INSIGHTS ON QUALITY CONTROL

• 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.

• Non-destructive Moisture Analysis Of Freeze Dried Product

  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.

• Advanced Digital Sensors Improve Lifecycle Management

  Digital sensors make it possible for the same sensor, lifecycle management software and SOPs to work in both lab and production environments.

• Introduction To Laser-Based Headspace Inspection And The Application To 100% Container Closure Inspection

  Gain insight into the process, ensure the maintenance of sterility for finished product after capping, and meet current regulatory guidance using laser-based headspace inspection.

• Root Cause Investigation Into A Possible Container Closure Integrity Failure

  In cases where oxidation of the formulation causes discoloration and eventual degradation of the product, non-destructive headspace analysis tests can give deep insight into the root cause. Since the samples are not destroyed by the headspace analysis, further testing can be done to accurately correlate headspace conditions with other product characteristics.

• Container Closure Integrity Testing Method Development

  Recent regulatory revisions have also put emphasis on robust method validation for container closure Integrity test methods. This webinar covers approaches that can be used for method development for CCI testing in all phases of the product life cycle.

• Shipping, Assembling, And Installing Bulky Exhaust Equipment In A Lab

  Though delivering, unloading, staging, and assembling are required steps in all lab construction, there are design aspects of lab equipment that can contribute to its successful field installation.

• 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.

• 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.