IPS was selected by BWXT ITG Canada, Inc. to provide basis of design and detailed design for BWX Technologies, Inc.’s (BWXT) isotope project, specifically the expansion of their medical isotope and radiopharmaceutical facility. 

IPS provided engineering solutions to BWXT for the development and commercialization of diagnostic medical isotopes in a new FDA-compliant manufacturing radio-pharmaceutical facility within an existing vacant location of their existing manufacturing site.

BWXT’s project, utilizing breakthrough technology, is for the development and commercialization of Molybdenum-99 (Mo-99) and Technetium-99m (Tc-99m).

IPS’ internationally recognized experts work collaboratively with BWXT engineering and development teams to safeguard the new design and implementation plan to meet the required facility change and support the demand for critical medical isotopes.

The manufacturing area (facility, utilities and processes) included support areas such as change rooms, secondary packaging, technical write-up area, and warehouse optimization. During the concept facility planning, several conceptual layouts were created to compare costs, constructibility, and compliance risk. 

IPS managed, coordinated, and led the design activities through the utilization of BIM and other 3D design approaches.  

The major schematic design included a project profile, process profile, containment and segregation, decontamination and cleaning, CGMP area classification, transition and gowning strategies, process architecture, hazardous materials, and utilities.

IPS developed and managed the commissioning, qualification and validation plan (VMP) that defined the testing strategy for the utilities and equipment associated with this project that complements the existing site validation strategy.

IPS provided construction assistance to collect the construction redlines and perform spot verifications as well as procurement services. 

The facility was designed to meet all applicable building standards to be compliant with current GMP regulations to support FDA approval, and consider EMA Annex 1 facility-related requirements to allow sufficient space for future accommodation.

Image courtesy of BWXT ITG Canada, Inc.