair, Conference Chair, Genesis Packaging Technologies Lonza

2 #pdapackaging WELCOME TO VENICE

SCHEDULE AT A GLANCE

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 March 9:00 – 18:00 Test-Methods for Pre-filled Syringe Systems Training Course 22 March 9:00 – 15:30

21 March 9:00 – 17:30 Container Closure Integrity Testing Workshop 22 March 8:30 – 16:30

21 March 9:00 – 18:00 Extractables & Leachables Training Course 22 March 9:00 – 16:30

Join @PDA_Europe on Twitter and post pictures and highlights of this meeting! #pdapackaging Follow us on LinkedIn linkedin.com/company/pda PDA ISHEADLINE 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: Casual

Please confirm your attendance at the PDA registration desk. CONFERENCE AGENDA

Tuesday, 19 March 2019

9:00 Welcome and Introduction Kerstin Wilken, PDA Europe Roger Asselta, Genesis Packaging Technologies Roman Mathaes, Lonza

OPENING PLENARY

9:15 Keynote: The Evolution of Parenteral Drug Substance and Karthik Vaideeswaran, Drug Product Primary Containers Eli Lilly Galen 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-temperatures. 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 Ronald Iacocca, Cryo- and Cold Temperatures Eli Lilly

10:15 Q&A, Discussion

10:45 Coffee Break, Poster Session & Exhibition

11:15 Nonlinear Finite Element Simulation of Holger Roehl, Roche Frozen Container Closure Systems Martin Zueger, PinPlus

11:45 Case Study: Ensuring Container Closure Integrity of a Josine Wilmer, Gene Therapy Cancer Vaccine in Need of Deep Cold Storage LIGHTHOUSE

12:15 Q&A, Discussion

12:45 Lunch Break, Poster Session & Exhibition

PARALLEL TRACKS

Session 2: TRACK A TRACK B

Glass Manufacturing in the Digital Age Moderator: Claudia Heinl, SCHOTT Moderator: Bettine Boltres, WEST

This session it is all about glass as a primary This session is all about using digital options to packaging material for parenterals: Despite it being prove the integrity of the chosen Container Closure one of the oldest materials known many recent System and to further optimize the manufacturing innovations in primary packaging are related to process. Starting with the assessment of the cho- glass. Issues of concern such as breakage or glass sen vial, stopper and seal combination using com- particles will be addressed by the speakers. The puter simulation for stack-up analysis and integ- respective case studies including possible solu- rity calculations, the theory can be proven using tions are either based on alternative glass types or micro-computed tomography. Once the system is achieved by optimization of glass production pro- decided on, keeping its integrity can be supported cesses. Furthermore, the results of the round robin by calculating crack initiation and propagation using work within the Technical Committee TC12 ‘Pharma FE and XFE methods and a by on-line data collec- Packaging’ on glass delamination will also be part of tion for an optimized set-up of the manufacturing this session. line.

14:00 Delamination in Glass Containers for Pharmaceu- Identification and Quantification: tical Application: The International Commission Multisensor Drone Technology on Glass (ICG) Technical Committee TC12 Massimo Guglielmi, University of Padova Fabian Thygs, Janssen J&J

#pdapackaging 5 CONFERENCE AGENDA

14:20 Next Generation of Comprehensive Container Closure System (CCS) Primary Packaging Glass Stack-up Simulation and Optimization in the Digital Age Robert Hayes, Gerresheimer Anthony Bucci, WEST

14:40 A Case Study for Mitigation of Visual Particulate Testing and Computational Modelling in in Glass Ready-to-Use Vials the Study of Cartridge Failure Anthony Vico, Stevanato Group Elizabeth Jane Pavlik, MSD Daniela P. Boso, University of Padova

15:00 New Parenteral Glass Packaging Option May Quantifying the Vial Capping Process Using Lead to Reduction in Particulates and Ultimately Micro-Computed Tomography Drug Shortages Kyle Hoff, Corning Robert Ovadia, Genentech

15:20 Q&A, Discussion Q&A, Discussion

15:40 Coffee Break, Poster Session & Exhibition

Session 3: TRACK A TRACK B

Considerations on Interactions of Drug Product Container Closure Integrity and Primary Packaging Moderator: Roger Asselta, Genesis Packaging Technologies Moderator: Galen Shi, Eli Lilly

Critical to maintaining drug product safety and This session will cover the important topic of quality, Container Closure Integrity remains a hot compatibility between parenteral drug product and topic in parenteral packaging. This session will container closure systems. Three presentations review some important and recent work in the will describe the leachables and surface coating area, including new looks at utilizing different test (e.g., silicone oil) coming from parenteral con- methods such as helium leak rate, laser headspace tainers, which may lead to physical or chemical analysis and the consideration of package aesthet- interactions with the drug molecules (impact to ics relative to seal tightness. drug) or functionality deterioration of the container closure (impact to container).

16:10 Balancing Container Closure Integrity and The Advantages of Considering Primary Aesthetics for Robust Primary Packaging Container Systems as an Excipient During Formulation Development Yusuf Oni, Bristol-Myers Squibb Cathy Zhao, WEST

16:40 Container Closure Integrity Testing – Method Comparative Leachable Study for Development for Freeze- Dried Products Using Glass Vials to Demonstrate the Impact of Laser-based Headspace Oxygen Analysis Low Fill Volume Søren Dahl, Novo Nordisk Jonas Olsen Hede, Technical University of Denmark Volker Rupertus, SCHOTT

17:10 Interlaboratory Study of Container Closure Interactions of Leachables with Proteins: Integrity He-leak Test Method - Comparison of Combined In-Silico and Experimental Model Different Types of Artificial Leaks to Monitor the Potential Impact on Quality and Klaus Wuchner, Janssen J&J Safety of Therapeutic Proteins Daniel Wagner, Sanofi Piet Christiaens, Nelson Labs

