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The Particle Articles

In Depth Analysis of Particle Contamination for Tablet and Semi-Solid Drug Products

[fa icon="calendar'] Aug 28, 2013 12:00:17 AM / by Admin posted in analytical testing, Blog, drug product, foreign particulate matter, manufacturing, particle contamination, Pharmaceutical, Pharmaceutical QA/QC Investigations Webinars, Semi-Solid, tablet

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Original Event Date: Wednesday, August 28, 2013
Duration: 60 minutes
Presenters: David Exline, Senior Vice President & Cara Plese, M.S., Scientist I at Gateway Analytical
Host: Tifanie Tiberio, Event Coordinator at Gateway Analytical

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Q&A Recap for Identify Agglomerates by their Chemical Makeup using Raman Chemical Imaging

[fa icon="calendar'] Jul 15, 2013 3:46:32 PM / by Admin posted in Blog, Pharmaceutical

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On July 10th, Oksana Olkhovyk, Ph.D., Senior Scientist  at Gateway Analytical hosted a webinar designed for scientists working to develop various pharmaceutical drug products. During this webinar, we discussed how Raman Chemical Imaging (RCI) is an effective tool that can be used to identify agglomerates by their chemical makeup in various drug formulations, and how it can benefit developers of OINDPs such as nasal spray suspensions, dry powder inhalers (DPIs), metered dosed inhalers (MDIs), as well as semi-solids: topical creams, emulsions and gels. We also discussed the validation of the RCI method to objectively and precisely evaluate the extent and size of drug to drug or drug to excipient aggregates and compare it to other methods for identifying agglomerates including, optical microscopy, Anderson Cascade Impaction, Raman Microscopy and Confocal Spectroscopy.

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Identify Agglomerates by their Chemical Makeup using Raman Chemical Imaging

[fa icon="calendar'] Jun 13, 2013 9:13:44 AM / by Admin posted in Agglomerates, Blog, Dry Powder Inhalers, metered dosed inhalers, nasal spray suspensions, OINDPs, Orally Inhaled and Nasal Drug Products, Pharmaceutical, Pharmaceutical Webinars, Raman chemical imaging, Recorded Webinars

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Original Event Date: Wednesday, July 10, 2013
Duration: 60 minutes
Presenters: Oksana Olkhovyk, Ph.D., Senior Scientist at Gateway Analytical
Host: Shawn Wilhelm, Marketing Coordinator at Gateway Analytical

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RDD Europe 2013 Workshop: Automated Ingredient Specific Particle Sizing

[fa icon="calendar'] Jun 12, 2013 9:00:42 AM / by Admin posted in bioequivalence, Blog, cGMP, Ingredient-Specific Particle Sizing, ISPS, particle characterization, particle sizing, Pharmaceutical

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Gateway Analytical Senior Scientist Oksana Olkhovyk, Ph.D. recently presented at RDD Europe 2013 in Berlin, Germany. The workshop titled: "Automated Ingredient Specific Particle Sizing" is now available for download.

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In Depth Analysis of Particle Contamination for Inhalable Drug Products

[fa icon="calendar'] Jun 4, 2013 6:05:49 PM / by Admin posted in analytical approach, Blog, dave exline, foreign particulate matter, Inhalable drug products, Medical Device Webinar Recordings, particle contamination, Pharmaceutical, Pharmaceutical QA/QC Investigations Webinars, Recorded Webinars

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Original Event Date: Tuesday, June 4, 2013
Duration: 45 minutes
Presenters: David Exline, Senior Vice President at Gateway Analytical
Host: Shawn Wilhelm, Marketing Coordinator at Gateway Analytical

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Polymorph Identification of Drug Particles in Orally Inhaled and Nasal Drug Products

[fa icon="calendar'] Jun 4, 2013 10:00:45 AM / by Oksana Olkhovyk posted in Blog, Pharmaceutical, Posters & Presentations

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Respiratory Drug Delivery Europe 2013
Authors:
 Oksana Olkhovyk,  Gateway Analytical,  5316 William Flynn Highway, Gibsonia, PA 15044
Release Date: Wed., May 22, 2013

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Q&A Recap for In Depth Analysis of Particle Contamination for Parenteral Drug Products

[fa icon="calendar'] May 20, 2013 11:26:01 AM / by Admin posted in Blog, Pharmaceutical, Quality Assurance

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On May 14th, Rebekah Byrne, Scientist I and David Exline, Senior Vice President at Gateway Analytical hosted a webinar designed for developers of parenteral drug products.  During this webinar, our presenters identified commonly found contaminants in parenteral drug products, how these contaminants are introduced into the manufacturing process, how they can be detected both visibly and non-visibly and laboratory techniques used to identify contaminates. They provided insight into terminology used when discussing parenteral contamination including the difference between particle-free vs. sterile and the standards for visual inspection. They also discussed the importance of taking a pro-active approach to quickly source and manage contaminant issues in the manufacturing process to reduce the risk of future contamination and potentially save your company money by preventing potential recalls.

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In Depth Analysis of Particle Contamination for Parenteral Drug Products

[fa icon="calendar'] May 15, 2013 4:40:45 PM / by Admin posted in Blog, manufacturing, Medical Device Webinar Recordings, parenteral drug products, particle contamination, Pharmaceutical, Pharmaceutical QA/QC Investigations Webinars, Recorded Webinars

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Original Event Date: Tuesday, May 14, 2013
Duration: 60 minutes
Presenters: David Exline, Senior Vice President & Rebekah Byrne, Scientist I at Gateway Analytical
Host: Shawn Wilhelm, Marketing Coordinator at Gateway Analytical

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In Depth Analysis of Particle Contamination for Inhalable Drug Products

[fa icon="calendar'] Apr 2, 2013 2:15:49 PM / by Admin posted in analytical approach, Blog, dave exline, foreign particulate matter, Inhalable drug products, particle contamination, Pharmaceutical, Pharmaceutical QA/QC Investigations Webinars, Recorded Webinars

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Original Event Date: Tuesday, June 4, 2013
Duration: 45 minutes
Presenters: David Exline, Senior Vice President at Gateway Analytical
Host: Shawn Wilhelm, Marketing Coordinator at Gateway Analytical

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IFPAC Presentation: Forensic Analysis of Foreign Particles in Pharmaceutical Materials

[fa icon="calendar'] Feb 26, 2013 12:20:56 PM / by Rebekah Byrne posted in Blog, contaminants, foreign particulate matter, IFPAC, Pharmaceutical, pharmaceutical forensics

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At this years IFPAC - 2013 27th International Forum and Exhibition Process Analytical Technology, I gave a presentation titled Forensic Analysis of Foreign Particles in Pharmaceutical Materials.

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