C&Q of a Sterile Fill / Device Assembly Facility - Integrated Project Services - IPS
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C&Q of a Sterile Fill / Device Assembly Facility

We designed, commissioned and qualified a new 5,000sf sterile fill and device assembly facility to enhance production of rapid onset prescription drug formulations and innovative drug delivery products.  The new facility was designed and built within an existing shell and was originally designed as office space, thus requiring unique design solutions and equipment selection.  IPS was key in designing, selecting, starting, commissioning and validating the owner’s process equipment.

The project was a complex undertaking due to the fact that it was a new process system not yet tested or fully developed. In addition, we provided factory start-up and testing of the new process equipment. IPS was also responsible for the development of the acceptance criteria and test methods along with the development and completion of pre-functional and functional lists. The team provided construction administration services and maintained the project punch-list and oversaw the corrective actions by the sub-contractors.

The result was an enhanced commissioning program; minimized qualification testing, reduced change control and faster system testing completion.