PH2011 Pogamme EXE - 20/11/10 15:47 Pagea2 24 Pharmapack ·

• Pharma Packaging Prospects and Regulatory Challenges in a Global Context

• Université Paris Descartes • Faculté des Sciences Pharmaceutiques, Paris Descartes •Boehringer Ingelheim Pharma • Hogan Lovells • AFSSAPS

• Pharmapack Awards Ceremony: From 1997 to 2011What has happened to yesterday's innovations? What channels have they opened? Which packaging innovation launched in 2010 will be the winner?

Compete at the 10th edition of the Pharmapack Awards – Details on p.2

• Innovations in the Adminis tration of Parenteral Drugs

• Boehringer Ingelheim Pharma • Novo Nordisk • TERUMO • Transcoject • Bayer ScheringPharma AG • BD Medical - Pharmaceutical Systems • Laboratoire Aguettant • Vetter PharmaFertigung • Gerresheimer Plastic Packaging • Schott Forma Vitrum • SGD • WestPharmaceutical Services • Nuova Ompi

Over 250 leading technology and service suppliers for the design and manufacturing of drug packaging and delivery devices will showcase theirlatest innovations. Exhibitors List • 6

Contrefaçon

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Day 1

HOW INNOVATION IN PACKAGING AND DRUG DELIVERY PACKAGINGENHANCE HEALTH PRODUCT SAFETY

WEDNESDAY 23 FEBRUARY 2011

THURSDAY 24 FEBRUARY 2011

PARIS 2011FEBRUARY23& 24GRANDE HALLE DE LA VILLETTE

1997 - 1999 - 2001 - 2003 - 2005 - 2007 - 2008 - 2009 - 2010 - 1997 - 1999 - 2001 - 2003 - 2005 - 2007- 2008 - 2009 - 2010 - 1997 - 1999 - 2001 - 2003 - 2005 - 2007 - 2008 - 2009 - 2010 - 1997 - 1999 -2001 - 2003 - 2005 - 2007 - 2008 - 2009 - 2010 - 1997 - 1999 - 2001 - 2003 - 2005 - 2007 - 2008 - 2009- 2010 - 1997 - 1999 - 2001 - 2003 - 2005 - 2007 - 2008 - 2009 - 2010 - 1997 - 1999 - 2001 - 2003 -2005 - 2007 - 2008 - 2009 - 2010 - 1997 - 1999 - 2001 - 2003 - 2005 - 2007 - 2008 - 2009 - 2010 - 1997- 1999 - 2001 - 2003 - 2005 - 2007 - 2008 - 2009 - 2010 - 1997 - 1999 - 2001 - 2003 - 2005 - 2007 -2008 - 2009 - 2010 - 1997 - 1999 - 2001 - 2003 - 2005 - 2007 - 2008 - 2009 - 2010 - 1997 - 1999 - 2001- 2003 - 2005 - 2007 - 2008 - 2009 - 2010 - 1997 - 1999 - 2001 - 2003 - 2005 - 2007 - 2008 - 2009 -2010 - 1997 - 1999 - 2001 - 2003 - 2005 - 2007 - 2008 - 2009 - 2010 - 1997 - 1999 - 2001 - 2003 - 2005- 2007 - 2008 - 2009 - 2010 - 1997 - 1999 - 2001 - 2003 - 2005 - 2007 - 2008 - 2009 - 2010 - 1997 -1999 - 2001 - 2003 - 2005 - 2007 - 2008 - 2009 - 2010 - 1997 - 1999 - 2001 - 2003 - 2005 - 2007 - 2008- 2009 - 2010 - 1997 - 1999 - 2001 - 2003 - 2005 - 2007 - 2008 - 2009 - 2010 - 1997 - 1999 - 2001 -

Co-located event: BIOMEDevice Europe conference & exhibition

• Packaging and Inno vation: Compliance, Security and Sustainability• Faculty of Pharmacy, Clermont-Ferrand • Novartis Consumer Health • Nolato Cerbo AB •Burgopak • Süd-Chemie Performance Packaging • Tekni-Plex • Rondo AG • ATT Advanced Track & Trace • AlpVision • Item GmbH

• Drug Delivery Device Techno logies: Review, Trends and Innovation• PharmaAccel Consulting • Toxikon Europe NV • Pharma Prescription • 3M Drug DeliverySystems • Rexam Healthcare • Amcor Flexibles • Press Part

Pharmapackwww.pharmapack.fr

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• Regulatory Update for Combination Products in Europe and the USA: Status,Lessons and Future Vision

• Roundtable Discussion: Exchanges between Industrial Representatives, ContractR&D Organisations and the Day's Speakers

• Combination Products Today and in the Future: Drugs and Biologicals - NewDelivery Systems

• Enabling Technologies for Combination Product Design and Development

The exhibition full of experts in enabling technologies for the design and manufacturingof drug device products. Discover the exclusive conference programme on the back cover.

Programme Back Cover • Exhibitors List p.17 • Registration p.40

Non contractual docum

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information non contractuel

EXHIBITION

CONFERENCE

Conference & Ex

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PH2011 Programme EXE_- 20/11/10 15:47 Pagea2

PH2011 Programme EXE_- 20/11/10 15:47 Pagea3

Synopsis

1Register Online at www.pharmapack.fr

DaY 2 – tHUrsDaY 24 FeBrUarY

PHARMA PACKAGING PROSPECTS AND REGULATORY CHALLENGES IN A GLOBAL CONTEXT

Pr Jean-Claude Chaumeil, Professeur Emérite, Université Paris Descartes, France

Pr Philippe Arnaud, Faculté des Sciences Pharmaceutiques, Paris Descartes, France

INNOVATIONS IN THE ADMINIS TRATION OF PARENTERAL

Dr. Michael Spallek, Director Global Skill Center Packaging Development, Boehringer Ingelheim Pharma,Germany

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PHARMAPACK AWARDS CEREMONY

Chairperson's Introduction and Opening of the Session:

DRUG PACKAGING AND INNO VATION: COMPLIANCE, SECURITY AND SUSTAINABILITY

Dr. Pascale Gauthier, Biopharmaceutical and Pharmaceutical Technology Department, Faculty of Phar-macy, Clermont-Ferrand, France

Lionel Jeannin, Senior Global Packaging Development Manager, Novartis Consumer Health, Switzerland

DRUG DELIVERY DEVICE TECHNO LOGIES: REVIEW, TRENDS AND INNOVATIONRené Bommer, Founder, PharmAccel, Germany

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TIME PAGE

ADVERTISERS:

AIRSEC SUDCHEMIE 18

BALDA 20

BD MEDICAL - PHARMACEUTICAL SYSTEMS Inside cover

CONSTANTIA 22

EMBALLAGES MAGAZINE 7

FAUBEL 24

ITALIA IMBALLAGGIO 29

JB TECNICS 27

LOG PLASTICS 30

LGR 5

ONDRUGDELIVERY 37

TERUMO 37

PHarMaPaCK eXHiBitiOn 2011

Back CoverBiOMeDevice europe Programme

40general information & registration for the Conference

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DaY 1 – WeDnesDaY 23 FeBrUarY

PRESS PARTNERS:

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PH2011 Programme EXE_- 20/11/10 15:47 Page1

Compete in the Pharmapack Awards 2011

Presentation of the ceremony by: The jury will reward health products and drugs whoseinnovative packaging system significantly enhancesthe proper use of drugs. Health products and drugspackaging for animals will be rewarded with a specialaward in the “veterinary category”. Innovations laun-ched on the European market between 1st December2009 and 8th December 2010 will be at the center ofattention.