17:40 Q&A, Discussion Q&A, Discussion

18:00 End of Day 1 and Networking Event

6 #pdapackaging CONFERENCE AGENDA

Wednesday, 20 March 2019

9:00 Keynote: Getting Ready for Annex1 and USP 800 Roman Mathaes, Lonza Hanns-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 Horst Koller, ISO Technical Committees TC76 and TC84 HK Packaging

11:00 Q&A, Discussion

11:30 Coffee Break, Poster Session & Exhibition

PARALLEL TRACKS

Session 5: TRACK A TRACK B

Challenges in Development & Manufacture Sterilization of Packaging Moderator: Brendan Zuralow, Containsure Solutions Moderator: Joerg Zuercher, Bayer

This session will discuss technical challenges in The session will cover non-standard, innovative manufacturing or development of parenteral pack- sterilization procedures for packaging components aging materials. Hear presentations about a QbD and/or assembled and packed products. You will approach to the manufacture of elastomers and learn about the benefits of vaporized hydrogene which points must be considered in the develop- peroxide and the equipment qualification and pro- ment of IV bag film development. 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 Packaging Committee and Speaker Biographies

https://goo.gl/ih9pdb

and many more....find them all online! CONFERENCE AGENDA

12:00 A Quality by Design Approach Toward Validation of VH2O2 Sterilization Manufacturing of Elastomeric Components for Process per ISO14937 Parenteral Packaging Applications Rahul Thakar, Datwyler Juha Mattila, STERIS

12:25 Multi-Chamber IV Bag Film Development Alternative Sterilization Techniques for Elastomeric Components for Primary Packaging Silvio Gianoli, Sealed Air Corporation 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 the next 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 function 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. milestone 14:00 Factors Influencing Quality of Susumu Uchiyama, Biopharmaceuticals in Pre-filled Syringes Osaka University

14:30 Lyophilization in Pre-filled Syringes: Timothy Dutill, Evaluating the Influence of Primary Container Material Lyophilization Technologies and Loading Device in drug Kevin Constable, Terumo

15:00 Coffee Break, Poster Session & Exhibition

15:30 Quality of Components & Containers – Robert Hormes, product Design, Materials, New Technologies Novartis

16:00 Q&A, Discussion

16:30 Conference Summary & Farewell Roger Asselta, Genesis development... Packaging Technologies Roman Mathaes, Lonza Kerstin Wilken, PDA Europe We’ll reach it together.

Successful drug product development DPS’s combination of unparalleled Visit lonza.com/drugproduct should integrate formulation, manufacturing experience, a strong scientific track USA +1 201 316 9200 process, primary packaging, device and record, and a state-of-the-art instrumental Japan +81 (0)3 6264 0600 delivery to the patient. Lonza’s Drug Product infrastructure provides industry best Europe +41 61 316 81 11 Services (DPS) offering delivers a holistic practices to successfully advance your Email [email protected] approach to DP development that anticipates drug product to the next milestone. © 2019 Lonza. All rights reserved. and prevents problems early and ensures the result is a product that is fit for purpose. 8 #pdapackaging

DPS_PDAConf_Ad_final.indd 1 3/5/19 9:10 PM the next milestone in drug product development... We’ll reach it together.

DPS_PDAConf_Ad_final.indd 1 3/5/19 9:10 PM FLOOR PLAN

Table Top 2 m x 2,8 m (5,6 m2) Catering PDA Registration & PDA Chapter Italy Poster Session

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29 31

22 21 CONFERENCE Co ee Station RAC ROO 20 V V 19

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PDA Registration PDA 15 14 13 12 11

10 9 8 30

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10 #pdapackaging EXHIBITORS

Company Name Booth Company Name Booth

Afton Scientific 28 OMPI - A Stevanato Group Brand Sponsor 13+14

Amri 20 OPTIMA 5

Atec Pharmatechnik 29 PTI Inspection Systems 16

Bausch + Ströbel 1 Rommelag ENGINEERING 7

Brevetti Angela 25 Schott 15

Bonfiglioli Engineering Sponsor 9 SiO2 Medical Products 26

Comecer 24 Smart Skin Technologies 27

Corning Sponsor 30 Smithers 8

Datwyler 2 Steelco 23

Eurofins BioPharma Product Testing Sponsor 19 Steriline 4

Eye-Tec 31 TERUMO 12

Genesis Packaging Technologies 10 West Pharmaceutical Services 17

Gerresheimer 18 Wilco 1

IWATA LABEL Europe 22

Kisico 11

LIGHTHOUSE Instruments 6

Lonza Pharma & Biotech Sponsor 21

Nelson Labs Europe 3

#pdapackaging 11 Largest scope of global services Sharpest focus on packaging testing

Delivering the most comprehensive global testing capabilities and expertise, quality systems, and data integrity, we offer a complete range of services for Packaging Testing including QC testing (EP/USP/JP), Extractables & Leachables and CCIT.

With over 15 years of experience we have developed sophisticated deterministic and probabilistic methods to verify the safety of your container closure system and meet the stringent regulatory framework.

Since we are part of an international network of laboratories and testing units with global reach, we can provide full support to determine the best CCIT method to meet the needs of your project.

