Leak testers Print E-mail

Installation of leak testers to test the integrity of vaccin vials



 

Activity and interventions

  • Project Management.


Technical environment

 

  • Pharmaceutical field & regulation.
  • High level of technology.

 


Key figures

 

  • 12 project members
  • Project duration: 2.5 years.

Context

 

To test the integrity of their vaccine vials, our client needed to install new and unknown technology for leak testing, using pressure and vacuum systems or several vision systems to detect defects (particles, cracks, damage on closers, …) on the product itself or on the container (vials or syringes).

The ALTEN consultant is fully responsible for project management until hand-over of the leak testers. His responsibilities include design, commissioning and qualification. He also supports the activities for developing recipes and performs qualification steps for the visual inspection machines.

 

 

ALTEN's achievements

 

Project Management:

  • Cost & planning management.
  • Purchasing & scope changes management.
  • Installation, commissioning & qualification management.

 

Support:

  • Technical support.
  • Recipes development & qualification.

 

 

 

ALTEN's Added value

 

  • Project management background.
  • Expertise with qualification activities.
  • Methodological approach to new technology implementation.