Enter by 8 December 2010To participate and receive the entry form pleasecontact us at:[email protected] or call us on +33 (0)1 77 48 10 00.

2 Register Online at www.pharmapack.fr

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Day 1 << ConferenceMERCRED I 2 3 F É VR I ER 2 011 / WEDNESDAY 2 3 F EBRUARY 2 011

8.30 WELCOME COFFEE

PHARMA PACKAGING PROSPECTSAND REGULATORY CHALLENGES IN A GLOBAL CONTEXT

Chairpersons

Pr Jean-Claude Chaumeil, Professeur Emérite, Université Paris Descartes, France

Pr Philippe Arnaud, Faculté des Sciences Pharmaceutiques, Paris Descartes, France

Pharmapack 10th Edition - Chair's Opening

Speculations on Future Trends in PharmaPackaging in 2020

Dr. Michael Spallek, Director Global Skill Center Packaging De-velopment, Boehringer Ingelheim Pharma, Germany

Expected Regulatory Changes on Information to Patients and Pharmacovigilance in the EU:What Does it Mean for the Pharmaceutical In-dustry?

Elisabethann Wright, Partner, Hogan Lovells, Belgium

Therapeutic Incidents and Accidents Due toPackaging: Review / Les incidents et accidentsthérapeutiques dus au packaging

Anne Castot, Chef du Service de l’évaluation, de la sur-veillance du risque et de l’information sur le médicament,AFSSAPS, France

10.45 COFFEE BREAK AND NETWORKING WHILST VISITING THEEXHIBITION

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Pharmapack Awards Special 10 11.30➔ 12.30

T he Pharmapack Awards, created in 1997,were designed to underscore the innova-tive drive of packaging professionals:

drugs, medical devices, health products andveterinary drugs. The prizes are awarded to in-novative packaging that significantly contri-butes to proper drug use and compliance.

The introduction of the 10th ceremony will pre-sent an opportunity to learn about:

• What happened to yesterday's innovations?• What channels did they open?

Pharmapack Awards Ceremony, 10 Editions of Innovation

WINNERS 2010

• Compliance category: NovoPen 4 - Novo Nordisk

• Safety category for hospital products: Seringue EPHEDRINE prête àl'emploi AGUETTANT - Laboratoire AGUETTANT

• Medical device category: Conveen Optima - Laboratoires Coloplast

• Prevention of domesticrisks, veterinary category:Milteforan - labo ra toiresVirbac

• New packaging specialdistinction: VitaflorBIO -Nutrition & Santé

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<< ConferenceMERCRED I 2 3 F É VR I ER 2 011 / WEDNESDAY 2 3 F EBRUARY 2 011


al 10th Edition: When Packaging Innovations Enhance Patient Safety and Compliance

WINNERS 2009

• Ease-of-use category: Actonel Combi - P&G Pharmaceuticals

• Safety category: Efferalgan - Somater, Airsec-Süd Chemie for BMS

• Medical device category : UriSet 24 avec Monovette - SARSTEDT

• Compliance category: easOtic - Laboratoires Virbac

WINNERS 2008

• Compliance category: Pocketpak - Société BurgoPak

• Safety category: Onko-safe - Ebewe Pharma

• Medical device category: ReCell® - C3 Clinical Cell Culture

WINNERS 2007

• EMEND - Laboratoires MSD – Chibret

• NovoFine® Autocover - Laboratoires Novo Nordisk

• M-Jet - Société Top Clean Injection (Groupe Top Clean Packaging)

WINNERS 2005

• Technical realisation, Rovip SA for Micropakine - Sanofi-Aventis

• Medical device category: Velairpack - Velfor groupe

• Special distinction of the Jury: Seringue DNS (Dry Needle System) - Plastef & m.b. innovation

• Special distinction of the Jury: Packaging of «Panadol» designed by Field Boxmore, Belfast -GlaxoSmithKline, UK

WINNERS 2003

• SmartDose - Laboratoire ProMed

• Safety category: Arixtra - Laboratoire Sanofi-Synthelabo

• Hospital Product Award: PhaSeal - Laboratoires Faulding

WINNERS 1997

• Distinction : Système Diskus de Flixotide - Laboratoire Glaxowellcome

• Award special hospital: Système de transfert des flacons de Tienam 500 I.V. - Laboratoire M.S.D

• Safety: nouvelles seringues pré-remplies de Fraxiparine - Laboratoire Sanofi

Winners of the Previous Editions

WINNERS 2001

• Pharmapack Award: Imigrane - Laboratoire Glaxowelcome

• Safety Award: Innohep - Laboratoire Leo

• Special distinction of the Jury: Miochole - Laboratoire Ciba Vision

• Hospital Product Award: Free Flex - Laboratoire Fresenius Kabi

WINNERS 1999

• Pour l’amélioration de la sécurité et de l’administration : Laboratoire A.G.A. MEDICAL, Laboratoire Air Liquide Santé, Laboratoire Air Products

• Pour la facilitation de l’utilisation : Stylo injecteur Apokinon - Laboratoires Aguettant

• Pour son concept de distribution : Rhinathiol adulte en gel - Laboratoires Synthelabo



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12.30 LUNCH AND NETWORKING WHILST VISITING THE EXHIBITION

INNOVATIONS IN THE ADMINIS -TRATION OF PARENTERAL

Dr. Michael Spallek, Director Global Skill CenterPackaging Development, Boehringer IngelheimPharma, Germany

Chair’s Opening

25 Years of Innovation in Insulin Devices Kylie Myers, Device Brand Team, Senior Global Product

Manager, Marketed Devices, Global Marketing, Novo Nor-disk, Denmark

It is 25 years since the development of the first ever insulin pendevice which changed the way patients with Diabetes injectedtheir insulin and also the insulin market worldwide. Novo Nordisk has been the leader and innovator in the developmentof insulin devices from the beginning. This presentation will de-tail the innovations in insulin delivery devices – showing howwe have been able to respond to market needs and customerfeedback to produce more convenient and preferred devicesfor patients and HCPs around the world.

