INSIGHTS ON QUALITY ASSURANCE

• Quality Assurance And Your CDMO

  The result of regulatory compliance with quality standards is binary, but the processes employed to get there don't need to be rigid, inefficient, and expensive. Learn how innovation drives efficiencies.

• 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.

• Using Laser-Based Headspace Moisture Analysis For Rapid Nondestructive Moisture Determination Of Sterile Freeze-Dried Product

  Rapid water vapor determination with an optical method could replace the slow destructive traditional methods for the moisture analysis of freeze-dried product. A description of industry applications of headspace moisture analysis including freeze drying cycle optimization, lyo chamber moisture distribution mapping, and 100% moisture inspection of commercial freeze-dried product.

• 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.

• When Clean Is Critical—Understanding Parameters And Definitions Of Clean

  Clean room environments necessitate high-quality materials and equipment that conform to a variety of specified standards. This white paper explains how clean parameters are defined and validated.

• The Evolution Of Supply Chain Security – Increased Focus On Raw Material Variability

  To maintain the bench-to-bedside continuum, companies must critically examine their supply chains and act to mitigate exposure to adverse supply events. Qualifying two suppliers, increasing capacity, implementing a scorecard methodology for strategic suppliers, and surveying suppliers for their number of production lines are all important ways to guarantee steady supply of materials and technologies – but we must ensure close attention is also paid to raw materials.

• 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.

• 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.

• 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.