Webinars – Gateway Analytical

WEBINAR: The Art of CCIT: Deterministic Method Selection

admin — Tue, 23 Jul 2024 16:53:16 +0000

Explore one of the most important topics on your journey to market, “The Art of CCIT: Deterministic Method Selection”. Our webinar was scheduled for July 9, 2024, 9:00am London. This webinar was designed to address the critical aspects of Container Closure Integrity Testing (CCIT) in pharmaceutical packaging, and beyond!

Our expert speakers, Patrick Dayton, Project Manager, and Antonio Scatena, Director of Sales & Marketing at Gateway Analytical, an Aptar Pharma company, explore the reliability of deterministic methods such as vacuum decay, high voltage leak detection, and laser-based methods, also discussing the importance of selecting the right testing method based on container type, product characteristics, and regulatory requirements. Additionally, you’ll gain actionable knowledge through case studies that illustrate the selection process and implementation of these methods in real-world scenarios.

To Request Access To The Webinar: Click Here

The post WEBINAR: The Art of CCIT: Deterministic Method Selection appeared first on Gateway Analytical.

Ensuring Container Integrity at Various Temperatures

admin — Fri, 06 Oct 2023 08:30:54 +0000

In the fast-paced world of pharmaceutical development and manufacturing, ensuring the integrity of sterile containers is paramount. This webinar, titled “Ensuring Container Integrity at Various Temperatures,” is a deep dive into the crucial considerations for validating Container Closure Integrity (CCI) across a range of storage temperatures. Subtitled “Considerations for Validating Container Closure Integrity at Five Different Storage Temperatures Using Laser Headspace Analysis,” the webinar session furnished attendees with invaluable insights into this vital yet often overlooked aspect of pharmaceutical production.

The importance of leak detection in finished sterile containers cannot be overstated. Undetected container-closure defects can compromise the sterility of parenteral medicines, posing a significant risk to patient safety. Often invisible to the naked eye, these defects can be elusive but are more likely to occur—or even transiently appear—as the storage temperature decreases. The webinar shed light on why storage temperature is a crucial factor in validating a CCI method and how it impacts the physical properties of the container and its components, particularly when stored at deep cold or cryogenic temperatures.

The session also reviewed the foundational understanding of USP <1207>, a standard that recognizes several deterministic technologies for CCI testing, including Laser-based Headspace Analysis (HSA). HSA has emerged as an especially useful tool for validating the integrity of containers made from glass and polymers and stored under diverse conditions, including extremely cold temperatures. However, several nuances must be considered when designing, developing, and validating an HSA-based CCI method, and the webinar aims to navigate these intricacies effectively.

The brief overview of USP <1207> set the stage for a more in-depth discussion on how a laser headspace method can be validated in accordance with a product’s storage temperature. This was followed by practical examples and guidance on utilizing a validated HSA CCI method for various applications. From assessing the shelf life of containers to optimizing and validating filling lines, and even conducting shipping studies, the webinar provided a comprehensive resource for professionals in the pharmaceutical industry and offered a detailed and informative guide to mastering CCI at various temperatures.

To Request Access To The Webinar: Click Here

The post Ensuring Container Integrity at Various Temperatures appeared first on Gateway Analytical.

The Value of Presumptive Screening of Physical Evidence

admin — Tue, 29 Aug 2023 05:18:06 +0000

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 can confirm if hair is human in origin and determine if a particular hair is suitable for nuclear DNA analysis. Both time and money can be saved by efficiently eliminating samples from further analysis when it is deemed unnecessary by a presumptive method. This webinar was designed for police and attorneys involved in cases with physical evidence. During this webinar, our presenters discussed the advantages of microscopic and presumptive screenings of physical evidence, especially suspected bodily fluid stains and hair prior to advancing to more expensive DNA analysis. They also provide examples of such screenings and discussed how these screening methods can save valuable time, money and resources by eliminating samples from being forwarded onto unnecessary further analysis.

Highlighted Topics Covered:

The advantages of microscopic and presumptive screening of physical evidence prior to expensive DNA analysis
How these screening methods can save time, money and resources by potentially eliminating unnecessary further analysis
The importance of proper packaging of evidence collected at the scene to ensure it is not compromised prior to analysis

Replay Webinar

The post The Value of Presumptive Screening of Physical Evidence appeared first on Gateway Analytical.

Case Studies in Foreign Particulate Analysis

admin — Sat, 19 Aug 2023 16:19:24 +0000

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 testing. To Request Access: Click Here

The post Case Studies in Foreign Particulate Analysis appeared first on Gateway Analytical.

