Althea cGMP Improvements

Overview:

 This project included the construction of additional manufacturing space within the Althea's Sorrento Valley headquarters facility.  The new spaces included a clean manufacturing space, a materials storage and distribution space, as well as flexible space for mechanized pharmaceutical equipment location.  When complete, the expanded manufacturing area will provide for their specialized areas for client manufacturing processes.  The new space is immediately adjacent to existing GMP manufacturing areas and administrative space.

 Design Approach:

 Interviews were conducted with scientific staff and facility managers in order to determine the best arrangement for the new space.  Additional interviews were conducted with City of San Diego Building Department personnel in order to resolve exiting issues that were identified during the initial building survey.  As built drawings for the facility were researched, and detailed in place measurements were taken, to reconcile the as built plans with the actual in place construction.  Surveys were conducted of the existing mechanical and electrical systems in order to determine how the new space could be most easily supported as an independent stand alone set of manufacturing suites.

Design Objective:

This new GMP manufacturing suite is immediately adjacent to existing similar spaces and the headquarters facility.  A primary objective is to make the new work appear to be part of the original construction, and to blend seamlessly from the old to the new.  The new finish fixtures and fittings were selected to match as closely as possible   the original construction.  The new space was to be designed as a stand-alone fully functional independent facility within the overall building HVAC and electrical systems framework.  In order to support on going manufacturing to within the building, a phased plan for the construction space was devised to allow ongoing operations in the existing facility to proceed unimpaired during the construction of the new work. 

Design Challenge:

 This new work was to take place inside an existing building, while all the exit systems in the building were to remain fully operational. Alternate temporary exit plans were devised and constructed. In addition, the control of dust was to be  put in place so that  no dust was to enter the existing manufacturing space.  All construction personnel and equipment materials and other related items were required to enter and leave the facility directly from the outside, neither entering the building proper, or exiting through part of the building to the outside.  All connections to existing utilities were required to be made inside the space. Special precautions were put in place, and training provided to construction personnel in the construction protocols required to keep the existing nearby spaces in operation at all times.