Media
Press Release 02-08-10
PDA Annual Meeting March 15-19, 2010
Presentation: Glass Vial Finish Defects - Leak Detection and Product Risk Assessment
February, 2010 - The PSIG (Packaging Science Interest Group) of the Parenteral Drug Association (PDA) will meet on Tuesday, March 16th from 4:15 to 6:00 PM in conjunction with the PDA Annual Meeting which will be held at the Gaylord Palms Resort in Kissimmee, FL. You may register for the meeting at www.pda.org and make hotel reservations at www.gaylordpalms.com or 1-407-586-2000.
Agenda:
- Presentation by Steve Orosz & Dana Guazzo (see below)
- Q&A & discussion of presentation including general discussion of glass quality
- Open Q&A/Discussion of Pharmaceutical Packaging Issues Identified by PSIG Meeting Attendees
Speakers:
Stephen T. Orosz, Jr, PhD, ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Dana M. Guazzo, PhD, RxPax, LLC and Whitehouse Analytical Labs
Abstract:
Defects in the finish of molded glass vials occurring at the time of vial manufacture were visually analyzed for their likelihood of leakage or extension over time (American Glass Research, Genesis Packaging Technologies). These same defective vials were filled with liquid, stoppered and sealed, and were leak tested using a vacuum decay method (Packaging Technologies & Inspection - PTI) and a high voltage leak detection instrument (Nikka Densok, U.S.A). Helium mass spec leak detection (Vacuum Instrument Corporation) was used as a referee method in cases of questionable or conflicting results. Additional package test samples included vials with artificially created defects and no-defect negative controls. Both vacuum decay and HVLD methods identified leakage from defective vials, although HVLD proved more sensitive and reliable. Leak detection factors investigated included defect size and type, packaged product storage time, product formulation, and capped vial residual seal force (Genesis Packaging Technologies). Repeated product exposure to HVLD had no effect on the physicochemical characteristics of various proteinaceous products. This research was conducted by Whitehouse Analytical Labs under the direction of RxPax, LLC, and was fully funded by ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company.
Speaker Details:
Stephen T. Orosz, Jr., Ph.D.
Director--Fill, Finish & Packaging Process Sciences
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company
33 ImClone Drive Branchburg, NJ 08876
Direct: 908-541-8056
Dana M. Guazzo, PhD President - RxPax, LLC, and
Package Integrity Lab Director - Whitehouse Analytical Labs
291 Route 22 East
Salem Industrial Park #4
Whitehouse, NJ 08888
Phone: 877-823-9300
Dana Guazzo Direct: 908-507-3905