INSIGHTS ON QUALITY ASSURANCE

• Using Positive Controls In Container Closure Integrity Studies

  This webinar describes the use of positive controls as an important element of CCI studies designed to validate packaging components for CCI or to qualify processes for producing good CCI.

• Quality Assurance Of Hotel Cosmetics

  Using checkweighers for 100% inline product control of bottles, jars and tubes.

• Managing Risks With Potent Pharmaceutical Products

  Managing the risks associated with potent compounds requires a knowledgeable team as well as the design and implementation of an effective safety program.

• 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.

• Materials Characterization In Pharma

  Materials science is now helping pharmaceutical companies to standardize and control areas such as drug form and manufacture to deliver new products more quickly and with greater quality.

• 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.

• 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.

• Implementing FDA Guidance: CCI Testing In Lieu Of Sterility Testing

  This application note details FDA released guidance titled “Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products."

• 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.