Insights On Quality Control

  1. 100% Container Closure Inspection Of Freeze Dried Drug Product In Quarantine
    12/26/2018

    A leading contract manufacturer approached LIGHTHOUSE for help after a suspected raised stopper issue motivated the manufacturer to place several batches into quarantine. A decision was made to perform 100% container closure inspection of the product vials with the help of LIGHTHOUSE.

  2. 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.

  3. Development Pathways For ATMPs: Virus Safety Challenges And Regulatory Perspective
    6/11/2019

    There is an increased risk of viral contamination in settings where ATMPs are prepared, making it critical to understand the contamination risks and the solutions available to control them.

  4. Container Closure Integrity Testing Method Development
    1/2/2019

    Recent regulatory revisions have also put emphasis on robust method validation for container closure Integrity test methods. This webinar covers approaches that can be used for method development for CCI testing in all phases of the product life cycle.

  5. Container Closure, Pharmaceutical Glass And Plastic Testing
    12/28/2018

    This presentation features testing overviews for container closures, pharmaceutical glass and plastic and covers common tests and techniques for each.

  6. ATC's Mass Extraction CCIT For Vials
    6/14/2019

    This video shows ATC's patented Mass Extraction technology in a container closure integrtiy testing example of system verification and system testing.

  7. 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.

  8. Common Fume Hood Containment Problems
    11/13/2018

    Most of us who start our careers being frustrated with this comment eventually learn that it is a cry for help from people who want effective exhaust and are focused on the most tangible element of the exhaust system, the exhaust hood.

  9. The Definitive Guide To Particle Sizing
    3/22/2019

    This paper provides an introduction to particle sizing comparing six widely used techniques, explaining how they work and what this means in terms of strengths and limitations. 

  10. 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.