Kylie is currently responsible for all Marketed Insulin Devices,working in Global Marketing at Novo Nordisk Headquarters inDenmark. She has a Masters in Business and Bachelors in Applied Science from Australia. Kylie has 10 years experienceas a Nuclear Medicine Technologist, followed by 6 years working in the pharmaceutical industry in sales and marketingwith Novo Nordisk both in Australia and now in Denmark.

Plastic Pre-Filled Syringe Systems for Biopharma-ceuticals - Experience in the Japanese Market

Hiromitsu Okabe, Business Development Manager andProject Leader – Drug & Device Group, Hospital ProductsCompany of TERUMO, Japan

Masahito Takahashi, Business Development Manager– Drug & Device Group, Hospital Products Company ofTERUMO, Japan

The transition from low-molecular drugs to large-moleculardrugs such as biopharmaceuticals has revealed many issuesto be addressed with respect to glass pre-filled syringes. As aresult, plastic pre-filled syringe made of novel materials suchas Cyclic Olefin Polymer (COP) and Cyclic Olefin Copolymer(COC) are gaining interest. Terumo has introduced a plastic pre-filled syringe for use with Biopharmaceuticals entering into

the Japanese market, which can be considered amongst theworld’s first commercialisation of plastic pre-filled syringes forsuch applications. Terumo’s pre-filled syringe system basicallyconsists of COP syringe barrel and rubber or ThermoplasticElastomers Plunger Stoppers. Our experience of plastic pre-filled syringe commercialisation in the Japanese market will bepresented.

Mr. Okabe was appointed a head of Business DevelopmentTeam. He has over 20 years of experience in product develop-ment.

Mr. Takahashi has over 20 years of experience in various business and product development positions in the field of me-dical device and pharmaceutical industry.

Particulate Matter Control in the Production ofPolymer Prefillable Syringes

Dr.-Ing Jochen Heinz, Director New-Products & Tech-nology, Transcoject, Germany

In the last decade more and more prefillable polymer syringeswere placed on the market. The majority of these syringes areproduced in clean rooms and later filled without a washing step(as needed for glass containers) in between. Therefore thecontrol of particulate matter during the production of such syringes is essential for the quality. In the presentation the different types and sources of particles including their specifi-cations are discussed. Information will be presented on howclean room environments, production technologies and trans-port packaging influence particle matter.

Jochen Heinz has a Master of Engineering in Material-Scienceand Technology. Since 2001 he has been working for Transco-ject, which is a manufacturer of medical products. In the boardof directors he is in charge for ‘New Products & Technology’.Prior to that he was at Schott Glas, and responsible for the product development of the business unit ‘PharmaceuticalPackaging’.

Large Volume Prefilled Syringes: Experiences andChallenges

Joerg Zuercher, PhD, Packaging Development, BayerSchering Pharma AG, Germany

Large volume syringes (50ml to 125ml) made out of glass andplastic were developed. The syringes are intended to be usedwith a pressure limit of 20 bar. Major challenges of the deve-lopment was to fulfill the functionally requirements (e.g. pressurelimit, gliding forces, influence of attached needle sizes, influence of aging of functionality). Besides functionality, theoverall pharmaceutical quality aspects were important. For thesubmission of the plastic syringe system, extended extractables& leachables testing was conducted.

Jörg Zürcher is responsible for the development of containersand packaging materials at Bayer Schering Pharma AG. Since2002 he is leading the group responsible for the developmentof container closure systems and application devices for liquidand parenteral dosage forms.

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Prefilled Syringes for Infusion Pump: A New Application From a Technology Platform for PrefillablePlastic Systems

François Urvoy, Worldwide Plastic Portfolio Director, BDMedical - Pharmaceutical Systems, France

IV infusion of drugs is very common in hospitals and increasinglyperformed with a programmed syringe pump. But a number ofpublications have highlighted issues with the drug preparationmethods when using disposable syringes. In addition, a proprie-tary study with hospital pharmacists and nurses highlighted apreference for prefillable syringes for a number of commondrugs infused with pumps. To address this, a new prefillablesystem was designed for syringe pumps, meeting the specificrequirements imposed by IV delivery, the composition and sensitivity of the drugs and compatibility with the installedpumps. New technologies have been used to meet these chal-lenges, including coatings and designs. A long experience withhospital practices, the understanding of the global regulatoryconstraints and partnership with the pump manufacturers haveall been critical. Thus, this development is an example of how awide platform of technologies available for plastic syringes andstudy of the clinical use enable the design of different customprefillable systems for a specific applications.

François Urvoy is plastic portfolio director at BD Medical -Pharmaceutical Systems. Before that François worked at Johnson & Johnson and in the automotive industry. Françoishas a Degree in Mechanical Engineering, an M.Sc. in MaterialsScience and an MBA.


How to Meet the Various Challenges Linked toPerfusion-Based Injectables Administration. A New Ge-neration of Perfusion Pouches: The Self-Rinse Pouch /Comment répondre aux diverses problématiques liées àl’administration de produits injectables par perfusion ?

Danielle Labrèche, Director Business Development & Innovation, Laboratoire Aguettant, France

The administration of injectables by plastic pouchperfusion began in the sixties. This mode of injection has sincebeen widely used in hospitals and increasingly for home care.

However, hospitals must now contend with several issues. Howdoes this mode of administration impact compliance? Does itcontribute to the risk of exposure during the administration ofdangerous products? What about the risk of nosocomial infec-tions and the increase in waste?

Thanks to studies published in France in 2008, we alreadyknow that this mode of delivery may lead to compliance issues,and under-administration, as, on average, 20% of the drugprescribed stagnates in the perfusion line.

Aguettant has therefore developed a totally new pouch. Theinnovation resides in the automatic rinsing of the perfusion line.This guarantees perfect compliance with the treatment regimenfor both doctors and patients, and protection against the risk

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of exposure during the administration of toxic substances forhealth workers. Furthermore, waste is reduced thanks to sim-ple, safe handling procedures.

This new delivery device is part of the AGUETTANT System®

range.

Une nouvelle génération de poche perfusion : La poche autorinçage.

L’administration de produits injectables par perfusion en pocheplastique a débuté dans les années soixante. Ce mode d’injec-tion est depuis largement utilisé par les hôpitaux et de plus enplus pour les soins à domicile.

Pourtant aujourd’hui, le secteur hospitalier doit faire face à plu-sieurs préoccupations et on peut se demander comment cedispositif intervient dans l’observance du traitement et si sonutilisation contribue aux risques d’exposition lors de l’adminis-tration de produits dangereux, d’infections nosocomiales, ainsiqu’à l’augmentation des déchets.

