Cytiva (Marlborough MA)
Cytiva needed to rapidly expand the capacity of its Fast Trak biomanufacturing services. This was to support a new customer filling an urgent public health need. Hart provided full turnkey services – basic and detailed design, construction, and passivation; as well as validation and quality support.
The expansion included 1300 s.f. of new cleanroom manufacturing, a new USP Purified Water loop extension, and high-purity compressed air points-of-use.
Hart self-performed all carpentry, process mechanical work and below-slab structural work. As general contractor, Hart procured HVAC, controls, plumbing, electrical, and flooring.
Construction was conducted successfully despite the COVID 19 pandemic because of the timely, careful and prudent application of safety procedures and protocols.
The design was subjected to Quality Risk Management (QRM) and the ASTM E2500 standard assuring cGMP, 21CFR Part 11, and data integrity compliance. IOQs, PQs and other validation documents were provided via a third party.