PITTSBURGH, November 17, 2015 — Gateway Analytical will present a webinar showcasing their scientific expertise in glass delamination analysis on Wednesday, November 18, 2015. Scientists at Gateway Analytical will discuss the variety of methods that have been investigated in an attempt to identify an automated protocol for the specific (chemical and/or morphological) counting and sizing of glass lamellae in parenteral drug solutions.
Glass delamination is a phenomenon which can occur in parenteral drugs stored in glass containers. By interaction of the drug product with the vial surface, the glass surface will sometimes break down, causing the layers to separate; ultimately this results in the presence of small glass flakes, known as lamellae, in the drug solution.
The webinar will include insight into the challenges faced attempting to size and count glass lamellae while differentiating them from other particulate present in the sample and the variety of methods investigated. Content will be presented jointly by Rebekah Byrne, Laboratory Manager at Gateway Analytical, and Emily Landsperger, Scientist at Gateway Analytical.
“The USP has issued a guidance outlining recommended parameters and methods to test the durability of the inner surface of glass containers," said Rebekah Byrne, Laboratory Manager at Gateway Analytical. “Automated methods with the ability to accurately count and size glass lamellae, along with verifying the flakes as being consistent with glass material, could save analysis time and reduce the degree of human error, as well as providing a more accurate measurement of the degree of delamination occurring in a sample."
Anyone involved in guaranteeing the quality and safety of parenteral drug products and are involved in glass delamination investigations is encouraged to attend this webinar presentation. For more information about the webinar or to register online, please visit Gateway Analytical.
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About Gateway Analytical
Based in Gibsonia, Pa., Gateway Analytical, LLC is a full service, FDA registered and inspected laboratory with specialized expertise in techniques for chemically specific particle sizing and particulate contamination identification. The lab is cGMP compliant, following 21 CFR parts 210 & 211, 21 CFR part 820, and ICH Q7. Accreditations include ISO 9001:2008, ISO 17025:2005, and ASCLD/LAB-International.
Gateway Analytical is a subsidiary of ChemImage Corporation, a leader in chemical imaging technology and instrumentation.
About Next Breath
Next Breath, LLC, a subsidiary of AptarGroup, is a cGMP specialty Contract Research Organization (CRO) with analytical expertise for pharmaceutical, biotechnology, and consumer health product development focused on pulmonary, nasal, topical and ophthalmic delivery systems. Next Breath provides comprehensive solutions to the development processes from proof of concept to commercialization. Next Breath has led successful submissions for pulmonary and nasal drug products and devices in the US and international markets.