Today’s drug delivery device market offers a wide selection of dispensing systems for various different applications. In general delivery devices can be classified into disposable unitdose systems and into multidose system for frequent drug administration. Disposable unitdose systems offer the advantage of the application of sterile and unpreserved drug products.
The ready to use feature and the ease of use 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 particularly dedicated for nasal, oral/sublingual or dental administration allows being an attractive alternative for new drugs and as well for added-value generic products.
The device technology is suitable for the application of aerosol and non-aerosol drugs and combines patient’s safety and compliance aspects with today’s economical expectations. 

Packaging systems are a critical component in the development cycle of a pharmaceutical product. The materials used in the production of the packaging systems consist of a variety of elastomers, plastics, and metals. Components from all of these packaging materials have the potential to leach into the drug product throughout the storage life of the product. Extraction studies are performed to determine the nature and quantity of extractable components.
Many of the observed extractable components are easily identified, such as anti-oxidants and curing agents. However there are generally many unknown components observed during extraction studies. Determining the risk presented by these unknowns can present a significant challenge. A systematic application of a variety of analytical techniques may be employed in investigating and identifying these unknown extractables in order to assess and mitigate those risks.

Paul G. CUMMINGS is Laboratory Operations Manager, Analytical Services for West Pharmaceutical Services, Inc. He joined West in August 2009 as a Principal Chemist in Analytical Services. His primary responsibilities included identification of unknowns in extractable and leachable studies. He was promoted to his current position of Manager in June 2011.

Prior to joining West, Mr. Cummings had been a quality control analyst with Merck from 1982 through 1986. From there he went to SmithKline Beckman Pharmaceuticals as an Analytical Chemist in the separations group until 1989. In May of 1989 he was promoted to Senior Analytical Chemist in the spectroscopy group as a mass spectrometrist. In May of 1995 he was promoted to Associate Senior Investigator. In September of 2001 he was promoted to Manager of the mass spectrometry group. In May of 2002 he was promoted to Manager of the Pilot Plant Analytical Support Team. His experience in the identification of unknowns in small molecule pharmaceuticals has been a significant asset to West in their extractable/leachable analysis group. He works closely with West customers on their extractable/leachable inquiries as well as with West R&D in the development of the next generation of container closures and pharmaceutical packaging systems. Mr. Cummings holds a Bachelor’s Degree in Chemistry from Old Dominion University and a Masters degree in Chemistry from Villanova University. 

Related regulatory background, requirements on container components: 

•  Milestones of Assessment
•  Inadequateness in Theory and Practices 

The drug market is tending to offer better designed products. Obviously, a product better suited to the user will be better employed and hence more effective. Dispensing systems that combine technology and efficacy can enhance safety: accurate, reproducible doses in addition to totally safe formula preservation. Formulations can even be changed, eliminating or considerably reducing preservatives.
These systems, which are developing apace, thus give manufacturers greater freedom. However, the pharmaceutical world is bound by strict rules in the drafting and delivery of licences; precise specifications are thus required during the development phase. Technological advances will be discussed in light of these specifications, together with future prospects for new dosage forms.

•  Sound design and its creative procedure in industry
•  Can one change the acoustic signature of an aerosol or dispensing system, identify one’s brand or function through sound?
•  What methodology and potential cost ?

Ludovic GERMAIN graduated from ENSCI-Les Ateliers Paris (École Nationale Supérieure de Création Industrielle). When designing novel objects in terms of form and function, he decided to design/invent their sounds. He thus became a sound designer and founded LAPS Agency in 2000, specialised in sound design and psycho-acoustics (sound perception) and mainly dedicated to manufactured goods. He also teaches at the Esba-talm sound design Masters course.  

An exploration of the complexities of developing and evaluating safe powder and particle based systems. Regulation changes, test method inconsistencies and technical requirements of multinational customers add significant complication to the aerosol formulator’s task. This is an exploration of some of those challenges to shed a light on the work needed by smaller organisations to meet the growing expectations in the market.

Adrian is the technical manager at Swallowfield plc. Joining the industry shortly after graduation and starting with Ambersil (CRC) he started working with the HCFC phase out in the last few industrial applications and gained experience in a variety of aerosol systems. Since joining Swallowfield in 1996 he has worked with a wide range of formulations and aerosol technologies in areas as diverse as foods, personal care and industrial maintenance products and has worked on projects for both small local brands and major multinationals. 

Today, aerosol cans are made via two different routes:

a) bend a sheet of steel to form a cylinder, weld it and add the top and the bottom via seaming,
b) extrude a piece of Aluminum to directly form a monobloc can without any welds or seams.

The second method obviously has less joints which is generally regarded beneficial to meet the required container performance. Further on the monobloc can is the preferred option for personal care products, also due to marketing requirements. Current monobloc cans require virgin Aluminum and some significant amount of this material.
Mall+Herlan has developed a method to produce monobloc cans with about 30% material savings via the DWI process. This process uses standard Aluminum coil material available all over the world. The material savings subsequently result in some lower cost of container and, maybe more important, result in a can made from recycled material. We will give some insight in the potential application of the DWI process for aerosols and the limits of the use of the process for the aerosol industry.   

