INSIGHTS ON PHARMACEUTICAL INSPECTION

• USP <1207> Updates Leak Testing Recommendations for Pharma Companies

  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.

• Determination Of Moisture Permeation During Product Shelf Life

  How non-destructive headspace analysis information can be critical for QC groups performing stability studies, or for packaging development groups responsible for choosing the optimal packaging.

• How To Properly Test Your Industrial Metal Detector

  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.

• Headspace Oxygen Formulation Oxidation

  Application of the LIGHTHOUSE headspace method demonstrates how ability to quickly and accurately determine headspace oxygen levels saves time and enables deep insight into formulation stability. 

• Container Closure Integrity Of Sterile Vials During Deep Cold Storage

  Learn how rapid, nondestructive laser-based headspace analysis can support with data generation to demonstrate the maintenance of seal integrity during deep cold storage and transport.

• Using Laser-Based Headspace Moisture Analysis For Rapid Nondestructive Moisture Determination Of Sterile Freeze-Dried Product

  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.

• Lyo Chamber Moisture Mapping

  Rapid non-destructive headspace moisture analysis from LIGHTHOUSE enables fast moisture determination of statistical numbers of lyo samples.

• Packaged Product Inspection

  Learn how Thermo Scientific product inspection systems help customers rapidly identify and correct problems in  pharmaceutical packaging. 

• Sterile Production Process Studies Using 100% Headspace Inspection Of Finished Product

  This app note describes the application of the PULSAR inspection platform to perform 100% headspace oxygen monitoring during the filling of oxygen-sensitive formulations, 100% container closure inspection of suspect batches, moisture inspection of freeze dried product, and automated media fill inspection.