YourGateway December 2011 Issue

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In this Issue:


Latest News

We’ve Moved!
In order to consolidate our cGMP and ISO testing laboratories, as well as expand some of our service offerings, we’ve moved to:
5316 William Flynn Highway
Gibsonia, PA 15044

Boasting 5,000 square feet of laboratory space, our new facility offers a wet chemistry laboratory, a chemical imaging laboratory, class 5 and class 100 sample preparation, as well as optical microscopy, digital imaging, FTIR, Raman, high-resolution SEM, automated SEM/EDS testing and confocal Raman spectroscopy.

Quality will still be a crucial focus, with the facility operating under a cGMP-compliant and ISO-accredited laboratory testing environment. In addition, we are also registered with the U.S. Food and Drug Administration.

Now ISO-Accredited
In August, we received certification from the International Organization for Standardization (ISO), the world’s largest developer and publisher of International Standards, under ISO standard 9001:2008 for the quality management system governing our analytical lab processes. Prior to certification, our system was subjected to an intensive audit by UL DQS Inc., one of the top five certification bodies in the world, with no nonconformances.

“This is a very significant milestone in our company’s history,” said David Exline, Senior Vice President at Gateway Analytical. “We’ve devoted a substantial amount of time and resources to ensure that our quality system, as well as resulting analytical tests performed, are of the highest caliber.”

In addition to ISO 9001:2008, we are also pursuing certification for the American Society of Crime Laboratory Directors Laboratory Accreditation Board (ASCLD/LAB) 2011 Supplemental Requirements. We are currently registered with the U.S. Food and Drug Administration and comply with current good manufacturing procedures.

  

Events

Forensic Webinar Series for Police and Attorneys Registration Now Open
This complementary webinar series is designed for police and attorneys looking to increase their knowledge and understanding of forensic trace evidence – from collection of evidence to interpretation of data.

Police and other law enforcement officials will find this webinar series especially useful as it covers the proper collection and documentation procedures as well as the investigative value of various types of trace evidence. Attorneys and legal representatives will find this webinar series can help them when reviewing or presenting forensic trace evidence in court.

Registration is now open for the upcoming webinars, click on a title to learn more.

Webinar Replay
Miss our introductory webinar on chemical imaging for pharmaceutical applications? Click below to catch the replay.
Characterizing Pharmaceuticals Utilizing Chemical Imaging

Summary
From determining a polymorphic form to evaluating the particle size distribution of an active pharmaceutical ingredient, chemical imaging can shed light on many of today’s complex challenges in drug development.

In this webinar, Dr. Priore presents an introduction to this method, focusing on what it is, why it’s effective and how it can be a valuable tool to support pharmaceutical analysis.

This one-hour webinar addresses:

  • A general overview of chemical imaging and common techniques used
  • Types of chemical imaging approaches, including line scanning, wide field and point mapping
  • Advantages in several pharmaceutical applications
  • Polymorph analysis
  • Layer thickness measurements
  •  Ingredient-specific particle sizing
  • Blend/content uniformity analysis

Upcoming Tradeshow Events
Check out where Gateway Analytical will be exhibiting:

  • DDL22
    Dec. 7-9, 2011
    Edinburgh International Conference Centre, Edinburgh, Scotland, UK
  • Poster Presentation: Characterization of Engineered Combination Respiratory Medicines by Raman Chemical Imaging
    When: December  9, Friday, 12.40 – 12.55pm
    Authored by scientists at Gateway Analytical and Prosonix, this poster takes a look at the processing of engineered combination particles of budesonide and formoterol fumarate dihydrate via a sonocrystallization methodology. In addition, it demonstrates the use of Raman chemical imaging as an important analytical tool to ascertain the distribution of active ingredients within these particles.