More than 12 billion aerosol cans are produced around the world every year. Due to rising raw material and energy costs, manufacturers are keenly interested in ways to optimize their use of materials and production processes. The issue of sustainability is also becoming increasingly important for can manufacturers and has increased the pressure to innovate.
Schuler’s ICON V-Drive is a new bodymaker which is able to form cans vertically. The process adapts the draw and wall-ironing method already used in beverage can production to the needs of aerosol can manufacturing. The ICON promises to meet two key requirements of aerosol can manufacturers and form a bridge between efficiency and sustainability: the change to a disc-to-can process with aluminium alloy material significantly reduces material consumption and the use of a vertical draw and wall-ironing process guarantees superior quality even when using recyclable materials.
The newpress was presented at the METPACK exhibition in Germany May 2011and the first machine will be installed at the plant of German aerosol manufacturer Tubex.

Michael MARSCHALL is Sales Director of the Packaging Division at Schuler and in charge of sales for canmaking systems worldwide. Before he was international sales manager at a German technology company for several years. He started as a development engineer at Robert Bosch GmbH.   

Sleeve is an innovative response to market expectation in terms of finishing and shaped aluminium aerosol decoration:

•  Complex shapes
•  Special effects: metal, mat, opalescent, etc.
•  3D surface finish: textiles metals, wood, etc.
•  Optimisation of the logistics chain

Sleever International is the world specialist of shrink sleeve decoration in the perfume and cosmetic markets with ranges of targeted products and tailor made solutions: decorating solutions for advanced shapes, new pallet of colors, new surface effects and late differentiation, etc. Discover the Solution Sleever Aerosol!   

“This year, we practically doubled the number of participants in the various workshops, and at the workshop I moderated, participants came from all around Europe. It is extremely worthwhile to concentrate so much expertise and collective intelligence over a two-day period in the same place. These “Innovation” workshops create new horizons and avenues for the future of our profession.” 

•  Which techniques for which applications
•  The place of aerosol and complementarities, possibilities for hybridization
•  Prospects  

• Fields of application
• Production
• Prospects  

• Ergonomics
• Trigger systems for aerosols: what are the advantages
• Refills – Safety

Xavier Camidebach, Precision - Aerosol Forum 2011 “This is the second year I have chaired a Workshop and it is an excellent initiative that provides for an exchange of ideas during a very short period of time. Working in a group brings together different skills and paves the way for joint projects.”   

Plastic material is widely used in packaging of food contact material. Since the early 80’s it is well known that substances are able to migrate from packaging into the packed food. Several arrangements have been taken to regulate the kind and amount of migrating substances in the EC. An overview about the legislation for packaging in contact with food stuffs will be given.

In the last years more and more reports of unwanted chemicals in food made consumers unsure. The chemical similarity of some cosmetics and food cannot be denied. For this reason the migration of unwanted substances from packaging into cosmetics is also possible. Chemicals which particular attract public attention, e.g. phthalates, bisphenol A are in focus. Especially in Germany, consumer magazines which denounce contaminants in consumer products periodical have a high priority. Manufacturers of cosmetic products can protect themselves, by using plastic packaging materials for cosmetics, which are allowed for food contact in the production.

Dr. Nadine PAUL is a Food chemist who graduated from Dresden Technical University, Germany, in 2003. In 2004, he passed his state examination. From 2005 to 2010, he worked on a PhD thesis on the food packaging migration into food and developed chromatographic and spectroscopic methods for the determination of migrating substances. He has been project manager for consumer products at SGS Institut Fresenius GmbH since 2009.

Powder coatings will be presented as a new and innovative route for internal coatings of aerosol cans and tubes. Powder coatings offer manifold advantages compared to the traditionally used solvent based epoxy coatings. Obviously there is no emission of VOCs during the whole powder coating process and no incineration systems are required for pollution control. Due to that fact powder coatings lower the CO foot print of internal coatings and there is potential to save thousands of tons CO emission beside on saving investment cost and space in the manufacturing environment.

Quality criteria for powders and the resulting coatings will be discussed. Excellent chemical resistance combined with high film elasticity and full compliance to legal regulations can be achieved with the latest powder coating generation. An outlook will be given on new developments in the powder coating chemistry such as BPA free systems or replacement products for PAM coatings.

Dr. Thomas SCHMIDT has been Global R&D and New Business Development Manager at TIGER Coatings in Wels/ Austria since 2002. In 2001, he was R&D Manager at TIGER Coatings in Toronto, Canada; from 1999 to 2001, Health, Safety and Environment Manager at Adidas-Salomon in Guangzhou, China.
In 1998-1999, he did a Postdoc at the University of Durham, UK, researching thin film photovoltaic solar cells. From 1995 to1998, he was a scientist and PhD student at Fraunhofer Institute für Silicatforschung ISC in Würzburg, Germany, in Nanotechnology and Material Science. He obtained his Chemistry Diploma in Nanotechnology and Material Science from the University of Würzburg, Germany, in 1994.

Jan’s lecture will focus on Niche and Technical Applications for Aerosols, exploring the present and future opportunities in these fields. The benefits of the aerosol are unique and allow us to explore many new applications, as global trends develop consumers’ lifestyles and needs evolve.

