INSIGHTS ON QUALITY ASSURANCE

• 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.

• Process Characterization And Validation For Biologic Processes

  Using a risk-based approach to generate an appropriate control strategy will help assure your product meets characterization and validation requirements, enabling timely approval and launch to market.

• Quality Stability Testing: Oxygen Monitoring During Shelf Life

  A manufacturer of a syringe product received complaints about discolored product that was nearing the end of shelf life. A root cause investigation was started and product syringes were put on stability. The headspace oxygen levels were monitored over time. The laser-based headspace analysis proved to be a useful tool to check package integrity and for the presence of reactive headspace gases that can degrade the formulation.

• Container Closure Integrity Testing Technologies - PTI Packaging Technologies & Inspection

  PTI-Packaging Technologies & Inspection is headquartered in Hawthorne, New York, a Westchester county community close to New York City. We are a team of engineers, scientists and professionals serving the packaging industry as a leading equipment manufacturer of package inspection equipment. PTI’s inspection technologies are deterministic test methods that produce quantitative test result data. Our technologies conform to ASTM and other regulatory standards. We specialize in offering our customers the entire solution including test method development and packaging inspection equipment validation. PTI installations have been successful in globally transferable and validated test methods.

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

  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 close attention must also be paid to raw materials.

• Protecting Oxygen Sensitive Formulations Throughout The Product Life Cycle

  Many biopharmaceutical drug formulations have some degree of oxygen sensitivity. Topics for this webinar include how oxygen levels in finished parenteral drug containers can be determined for oxygen scavenger & stability studies, for determining inherent primary packaging integrity, and for optimizing & qualifying inert gas purging system during filling.

• Filling Line Nitrogen Purge Qualification In Manufacturing

  A client had an existing filling line and wanted to optimize the nitrogen purge process to decrease headspace oxygen levels to 2%. In addition, frequent line stoppages resulted in a need to identify and reject high oxygen vials that had lost the nitrogen headspace during the stoppage. A purging process qualification study was performed using rapid non-destructive headspace oxygen analysis in an at-line set-up with samples being measured immediately from the line.

• 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.

• 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.