API Facility Commissioning

API Facility Commissioning

API Facility Commissioning

ALTEN Technology played a critical role in commissioning one of the world’s most advanced API facilities, supporting 24/7 operations with validation expertise, technical scripting, and GMP-compliant processes. From shift-based automation support to leak testing and deviation management, our consultants delivered hands-on solutions that helped bring this global healthcare client’s Montrose plant online—faster, safer, and fully…

This case study details how ALTEN Technology provided crucial support for the commissioning of a new API facility at a leading global healthcare company. This client, a science-led organization with extensive operations in pharmaceuticals, vaccines, and consumer healthcare, operates one of only two API manufacturing plants worldwide that adheres to the highest quality standards. Based in Montrose, UK, ALTEN Technology consultants integrated as shift technical support within the 24/7 facility, collaborating closely with operations and automation teams. Their comprehensive involvement included supporting validation activities, delivering technical solutions to ensure product requirements were met, assisting with HAZOP processes, updating functional specifications, and meticulously writing commissioning scripts for pre-validation tasks like leak and functional testing of new installations. ALTEN Technology’s ability to quickly ramp up resources and operate within a continuous production environment proved vital in developing non-routine activities to manage deviations between commissioning batches, all while working with tools such as DCS Emerson DeltaV and ensuring strict GMP compliance and data integrity.

API Facility Commissioning

API Facility Commissioning