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Comprehensive CCIT Testing Services Your Competence Center

HVLD ITALY [email protected] Vacuum Decay Helium Leak Detection THE NETHERLANDS [email protected] Pressure Decay Microbial Ingress Test Oxygen Headspace Aerosol Microbial Test US [email protected]

ad_ccit_final.indd 1 25/02/19 14:52 EXHIBITIOR ABSTRACTS

Afton Scientific Bausch + Ströbel Maschinenfabrik 2020 Avon Ct. Ilshofen GmbH & Co. KG 22902 Charlottesville, VA, USA Parkstr. 1, 74532 Ilshofen, Germany Tel. +1 434 979 3737 Tel. +49 7904 701 0 Largest scope of global services Fax. +1 434 979 3738 Afton Scientific [email protected] [email protected] cGMP Processing of Sterile Products www.bausch-stroebel.com www.aftonscientific.com Sharpest focus on packaging testing Design and construction of filling and packaging machines Afton is also the world premiere provider of pre-packaged for the pharmaceutical and similar industries. Containers empty sterile vials, stoppers and seals (Ready-to-Fill®) to such as ampoules, vials, syringes and cartridges are pro- companies worldwide for immediate use in cGMP aseptic cessed from cleaning to labeling. filling operations. These components are used not only for small clinical fills, but also for approved marketed injecta- Bonfiglioli Engineering S.r.l. ble drugs. Afton (DBA AnovaFill) provides cGMP contract Via Vespucci 20 sterile filling services of investigative new drugs, biologics, 44124 Ferrara, Italy and commercial injectable pharmaceuticals. Capabilities to Tel. +39 0532 715631 batch, sterilize, fill, label, and package. We specialize in small [email protected] batch clinical and commercial runs. AnovaFill is a part of www. bonfiglioliengineering.com Afton Scientific. Afton’s customers include small biotechs, Bonfiglioli Engineering is the world leader in the leak testing multinational pharmaceutical companies and major re- and inspection systems, offering a wide production range search institutions. Afton ships worldwide. of laboratories as well as in-line machines with the aim of verifying, based on four complementary technologies: AMRI 26 Corporate Circle Container Closure Integrity Testing, Visual Inspection, Leak 12212 Albany, United States Testing, and Headspace Gas Analysis: - Presence of leaks Tel. +1 518 522 3453 - Headspace gas content - The existence of visible foreign [email protected] materials. Superior Technology, reliability and high custo- Delivering the most comprehensive global testing www.amriglobal.com mization are Bonfiglioli Engineering's primary goals when it capabilities and expertise, quality systems, and data comes to delivering solutions that support our customers integrity, we offer a complete range of services for AMRI, a global contract research and manufacturing orga- in the final supply of high-quality products to the market. nization, partners with the pharmaceutical and biotechno- With over 5000 installations around the world, Bonfiglioli Packaging Testing including QC testing (EP/USP/JP), logy industries to improve patient outcomes and quality of Engineering serves a truly global customer base, making a Extractables & Leachables and CCIT. life. With locations in North America, Europe and Asia, AM- dramatic impact on the efficiency and the safety of the pa- RI’s team combines scientific expertise and market-leading ckaging industry worldwide. technology to provide a complete suite of solutions in Disco- With over 15 years of experience we have developed very, Development, Analytical and Solid State Services, API Brevetti Angela S.r.l. sophisticated deterministic and probabilistic methods Manufacturing and Drug Product. Via dell'Industria 99 to verify the safety of your container closure system 36071 Arzignano (VI), Italia Atec Pharmatechnik GmbH Tel.+390444474200 and meet the stringent regulatory framework. Schulstraße 48-50 Fax. +390444474222 24966 Sörup, Germany [email protected] Since we are part of an international network of Tel.+49 (0) 4635 293220 www.brevettiangela.com Fax. +49 (0) 4635 293229 laboratories and testing units with global reach, [email protected] BREVETTI ANGELA was set up in 1977 by Francesco Con- we can provide full support to determine the best www.atecgroup.de solaro, who was already working intensely in the field of pharmaceutical packaging from the 1960’s on. Since then CCIT method to meet the needs of your project. Atec Pharmatechnik GmbH specializes in sterile processing BREVETTI ANGELA has closely collaborated with many in technologies such as stopper processors, cleanroom lifts the pharmaceutical industry to address their needs for pri- and transfer equipment, CIP/SIP stations, process vessels, mary packaging. The fruits of its intense effort at the cut- bagging machinery and formulation systems. All equipment ting-edge of technology are realised in the latest generation is manufactured in Soerup, Germany within specialized of blow-fill-seal equipment series called SYFPAC® and LI- workshops. Our state-of-the-art FAT bay is furnished with QUIDPAC. Simultaneously, other packaging equipment, viz. www.eurofins.com/BPT cleanroom utilities for conducting factory acceptance tests. FLUIPAC, CYNOPAC, MECAS, BAGPAC and SACKPAC, have Our in-house laboratory was designed specifically for analy- also been developed by Brevetti Angela, whereas SECURE- zing quality standards such as particle reduction, endotoxin JECT® pre-filled syringes made on SYFPAC® machine are Comprehensive CCIT Testing Services Your Competence Center reduction, and temperature uniformity, among others. We our latest development. offer full-service project management, from engineering to HVLD ITALY [email protected] post-installation services and everything in between. Vacuum Decay Helium Leak Detection THE NETHERLANDS [email protected] Pressure Decay Microbial Ingress Test Oxygen Headspace Aerosol Microbial Test US [email protected] #pdapackaging 13

ad_ccit_final.indd 1 25/02/19 14:52 Valor® Glass—It’s About Machinability. Enduring quality and reliability to help increase your eciency. Eciency is critical in drug manufacturing. Breaks, interventions and rejection rates put production volumes and supply chains at risk. Valor Glass signicantly* reduces production downtime and enables increased speed and ecient 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.

