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Registration Form
Hotel Information
Hyatt Regency New Brunswick
Limited rooms are available at the group rate until August 30th. To make resevartion go to link below or contact the hotel.
https://resweb.passkey.com/Resweb.do?mode=welcome_ei_new&eventID=2614992
Phone: 800.233.1234
Code: Global BioPharmaceutical Resources
Group Rate: $145
Deadline to reserve room at group rate: August 30
Registration Fee
Before September 1: $1050
After September 1: $1450
Overview
The Pre-Filled Syringes conference brings together industry experts to share their experiences in Development, Regulatory Compliance, New Technologies and Trends in Manufacturing Processes. Join these experts to learn about advances, safety requirement and challenges in this area. Below are presentations from experts in industry.
Fundamental of Lyophilization in Syringes
Rob Worsham
Hyaluron, Inc.
An understanding of the basic fundamental principles in the syringe lyophilization process. It will include an overview of the lyophilization in Syringe vs. vial, and will discuss challenges involved in freeze-dried products in syringes.
Silicone Deposition Optimization in PFS and real time control of distribution and droplet Size
Howard Drake
Ompi of America
Selecting Container Closure Components
Edward Smith, Ph.D.
Pre-filled syringe processing with RABS, Isolators, E-beam & Alternatives
Jim Spolyar, Skan AG
This presentation will highlight the aseptic processing lines that have been installed for pharmaceutical syringe filling around the world. There will be an analysis of RABS and Isolator technology, as well as the use of E-Beam for tub entry, with some alternatives for low speed production.
• 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
Container Closure Studies for Prefilled Syringes
James Veale, Ph.D.
Lighthouse Instrument
Extractables and Leachables Consideration for Prefilled Syringes
Edward Smith, Ph.D.
Packaging Science Resources
SCHOTT InJentleTM, An Innovative Staked Needle Syringe
Christian Helbig
Schott Forma Vitrum
There is a growing segment of biotech drugs that are not only highly effective but also very sensitive.
To protect such very sensitive drugs during storage new innovative packaging solutions are necessary.
SCHOTT InJentleTM is an innovative staked needle syringe system. The unique design offers improved drug stability and a gentle application.During the shelf life there is no contact between the drug and the needle, adhesive or fluid channel. The included tamper-evident closure enables physicians or patients to determine if the syringe is still unused. SCHOTT InJentleTM is a completely tungsten-free syringe as during the glass forming process the use of tungsten is not required anymore. SCHOTT InJentleTM is very simple to handle and the use of particularly thin needles up to 32 gauge reduces pain during injection. The packaging is provided in standard nest and tubs and therefore, is compatible with the existing filling lines.
SCHOTT InJentleTM is on the one hand drug friendly, it enables even very sensitive drugs to be stored safely and on the other hand patient friendly, it offers easy handling and the ability to use particularly thin needles for a gentle application.
Challenges and Solutions to Tip Caps and Needle Shields
Brian Gallagher
American Stelmi
Closure Container Requirements for the PFS System
Elastomeric Formulations-Function and Types
Tip Cap Designs
Needle Shield Designs
Rigid Needle Shields
Rigid Needle Shield for Auto-injectors
Latest Developments-Formulations, Technology, Safety
EP Needle Stick Prevention Legislation
Innovations in Syringe Container Closure Systems and New Industry Technologies
Michael Gills
West Pharmaceutical Services
The presentation will highlight the following:
- Injectables Market Analysis
- Historical
- Future Trends
- Primary Container Considerations
- Innovative Solutions for Sensitive Drug Products
- Total Life Cycle Containment
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