Analytical Laboratory Webinars

Industry-leading expertise at your fingertips.

See the latest technical contributions from our expert team.

Technical concepts, demystified.

Any field of science can quickly get bogged down in technical jargon that makes it difficult to understand, well, anything. We’ve encouraged our scientists to slow things down with easy-to-understand webinars.

Solving Contamination Issues with Pharmaceutical Forensics

Authors & ContributorsDavid ExlineApril 22, 2011 The presence of foreign particulate matter and other contaminants can halt the production of drug products for weeks, even months, until the contaminant and the source are identified and the issue is fully resolved. This webinar recording examines how a new, advanced problem solving approach called pharmaceutical forensics can

Characterizing Pharmaceuticals Utilizing Chemical Imaging

July 26, 2011 Chemical imaging is an analytical technique that combines digital imaging with spectroscopy to characterize materials in various drug delivery systems, including nasal spray and inhalation products, semi-solids, solids, transdermal and controlled release systems, as well as medical devices. From determining a polymorphic form to evaluating the particle size distribution of an active

Forensic Analysis of Hair and Fibers for Police & Attorneys

Authors & ContributorsDavid Exline February 10, 2012 This webinar was designed for police officers and attorneys engaged in collection and investigations relating to hair and fiber evidence. Current methods of hair and fiber collection and  interpretation is discussed. This webinar also reviews past and current testing methods with emphasis on the most current methods used

Laboratory Methods for Failure Analysis of Pharmaceutical Products

Authors & Contributors Rebekah Byrne David Exline May 09, 2012 Failures in pharmaceutical products may range from issues with delamination and  packaging failures to polymorphs arising in the pharmaceutical product.This webinar is designed for laboratory and manufacturing personnel that are responsible for quality assurance and quality control of processes in the manufacturing of pharmaceuticals. This

Determining Content Uniformity Using Raman Chemical Imaging

May 11, 2012 Content uniformity of a drug product has a direct impact on product performance, quality and efficacy.  Raman and near-infrared chemical imaging are novel techniques used to provide an accurate, timely and cost-effective method, which is important when evaluating a drug product’s content uniformity.  By using these techniques, drug developers can ensure the

Polymorph Analysis Using Raman Chemical Imaging

May 12, 2012 Screening for polymorphs is crucial during drug development, since the crystal form of the active pharmaceutical ingredient (API) directly correlates with its pharmacokinetic properties.  The ability to image and detect spatially variable changes in the drug substance becomes important in determining the drug products efficacy and performance and has significant impact on

Forensic Analysis of Paint and Tapes for Police & Attorneys

Authors & ContributorsDavid Exline May 13, 2012 This webinar covers the forensic investigation process for paint and tape evidence. Topics include the most current methods used for today’s investigators and discuss the interpretation of paint transfer evidence. Case studies related to the analysis of duct tapes, automotive and architectural paints are also be presented. Highlighted

Ingredient-Specific Particle Sizing Using Raman Chemical Imaging

May 14, 2012 In accurate, timely, and cost effective method of measuring drug particle size distribution is important during formulation as well as batch release testing.  Raman chemical imaging is a novel technique used during these phases, which enables scientists to accurately measure drug particle size distribution and identify the chemical makeup of aggregates and

Controlled Release Testing Using Raman Chemical Imaging

May 14, 2012 When developing controlled release products, it is important to establish coating consistencies in the laboratory and manufacturing environments to produce a predictable result.  The ability to effectively test and gain feedback about the coating processes for ingredient-specific measurements of individual coating layers, allows scientists to accurately predict the quality and performance of

Ensure Quality Inhalation Products with Wear Debris Analysis of Medical Devices

Authors & ContributorsDavid Exline May 16, 2012 Medical devices such as inhalers tend to experience wear debris, which can cause a number of quality issues.  Characteristics of wear debris, including particle size and shape distribution, number of particles and chemistry is important to assess for specific medical devices. This webinar provides an overview of wear

Forensic Analysis of Condom Lubricants for Police & Attorneys

Authors & ContributorsCara PleseAntonio Scatena May 17, 2012 This webinar covers the collection, documentation, and forensic analysis  of condom lubricants and sexual assault evidence. Scientific principles and current methods of condom lubricant analysis are covered to help investigators review and present in casework. Case studies related to the use of condom lubricant trace evidence are also

What Police and Attorneys Need to Know about Gunshot Residue Analysis

Authors & ContributorsRebekah ByrneDavid Exline January 02, 2013 This webinar was designed for police and attorneys and built upon the information provided in our previous webinar, “Forensic Analysis of Gunshot Residue for Police & Attorneys.”  During this webinar, our presenters provided police officers with tips on the proper collection for gunshot residue  analysis, as well

