Package Inspection White Papers & Case Studies

51. 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.

52. 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.

53. 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.

54. 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."

55. 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.

56. 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.

57. 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.

58. 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.

59. Aseptic Blow-Fill-Seal: A Sustainable Process For Packaging Pharma Liquids 10/17/2018

    Aseptic blow-fill-seal systems for packaging pharmaceutical liquids incorporate materials and processes that provide critical advantages for sustainable initiatives.

60. Replace Dye Ingress With Mass Extraction To Mitigate Risks 10/2/2018

    A major pharma company had a problem. Its manufacturing process engineers could not reliably verify that pouch packages were sealed properly. Product could potentially ship with questionable packaging.