Insights On Quality Assurance

  1. Calibration Management Increases Plant Availability

    Thanks to the set-up of a result-based calibration contract with Endress+Hauser and to the simplification of the operation, this major biotechnology plant has significantly reduced overall effort and calibration costs. The calibration time has also decreased, with positive impact on the plant process’s availability rate.

  2. Sterile Production Process Studies Using 100% Headspace Inspection Of Finished Product

    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.

  3. Non-Invasive Headspace Analysis For Automated Media Fill Microbial Inspection

    Laser-based headspace provides yet another alternative approach for detecting microbial contamination in sterile pharmaceutical product allows for quicker, more sensitive, accurate, and reproducible test results when compared with conventional, growth-based methods.

  4. Headspace Oxygen Monitoring On A Pre-filled Syringe Line Filling Oxygen-Sensitive Product

    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.

  5. ATC's Mass Extraction CCIT For Vials

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

  6. How To Clean And Handle pH Sensors

    For a pH sensor to maintain an accurate reading, the sensor must remain clean. Specifically, the glass measuring electrode cannot become coated, and the reference electrode assembly must not become coated, plugged or otherwise contaminated by the process solution. Here’s how to clean pH sensors to ensure correct operation.

  7. 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.

  8. Materials Characterization In Pharma

    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. Nitrogen Purge Optimization And Validation Of Sterile Liquid Filling Lines

    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.

  10. CCI Testing And Revisions To EU Annex 1

    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.