En effet, nous savons déjà, par des études publiées en 2008en France, que ce mode d’administration pose une questionrelative à l’observance de la prescription avec un risque desous-dosage d’en moyenne 20%, une partie du médicamentstagnant systématiquement dans la ligne de perfusion.

C’est à partir de cette réflexion qu’Aguettant a mis au point unetoute nouvelle poche dont l’innovation réside dans le rinçageautomatique de la ligne de la perfusion. Cela garantit au patientet au médecin le parfait suivi du protocole de traitement et pourle personnel soignant, l’assurance contre le risque d’expositionlors de l’administration de produits toxiques et une réductiondes déchets liée à une manipulation simplifiée et sécurisée.

Ce nouveau dispositif d’administration fait partie de la gamme“AGUETTANT System®”.

Danielle Labrèche graduated from Hautes Etudes Commer-ciales (HEC) Montréal, has worked as Marketing Director overthe last decade in the Generic Pharmaceutical Industry in Canada at PHARMASCIENCE in Montréal, and overseas at RANBAXY PHARMACIE, in Paris. As the Business Development & Innovation Director at LABORATOIRE AGUETTANT (Lyon,France), a company dedicated to the development and marke-ting of injectable drugs for hospital care, she is in charge of theinnovation process for new products developments and is heading the licensing activities of proprietary dossiers and Delivery Devices patented worldwide by AGUETTANT.

Dual Chamber Syringes - Lessons Learned fromthe Last Decade / Seringues à double compartiment - expérience accumulée au cours de la dernière décennieet futur développement

Tilman Roedle, Head of Packaging Development, VetterPharma Fertigung, Germany

Dual chamber technology – this all-in-one system lends itselfperfectly to those conditions that require the up-most patientcomfort and security. The presentation describes how dualchamber technology has opened up an alternative market forend user friendly application systems and shows the historyand challenges over to deliver medication in this fashion.

Technologie double compartiment - ce système tout-en-un correspond parfaitement au besoin de confort et de sécuritédes patients. La présentation décrit comment la technologiedouble compartiment a permis d´offrir une alternative optimaleaux utilisateurs finaux de systèmes d´administration , et mon-tre l’évolution et les défis de ces systèmes pour les produitsinjectables.

Tilman Roedle holds a university degree in manufacturing sys-tems engineering. Between 2003 and 2005, he was team lea-der of Technical Services at Vetter, responsible for consulting,selection and implementation of packaging systems in custo-mer projects. Since 2005 he is Head of Packaging Developmentand responsible for the development of aseptically pre-filledsyringe systems and the related relevant production processes.

Plastic Versus Glass: High Performance Vials Dr. Wolfgang Dirk, Product Manager of Parenteral and

Business Development, Gerresheimer Plastic Packa-ging, Germany

The packaging components for the new generation of (bio)phar-maceuticals play, in the phase of the development of the drugdelivery, a major role as they have significant influence on thestability and safety of the respective drug formulation usuallylaunched as parenteral solutions. The specific properties of new(bio)pharmaceutical drug formulations have led glass asconventional material for injection vials to its limitations.

The new multilayer vials based on high-performance plasticmaterials are designed to address these requirements like verylow drug-container interaction with the typically sensitive drugsand high barrier properties to protect the reactive drug formu-lations against oxidisation or water vapor. The inertness of theplastic surface and the improved barrier of the multilayer vialsagainst oxygen improves the drug stability over shelf life signi-ficantly. Advantages for the pharma industry are increased efficiency and higher dose accuracy.

For various reasons safety requirements has been forcing thepharmaceutical industry to look for high crack-resistant packa-ging. Here the multilayer vials demonstrate superior resistanceagainst break or crack compared to glass vials. The specificmultilayer design with its inner polyamide layer adds additionalintegrity assurance even when unusual forces are applied tothese type of containers.

Wolfgang Dirk obtained his PhD in chemistry at RWTH Aachen,Germany, working on hydroboron-based cage-structured molecules for cancer treatment. For the following seven yearsWolfgang gained experience in international pharma markets

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and development of generic drugs. From 2006 Wolfgang wor-ked for four years at West Pharmaceutical Services as Mangerfor Technical Support on primary packaging components forparenterals, before he joined Gerresheimer’s Plastic Packagingbusiness unit as Product Manager being in charge of the business development for parenteral packaging.

Impact of Vial Material on Lyophilisation Dr. Claudia Dietrich, Global Product Manager of Vials

& Coating, Schott Forma Vitrum, Switzerland

• Influence of container surface on optical properties of lyophili-sation product

• Lyo cake aesthetics

• Interaction of formulation and vial surface

• Composition of drug formulation in lyophilisation.

After obtaining an M.Sc. in Genetics, a Ph.D. in Biochemistryand a Masters from Vienna Management College, Dr. Dietrichwas employed in positions in R&D, product development, marketing and product management at Biotechnical/ Phar -maceutical/Medical companies. Since September 2007, Dr. Dietrich has been Global Product Manager of Vials & Coatingwith SCHOTT Forma Vitrum AG in Switzerland.

Comparison in Heat Transfer and Other ImportantFeatures for Molded and Tubing Vials

Vincent Langlade, Marketing Director of Pharmaceuti-cals, SGD, France

• Comparison in heat transfer characteristics in the pressurerange of interest for pharmaceutical freeze-drying, i.e. 50-200mTorr

• Bottom geometry changes and its influence

• Measurements with actual products

• Homogeneity in heat transfer of batches in actual freeze dryingarrangements.

From 1991 to 2002, Vincent held several positions includingProduct Development, Quality Assurance and Regulatory Affairsat Stelmi, a supplier of primary packaging for parenteral pro-ducts. He received his Chemical Engineering degree from LyonUniversity (France) in 1989 and his Master of Sciences in Polymers Science and Biotechnology from the PolytechnicSchool of Montreal (Canada) in 1991. As a pharmaceutical primary packaging expert, Vincent is a contributor to ISO TC76committee and delivered numerous papers at PDA, Pharma-pack, ISPE, A3P, PMP and AFI conferences.

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Minimizing the Variation of Volume Withdrawnfrom a Container for Injectable Drug Products and Impactto Overfill / Minimisation de la variation de volume aspiréd'un conteneur de médicaments injectable et Im-pact sur l’overfill

Jessica Saggers, Technical Account Specialist, West-Pharmaceutical Services, USA

• Maintaining a consistent dose of drug product to the patient isa critical aspect of patient safety and therapeutic efficacy

• Innovations in the drug delivery market have provided safetyadministration systems such as a vial adapter, which not onlyprovide the opportunity for needle-free transfer of liquid for reconstitution of lyophilized drug products, but also a meansfor consistent withdrawal of drug product from a vial.

