Insights On Quality Assurance

  1. 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.

  2. Oxygen Permeation In Pre-Filled Syringes
    1/2/2019

    This webinar presents how to design and conduct studies to assess the total oxygen permeation rate of your pre-filled syringes, and how to determine if the permeation is primarily through the plunger or through the tip.  Protecting oxygen-sensitive formulations during filling will also be discussed. 

  3. 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.

  4. Raman Spectroscopy Beyond The Lab: From Loading Dock To Production
    5/13/2019

    Raman spectroscopy offers a wide range of benefits in industrial and academic research, helping drive profitability in development, research, and quality control.

  5. 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.

  6. 10 Considerations For Balance Stability
    3/27/2019

    Stability of your weighing balance is paramount when it comes to collecting reliable data for project. As the old adage goes, “Anything that can go wrong will go wrong.”. Depending on the problem, taking obvious action for a seemingly obvious solution may not result in success. The purpose of this paper is to inspire thought and dialogue regarding those “not so obvious” sources of balance stability issues. Below, you may find 10 prompt questions that will hopefully guide one in resolving those pesky head-scratchers.

  7. Using Laser-Based Headspace Moisture Analysis For Rapid Nondestructive Moisture Determination Of Sterile 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.

  8. Materials Characterization In Pharma
    9/5/2018

    Materials science is now helping pharmaceutical companies to standardize and control areas such as drug form and manufacture to deliver new products more quickly and with greater quality.

  9. 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.

  10. External Management Improves Operational Quality And Increases Reference Meters’ Availability
    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. Endress+Hauser took the responsibility to manage the whole calibration process of the reference standards resulting in a reduction of non-conformities achieved has led to better operational quality.