COMECER S.p.A. Eurofins BioPharma Product Testing Via Maestri del Lavoro, 90 Via Bruno Buozzi 2 48014 Castel Bolognese, Italy 20090 Milano, Italy Tel. +39 0546 656375 Tel. +39 022 507 151 Fax. +39 0546 656353 [email protected] www.comecer.com https://www.eurofins.com/BPT

The COMECER GROUP is a developer and manufacturer With an outstanding analytical expertise, highest standards of high-tech systems in the field of Aseptic Processing and of quality and state-of-the-art instrumentation, Eurofins Bio- Containment for the Pharmaceutical and Nuclear Medicine Pharma Product Testing delivers the most complete range Industries, specialising in isolation technology solutions for of services for Packaging Testing including QC testing (EP/ regenerative medicine and tissue engineering. COMECER’s USP/JP), E&L and CCIT. With focus on CCIT, we offer de- products are used worldwide in hospitals, universities, re- terministic and probabilistic methods such as HVLD, Vacu- search institutes, pharma companies and large industrial um & Pressure Decay, Microbial Ingress Test and Aerosol groups. Microbial Test to verify the safety of your container closure system and meet the stringent regulatory framework. Euro- Corning fins BioPharma Product Testing sites in Italy and in The Net- 1 Riverfront Plaza herlands provide full support to determine which method is 14831 Corning, USA best for your packaging project needs. Tel. +1 607 974 9000 [email protected] Eye-Tec www.corning.com/valor Ballaarstraat 72 2018 Antwerpen, Belgium Corning is a world-leading innovator in materials science. Tel. +32 0497708607 For over 165 years, we have applied our unparalleled expertise in glass science and precision process technologies to [email protected] solve tough industry challenges and transform lives. Our www.eye-tec.eu innovations enhance quality and drive efficiencies in every Eye-Tec provides support in the domain of Visual Inspection industry that we serve. Learn more about Corning Pharma- to pharmaceutical companies around the globe. We are ceutical Technologies’ solutions and services for the phar- the ‘bridge’ between pharmaceutical manufacturers and maceutical industry. inspection machine builders. We do this through our combined competence in both compliance and technology Datwyler and our own past experience in parenterals manufacturing. Belgium Our projects can be on corporate strategies but just as Genny Fiore well about hands-on vision process improvements or Industrieterrein Kolmen 1519 qualification. With the enhanced focus on Container Closure 3570 Alken, Belgium Integrity (CCIT) we provide Leak Test Samples with pinholes Tel. + 39 3456685496 from 5µ onward. The client chooses pinhole location and [email protected] diameter and provides us with his own empty containers. Valor® Glass—It’s About Machinability. http://sealing.datwyler.com/ Enduring quality and reliability to help increase your eciency. Datwyler Sealing Solutions is a leading industrial supplier Genesis Packaging Technologies and a key player in the global health care world. Our state-of- 435 Creamery Way, Suite 100 the-art solutions for drug packaging and medical devices, 19341 Exton PA, United States Eciency is critical in drug manufacturing. Breaks, interventions and build on over 100 years of experience. Within our health care Tel. +1 800 552 9980 rejection rates put production volumes and supply chains at risk. Valor Glass offering and its three pillars Bio Care, Pharma Care and Med Fax. +1 610 458 4939 Care, we provide a unique range of products and services [email protected] signicantly* reduces production downtime and enables increased speed and including the most advanced elastomer formulations, coa- www.gen-techno.com ecient lling on both old and new lines. tings, aluminum seals, and processing technologies. Part- Genesis Packaging Technologies is a worldwide leader in nering up with the world’s top pharmaceutical and medical the science and technology of parenteral vial sealing and re- companies, we are a vital link and stand by our mission to sidual seal force testing. We provide the best capping equip- With so much riding on your throughput, isn’t it time to consider a more ensure all patient’s safety and improve patients’ lives. ment in the world and we offer both the global service and reliable option? technical support to back it up. Offering our customers the tools and knowledge to consistently achieve container clo- Make plans to attend Corning expert, Kyle Ho’s, presentation on Tuesday, sure integrity remains our priority. March 19th (Track A) or visit Corning (#30) to nd out how Valor Glass may increase your capacity.

Gerresheimer LIGHTHOUSE Instruments Klaus-Bungert-Str. 4 Science Park 408 40468 Düsseldorf 1098 XH, Amsterdam, Germany The Netherlands Tel. +49 211 618 100 Tel. +31 6 4226 7380 [email protected] [email protected] www.gerresheimer.com www.lighthouseinstruments.com

Gerresheimer is a leading global partner to the pharma and LIGHTHOUSE is the leading global provider of laser-based, healthcare industry. With our specialty glass and plastic non-destructive headspace inspection systems. LIGHT- products, we contribute to health and well-being. We have HOUSE introduced the laser-based headspace method into worldwide operations and about 10,000 employees ma- the pharmaceutical industry in 2000 and offers a range of nufacture our products in local markets, close to our cus- benchtop and in-line platforms with patented laser sensor tomers. With our plants in Europe, North America, South technology commercialized with the help of funding from America and Asia, we generate revenues of approximately the Food and Drug Administration. In addition to delivering EUR 1.4 billion. The comprehensive product portfolio inclu- equipment, Measurement Services & Support are delivered des pharmaceutical packaging and products for the safe, from laboratory facilities in Amsterdam and Charlottesville, simple administration of medicines: Insulin pens, inhalers, Virginia. A staff of Application Scientists supports custo- prefillable syringes, injection vials, ampoules, bottles and mers with outsourced testing services, scientific studies, containers for liquid and solid medicines with closure and and lease equipment projects. safety systems. Lonza Pharma & Biotech IWATA LABEL Europe Hochbergerstrasse 60 A Berliner Allee 59 4057 Basel 40212 Düsseldorf, Germany Switzerland Tel. +49 211 5403 9784 Tel. +41 61 316 8111 [email protected] [email protected] www.iwatalabel.com lonza.com/drugproduct