Working to Address the FDA Critical Path Opportunity for Generic Nasal Spray Suspensions

January 22, 2013 The FDA stated in their 2007 Critical Path Opportunity for Generic Drugs that “If the drug particle size distribution of test and reference products can be demonstrated to be equivalent, then nasal spray suspensions could be treated like nasal spray solutions. The critical path opportunity is to develop methods to measure drug particle size in

Intro to Forensic Analysis for Civil Product Liability Claims

Authors & ContributorsDavid Exline February 13, 2013 Product liability issues have become increasingly important to industrial and pharmaceutical companies, as every product presents the potential for liability. Stringent quality control and processes are imperative when manufacturing a quality product to insure that product failures, such as contaminations, discolorations and product defects do not occur. However,

Introduction to Industrial Forensics

Authors & ContributorsDavid ExlineAntonio ScatenaFebruary 20, 2013 Industrial Forensics is a specialized field of examination that leverages the expertise of forensic analysis and problem solving and applies these principles to difficult manufacturing and product investigations. Often times, particulate contamination occurs in products, processes and customer related investigations. In other instances, the need of detailed problem

Spectral Analysis of Materials using Raman Chemical Imaging

Authors & ContributorsRebekah ByrneDavid Exline March 30, 2013 This webinar was designed for professionals (e.g. Quality Control, Industrial Engineers) involved in the production and development of various materials, ranging from adhesives and polymers to plastics and glass. During this webinar, our presenters provided an overview of RCI and the type of data that can be generated

In Depth Analysis of Particle Contamination for Inhalable Drug Products

Authors & ContributorsDavid Exline April 02, 2013 The overall objective of a solid quality foundation in the evaluation of particle contamination analysis of inhalables is based on many things. The complete evaluation and root cause analysis of foreign particulate matter, as well as the affects of particulate on product quality, are essential when evaluating the

The Value of Presumptive Screening of Physical Evidence

Authors & ContributorsDavid ExlineCara Plese May 06, 2013 Presumptive tests for blood, seminal fluid, urine, and saliva are fast, relatively inexpensive, and can quickly eliminate a stain from further analysis if the results show the sample is not the fluid originally suspected. Likewise, microscopic analysis of hair is a nondestructive test involving minimal preparation and

In Depth Analysis of Particle Contamination for Parenteral Drug Products

Authors & ContributorsRebekah ByrneDavid Exline May 15, 2013 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

What Police and Attorneys Need to Know about Condom Lubricant Analysis

Authors & Contributors Cara Plese & Antonio Scatena August 06, 2013 This webinar was designed for police and attorneys and built upon the information provided in our previous webinar  “Forensic Analysis of Condom Lubricants for Police and Attorneys.” During this webinar, our presenters provided a more in depth explanation of the analysis of condom lubricants and

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

Authors & ContributorsDavid ExlineCara PleseAugust 28, 2013 This webinar was designed for professionals (e.g. Quality Control, Industrial Engineers) involved in the production and development of tablet and semi-solid drug products. During this webinar, our presenters provided examples of commonly found  particle contamination in tablet and semi-solid drug products and how these contaminants are introduced into the

Evaluation of Pharmaceutical Vials for Glass Delamination

Authors & ContributorsAntonio ScatenaFebruary 04, 2014 Glass delamination can be a costly problem for pharmaceutical drug vial manufactures. For one vial manufacturer glass delamination can cause the recall of thousands of vials of drug product. In this webinar, you will learn about the common types of problems caused by glass delamination in pharmaceutical vials and the

The Benefits of Using Raman Spectroscopy and LIBS for Automated Particle Identification

Authors & ContributorsDavid ExlineMarch 26, 2014 Identification of foreign particles in a drug product is a serious concern for today’s pharmaceutical drug manufactures. Manufactures often need to quickly understand where these particles come from and what they are in order to avoid potential quality concerns that could lead to an expensive recall. This webinar offers

Structuring Your Materials Characterization with Raman Spectroscopy

Authors & ContributorsRebekah Byrne June 05, 2014 Do you find you’re not getting the whole picture using your current testing methods to determine a material’s chemistry? Would a complete understanding of a material’s molecular structure aid in the development of a new product or determine the root-cause of a product failure during manufacturing? Incorporating Raman

Case Studies in Foreign Particulate Analysis

Authors & ContributorsDavid Exline July 01, 2015 Foreign particulate analysis is a critical aspect of pharmaceutical manufacturing and nonconformance investigations. The approaches and methodologies for analyzing foreign particulate vary depending on whether it is a single particle or a population of particles, as well as the physical properties of the particles themselves. Highlighted Topics An

