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Gateway Analytical to Promote Medical Device Testing Services at the 7th Annual Pharmaceutical and Medical Device Manufacturing and Quality Operations Forum

[fa icon="calendar'] Oct 6, 2015 2:03:45 PM / by Tifanie Tiberio posted in Blog, News Releases

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PITTSBURGH, October 6, 2015  — Gateway Analytical announced today that they will be exhibiting at the 7th Annual Pharmaceutical and Medical Device Manufacturing and Quality Operations Forum in New Orleans, Louisiana, October 8-9th. This forum meeting brings together executives from throughout the pharmaceutical and medical device industries to discuss the key challenges faced by manufacturers, and to explore innovative strategies and solutions for addressing the increasing challenges faced by the industry.

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Gateway Analytical Promotes 1-Day Turnaround for Analytical Services at 14th Annual Contract Pharma Conference

[fa icon="calendar'] Sep 14, 2015 2:01:32 PM / by Tifanie Tiberio posted in Blog, News Releases

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PITTSBURGH, September 14, 2015 — Gateway Analytical announced today that they will be exhibiting at the 14th Annual Contract Pharma 2015 Contracting and Outsourcing Conference in New Brunswick, New Jersey on September 17th and 18th. The conference is focused on helping to address challenges that today’s drug manufacturers face, such as the increasing pressure to grow and evolve beyond strategies of the past, understanding new technologies, heightened regulatory guidelines, and the continuous growth of generic products.

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Addressing Glass Delamination Concerns Proactively with USP 1660 Testing

[fa icon="calendar'] Jun 4, 2015 11:06:48 AM / by Rebekah Byrne posted in Addressing Glass Delamination, Blog, glass testing requirements, ICP spectroscopy, Pharmaceutical, screening methods, SPE, USP, sem-eds

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Glass delamination(1) has become a bit of a hot topic in the area of parenterals over the past several years.  Glass delamination is, indeed, a serious issue which can not only cause pharmaceutical companies millions of dollars in recalls, but also stands as a safety hazard to end users.  Delamination is essentially the flaking off of the top layers of a glass surface into the liquid contents of a pharmaceutical vial, syringe, or other container.  Numerous companies have experienced this issue, and have had to open investigations(2) to address the issue.  The question is, how can we be proactive, rather than reactive, in addressing concerns with glass delamination?  How can we minimize the risk of experiencing a delamination issue, in order to protect the welfare of end-users and uphold the quality of our products?

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Gateway Analytical to Present a Workshop on Assessing Aggregate Performance and the Presence of Foreign Particulate in OINDPs

[fa icon="calendar'] Apr 16, 2015 10:28:48 AM / by Admin posted in Blog, News Releases

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PITTSBURGH, April 16th, 2015 — Gateway Analytical announced today that they will be presenting an interactive workshop titled “Assessing Aggregate Performance and the Presence of Foreign Particulates in OINDPs” on Wednesday, May 6, 2015, from 2:00 pm to 6:00 pm at the Congress Center during Respiratory Drug Delivery (RDD) Europe 2015, May 5th-8th, in Antibes, France.

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Identification of Foreign Particulate Matter Using Automated Raman & Automated SEM-EDS

[fa icon="calendar'] Mar 27, 2015 3:29:03 PM / by Rebekah Byrne posted in Articles & Publications, Blog

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Published in: Drug Development & Delivery Online
Written by: Angela Flowers, Emily Landsperger, Rebekah Byrne, and Dave Exline,Gateway Analytical

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Shedding light on the Utility of FTIR vs. Raman spectroscopy

[fa icon="calendar'] Mar 25, 2015 2:49:34 PM / by Rebekah Byrne posted in Blog, Emerging Technology, Featured Instruments, foreign particulate matter investigations, FTIR, Raman

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We get some FAQs here in the analytical lab…one recurring question here at Gateway is “Why did/didn’t you do Raman?”  During foreign particulate matter investigations, the use of spectroscopy is pretty common.  Spectroscopy allows us to study the way a material interacts with energy, in order to identify a material.  Sometimes, a scientist may use FTIR (Fourier Transform Infrared Spectroscopy)(1) …sometimes, Raman(2) may be chosen as the choice method; however, there are times where both methods are employed.

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Glass Delamination Analysis

[fa icon="calendar'] Mar 11, 2015 12:11:28 PM / by Admin posted in Blog, Featured Applications, glass delamination analysis, glass vials, parenteral drug products, particulate contamination

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Foreign Particulate Matter Testing

[fa icon="calendar'] Mar 11, 2015 11:34:23 AM / by Admin posted in Blog, Case Studies

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Overview

 

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Chemically-specific Characterization of Particulate in Inhalable Drug Products using Raman and Laser-induced Breakdown Spectroscopy

[fa icon="calendar'] Dec 11, 2014 3:00:08 PM / by Oksana Olkhovyk posted in Automated Raman/LIBS, Blog, foreign particulate, non-conformance/safety, particle size distribution, particles aggregation, Posters & Presentations

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Presented at: Drug Delivery to the Lungs 25 (DDL25)
Authors:
 O Olkhovyk1, C Vernall2, R Price2 and J Shur2
1. Gateway Analytical, 5316 William Flynn Highway, Gibsonia, PA, 15044, USA,
2. University of Bath, Bath, BA2 7AY, UK
Release Date: December 2014

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Foreign Particulate and Glass Delamination Investigations using Automated Raman/LIBS

[fa icon="calendar'] Nov 19, 2014 1:29:23 AM / by Rebekah Byrne posted in 2014 AAPS Poster, analytical testing, automated Raman, Blog, foreign particulate, foreign particulate matter, glass delamination, particulate characterization, Posters & Presentations, Raman/LIBS

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Presented at: 2014 AAPS Conference
Authors:
 Angela Flowers, Rebekah Byrne, Emily Landsperger, David Exline
Release Date: November 2014

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