• In order to better understand industry concerns surroundingconsistent dosing, a study was initiated to compare the volumes of liquid withdrawn from a vial using two methods: traditional needle penetration and vial adapter with spike pe-netration.

• Three groups were included in the study: - Experimental – nurses and hemophilia patients without prior

vial adapter experience

- Control – lab analysts with previous vial adapter experience

• Overall, the use of the vial adapter resulted in greater consis-tency for liquid withdrawal than the use of a needle for all experimental groups.

• Le maintien d'une dose cohérente de médicament au patientest un point critique d'efficacité thérapeutique et de sécuritépour le patient

• Les innovations sur le marché de livraison de médicament ontfait apparaitre des dispositifs sécurisés d'administration telsles adaptateurs de flacons, qui permettent non seulement letransfert de liquide pour la reconstitution de médicament lyo-philisés sans l’utilisation d’aiguille, mais aussi le meilleurmoyen pour un retrait d’une dose fiable de produit injectable àpartir d’un flacon.

• Pour mieux comprendre les préoccupations de l’industrie pharmaceutique au sujet d’un dosage cohérent, une étude aété initiée pour comparer les volumes de liquide aspiré d'unflacon en comparant deux méthodes : utilisation d’une aiguilletraditionnelle et utilisation d’un adaptateur de flacon avec per-forateur.

• Trois groupes ont été considérés dans l'étude : - Expérimental - infirmières et patients hémophiles sans

aucune expérience de l’utilisation d’un adaptateur de flacon

- Contrôle - analystes de laboratoire avec expérience de l’uti-lisation d’un adaptateur de flacon

• Au global, et ce pour tous les groupes expérimentaux, l'utilisa-tion de l'adaptateur de flacon a montré une plus grande cohérence en terme de quantité aspirée de médicament injec-table que l'utilisation d'une aiguille.

Jessica Saggers: - B.S. Biology from Ursinus College in Pennsylvania - MBA from Pennsylvania State University - Two years with West Pharmaceutical Services as a Technical

- Account Specialist - Over eight years in the pharmaceutical industry

Anti-Counterfeit Glass Marking Based System onPrimary Packaging for Pharma Products Keeping Qualityand Safety

Paolo Golfetto, R&D Manager, Glass Division, NuovaOmpi, Italy

Safety and anticounterfeiting issues are on the edge due to theincreasing challenge of fake drugs. The stringent quality requi-rements defined by the Pharma industry for glass containersare driving the development of new and complex safety sys-tems. Several technologies have been developed in the lastyears directly involving primary packaging. Ompi has develo-ped, in partnership with a specialised permanent marking company, a specific method allowing a 100% traceability ofproducts keeping the complete integrity of glass surfaces. This paper will illustrate how to set up a functional track andtrace system that completely integrates with the standard process line.

Paolo Golfetto manages all the new products design, testingand development activities starting from the initial customerrequirements to the final industrial product validation, with thecoordination of many experts in glass technology, process engineers and designers. Formerly he was the R&D Managerof the Appliances Engineering Team within a well known world-wide manufacturer of household appliances. During his latestthree years of employment in this position, he was in chargeof the harmonisation team, made of local engineers and des-igners, responsible of moving the company’s production plantsto the Guangdong area, China. As a Member of the EuropeanElectro-technical Commission until 2005, Mr. Golfetto contributed in the development of European Norms and Regu-lations focused on users safety and environmentally friendlyconsumer products.

6.30 END OF DAY 1, EXHIBITION CLOSES

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8.30 WELCOME COFFEE

PACKAGING AND INNO VATION:COMPLIANCE, SECURITY AND SUSTAINABILITY

Dr. Pascale Gauthier, Biopharmaceutical and Pharma-ceutical Technology Department, Faculty of Pharmacy,Clermont-Ferrand, France

Lionel Jeannin, Senior Global Packaging DevelopmentManager, Novartis Consumer Health, Switzerland

OTC Packaging Development in a GlobalContext

Lionel Jeannin, Senior Global Packaging DevelopmentManager, Novartis Consumer Health, Switzerland

Using Design in Pharma Packaging for ImprovingCompliance and Avoiding Overconsumption / Design etmédi caments : des solutions pour améliorer l’observancesans provoquer de surconsommation

Dr. Pascale Gauthier, Biopharmaceutical and Pharma-ceutical Technology Department, Faculty of Pharmacy,Clermont-Ferrand, France

Now design is more and more present in everyday life. It becomes an essential element of drug formulation because themore a drug form is consistent with its route of administration,the more users will comply with their treatments. By this way,the drug could be used correctly by all kind of patients, fromchildren to the elderly. In detail, a drug taken properly thanks toa more adapted design will be more efficient. But, design musthelp, and not prevail to fancy or attractive production which canlead to overconsumption. Drugs are specific products whichobey strict rules. An overview of design solutions in the pharmaceutical field will be prepared within the limits of theethics of medicine.

Le design fait partie intégrante de notre vie quotidienne. Il de-vient désormais un partenaire incontournable de la formulationgalénique en permettant la conception de médicaments en parfaite adéquation avec la voie d’administration et d’emploiplus facile pour les patients. De cette façon, les traitements, tantpour les enfants que pour les séniors, peuvent être aisémentsuivis. In fine, un médicament mieux pris, grâce à un designmieux adapté, sera plus efficace. Mais, si le design doit faciliterla compréhension et l’observance, il ne doit surtout induire lacréation de formes trop fantaisies provoquant une surconsom-mation médicale. Les médicaments restent des produits bienspécifiques, obéissant à une législation très contrôlée. Un panorama des solutions amenées par le design dans le mondepharmaceutique sera proposé dans les limites des règles del’éthique régissant l’univers des médicaments.

Dr. Pascale Gauthier, Biopharmacy & Pharmaceutical Techno-logy Department, Faculty of Pharmacy, France.

Pascale Gauthier graduated as a Pharmacist in the Faculty ofPharmacy of Clermont-Ferrand in 1989 and continued in research work (master of Biopharmacy in 1990) on "new gelification method for vegetable oils" followed in 1991 by aSpecific Master (DEA) in Pharmacokinetics "Pharmacokinetic

study of antihypertensive drug and its metabolites after singleand repeated dose". Then she worked in the BiopharmaceuticsDepartment of Clermont-Ferrand (Pr Aiache) on industrial research on multiparticulate dosage forms and in 1995 obtai-ned a PhD in Pharmaceutical Technology on "rotogranulationprocesses used for the manufacture of spheres". She was involded in several patents, international publications andconferences. She is a member of PharmaDesign, the associa-tion for the promotion of Design in Pharmaceutical Area. Togetherwith designers, the PharmaDesign team centred their effortson several categories of users and especially on elderly peopleand children. Since 1996 she is an associated Pharmacist in aPharmacy and in charge of Marketing and Design courses inthe Faculty of Pharmacy of Clermont-Ferrand.