Using Raman Spectroscopy and LIBS for Automated Particle Identification

Authors & ContributorsDavid Exline July 01, 2015 Identification of foreign particles in a drug product is a serious concern for today’s pharmaceutical drug manufactures. Manufactures often need to quickly understand where these particles come from and what they are in order to avoid potential quality concerns that could lead to an expensive recall. Highlighted Topics

Wear Debris Characterization using Automated Raman and SEM-EDS

Authors & ContributorsRebekah ByrneDavid ExlineSeptember 17, 2015 Wear debris contamination is not a new problem within various industries: however, the way that the contamination is identified and monitored is evolving. Automated Raman coupled with automated SEM-EDS analysis allows you to evaluate size, shape, elemental distribution and characterization of particles within a single sample. These combined

In-depth characterizations of OINDPs from R&D to regulatory submission

October 15, 2015 Next Breath and Gateway Analytical will present their OINDP Webinar Series for Dry powder Inhalers (DPIs), pressurized Metered Dose Inhaler (MDIs), and Nasal drug products which are complex delivery systems and their development require key specialized expertise. Next Breath and Gateway analytical are pleased to present a webinar to provide a comprehensive

Challenges in Counting and Sizing Glass Lamellae using an Automated Method

Authors & ContributorsRebekah ByrneDavid ExlineNovember 18, 2015 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

Proactive vs. Reactive Testing for Glass Delamination in Pharmaceuticals

Authors & Contributors Emily Landsperger February 16, 2016 Glass delamination is a phenomenon which can occur when top layers of a glass surface separate and flake off or detach from the inner surface, typically in the microscopic range. Glass delamination is the result of several factors including the product formulation, the glass resistance and the

Case Studies in Foreign Particulate Analysis Using Manual Testing Methods

April 27, 2016 Foreign particulate analysis is a critical aspect of pharmaceutical manufacturing and nonconformance investigations. The approaches and methodologies for analyzing foreign particulate vary depending on whether it is a single particle or a population of particles, as well as the physical properties of the particles themselves. Case Studies in Foreign Particulate Analysis will

Hair as a Pharmaceutical Contaminant: How It Is Identified, and How We Can Tell Where It Originated

Authors & ContributorsCara Plese July 27, 2016 Foreign particulate in drug products originate from a variety of sources. Such sources can include machinery used in drug manufacturing, drug packaging components, cleaning utensils and products, personnel wearing personal protective equipment (PPE) and laboratory surfaces. Typical contaminants include polymers, fibers, burnt material and metallic particulate. Hair is

Determining Metal Cleanliness Using SEM-EDS

August 02, 2016 The need for metals cleanliness in the automotive industry has increased in the last decade. As technology continues to evolve, automotive part suppliers are increasingly being compelled to follow more stringent fluid system purity standards. Metals cleanliness is an important component to meeting these standards. Analyzing automotive parts for cleanliness aids parts

Strategies for Biowaiver Application for Generic Nasal Sprays

Authors & ContributorsDavid Exline October 27, 2016 The active pharmaceutical ingredient (API) size distribution within the final formulation of a drug product is critical as it relates to bioavailability, rates of absorption, and stability of that drug product. Gaining an understanding of the API particle size distribution (PSD) is becoming of greater importance to regulatory

Advancing Development of Generic OINDPs through In Vitro Testing

May 04, 2017 According to a 2007 report Measuring Trends in the Development of New Drugs: Time, Costs, Risks and Returns by J.A. DiMasi, companies spend an estimated $1.2-$1.3 billion on research and development for each approved drug due to the increasing complexity of the research and development process—particularly clinical trials. That’s a $500 million

Orthogonal API Particle Size Methods for Structural Equivalence & In Vitro Bioequivalence

June 25, 2018 Join Gateway Analytical and our partner, Next Breath, An Aptar Pharma Business, for our webinar presentation, Orthogonal API Particle Size Methods for Structural Equivalence and In Vitro Bioequivalence. Topics covered will include analytical techniques and methods suitable for API particle sizing and in vitro bioequivalence for nasal drug products as well as preparation methods and

Case Studies of Foreign Particulate Analysis

Authors & ContributorsDavid Exline January 23, 2019 Topics covered include analytical techniques and methods suitable for API particle sizing and in vitro bioequivalence for nasal drug products as well as preparation methods and a review of case studies. The presentation also provides FDA guidance related to particle size distribution (PSD) and regulatory considerations for PSD