Case Studies in Foreign Particulate Analysis Using Manual Testing Methods

admin — Mon, 03 Apr 2023 03:20:58 +0000

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 present an overview of manual methodologies for characterizing foreign particulate matter in pharmaceutical investigations and cleanliness studies. Several examples will be presented showing the various approaches to particulate identification.

During this webinar we will discuss manual types of analysis (including SEM-EDS, microscopy, FTIR, and Raman). In addition, several case studies will be presented as examples of these testing methods.

Topics Covered Will Include

An overview of manual foreign particulate characterization
How manual analysis compares to automated technologies for particle identification
Commonly found sources of particulate contamination
Application and case study examples of manual particulate analyses

Who Should Attend?

You should attend this webinar if you are involved in guaranteeing the quality and safety of drug products and are looking for an effective method for identify foreign particulate.

To Request Access: Click Here

The post Case Studies in Foreign Particulate Analysis Using Manual Testing Methods appeared first on Gateway Analytical.

Controlled Release Testing Using Raman Chemical Imaging

admin — Wed, 15 Mar 2023 08:45:44 +0000

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 the product. In addition, product attributes such as content conformity and particle size distribution effect dissolution properties.

This webinar discusses specific methods of analysis for controlled release testing using Raman Chemical Imaging to measure layer thicknesses, content and blend uniformity of ingredients, particle size characterization, and polymorph analysis. Specifically, we discuss how such analytical data is important in determining the quality and performance of a product.

Highlighted Topics Covered:

Measuring layer thickness to understand and ensure product performance
Analysis of content and blend uniformity of ingredients and particle size characterization to ensure proper dissolution properties
Analysis of polymorphs related to product performance and quality

Replay Webinar

The post Controlled Release Testing Using Raman Chemical Imaging appeared first on Gateway Analytical.

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

admin — Thu, 05 Jan 2023 17:49:28 +0000

Foreign particulate in drug products originates 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 a significant type of contamination seen in pharmaceutical products. The biological nature of hair can generate many types of concerns when this contaminant is found in drug products. Identification of hair as a contaminant and narrowing down possible sources of contamination can aid in determining the impact on product. It can also provide valuable information to remediate the problem in the future.

Microscopy is a valuable tool in the analysis process, enabling a scientist to accurately determine if a contaminant is a hair. Microscopy also provides additional relevant information, such as hair type (i.e. human, animal or textile in nature) that can lead to the source of the contamination.

Participants of this webinar will learn how microscopy is used to identify hairs and what characteristics the analyst evaluates to determine potential sources of hair contamination.

To Request Access: Click Here

The post Hair as a Pharmaceutical Contaminant: How It Is Identified, and How We Can Tell Where It Originated appeared first on Gateway Analytical.

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

admin — Fri, 23 Dec 2022 14:36:55 +0000

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 manufacturing process. They presented a basic multi-tiered analytical approach to characterize foreign particulate matter and how to solve particulate contamination issues using a scientific approach. 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 was also discussed.

Highlighted Topics Covered:

Examples of commonly found contaminants in tablet and semi-solid drug products
How these contaminants are introduced into the manufacturing process
A basic multi-tiered analytical approach to characterize foreign particulate matter
How to solve particulate contamination issues using a scientific approach.
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

Replay Webinar

The post In Depth Analysis of Particle Contamination for Tablet and Semi-Solid Drug Products appeared first on Gateway Analytical.

Solving Contamination Issues with Pharmaceutical Forensics

admin — Thu, 15 Dec 2022 12:22:21 +0000

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 help to quickly identify foreign particulate matter and answer questions as to how, where and when it originated. Highlighted Topics Covered

How a forensic approach yields more valuable information
Common analytical techniques used
Source determination of contaminants
Role of a quality system in preventing future contamination issues
Cost advantage of outsourcing such investigations

To Request Access: Click Here

The post Solving Contamination Issues with Pharmaceutical Forensics appeared first on Gateway Analytical.

What Police and Attorneys Need to Know about Gunshot Residue Analysis

admin — Fri, 02 Dec 2022 15:52:34 +0000

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 as, the methodology used to analyze and interpret the data utilizing automated scanning electron microscopes (SEM). Our presenters also took attendees into the courtroom, providing attorneys with insight into the significance of gunshot residue evidence during a case, and what implications can be made from this type of evidence during expert testimony.

Highlighted Topics Covered

Tips for proper evidence collection methods for gunshot residue
Detailed information on methodology and interpretation of automated SEM data for gunshot residue analysis
Significance of gunshot residue evidence to a case
Implications that can be made from this type of evidence

Replay Webinar

The post What Police and Attorneys Need to Know about Gunshot Residue Analysis appeared first on Gateway Analytical.