INSIGHTS ON QUALITY ASSURANCE

• 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.

• 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.

• 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.

• Headspace Oxygen Monitoring On A Pre-filled Syringe Line Filling Oxygen-Sensitive Product

  This application note describes how laser-based headspace analysis is used for the rapid non-destructive determination of headspace oxygen levels in pre-filled syringes. Data is presented demonstrating two major applications of this technique: 1) headspace oxygen monitoring on a pre-filled syringe line filling oxygen-sensitive product, and 2) container closure testing of pre-filled syringes.

• 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.

• 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.

• 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.

• 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.

• A Guide To Weigh Cell Technologies For Food And Pharma Industries

  For parcel processing, as well as food and healthcare packaging, recent technology advancements have made in-motion weighing operations more precise and profitable. The latest and greatest catchweighers and checkweighers incorporate weigh cells featuring Electro-Magnetic Force Restoration, or EMFR. In addition, combining EMFR with AVC (Active Vibration Compensation) enables accurate product weight measurements.