IWATA LABEL Europe GmbH is a specialty manufacturer of As a leader for contract development and manufacturing, adhesive labels and labeling machines for pharmaceutical Lonza Pharma & Biotech is recognized for reliable, high-qua- products. Our products add high value and multiple functi- lity services, global capacity, innovative technology plat- ons to pharmaceutical labeling needs. The need for labeling forms and extensive experience. Our broad capabilities span solutions, which protect medical staff, greatly helps us fo- across biologics, small molecules, bioconjugates, and cell cus on innovation and develop new products and services. and gene therapies. We manage projects from pre-clinical stage through to commercialization and our expertise covers KISICO GmbH both drug substance and drug product. We believe that the Rieslingstr. 41 best outcome – for you and your patients – can only come 65375 Oestrich-Winkel, Germany as a result of a successful collaboration. Together, we can Tel. +49 6723 99650 solve the next challenge and bring your next medicine to life. Fax. +49 6723 9965550 [email protected] www.kisico.de 2019 PDA Europe Conference KISICO is a German producer of screw caps, laboratory caps, 2 and 3 component caps, desiccant caps, child re- The Universe of 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- Pre-filled Syringes & ment will help you with the realization of your customized solution, but you can also choose from the wide range of Injection Devices our standard program.

22-23 October 2019 Gothenburg, Sweden

16 #pdapackaging EXHIBITIOR ABSTRACTS

Nelson Labs Europe OPTIMA pharma GmbH Piet Christiaens Otto-Hahn-Str. 1 Romeinsestraat 12 74523 Schwäbisch Hall, 3001 Heverlee, Belgium Germany Tel. + 32 16 400484 Tel +49 791 9495 0 [email protected] Fax. +49 791 9495 2610 www.nelsonlabs.be [email protected] www.optima-packaging.com/pharma Nelson Labs Europe is an independent contract research or- ganization, specialized in providing premium Extractables & For uncompromising pharmaceutical applications: Optima Leachables services to the pharmaceutical industry. Based Pharma develops and manufactures filling, sealing and pro- in Belgium, Nelson Labs Europe supports pharmaceutical cess technology for pharmaceuticals. Highly sophisticated, companies across the globe in developing worldwide com- fully automated systems from Optima Pharma are used to pliance testing strategies to qualify Container/Closure Ap- process blood plasma products, vaccines, oncology and plications and Pharmaceutical Production Equipment from biotech products in prefilled syringes, vials, bottles and car- an Extractables & Leachables perspective. Nelson Labs tridges. Non-sterile pharmaceuticals and diagnostics are Europe supported over 200 submissions to the FDA and to further applications. The company’s extensive technology the EMA. Nelson Labs Europe is ISO 17025 accredited and portfolio includes washing machines, sterilization tunnels, GLP-certified. Nelson Labs Europe has received a GMP ac- filling and sealing, robotic product handling and other functi- creditation from the European Authorities. In 2017, Nelson ons. Freeze drying systems and isolator technology are part Labs Europe was successfully audited by the FDA. of turnkey systems by Optima Pharma. The product range comprises machinery for laboratory filling up to high-speed OMPI - A Stevanato Group Brand systems. The division guarantees quick, professional ser- Via Molinella, 17 vice with 13 international locations. 35017 Piombino Dese, Italy Tel. +39 04 993 18611 PTI Inspection Systems Fax. +39 04 993 18611 145 Main Street, 10707 Tuckahoe, USA [email protected] Tel. +1 914 337 2005 www.ompipharma.com/ Fax. +1 914 337 8519 [email protected] OMPI is part of the Pharmaceutical Systems division of www.ptiusa.com Stevanato Group and boasts a unique expertise in providing superior pharmaceutical containers from glass tubing. PTI is a global leader in package testing equipment. We With operations in Italy, Slovakia, Mexico and China, Ompi manufacture non-destructive solutions for package integri- offers the widest range of glass primary packaging, from ty testing, leak detection, container closure integrity (CCI), the traditional ones such as vials and ampoules, to the high and seal integrity testing. PTI's inspection technologies are value ones as syringes and cartridges for auto-injectors and deterministic test methods that produce reliable quantitati- pen-injectors. Vials, cartridges and syringes are available ve test data. Our technologies conform to ASTM, USP 1207 also sterile and ready to fill (Ompi EZ-fill®). and other regulatory standards. We specialize in offering our customers comprehensive solutions including test method development. Applications include testing parenteral products: 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 leader 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 production, 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- pda.org/EU/UPS2019 spection machines for BFS containers.

