Insights On Quality Assurance

  1. 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.

  2. Managing Risks With Potent Pharmaceutical Products 7/2/2019

    Managing the risks associated with potent compounds requires a knowledgeable team as well as the design and implementation of an effective safety program.

  3. 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.

  4. Container Closure Integrity Testing For Sterile Vial Products In Deep Cold Storage 12/28/2018

    A vaccine-focused biotechnology company approached LIGHTHOUSE to help investigate a phenomenon observed in liquid vaccine product stored at -80°C. During QC testing, a number of vials were found to have an overpressure. This phenomenon represented a serious safety risk and LIGHTHOUSE was asked to support an investigation to identify the root cause.

  5. Protecting Oxygen Sensitive Formulations Throughout The Product Life Cycle 6/13/2019

    Many biopharmaceutical drug formulations have some degree of oxygen sensitivity. Topics for this webinar include how oxygen levels in finished parenteral drug containers can be determined for oxygen scavenger & stability studies, for determining inherent primary packaging integrity, and for optimizing & qualifying inert gas purging system during filling.

  6. Non-destructive Moisture Analysis Of Freeze Dried Product 1/2/2019

    This webinar describes how non-destructive headspace moisture analysis can be used for characterizing batch moisture distributions, for lyo cycle development and optimization, and for freeze dryer moisture mapping and validation.

  7. External Management Improves Operational Quality 6/3/2019

    A biotechnology plant was struggling with the management of the calibration of the more than 100 reference standards covered about 20 calibration service providers. 

  8. The Effects On Container Closure Integrity Of Freeze Dried Vials 12/26/2018

    Non-destructive headspace analysis is a powerful method for monitoring container closure integrity in finished vials of freeze dried product and for building quality into the manufacturing operation.

  9. 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.

  10. CCI Testing And Revisions To EU Annex 1 1/2/2019

    The new language in EU Annex 1 will likely have a significant impact on your CCI testing practices. In this webinar CCI testing strategies and the proposed revisions to EU Annex 1 are discussed.