Six Sigma Deployment For Complete Package Quality Control Presentation

Heinz Wolf, general manager of PTI Inspection Systems, recently gave a presentation during the 2012 PDA Berlin Chapter Parenteral Packaging Workshop on the topic of Six Sigma Quality and Container Closure Integrity

Package quality assurance and container closure integrity are fundamental concerns for all pharmaceutical applications, and the key to eliminating critical package failures boils down to two main factors:

• A comprehensive understanding of the packaging process and its variables
• Quantifiable, non-subjective, accurate, and reliable test methods for total package quality

This presentation focused on container closure integrity and provided an update of current best practices of integrity and leak testing of containers used for parenterals.

The methods will be applied in case format, describing the test method application to liquid filled & lyophilized vials, ampoules and pre-filled syringes." This presentation will review multiple test methods currently available:

• Dye (ASTM F1929-98)
• Visual (ASTM F1886, F1886M-09)
• Vacuum/Pressure Decay (ASTM F2338-09, F2095)
• HVLD

The attached pdf contains and outline/overview of the presentation. For more detailed information about container closure integrity testing, please contact PTI.