Case Study

HPAPI Laboratory

Challenge:

A client that provides contract research and development and clinical supplies services was interested for the first time in incorporating highly potent active pharmaceutical ingredient (HPAPI) cabilities to their offering of services. They wanted to take a three-phase approach to gradually introduce HPAPI production cabilities to their facility by repurposing exisiting space.

Solution:

Valdes worked with the client to develop a phased approach for incorporating a HPAPI facility into the first level of the client's building. First, the facility will have capacity for a small scale HPAPI kilo lab, followed by a large scale HPAPI kilo lab and, finally, a HPAPI Quality Control (QC) laboratory. The first phase will include a renovation of three exisiting rooms that are currently office and general laboratory spaces and will include a common cooridor, material airlock and personnerl airlock when the project is finished.

Impact:

Valdes' HPAPI facility design allows for the installation of a client specified glove box isolator, necessary buildout fit-and-finish, comfort cooling chiller upgrade, stand-alone HVAC and exhaust systems, and necessary utilities including their distribution. The client will be able to add HPAPI cabilities to its offerings once the small scale HPAPI kilo lab is operational, including startup, commissioning, and qualification, by Spring of 2023.