Olde Mill Inn
225 Route 202,
Basking Ridge, NJ 07920
5:00 - 6:30 PM Registration, Cash Bar, Food, Vendor Booths
6:30 - 7:30 PM Dinner
7:30 - 8:30 PM Welcome, Seminar, Closing Remarks
Abstract & Speaker Bio's
Research Scientist, Global Product Development and Supply Bristol-Myers Squibb, New Brunswick
Package systems such as vials and prefilled syringes, must provide a barrier that protects drug product throughout the entire shelf life. Manufacturers are required to demonstrate that the primary packaging systems are capable of maintaining microbial barrier integrity. Container closure integrity testing (CCIT) performs an important role of verifying container closure integrity (CCI) performance. The recent USP update have prompted the use of deterministic methodologies to assess CCI throughout the product lifecycle, material selection, and de-risking container or device system design. This presentation will review the available methods, the pro and cons of each, and how they can be utilized to effectively detect, mitigate, and control package integrity.
Mrs. Casey Tyrrel-Pawlowic is a Research Scientist with Bristol-Myers Squibb (BMS) in New Brunswick, NJ and is the SME for container closure integrity testing (CCIT). She received her Bachelors of Science degree from Thomas Edison State College and was a Senior Scientist for 12 years at Taylor Technology performing project management and managing a group carrying out method development, validation, and analysis for bioanalytical studies. Mrs. Tyrrel-Pawlowic joined BMS in 2011 and currently is developing BMS's CCIT program by obtaining new technology and performing project management, method development, and validations for CCIT studies.
Paul Bilotti, North America Sales Manager for Wilco, AG (Switzerland)
The Container Closure Integrity Testing (CCIT) of auto-injectors has been accomplished to date by the use of destructive sampling. The assemblies to be tested are taken apart and the syringe within is inspected and leak tested using traditional methods, such as blue-dye immersion. This presentation is a case study of the testing methods and results of a customer’s auto-injector system with a variety of syringe fill levels and headspace volumes.
Paul received his BSEE from Manhattan College and his MSCS from Stevens Institute of Technology. He began his career as an Electrical Engineer in Hardware, Software, and then Systems design for the Aerospace Industry and moved into the Packaging Industry in 1994, ultimately transferring his engineering experience to Sales in 2000. He began working with Wilco, AG in 2011, first as their agent in the US, and then directly as their North America Sales Manager. His favorite projects are when he can sit down and work closely with his customers as a free systems consultant, leveraging his years and experience as an engineer. Of course the very best projects involve primary packaging inspection and CCI testing, where he’s been focused for the past 5+ years.
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