Package integrity is defined as a package’s ability to prevent product loss, maintain product sterility, and in some cases, prevent oxygen ingress or maintain sub-atmosphere headspace pressures.
The Thermo Scientific AuditCheck metal detection verification performance system is a unique performance verification system which utilizes an automated test shuttle that moves through the metal detector’s field at user-specified points in time.
This guide explains the concept of metal detector sensitivity, key factors that impact it, and why a small difference in spherical sensitivity performance can mean a big difference in contaminants detected.
This white paper provides an explanation of the differences between validation, verification and routine performance monitoring as well as an overview of recommended test methods for different types of metal detection systems.
Rapid water vapor determination with an optical method could replace the slow destructive traditional methods for the moisture analysis of freeze-dried product. A description of industry applications of headspace moisture analysis including freeze drying cycle optimization, lyo chamber moisture distribution mapping, and 100% moisture inspection of commercial freeze-dried product.
A vaccine-focused biotechnology company approached LIGHTHOUSE to help investigate a phenomenon observed in liquid vaccine product stored at -80°C. During QC testing, a number of vials were found to have an overpressure. This phenomenon represented a serious safety risk and LIGHTHOUSE was asked to support an investigation to identify the root cause.
Laser-based headspace provides yet another alternative approach for detecting microbial contamination in sterile pharmaceutical product allows for quicker, more sensitive, accurate, and reproducible test results when compared with conventional, growth-based methods.