Vector Suite for Non-Antibacterial Beta-Lactams
Precis provided the architectural and engineering design for the development of a new non-antibacterial Beta-lactams drug production suite. The project included the fit-out of an existing manufacturing suite, approximately 4,000 SF, to be used for a revised manufacturing process. Design also included the modification of a primary packaging line for a more robust dust collection.
Precis did the original engineering design for the suite in 2007. For this project, Precis was competitively contracted for the preliminary design study. Upon Client satisfaction with the work provided in the study, additional sole-source awards were given to Precis for the detailed design and construction administration services.
The project included multiple design hurdles that Precis was able to overcome through planning and close coordination with the Client. The largest hurdle was the adjacent manufacturing suites sharing a Corridor with the Ezetimibe Suite, as well as the Ezetimibe Suite and an adjacent Suite sharing a mechanical corridor and mezzanine that would require separation to meet the requirements for a monobactam manufacturing facility. Precis was able to provide new layouts to meet the requirements of the space, as well as designing dedicated material airlocks between the Ezetimibe Suite and common clean corridor. Precis worked with the Client to complete several conceptual design iterations before participating in the FMEA to determine the ultimate design for construction that best suited the Client’s needs.
All design options carefully considered construction cost and attempted to minimize modifications to the existing space layouts while still providing the required elements for containment and proper flows for materials and personnel in order to meet the strict isolation requirements for the product manufacturing. This included the transition of a bubble-type suite to a cascade. Precis’ deep understanding of clean spaces and manufacturing standards allowed for innovative solutions that ensured compliance while optimizing operational efficiency and the project.
Kremers Urban Pharmaceuticals – Oral Solid Dosage (OSD) Manufacturing Suite
Precis designed a 10,000-sf oral solid dosage (OSD) manufacturing suite expansion for Kremers Urban Pharmaceuticals, a specialty generic pharmaceutical company. The architectural design included layout, code analysis for high hazard occupancy, and specifications for partition systems and finishes. The engineering design included mechanical, electrical, and plumbing systems required for solvent dispensing, solution preparation, and controlled humidity, along with HVAC systems and ductwork, electrical distribution, and chilled water, steam, and compressed air distribution. The design also included spaces for future expansion.
The manufacturing suite incorporated Glatt GPCG 120s with three-column Wurster coaters and thermal oxidizers, drum and bowl inverters for bin loading, bin blending and handling (1,000L), a central chilled water plant, a waste neutralization system, and support spaces including protected and utility corridors, a wash area, and USP water system.
In addition to the manufacturing space design, the team performed a central utility upgrade, adding a new 1,200-ton chiller plant, as well as a new central batch-type waste neutralization system.
Image © Ivan Milovanov / IM Imagery OU
QO Micro/Sterility Lab Consolidation
Precis provided process, automation, mechanical, electrical, plumbing, and fire protection engineering services for the renovation of an existing maintenance shop to consolidate several existing QO micro-sterility laboratories into one new space with shared support areas. The QO lab will support vaccine testing for the entire site and increase reliability and efficacy of overall facility function. Key components of the project included lab programming, lab and process equipment specification, hazard analyses, expansion of the United States Pharmacopeia (USP) purified water loop, installation of a new mechanical penthouse, and design of HVAC, plumbing, and electrical infrastructure to support lab processes. The automation design included instrumentation for the USP loop expansion, including service to new parts washers and autoclaves via an Allen-Bradley programmable logic controller (PLC) control system.
Decarbonization Site Audits
Precis performed a decarbonization study of four of the client’s 15 highest carbon-generating sites. These sites consisted of pharmaceutical manufacturing, laboratories, warehouses, offices, and central utility plants comprising of over 3.1 million sf of occupiable space.
Precis performed detailed energy analyses to help the company achieve its decarbonization goals, with measures specifically tailored for decarbonization including renewable energy generation, electrification, and thermal energy/battery storage. Precis evaluated all energy-consuming systems at each facility including water-cooled HVAC chilled water systems; process chilled water systems; high- and low-pressure steam boiler systems; central cogeneration facility; air-handling systems for manufacturing, laboratory, and office spaces; exhaust systems; clean utilities including water for injection (WFI) and clean steam; compressed air; and lighting.
Precis identified over 375 viable opportunities across the four campuses with annual cost savings opportunities across all facilities totaling over $4.4 million. This resulted in a nearly 40 percent carbon reduction at the sites with the greatest opportunity. Strategic recommendations were made at each site to eliminate Scope 1 emissions in their entirety. Detailed energy savings calculations, cost estimates, payback analysis, and narrative to support a business case for implementing over 103 projects were also provided. Following the study, the client engaged Precis for the design of several opportunities relating to cogeneration feasibility, chilled water optimization, and boiler replacement.