Child Resistance and Senior Friendliness: “Pan-doras Box for the Packaging Industry” / Sécurité enfantet ouverture “senior friendly” : la boite de Pan-dore pour le secteur de l'emballage

Glenn Svedberg, Managing Director, Nolato Cerbo AB,Sweden

Twenty percent of Europe’s inhabitants have limited dexterityand the percentage is increasing with the demographic deve-lopment resulting in a higher average age. An internationalstandard is in progress for determining whether a package is“easy-to-open” or not. At the same time still few countries havea legislation enforcing child resistance (CR), but we believe itis not a question about if but instead when it will be implemen-ted in a more strict way in the EU. Is it possible to combine childresistance with senior friendliness?

• What factors for opening a package are important for personswith limited dexterity and what does this mean for child resis-tance?

• Results from some comparative tests

• Different solutions. Vingt pourcent des européens ont une dextérité limitée et la

proportion est en constante progression due à l'accroissementdémographique des populations âgées. Un standard internatio-nal est en cours afin de déterminer si un emballage est "facileà ouvrir" ou pas. Dans un même temps, seulement quelquespays ont une législation imposant les ouvertures sécurités enfants. Mais, pour nous, la question n’est pas de savoir si celapourrait être généralisé de façon plus stricte au sein de l’Europemais plutôt quand cela devrai arriver. Est il possible de combinersécurité enfant et ouverture sénior facile ?

• Quels sont les facteurs importants d'ouverture pour les per-sonnes à dextérité limitée et quelles sont les interférences avecla sécurité enfant ?

• Résultat de tests comparatifs

• Propositions de diverses solutions.

Glenn holds a M.Sc degree in Industrial Engineering & Mana-gement. He has worked in manufacturing companies for 20years, in positions covering purchasing, marketing, business de-velopment and factory management. He is currently responsiblefor the pharmaceutical packaging business at Nolato Medical.Before joining Nolato Medical in 2007, Glenn worked at Rexam,later on Polimoon/Promens where he was responsible for the“Food Nordic” division, with one site in Sweden and another onein Denmark.

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Key Packaging Drivers to Enhance Compliance? Sue Rockhill, Business Development director,

Burgopak, UK

Sue has many years experience in the ConsumerHealthcare & pharmaceutical industry. At Alliance Boots she wasCommercial director as well as developing global business withHealthcare Companies.

She joined Burgopak developing their innovative packaging intothe Healthcare sector in 2009.

Moisture, Oxygen & Shelf life: Keys to PackagingPerformance / Protection contre l’humidité et l’oxygène :Les clés d’un packaging performant

Valère Logel, Development Manager, Süd-Chemie Per-formance Packaging, France

Drug performance is linked to interactions with thepackage environment and the control of their effects over time.Shelf life is not an absolute number. It depends not only on formulation properties and climactic conditions, but also on theselected package design.

Many packaging solutions exist to fulfil product requirementsand marketing goals. Design and functionality can be combinedwith several forms of protection, such as protection againstmoisture, oxygen, UV and breakage, etc.

La performance d’un médicament est sujette aux interactionsavec l’environnement et à la maitrise de leurs effets dans letemps. La durée de protection d’un produit n’est pas une valeurabsolue, elle dépend principalement de ses propriétés, desconditions extérieures mais également du packaging retenu.

De nombreuses solutions de packaging existent pour répondreaux contraintes du produit comme aux attentes du Marketing.Au design et à la fonctionnalité peuvent s’associer plusieursformes de protection : Protection contre l’humidité et protectioncontre l’oxygène mais aussi protection contre la lumière, lesodeurs, les chocs…

With a master degree in Polymer Engineering, Valère Logel hasbeen Head of Development within Süd-Chemie’s PerformancePackaging division since 2005.

An expert in product design and engineering, he has leaded theintroduction on the market of innovative packaging solutions inmoisture control, oxygen absorption and multi-layer polymerbarriers.

Transparent Push-Through Lidding Foil for Phar-maceutical Blisters

Michiel van den Berg, Global Pharmaceutical PackagingDevelopment, Tekni-Plex, Belgium

• Lidding foil technical performance requirements

• Current lidding foil technologies

• Sealing properties and sealing methods of lidding foils on pharmaceutical blister packs

• Push-trough feature of lidding foils

• Aluminium or Polymer based lidding foil comparison: barrierproperties

• A new plastic transparent lidding foil with push-through capability

• Polymer composition and key properties.

After finishing his education in Electro Mechanical Engineeringand Material Sciences, Michiel van den Berg started his professional career in the European Packaging Developmentteam of Procter & Gamble in 1991. In 1995, he left the world offast-moving consumer goods for a role in pharmaceuticalpackaging with Eli Lilly and Company as a Packaging Engineerand later as manager of the Global Packaging Technology andDevelopment group. In 2001, he became director of Global Phar-maceutical Packaging Development at Tekni-Plex. and has global responsibility for pharmaceutical and medical packagingdevelopment.


Tamper Evidence* With Additional Security

Dr. Markus Staub, CEO, Rondo AG, Switzerland

The counterfeiting of pharmaceutical products is a multi-billiondollar industry. In previous years it was mainly a problem ofdeveloping countries, but in recent years the industry has alsothrived in industrialised nations such as the US and in the EU.

Due to this, the security of pharmaceutical products is beco-ming more and more important. Especially the security of thesecondary packaging is very important, because a safepackage helps to increase the security of the product.

The presentation will show the new developments in packageprotection, especially a new and very cost-effective tamper-evident solution.

*Patent pending

Dr. Markus Staub, Doctor in chemistry, studied in Winterthurand Basle and did his dissertation at the Polytechnical FederalSchool (ETH) of Zürich. After that, he assumed various positionsat the experimental sector in the project administration and waspromoted to Head of a Pharmaceutical Production. Since 1999,Dr. Staub has been CEO of Rondo AG in Allschwil (Switzerland)as well as their subsidiaries Rondo Obaly s.r.o., Pilsen (CzechRepublic) and Rondo-Pak Inc. (USA).

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Traceability and Authentication for Drug Packa-ging / La traçabilité et l’authentification des produitspharmaceutiques

Eric Dardaine, International Project Manager, ATT Advanced Track & Trace, France

This lecture will point out the real necessity for security all alongthe product life cycle from the providers’ materials to the pointsof retail and the end user (patient or physician).

The way a secure traceability system is implemented will bedetailed.

• Difference between Identification and Authentication?

• How both concepts are closely cross-dependent?

• What has been learnt from the deployments of the new requi-rements on serialisation of pharmaceutical products?

• What about the controls on the field?

