Conference on Pre-filled Syringes Americas(Workshop Only)

URL: http://www.bharatbook.com/detail.asp?id=129730&rt=Conference-on-Pre-fill...

Pre-filled Syringes Americas
Realising high performance through innovation in injection devices and parental packaging system
12th - 14th April 2010, Philadelphia, USA

Background Info

Key Speakers
Shawn Kinney, President, Hyaluron Contract Manufacturing
Stefan Sundström, Director, Sterile Aseptic Manufacturing, Engineering and Maintenance, AstraZeneca
Horst Koller, Manager Scientific Advisory, Schott
Arno Fries, Head of Sales USA Syringes, Gerresheimer
Claudia Petersen, Director, Gerresheimer
Tibor Hlobik, Associate Director, PFS Technologies , West Pharma
Renaud Janssen, Technical Support Director, Helvoet Pharma
Matthias Poslovski, Director Technical Sales, Optima Group Pharma
Jim Spolyar, Sales and Technical Director, Skan US
Sterling Kline, Director of Project Development, Integrated Project Services

Services

Pre-filled syringes and injection devices are now regarded as the delivery method of choice for a wide range of parental products. According to industry research, the current market for pre-filled syringes is expected to reach 2.5 billion units by 2010. The growth rate is to be expected to remain at a high level of more than 10% annually due to a number of factors such as greater medication safety and increased convenience from using a pre-fillable device. However, there are some challenges and potential threats to syringe and needle supply manufacturers.

Proud to present Pre-filled Syringes Americas, which will be held in Philadelphia USA on 12-14 April 2010.This conference will feature keynote addresses, presentations, case studies and interactive discussions from development to manufacturing, quality control, supplier issues, regulation and inspection, handling and use of devices. Please be sure to register your participation amongst the industry's elite for this intensive two-day of learning, networking and exploiting business opportunities.

By attending this conference, you will:
• Understand today's market, how it has evolved and what to expect in the future
• Hear about pre-filled syringes for biotech products and auto injector devices
• Understand pre-filled syringe processing with RABS, Isolators, E-beam & Alternatives
• Examine factors and recent developments in processing syringe nests
• Analyse elastometric pre-fillable syringe component
• Evaluate the impact of economic, technology, and regulatory factors
• Develop new strategies to remain competitive
• See manufacturers showcase some of their products

Who should attend:

Vice/Presidents, Directors, Heads of:
• Packaging
• Labelling
• Manufacturing
• Product design
• Technical support
• Drug product process development
• Drug device process development
• Pharmaceutical sciences
• Safe medication practice
• Drug discovery & delivery
• Strategic alliances
• Clinical product resourcing
• Supply outsourcing
• Contract management
• Process development
• Investment and venture capital

Day 1

09:00 Registration and refreshments
09:30 Chair’s opening remarks

09:40 Innovative solutions for pre-fillable syringe systems
• Market trends and emerging requirements
• Considerations for component and system selection
• Supplier role in quality by design
• Safety and device add-ons

Tibor Hlobik
Associate Director, PFS Technologies
West Pharmaceuticals

10.20 Pre-filled syringes for biotech products and auto injector devices
• Product contact materials
• Tungsten free syringes
• Baked on siliconisation
• Ideal auto injector syringes
• Design of efficient systems

Arno Fries
Head of Sales USA Syringes
Director Product Management Syringes
Gerresheimer

11:00 Morning refreshment & networking session

11:20 Technology advances and market trends
for auto-injectors
• User benefits
• Creating and protecting market share
• A new generation of device and compromises in device design
• Future opportunities

12:00 The use of computational fluid dynamics to optimise handling aseptic processes

Stefan Sundström
Director, Sterile Aseptic Manufacturing, Engineering and Maintenence
AstraZeneca

12:40 Lunch

13:40 Pre-filled syringe processing with RABS,
isolators, e-beam & alternatives
• Isolator technology with latest e-beam design features
• Comparison of RABS vs Isolators
• Alternative tub entry system for slow speed production
• Expansion of the areas of application of syringe technology

Jim Spolyar
Sales and Technical Director
Skan US

14:20 Facility design for RABS and Isolator production
• Basic concepts and lesson learnt
• Examining techniques used for different processing scenarios
• Comparison of operating costs
• Recommendations and conclusion

Sterling Kline
Director of Project Development
Integrated Project Services

15:00 Afternoon refreshments & networking session

15:20 Panel discussion: Why new developments are important in injectable delivery today?

