Package Inspection White Papers & Case Studies

51. 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.

52. 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.

53. Sterile Production Process Studies Using 100% Headspace Inspection Of Finished Product 12/27/2018

    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.

54. 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.

55. 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.

56. 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."

57. 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.

58. Smoke Signals – One Plant's Secret For Assuring Aseptic Control 11/29/2018

    Airflow visualization testing, conducted as part of a routine review program, can help assure that aseptic filling areas remain under a state of proper control.

59. Container Closure Integrity Testing: Risks And Methods 11/12/2018

    We share an overview of integrity tests where high sensitivity is required to prevent the risks of stability failure of highly moisture-sensitive drugs or biological ingress of sterile parenteral drugs.

60. How An Outsourcing Partner Can Deliver Efficient Serialization Solutions 11/5/2018

    Are you serialization-ready? Failure to comply could result in penalties and the inability to sell your un-serialized products.