Package Inspection White Papers & Case Studies

51. How To Properly Test Your Industrial Metal Detector 2/7/2019

    In this paper, we explain the differences between validation, verification and routine performance monitoring and give an overview of recommended test methods for different metal detection systems.

52. Rapid Nondestructive Moisture Determination Of Freeze-Dried Product 12/28/2018

    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.

53. Non-Invasive Headspace Analysis For Automated Media Fill 12/28/2018

    Explore how laser-based headspace provides an alternative approach for detecting microbial contamination in sterile products, which allows for quicker, more accurate test results.

54. Headspace Oxygen Monitoring On A Pre-filled Syringe Line Filling Oxygen-Sensitive Product 12/28/2018

    This application note describes how laser-based headspace analysis is used for the rapid non-destructive determination of headspace oxygen levels in pre-filled syringes. Data is presented demonstrating two major applications of this technique: 1) headspace oxygen monitoring on a pre-filled syringe line filling oxygen-sensitive product, and 2) container closure testing of pre-filled syringes.

55. Lyo Chamber Moisture Mapping 12/27/2018

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

56. Root Cause Investigation Into A Possible Container Closure Integrity Failure 12/27/2018

    In cases where oxidation of the formulation causes discoloration and eventual degradation of the product, non-destructive headspace analysis tests can give deep insight into the root cause. Since the samples are not destroyed by the headspace analysis, further testing can be done to accurately correlate headspace conditions with other product characteristics.

57. Nitrogen Purge Optimization And Validation Of Sterile Liquid Filling Lines 12/27/2018

    Large molecule biopharmaceuticals can be prone to oxidation and to prevent this from occurring, the headspace is often purged with an inert gas during filling to ensure a longer shelf life.

58. In-Process Monitoring Of Headspace Oxygen Levels In Parenteral Containers 12/27/2018

    Using a high sensitivity detection technique known as Frequency Modulation Spectroscopy (FMS), LIGHTHOUSE rapid non-destructive headspace oxygen inspection can help streamline the monitoring of purge performance on the filling line. This paper demonstrates the correlation of the FMS rapid non-destructive technique for analyzing headspace oxygen levels with the most commonly used conventional destructive techniques for headspace oxygen inspection.

59. Implementing FDA Guidance: CCI Testing In Lieu Of Sterility Testing 12/26/2018

    This application note details FDA released guidance titled “Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products."

60. Introduction To Laser-Based Headspace Inspection And The Application To 100% Container Closure Inspection 12/26/2018

    Gain insight into the process, ensure the maintenance of sterility for finished product after capping, and meet current regulatory guidance using laser-based headspace inspection.