• Is Serialisation a patient safety guarantee?

• Authentication and Serialisation: The basis of patient and supplychain security

• New applications: Patient Relation Management.

Without any pace change, primary and secondary packagingcomponents are becoming autonomous multi-function supportsfor many consumer products. The pharmaceutical industry isvery concerned and is then able to fight efficiently againstcounterfeiting, to monitor its distribution networks and to initiate patient relation management using ATT solutions.

Lors de cette conférence nous soulignerons la nécessité absolue de sécurité tout au long du cycle de vie du produit,des composants fournisseurs jusqu’au point de vente et à l’uti-lisateur final (patient ou médecin).

Nous détaillerons l’implémentation d’un système de traçabilitésécurisée.

• Différence entre Identification et Authentification

• Quelle est l’importance de la relation entre ces deux concepts ?

• Le retour d’expérience des déploiements des nouvelles régle-mentations sur la sérialisation des produits pharmaceutiques

• Qu’en est-il des vérifications sur le terrain ?

• La sérialisation constitue-t-elle la garantie de la sécurité patient ?

• Authentification et Sérialisation : les fondements de la sécuritédu patient et de la chaine d’approvisionnement

• De nouvelle applications : La Gestion de la Relation Patient.

Sans changer les cadences de production, les composantspackaging primaires et secondaires deviennent les supportsmultifonction autonome de nombreux produits de consom -mation. L’industrie pharmaceutique est très impliquée et peutlutter efficacement contre la contrefaçon, assurer la surveil-lance de ses réseaux de distribution et impliquer le consom-mateur en utilisant les solutions ATT.

Eric Dardaine, an ISG graduate, is an expert in secure informa-tion systems. For the past 6 years, he has been managing security and traceability projects in the pharmaceutical industryfor ATT. Prior to this, he was Managing Director of RPM GroupS.A., specialising in information systems.

Managing a Worldwide Anti-Counterfeiting Pro-gram Using an Internet Web Application / Une applicationWeb Internet pour le management global de la lutte contreles contrefaçons

Dr. Martin Kutter, co-founder, President, AlpVision,Switzerland

An anti-counterfeiting program does not consist of just selec-ting security features or anti-counterfeiting technologies; themost important part of the project is the worldwide deploymentof a security solution which will be integrated into the Manu-facturing Execution System (MES) and which has to complywith to the various government regulations, such as FDA CFR21 Part 11 for the medicines sold in the US.

The presentation will describe the essential steps of an anti-counterfeiting project that enables the brand owner to generateand manage the various security features and have them pro-duced with regard to the “genuine-or-fake” verification process.

Examples will be given on how the management of the anti-counterfeiting program will allocate specific security featuresto various product items, production batches and productionlocations, and how subcontractors such as packaging des-igners, printers and converters will interact with the productsecurity Internet Web application.

The presentation will also show how a single computerisedsystem, located in a highly secure environment to protect thebrand owner against leaks, can cope with a decentralised industrial organisation, having manufacturing facilities of dif-ferent brands in different markets.

Un projet de lutte contre les contrefaçons ne se réduit pas à laseule sélection d’une technologie anti-contrefaçon ou d’un

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élément de sécurité; la partie la plus importante du projet com-prend le déploiement mondial de la solution, qui doit être inté-grée dans les processus de fabrication (MES). La solution doitégalement être conforme aux diverses ordonnances et régle-mentations gouvernementales en vigueur dans le domaine desmédicaments, telle que FDA CFR Part 11 pour les médicamentsvendus aux USA.

La présentation décrit les étapes essentielles d’un projet delutte contre les contrefaçons qui permet au fabriquant des produits de marque de créer et de gérer les divers élémentsde sécurité, en prenant en compte les processus de vérification“vrai ou contrefait” qui seront déployés.

Des exemples sont donnés, montrant comment l’applicationWeb Internet permet l’allocation des éléments de sécurité spé-cifiques à chaque produit ou lot de fabrication, ou même enfonction des lieux de production. La manière dont les différentssous-traitants (designer d’emballages, imprimeurs et transfor-mateurs d’emballages) interagissent avec l’application Web Internet est également décrite.

La présentation démontre enfin comment une seule applicationinformatique centralisée dans un lieu hautement protégé et sécurisé est parfaitement compatible avec une organisation industrielle décentralisée, comprenant de nombreuses mar -ques avec de multiples centres de production dans de nom-breux marchés

Dr. Martin Kutter is a co-founder of AlpVision and today servesas President and Chairman of the Board. He holds a PhD degreefrom the “Ecole Polytechnique Fédérale de Lausanne (EPFL)”,and an MS degree from the University of Rhode Island, Kingston,USA. He is the co-inventor of Cryptoglyph and Fingerprint, thecore technologies currently being used by AlpVision.

Sustainability in Medical and PharmaceuticalDevice

Peter Wallrabe, CEO, Item GmbH, medical device design

• Overview of sustainability in medical and pharmaceutical tech-nology

• Determining factors for the shift in trend

• Market trend from multi-use to single-use products

• Examples of multi-use devices that have been replaced by single-use products in the field of pharmaceutical devices/drugdelivery

• Validation of the trend with appropriate reasons

• Key players

• Opportunities to optimise the sustainability in the field of me-dical devices.

Peter Wallrabe started his career with the study of industrialdesign and graduated with an excellent diploma. Additionally tohis interest in design, he studied mechanical engineering. Afterbeing Director of the German subsidiary WeLL Industrial DesignGmbH, a product design and development enterprise headqua-tered in Amsterdam, he was nominated Partner of WeLL DesignAssociates BV, Amsterdam. Since 2006, he has been managingowner of the item GmbH medical device design, service providerin medical technology and the Co-Founder of DocNology UG, acompany specialized in innovative medical devices.

12.15 LUNCH AND NETWORKING WHILST VISITING THE EXHIBITION

DRUG DELIVERY DEVICE TECHNO -LOGIES: REVIEW, TRENDS AND INNOVATION

René Bommer, PharmaAccel Consulting, Germany

Chair’s Opening

Regulatory Requirements for BiocompatibilityTesting of Drug Delivery Devices

Dr. Piet Christiaens, Scientific Director, Toxikon EuropeNV, Belgium

• Classification of a Drug Delivery Device: Is the product a Drugor a Device?

• General Considerations regarding Biocompatibility testing

• Typical Biocompatibility Tests to be considered

• Testing/Documentation requirements for the submission of aMedical Device

• Testing/Documentation requirements for the submission of aMedicinal Product/Pharmaceutical Container.

Piet Christiaens received his Ph.D. from the Analytical Che-mistry Department of the University of Leuven (Belgium) in1991. From 1992 to 1997, he was Lab Manager in two AnalyticalContract Laboratories.

