Application Note

Stopper 'Pop-Up' And The Effects On Container Closure Of Sterile Vials

Source: Lighthouse Instruments

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Application Note: Stopper 'Pop-Up' And The Effects On Container Closure Of Sterile Vials

By Lighthouse Instruments, LLC

Container closure integrity plays an important role in maintaining the stability and sterility of lyophilized products. The increased number of biological products coming to market and the need to extend product shelf life has driven the growth of lyophilization capacity worldwide. Lyophilization is a complex process that presents many manufacturing challenges one of which is maintaining and monitoring container closure integrity. Recent attention to package integrity issues can be seen in both the revised aseptic processing guidance from the regulatory agencies (for example, Annex 1 revisions to the European Guidelines for the Manufacture of Sterile Products) and an increasing number of package integrity related product recalls. Concerns over the number of customer complaints and the cost of investigations and recalls has motivated investment in container closure inspection systems by the industry as a means of building quality into manufacturing operations.

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Application Note: Stopper 'Pop-Up' And The Effects On Container Closure Of Sterile Vials