Insights On Quality Assurance

  1. In-Process Monitoring Of Headspace Oxygen Levels In Parenteral Containers

    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.

  2. Advances In Flowmeter Technology

    Thist article disucsses two trends turning the flowmeter industry on its ear: advances in flowmeter diagnostics and the adoption of smartphone-like technology to improve access and communications.

  3. Container Closure Integrity Of Sterile Vials During Deep Cold Storage

    Learn how rapid, nondestructive laser-based headspace analysis can support with data generation to demonstrate the maintenance of seal integrity during deep cold storage and transport.

  4. Elemental Impurities: Steering Clear Of The Big Four

    With new regulations having established a need for the testing of certain elements, correct sample preparation is crucial.

  5. Quality Assurance And Your CDMO

    While the end result of regulatory compliance with quality standards is binary, the processes employed to get there do not need to be rigid, prescriptive, inefficient, and expensive. In fact, updating quality assurance strategies and business practices with a healthy dose of flexibility and innovation can create an important point of differentiation by driving lower costs and higher efficiencies.

  6. Protecting Oxygen Sensitive Formulations Throughout The Product Life Cycle

    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.

  7. Implementing FDA Guidance: CCI Testing In Lieu Of Sterility Testing

    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."

  8. Container Closure, Pharmaceutical Glass And Plastic Testing

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

  9. Advances In Temperature Calibration Procedures

    Recent developments eliminate the need for unnecessary calibrations and speed up the time it takes to do calibrations in the field.

  10. Bioprocess Plant Cuts Down Time With Self-Calibrating Temperature Sensor

    To keep the risks in bioproduction as low as possible, an increase in calibration frequency is required. Read how the self-calibrating iTHERM TrustSens temperature sensor kept downtime to a minimum.