From 1997 to 2000, he worked as an independent consultantwith Shell Chemical Company in Houston, TX (US) where heconducted research on a new hydrogenation catalyst systemfor Hydrogenated Triblock Co-polymers (Kraton Polymers).

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From 2001 onwards, Mr. Christiaens holds the position of Scien-tific Director at Toxikon Europe where he develops analyticalmethods and protocols for both extractables and leachables stu-dies for the Medical and Pharmaceutical Industries. Mr. Chris-tiaens oversees all laboratory operations at Toxikon Europe andis also giving support to the European business development.

Existing and Emerging Technologies/Markets forNasal, Pulmonary & Ophthalmic Drug Delivery Devices /Les marchés et technologies existants et futurs dans ledomaine des médicaments pour les voies nasale, pulmo-naire et ophtalmique

Gerallt Williams, Scientific Affair Director, AptarPharma Prescription, Germany

This talk will review existing drug delivery devices with parti-cular focus on the nasal, pulmonary and opthalmic areas, looking at some successfully commercialised products. The dynamics of the pharmaceutical market are evolving quicklydriven by factors such as the introduction of new drugs and akeen focus on health care costs including the ever-increasinggeneric market. Other drivers changing this marketplace areevolving regulatory standards, the fast-growing emerging market sector and the need to prolong market shares of drugscoming off patent in the near future with differentiation and lifemanagement strategies. This talk will also review how all theabove factors are currently driving emerging device technolo-gies in these drug delivery areas.

Le marché pharmaceutique évolue rapidement en raison defacteurs tels que l'introduction de nouveaux médicaments, la maîtrise des dépenses de santé y compris la dynamique dumarché des médicaments génériques, l'évolution des normesréglementaires, la croissance des marchés émergents et lagestion du cycle de vie des médicaments dont les brevets arrivent à échéance.

Cette présentation traitera des dispositifs d’administration demédicaments existants pour les voies nasales, pulmonaires etophtalmiques y compris des exemples de produits commer-cialisés, ainsi que l’impact des facteurs cités sur le dévelop-pement et la commercialisation de nouvelles technologies.

After obtaining his Ph.D. from the University of Wales in 1985,Gerallt Williams has held various industrial positions at Monsanto Inc. (UK), Fisons Ltd (UK), Valois (France) and NektarTherapeutics (USA). He is now in charge of scientific affairsAptar Pharma Prescription Division, Le Vaudreuil, France andis engaged in the development of new devices for nasal andinhaled drug products.

Improving nasal delivery Patrice Lewko, Global Marketing Director, Rexam

Healthcare, France

User independance, preservative free features, better consis-tency and compatibility, protection of formulations: new gene-ration sprays will improve compliance and safety for the benefitof patients. We will focus on key features for a nasal deliverydevice.

A New Disposable Delivery Device Platform forthe Administration of Liquid Medication

René Bommer, Founder, PharmAccel, Germany

Today’s drug delivery device market offers a wide selection of dispensing systems for various different applica-tions. In general, delivery devices can be classified into disposable unitdose systems and into multidose systems for frequent drug administration. Disposable unitdose systemsoffer the advantage of the application of sterile and unpreser-ved drug products. The ready-to-use feature and the ease ofuse are further steps to an increased patient compliance. Without doubt the cost per dose plays a crucial role in the decision-making process. A new delivery device platform par-ticularly dedicated for nasal, oral/sublingual or dental adminis-tration allows being an attractive alternative for new drugs andas well for added-value generic products. The device techno-logy is suitable for the application of aerosol and non-aerosoldrugs and combines patient’s safety and compliance aspectswith today’s economical expectations.

Dr. René Bommer is founder and owner of PharmAccel Consul-ting. He received his Ph.D. in Chemistry from the University ofConstance in Germany. After research positions at the ScrippsClinic in San Diego, USA, at Altana Pharma Germany (now Nycomed) and a lectureship at the University of Buenos Aireshe joined the device developing and manufacturing companyIng. Erich Pfeiffer GmbH in Germany and became Director Bu-siness Development. In 2007 he founded his own consultingcompany focusing on delivery devices and its relevant activities.

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Packaging Considerations for Dry Powder Inha-lation

Peter Claessens, R&D Product Development Manager,Amcor Flexibles, Singen, Germany

• Dry Powder Inhalation types

• Protection of the powder in various formats (capsule/bulk),packaging performance as part of the device

• Excellent seal ability between base and lid foil high flexibility orhigh stiffness of the blister materials

• Peelable or tight seal strong or easy pierceable foil lid. Releaseof the dose from the inner product contact material.

Inhalation projects are complex in nature and require the highestlevel of co-operation among all partners: the pharmaceuticalcompany, the machine manufacturing company, and the packagingmaterial supplier. The expertise of all involved parties and theuse of development tools like simulation programs for cold for-ming of blister, moisture diffusion through sealing layers andextractable know how is key in assuring the success of a com-pany’s inhalation project. It is therefore advisable to organize adetailed exchange of information in the earliest possible stageof the development.

Sandra Luciano is the Global Product Manager for Amcor’s lineof “Aluminum Free” thermoformable products such as Polybar®

Aclar® and COC. She has been involved in pharmaceutical and medical device packaging for over twenty years and hasbeen on the Board of Directors for the Healthcare CompliancePackaging Council in the U.S. for fifteen years.

Peter Claessens is a chemical engineer and has over 20 yearsof experience in packaging development. As an R&D ProductDevelopment Manager with Amcor since 18 years, he has beenmainly concentrating on inhalation projects as well as Child Resistant and Senior Friendly solutions for blister packs.

Plasma Coating - Meeting the HFA Challenge, the Latest in Can Technology Richard Turner, Pharmaceutical Business Develop-

ment Director, Presspart Manufacturing, UK

Internal surface interactions play an important role in shelf lifeand stability of many drug formulations delivered by pMDI’s.Whether solution drugs or suspension, plasma coatings are nowavailable for prevention of suspension particulates binding tocan/component walls or catalytic degradation from, for example,metal oxides with solution formulations. Presspart will presenta new scaled-up sub-micron plasma process for coating the internal surfaces of pMDI cans with resulting exceptional per-formance.

Mr Richard Turner has spent the past nine years with PresspartManufacturing Ltd, part of the Heitkamp and Thumann Group,currently as the Pharmaceutical Business Development Director.Prior to joining Presspart, Mr Turner held positions with Steritechand the AptarGroup in both a commercial and technical capacity.Mr Turner originally trained as an accountant. In 1996, he received his business and science honours degree from the University of Bristol, with additional emphasis in biomedical instrumentation.

4.30 END OF DAY 2, EXHIBITION CLOSES

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PH2011 Pogamme EXE - 20/11/10 15:47 Pagea2 24 Pharmapack ·

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