BlogCategory: Container Closure Integrity Testing

In this first part of a series of blogs discussing High Voltage Leak Detection (HVLD), I will provide a general overview of one of the more popular HVLD units, an EScan 625 manufactured by PTI Inspect
Method Validation effects the development and quality control testing of most products. Updated FDA guidance titled Analytical Procedures and Methods Validation for Drugs and Biologics
With the increasing utilization of ultracold frozen storage to maintain product potency, the question arises: how do we verify container closure integrity at these extremely low temperatures?
A few months back I published a blog article on the value of attending Interphex. For the regular readers (I know there are few), you will recall that I started that article by simply stating my dista
As development of biologics and biosimilars forges on, the autoinjector remains on the rise. Industry shifts to deterministic test methods translate to a need to develop and validate methods for autoinjectors
Three years ago, the executive management of Whitehouse Laboratories implemented a major reorganization plan. Over the previous ten years, the company had experienced many areas of growth to include e
CCIT programs in lifecycle of a product-package system; from development of the package, to stability, to analysis of package integrity after distribution cycles. As related to proposed revisions to USP 1207
In the past four or so years working with clients to develop and validate container closure integrity (CCI) test methods, there have been a number overarching trends that have become readily apparent.
Available tools to navigate the USP flow of information that will help remain abreast of changes that may affect your organization
implementing an intern program for college students specific to engineers, chemistry, biology and material science students can lead to a mutually rewarding results
Contract laboratories go beyond routine laboratory work and provide the consultancy support required to meet theses ever changing regulatory developments.
Three key observations as to why Interphex is a must attend event. Interphex will bring over 12,000 global pharmaceutical and biotechnology professionals together in New York
Key areas to focus on when qualifying an outsourcing partner are Good Manufacturing Practices (GMP), and ISO 17025 quality standards.
Pending United States Pharmacopeia (USP) changes for container and package systems.
In part three of this series on CCIT, two commonly used methods – Residual Seal Force and Laser Diffraction – will be reviewed.
In part three of this series on CCIT, two commonly used methods – Helium and Mass Extraction – will be reviewed.
In part two of this series on CCIT, two commonly used methods – Vacuum Decay and High Voltage Leak Detection – will be reviewed.
This series of articles will review the present state of Container Closure Integrity Testing, the various methods currently available, the factors for choosing the most optimal method and current regulatory guidelines under development.