Panellists will identify and understand the growing importance of injectable drug delivery on self-administration, drug formulations, drug-device development, and therapeutic treatment protocols. If you want to submit a question, please email it to info@bharatbook.com

16:00 Silicone oil droplet enumeration using Micro-Flow Imaging (MFI)
• Silicone oil droplets from pre-filled syringes can introduce a significantly large and varying population of sub-visible particles into an exposed protein formulation
• Quantifying the degree of silicone oil droplet introduction, in order to understand their affect (if any) upon formulation stability in terms of protein aggregation formation
• Classifying and reporting on protein aggregates alone in a formulation containing both oil droplets and aggregates, in order to track the stability of a formulation
• Micro-Flow Imaging (MFI) is a relatively new highly sensitive imaging-based particle analysis technique designed to image, count, and size sub-visible particles in protein formulations
• Demonstrating how MFI can be used to quantify very low quantities of silicone oil droplets introduced by a pre-filled syringe
• How the morphological parameters may be used to classify and isolate the protein aggregate population from the silicone oil droplet population

Dave Thomas
Director, Sales and Marketing
Brightwell Technologies

16:40 Chair’s closing remarks

16:55 Networking drinks
Take your discussions further and build new relationships in a relaxed and informal setting.

Day 2

09:00 Registration and refreshments
09:30 Chair’s opening remarks

09:40 Lyophilisation in pre-filled syringes
• Allowing for pre-clinical, clinical scale lyophilisation while utilising commercial grade redundant components
• Programmable recipe automation for assured repeatability of multiple lots
• Filling specifications

Shawn Kinney
CEO & President
Hyaluron

10:20 Elastometric pre-fillable syringe component
• Compatibility of rubber plungers with WFI
• How irradiation sterilisation imposes different requirements on the behaviour of prefilled syringe plungers?
• Illustration of chemical and physical effects of irradiation on pre-filled syringe plungers
• Phasing-out of natural rubber as elastomeric base material

Renaud Janssen
Technical Support Director
Helvoet Pharma

11:00 Morning refreshment & networking session

11:20 Case Study: Extractables and leachables analysis for primary packaging
• E&L through the Eye of an Expert
• E&L through the Eye of the manufacturer
• Extractable Approach: Study Purpose and results
• Leachable Approach: Study Purpose / Samples
• Assessment and conclusion

Horst Koller
Manager Scientific Advisory
Schott

12:00 Track & Trace for glass syringes using laser coding technology
• Introduction on the technology
• Developing a reliable track & trace system
• Main validation results obtained
• Reducing the risk of mix-up of syringes and batches
• Describing experimental scenarios

Claudia Petersen
Director Business Development
Gerresheimer

12:40 Lunch

13:40 Panel Discussion: The role of partnerships in developing and delivering pre-filled syringe products
Panellists will assess the importance of pharma-device alliances and design partnerships on pre-filled syringe products. If you want to submit a question, please email it to info@bharatbook.com

14:20 Case study of high speed nested syringe filling line (performance 1,000 syringes/min. )
featuring :
• automatic and manual debagging
• ebeam decontamination
• automatic and manual Tyvek lid and liner removal
• exchangeable dosing system: rotary piston pumps / time pressure dosing
• stopper placing via vent tube - vacuum stopper insertion
• supply of components via RTP port / IDC port or VHP chamber
• IPC In - process weigh control
• tub buffer system
• tub coding

Matthias Poslovski
Director Technical Sales
Optima Group Pharma

15:00 Afternoon refreshments & networking session

15:20 Quality control challenges for pre-filled syringes
• Analysing the major quality challenges for syringe filling
• Assuring drug product potency, identity, safety, and stability
• Identifying and analysing the most challenging aspects of quality control
• How to ensure container/closure integrity during and after filling and terminal sterilisation?

16:00 Legislation and regulatory requirements for developing pre-filled syringes and injection devices
• Consideration of new policies and procedures to regulate
• Obstacle and challenges to efficient regulation of pre-filled syringes and injection devices
• Legal Framework: Examining regulatory requirements in the US
• Case studies: Coordinating national and international requirements

16:40 Chair’s closing remarks

16:50 End of conference

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