Application Note

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

MBailey-120501-039

Recent regulatory guidance on process validation in the pharmaceutical industry has emphasized product and process understanding and process control, based on sound science and quality risk management. The analysis of statistical sets of finished pharmaceutical product is increasingly being used to determine if the process is capable of reproducible commercial manufacturing. An assessment can then be made if the risk in the commercial manufacturing process merits 100% inspection of finished product. The Lighthouse PULSAR Headspace Inspection System is an automated 100% inspection platform designed to measure the physical headspace conditions in sealed parenteral containers. The measurements are based on spectroscopic methods and are analytical, rapid, and non-destructive. This Application 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.

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