There are many challenges facing the aerosol industry and collectively we need to consider which new applications and products will provide new, exciting and sustainable products for the future. The presentation will include overviews on:

• Successful aerosol niches today
• Unique benefits of the aerosol
• New niches and untapped technical applications
• Aerosol applications of the future

German born Dr Jan BAUMEISTER graduated from Konstanz University in 1997, and went on to complete his Doctorate in Chemistry from the University of Basel, Switzerland. Jan is an experienced Product Development Manager, with in depth knowledge of formulation development, manufacturing processes and patent management. He worked for Procter and Gamble for 6 years, developing hair care formulations and applications, before going on to be a Senior Consultant in R&D outsourcing and third party manufacturing. Jan joined Colep in June 2011, as Corporate Product Development Manager, based in Laupheim, in southern Germany. 

• Perspective on aesthetics and comfort trends in the aerosol industry and future outlook
• Expertise in ergonomics, force to actuate and the importance of spray patterns
• Research in the role of trigger-actuated aerosols in the consumer experience
• Creation of brand impressions through packaging, including trigger actuated aerosols

MWV Home & Garden has been working in the aerosol space for about ten years, and in that time, MWV has driven several factors that differentiate its aerosol products from competitors.

It’s critical to understand what a customer needs to differentiate its product on the shelf from its competitors.For example, MWV worked with one long-standingclient to develop custom aerosol actuators, such as a trigger actuated aerosol cap, for low pressure propellant applications. Revolutionary and ergonomic, these exclusive aerosol solutions set this consumer products company’s products apart in the marketplace.

MWV understands its customers’ consumers and provides innovative solutions to meet their desire for better, more efficient and more powerful dispensing systems -- all while protecting the brand’s reputation with high quality sprayers that work every single time. Our research has shown that trigger failure can lead to brand abandonment, so for customers, it’s of the utmost importance to have a sprayer that works every time.

From aerosol actuators that revolutionize markets to sustained duration sprayers that reduce finger and hand fatigue, MWV is behind many innovative products found in millions of consumers’ homes today. Packaging shouldn’t force customers choose between triggers that work and a offering positive consumer experience. The best solutions optimize both.

Luis MONDRAGON is MWV’s global director of new business development for Home and Garden. Mr. Mondragon began his career with the company (known as Calmar at the time) in 1999. He has held sales and marketing manager roles across different regions at MWV, including Latin America based in Mexico and Asia Pacific based in China, before moving to the U.S. where he was named to his current role in 2008.
MWV is a leader in global consumer packaging and offers superior end-to-end capabilities and the most advanced customized sprayers available for the home and garden market. With a deep understanding of consumer insights and trends related to packaging and purchasing behaviors, Mr. Mondragon helps bring innovative solutions to market to support well-known brands around the world. 

• CSV valves (Counter Sink Valve)
• New Design Guns NDG
• Combi – Adapter (patent pending): gun – straw and combi
• Fast filling PU BoV

Philip studied « Business Administration » at Hamburg University. His thesis analysed the benefits of Truspray technology for consumers. In 2008, he joined the Lindal Marketing Team. 

Flair® is an airless bag-in-bottle technology which can dispense fluids in any manner - from viscous liquids to mistlike sprays. Flair® is useful for packaging and dispensing liquids, high-viscosity products, soft food and a variety of other products that are susceptible to oxygen degradation or liquids that are difficult to dispense with existing systems. The principle of Flair® is a container within a container, with the liquid being held in the inner container. A device is used to create either overpressure (by introducing air into the space between the inner and the outer containers) or underpressure (by pumping the liquid).

Flair® is relative simple and low-risk to produce as it builds on existing production techniques and supply chains. The production of the double-layered Flair®preform requires special production equipment. The Flair® preform is blowmolded into a bottle using standard blow-molding machinery. The bottle can be filled and capped on standard filling lines. Based on the Flair® principle, Flairosol consists of a dispensing head and an all-plastic Flair® container. The system works by separating a small, metered amount of the liquid and bringing it under pressure, releasing a consistent mist-like spray. Flairosol bridges the gap between trigger sprayers and aerosol cans - combining the metered dosages of trigger sprayers with the fine spray of aerosols.

Dennis STEVENS was appointed Commercial Director for Afa Dispensing Group (Afa) on joining the company in November 2008. His responsibilities include driving the market introduction of the Flair® technology platform and business development.
Dennis has extensive experience in product marketing and business management. Prior to joining Afa he spent six years in managerial roles with the BeerTender® business of Heineken International in Amsterdam, where his achievements included the product and marketing strategy for Heineken’s BeerTender™ proposition and rolling out the concept in the 15 most important Heineken markets. Dennis’ previous appointments include: Marketing Director for Motorola PCS; Marketing Manager for Philips France S.A. Division Appareils Domestiques; and Product Manager at Philips Domestic Appliances and Personal Care B.V.
Dennis holds a Business Economics degree from the University of Amsterdam. He is a native Dutch speaker, and fluent in English and French. Born in 1968, Dennis is married with two daughters.