#pdapackaging 17 EXHIBITIOR ABSTRACTS

SCHOTT AG Smart Skin Technologies Hattenbergstr. 10 527 Queen St. Suite 210 55122 Mainz, Germany E3B1B8 Fredericton Canada Tel. +49 6131 66 1589 Tel. +1 506 206 8778 Fax. +49 3641/28888-9408 [email protected] [email protected] www.smartskintech.com www.schott.com/pharma At Smart Skin, we believe the first step in management is SCHOTT Pharmaceutical Systems is a leading supplier measurement. We market a smart-sensor based quality as- of primary pharma packaging and analytical lab services. surance platform that enables customers to measure and We provide quality solutions while meeting the highest de- manage previously unmeasurable adverse forces experien- mands. Our product portfolio includes ampoules, syringes, ced by containers throughout their operations and supply cartridges and vials as well as various polymer solutions. chain. Smart Skin’s patented QuantifeelTM platform utili- Furthermore, we are constantly improving our products and zes wireless smart sensor vials to simultaneously stream offer individual customer solutions to remain on top of the production and quality information pertaining to pressure, market’s needs. Our lab analytics experts offer a wide va- shock, rotation, tilt, and precise line location to a tablet PC riety of lab services for pharmaceutical packaging to our running our award-winning visualization software. customers in finding solutions to their most challenging packaging requirements. Our production facilities and pro- Smithers ducts comply with the highest international standards for Shrewsbury Road SY4 4NR pharmaceutical needs. Shawbury, United Kingdom Tel. +44 1939 250383 SiO2 Medical Products, Inc. [email protected] 350 Enterprise Drive www.smithersrapra.com 36832 Auburn, AL, USA Tel. 334-321-5000 Smithers offers a range of testing services for the medical Fax. 334-321-5005 and pharmaceutical industries, supporting you at every part [email protected] of your path to market. Our services help clients demonstra- www.sio2med.com te compliance to regulatory guidance or specifications set out by the FDA, EMA, USP, ASTM and ISO: Pharmaceutical SiO2 Medical Products manufactures precision-molded pri- and Medical Device Chemical Analysis, Drug Delivery Device mary containers molded from medical grade engineered po- and Accessories Testing, Healthcare Product and Packa- lymer, such as cyclic olefin polymer (COP). SiO2’s products ging Validation, Support Demonstrating Regulatory Compli- incorporate a silicon-based barrier coating system that com- ance, Materials Selection, Characterisation and Testing 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. 2019 PDA Europe Workshop Modern Polymer Pharmaceutical Packaging

22-23 May 2019 Berlin | Germany

18 #pdapackaging EXHIBITIOR ABSTRACTS

Steelco S.p.a. TERUMO Riese Pio X (TV) Interleuvenlaan 40 Italy 3001 Leuven, Belgium Tel. +39 042 375 61 Tel. +32 16 38 12 11 [email protected] [email protected] www.steelcospa.com www.terumo-ps.com

Steelco Pharma | Solutions for the pharmaceuticals and Terumo Pharmaceutical Solutions Carefully Crafted We de- biotechnology companies Based close to Venice (Italy) velop alliances with pharmaceutical companies on a global Steelco Group has been at the forefront of the washers and scale, using Terumo technology to develop, manufacture sterilizers production for over 30 years with a strong global and supply carefully crafted solutions to their injectable drug customer base. Steelco, through its branch offices for sa- delivery challenges. We pride ourselves on offering a full les and after sales based in Hungary, Malaysia, Denmark, portfolio of products and services for the pharmaceutical Germany, India, USA and thanks to its worldwide partners industry, backed by unrivalled scientific expertise and know- provides its products in more than 100 countries. Steelco how. By anticipating new trends and maintaining a constant Pharma division is specialized in design and manufacturing dialogue, we provide a first class customer experience. of: • cGMP washers; • cGMP sterilizers; • cGMP for terminal sterilization; • Ethylene Oxide low temperature sterilization; • West Pharmaceutical Services cGMP Closure processor to wash and sterilize rubber stop- Deutschland, GmbH & Co. KG per and aluminum caps; • Class 100 Depyrogenization oven Stolberger Straße 21-41 and Granulate Dryer (ATEX 94/9/EC compliance). With a 52249 Eschweiler, Germany comprehensive range of pharmaceutical equipment, Steel- Tel. +49 24037960 co has set a new standard in the automated cleaning pro- West.Pharmaceutical.Services cess equipment. Modular design and excellent quality are @westpharma.com at the heart of these products. Steelco’ s GMP washers are www.westpharma.com designed, manufactured, validated and documented accor- West Pharmaceutical Services, Inc. is a leading manufactu- ding to the latest global practices and standards to facilita- rer of packaging components and delivery systems for in- te customer compliance with current Good Manufacturing jectable drugs and healthcare products. Working by the side Practices (cGMP's). The design of the GMP range ensures of its customers from concept to patient, West creates pro- self-cleaning of the machine chamber and pipework at each ducts that promote the efficiency, reliability and safety of the process stage, to prevent avoiding the risk of cross conta- world's pharmaceutical drug supply. West is headquartered mination. in Exton, Pennsylvania, and supports its customers from locations in North and South America, Europe, Asia and Aus- Steriline Srl Via Tentorio, 30 tralia. West's 2015 sales of $1.4 billion reflect the daily use 22100 Como, Italy of approximately 110 million of its components and devices, Tel.+39-031-592064 which are designed to improve the delivery of healthcare to [email protected] patients around the world. www.steriline.it WILCO AG We are an expanding European manufacturer founded in the Rigackerstrasse 11 Lake Como area in 1989, highly specialized in the production 5610 Wohlen, Switzerland of complete lines for the aseptic processing of injectable Tel. +41 566 184 343 products, supplying pharmaceutical companies worldwi- Fax. +41 566 184 344 de. We are focused on the development and production of [email protected] highly technological and distinct solutions based on advan- www.wilco.com ced engineering, providing tangible added value to custo- WILCO AG provides in-line, off-line and laboratory machi- mers looking for strong specificity combined to consistent nes with non-destructive testing methods for monitoring quality. Our approach is based on building a close partner- the oxygen content and container closure integrity simul- ship with our customers, where dialogue is frequent, open taneously. Our patented leak detection methods based on and ongoing at all stages of product lifecycle, to provide the the process analytical technologies (PAT) offers the oppor- most effective responses to clients’ needs and the highest tunity for monitoring the finishing processes as well. We reliability in the long term. 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.

