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.
Some manufacturers still have reservations about adopting x-ray inspection as a safe method of product inspection. Their primary concern is that products being inspected could be affected by radiation during the inspection process, and that their therapeutic effectiveness might be compromised. This white paper examines the potential effects of x-ray inspection on pharmaceutical products.
The AuditCheck metal detection verification performance system 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 article explains the differences between validation, verification and routine performance monitoring and gives an overview of recommended test methods for different 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.