INSIGHTS ON QUALITY ASSURANCE

• Determining And Controlling Oxygen Levels In Sensitive Formulations

  This webinar will review how oxygen levels in finished parenteral drug containers can be determined and controlled throughout the product life cycle by using laser-based headspace analysis.

• Raman Spectroscopy Beyond The Lab: From Loading Dock To Production

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

• 10 Considerations For Balance Stability

  Stability of your weighing balance is paramount when it comes to collecting reliable data. Depending on the problem, taking obvious action for a seemingly obvious solution may not result in success.

• 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.

• External Management Improves Operational Quality

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

• The Effects On Container Closure Integrity Of Freeze Dried Vials

  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.

• Assurance Of Quality Supply For Single-Use Pre-designed Solutions

  Read how resin specifications, process qualification and process controls established at all stages of the manufacturing process can ensure quality, change control and business continuity.

• 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.

• 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.