#pdapackaging 19 SG_DDS_PDA_Venice_2019_FullPage_A4.pdf 1 25/02/2019 14:16

POSTER SESSION Our Drug Delivery Systems Parenteral Packaging: Valor Glass Extract- Needle Shield/Tip Cap Portfolio Testing and Inspection ables Confirm Uniform compound selection for for Quality Assurance Surface Chemistry and Glass or COP syringe Suitability for Parenteral barrels Packaging Wearables Pen Injectors Respiratory Auto Injectors Your Giovanni Golinelli, Carol Flynn, Tine Hardemann, Bonfiglioli Engineering Corning Datwyler 1 2 3 Integrated Assembling, Packaging Solution & Serialization

Practical Approaches Characterization of Particle Detection in Provider of Container Closure Ocular Transfer Syringes Printed IV-Bags Using Integrity Symbol Verification Testing (CCIT) – a Comparability Study at a cGMP Contract Laboratory

Lisa-Antje Sünnemann, Sarah Peláez, Dietmar Karepin, Labor LS 4 Lonza 5 Vitronic 6

Specialty Plastics

Glass Primary Analytical Packaging Services

Come to visit Ompi at booths 13 & 14! stevanatogroup.com 20 #pdapackaging SG_DDS_PDA_Venice_2019_FullPage_A4.pdf 1 25/02/2019 14:16

Our Drug Delivery Systems Portfolio

Wearables Pen Injectors Respiratory Auto Injectors Your

Integrated Assembling, Packaging Solution & Serialization Provider

Specialty Plastics

Glass Primary Analytical Packaging Services

Come to visit Ompi at booths 13 & 14! stevanatogroup.com 21 MARCH – INTEREST GROUP MEETING Packaging Science Focus 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 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 co-chair of the PDA Parenteral 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.

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.

22 #pdapackaging INTEREST GROUP MEETING AGENDA

Thursday, 21 March 2019 10:00-17:00

10:00 Welcome: Opening Remarks & Introductions Kerstin Wilken, PDA Europe Bettine Boltres, WEST Derek Duncan, LIGHTHOUSE Roger Asselta, Genesis Packaging Technologies

10:10 Cell & Gene Therapy – Production, Storage and Transport: Richard Zajicek, GSK Current Challenges and Solutions

10:40 Introduction to the Chemical and Physical Properties of Bettine Boltres, WEST Different Packaging Materials Otto 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 temperatures 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 Jean-Sebastien Parisse, Gene Therapies – A Current Update Aseptic Technologies

11:30 Current Packaging Solutions and the Reactions of Materials in Deep Nicolas Brandes, WEST Cold Temperatures – A Supplier Update

11:50 Coffee Break, Poster Session & Exhibition

12:20 Polymer Container System for Storage of Robert Sassa, WL Gore Cell Therapy Products at Cryogenic Temperature Jean-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 session 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: Chris Folta, Janssen J&J Challenges for Glass and Stoppers in Deep Cold Temperatures

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, WEST Derek Duncan, LIGHTHOUSE Roger Asselta, Genesis Packaging Technologies Kerstin Wilken, PDA Europe

#pdapackaging 23 21 MARCH – 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.

24 #pdapackaging 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 25 TWO-DAY TRAINING COURSE

Test-Methods for Pre-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 lecture includes the life cycle of a PFS from the idea to finished marketed product.

Who Should Attend • The course is designed specifically for those who are • Engineers and Managers in Device Development and all involved or interested in the development, manufacturing other technical functions surrounding syringe systems and QC-testing of a Pre-filled Syringe System • Quality Personal / Regulatory Personal • Clinical and commercial Drug Product Manufacturing

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

Faculty Horst Koller, CEO, HK Packaging Consulting Prior 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.

26 #pdapackaging TRAINING COURSE AGENDA

Thursday, 21 March 2019 9:00 – 18:00 Friday, 22 March 2019 9:00 – 15:30

9:00 Welcome 9:00 Regulatory Requirements of Finished Pre-filled Syringes – Part 1 • System Characterization / Physical 9:15 Introduction of Pre-filled Syringes and Characterization Materials Used to Manufacture Syringes

10:15 Coffee Break 10.30 Coffee Break

10:45 Regulatory Requirements of 11:00 Luer cone and Luer lock Compliance Testing Finished Pre-filled Syringes – Part 2 for Glass and Polymer Syringes • Pharmaceutical Characterization

Requirements for the Empty Sterile Sub- assembled Syringes Ready for Filling- Part 1) 11:45 Challenges of Syringe Systems and • Cone Breakage / Flange Breakage Components • Parenterals and Ophthalmics

12:30 Lunch Break 12:30 Lunch Break

13:30 Requirements for the Empty Sterile Sub- assembled Syringes Ready for Filling- Part 1 13:30 Challenges of Syringe Systems and (cont.) Components (cont.) • Closure Testing • Parenterals and Ophthalmics

15:30 Coffee Break 14:15 Additional Testing for Use in Delivery Devices

16:00 Requirements for the Empty Sterile Sub- 15:15 Wrap-up of Day 2 assembled Syringes Ready for Filling- Part 2 • Break Loose and Gliding Force / Needle Testing / Particulate Matter 15:30 End of Training Course

17:30 Wrap-up of Day 1

18:00 End of Day 1

#pdapackaging 27 21-22 MARCH – TWO-DAY WORKSHOP

Container Closure Integrity Testing

Overview This 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

Who Should Attend • Parenteral drug packaging engineers and formulation scientists Presentation of Technology, • Laboratory scientific staff and managers Instruments Demo and Hands-on Training kindly supported by • Parenteral manufacturing staff • Sterility Quality Assurance Eurofins, Genesis Packaging Technology, Lenox Laser, • Regulatory affair scientists Lighthouse, Pfeiffer Vacuum, pti, • Pharmaceutical packaging component manufacturing staff Sartorius Stedim, Wilco

Learning Objectives This workshop 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.

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 product 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.

28 #pdapackaging WORKSHOP AGENDA

Thursday, 21 March 2019 9:00 – 17:30 16:00 Application Case Studies – Part 1 • Tracer gas (helium leak detection) 9:00 Welcome and Introduction • API container testing using helium leak detection & video 9:15 Regulatory Requirements: CCI introduction, regulatory requirements, and 17:30 End of Day 1 industry trends

10:00 Introduction Friday, 22 March 2019 8:30 – 16:30 • CCI assurance throughout product lifecycle • Testing requirement definition – risk based 8:30 Application Case Studies – Part 2 approach • Vacuum and pressure decay • CCI profile & testing strategy development • Mass extraction

10:30 Coffee Break 9:10 Hands-on Training

11:00 CCI Test Methods: Fundamentals 10:10 Coffee Break • CCI defects and commonly used positive controls 10:40 Application Case Studies – Part 3 • Evolution of CCI testing technology: liquid • Headspace analysis flow, gas flow, electron flow (electric current) • HVLD

11:40 Methodologies for Sizing CCI Defects Using 11:20 Hands-on Training Gas Flow Dynamics 12:00 Lunch Break 12:00 Lunch Break 13:00 Development and Validation of 13:00 CCI Test Methods: Overview Integrity Test Methods • Deterministic vs probabilistic definitions • Method development best practices • Physicochemical methods vs microbiological • Method validation strategy methods: differences and correlations • Pitfalls and solutions • Microbial and dye ingress testing basics • A Case study

14:00 CCI Testing Technologies 14:10 Approaches to CCI Testing Method Selection • Vacuum and pressure decay Introduce group exercise: • Mass Extraction Product life cycle testing and method selection • Headspace analysis • HVLD 14:30 Coffee Break • Tracer gas (helium leak detection) • Seal quality testing (residual seal force) 15:00 Group Exercise - Breakout

15:00 Coffee Break 16:00 Group Exercise - Presentations & Discussion

15:30 • Current Topics: Industry Best-Practices 16:30 End of Workshop and Novel Technologies • AMI optical emission spectroscopy for CCI testing & demo

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.

#pdapackaging 29 21-22 MARCH – 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, storage 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 primary 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 • Analytical Chemists, working on E/L changes could impact a future evaluation of a pharmaceutical C/C- 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.

30 #pdapackaging TRAINING COURSE AGENDA

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

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.

#pdapackaging 31 TRAINING COURSE AGENDA

Friday, 22 March 2019 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

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.

32 #pdapackaging

pda.org/calendar

2019 PDA EUROPE PDA Exchange Series Meet, Exchange and Connect with Professionals from Related Fields and Expand you Knowledge!

Pharmaceutical Freeze Drying Technology

Particles in Injectables

24-25 SEPTEMBER 2019 BERLIN, GERMANY EXHIBITION: 24-25 SEPTEMBER 2019 EDUCATION & TRAINING: 26-27 SEPTEMBER 2019

VENUE Hilton Molino Stucky Venice 2019 PDA EUROPE Giudecca, 810 30133 Venice, Italy Tel. + 39 041 272 3311 PDA Exchange Series https://goo.gl/r1dN9L

Meet, Exchange and Connect with Professionals CONTACT INFORMATION Conference Inquiries from Related Fields and Expand you Knowledge! Melanie Decker Director Events & Exhibitions [email protected] Conference Program Inquiries Teresa Schubach [email protected] Registration Customer Care Tel: + 49 30 436 55 08-10 [email protected] Education Program Inquiries Elke von Laufenberg PDA Europe supports the [email protected] children's hospice „Sonnenhof” Exhibition/Sponsorship Inquiries Melanie Decker The Sonnenhof Hospice, located near [email protected] PDA’s office in Berlin, offers support and assistance to families with children suf-

GENERAL ADDRESS fering from incurable and/or debilitating PDA Europe gGmbH diseases. At Sonnenhof, children, together Am Borsigturm 60 with their families, can spend the time they 13507 Berlin, Germany have left as they wish and find some relief Pharmaceutical Tel: + 49 30 436 55 08-0 Freeze Drying Fax: + 49 30 436 55 08-66 from their suffering. Instead of purchasing expensive gifts for the conference speakers, Technology PDA has decided to donate this amount to CONFERENCE REGISTRATION HOURS Tuesday, 19 March: 8:00 – 17:30 the Sonnenhof Hospice. You can also con- Wednesday, 20 March: 8:00 – 13:00 tribute and help us increase the amount, it is easy: Particles COURSE REGISTRATION HOURS buy a package of chewing gums at the Thursday, 21 March: 8:00 – 16:30 registration desk. THANK YOU! in Injectables Friday, 22 March: 8:00 – 12:00 To know more about the Sonnenhof Hospice, please visit www.bjoern-schulz-stiftung.de SPECIAL REQUIREMENTS If 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]. 24-25 SEPTEMBER 2019 BERLIN, GERMANY EXHIBITION: 24-25 SEPTEMBER 2019 EDUCATION & TRAINING: 26-27 SEPTEMBER 2019

This PDF-file provides an automatic 18-22 March 2019 | Venice | Italy 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.

Registration 1 A 200€ late fee will apply for conference registrations after 16 March 2019

All fees given in Euro, excluding VAT (22 %) 19-20 March Conference only Conference Fee Parenteral Packaging PDA Member 1695 Nonmember 1995 Early Bird 750 € Regulatory/Academic 850 Poster Presenter please mark here (written approval required, conference fee applies)

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 Workshop Training Course Fee Test-Methods for Pre-filled Syringe Systems All Participants 1595

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

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36 pda.org/EU/ParPack2019 Reg Form Page 2 Parenteral Packaging

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pda.org/EU/ParPack2019 37 Save the Date Parenteral Packaging 25 - 26 February 2020 Basel | Switzerland