Terumo Medical Corporation – Project Gemini
Terumo Medical Corporation is one of the world’s leading manufacturers of medical devices and supplies. Precis developed a master plan for phased renovations to the company’s existing 180,000-sf production facility, which contains a combination of ISO 8 and Controlled-Non-Classified (CNC) spaces. The existing layout had production spaces along perimeter exterior walls, and most of the HVAC used a plenum return, making it difficult to control pressurization, temperature, and humidity.
Precis developed a phased master plan to provide redundant primary air-handling units (AHUs) and flow-control devices to support ventilation, pressurization, dehumidification, preheat, and humidification requirements. In this approach, construction could occur in phases while maintaining production activities. Existing AHUs were utilized to support sensible cooling within each suite. Ducted fan filter units and low wall return grilles were used to provide for additional air turnover.
The first phase of implementation consisted of interior renovations to provide a modern clean room production space and involved providing primary air to the Project Gemini clean room and an adjacent clean room. The total project area of the two clean rooms, utility closet, and adjacent corridors totals approximately 15,300 sf.
The second phase of implementation included adding the third and fourth primary air units, connecting them to three additional production air-handling systems, and replacing and supplementing the existing fan filter units and low wall return grilles to improve space pressurization, temperature, and humidity control.
ForDoz Pharma – Sterile Biopharm Manufacturing Facility
ForDoz Pharma is a commercial-stage pharmaceutical company focused on developing, manufacturing, and commercializing innovative complex injectables for patients with severe and chronic diseases.
Precis completed the design of a new process-intensive biopharmaceutical manufacturing facility in Central New Jersey. The project consisted of the partial demolition of an existing structure and creation of a new multi-level building to provide space for process equipment and new central utilities. The facility incorporates all functions necessary for sterile production, including warehousing, filling, and packaging. The processing areas are composed of pre-engineered cleanroom modular panels with walkable ceilings. The process rooms house multiple compounding systems which are followed by a fill line isolator and lyophilizers. Additional future processing spaces were integrated into the layout. All new central utilities, including new electrical service, backup generator, steam, chilled water, and clean utilities, were added as part of the project scope.
Compliance Upgrades
Precis provided mechanical, electrical, plumbing, fire protection, and process engineering services for a new building addition and renovation of 40,000 sf of GMP multi-product biological pilot plant space. Renovations were required to upgrade the suites to comply with quality and regulatory agency requirements. The design included a new second-story locker room addition, fire water containment, aseptic isolator, airlock and suite reconfiguration, and renovation of existing utilities including water for injection (WFI), clean filtered gases, HVAC, and electrical.
Precis also designed an 18,000-sf renovation of the first-floor pilot plant, which included a new Occupational Exposure Band (OEB) 3-4 weigh and dispensing area and new media and buffer prep area. The project added gowning modifications and additional airlocks to accommodate GMP compliance requirements. A new Biosafety level (BSL) 2+ laboratory area was built which included a -70°C reach-in freezer area within a -25°C cold storage area.
Cold Vault Upgrade
A confidential client had an existing -25º C cold storage facility with major temperature control issues. The facility experienced severe floor slab heaving due to a malfunction of the underfloor heating system. Precis was retained to renovate the area to correct the slab heating issues. Precis also replaced the configurable temperature units (CTUs) to provide a more robust cooling system with multiple levels of mechanical and electrical redundancy and the ability to operate in varying refrigeration or freezer modes to support the needs of the client’s business.
Precis provided full mechanical, electrical, plumbing, and fire protection engineering services for the implementation of a new refrigeration system that could accommodate varying temperature needs, ranging from -25º C to +5º C, and maximize system reliability and redundancy. The client will store over $500 million in finished vaccines at any given time. To ensure maximum system uptime, Precis designed a six-circuited refrigeration system that could maintain box operation under multiple mechanical or electrical power failure scenarios.
Precis also designed an innovative, efficient electrical underfloor heating system with two levels of redundancy. The new system included full emergency power backup and separate liquid nitrogen system containing six evaporators for -25º C backup.
WuXi AppTec, Inc. – 4701 Master Plan + Basis of Design + Detailed Design
Precis was retained by WuXi AppTec, Inc. to develop the master plan program and basis of design for a new 150,000-sf manufacturing and laboratory facility in the Philadelphia Navy Yard.
The new building consists primarily of two floors of approximately 75,000 sf each, a single-story office/entry way, a single-story high-bay warehouse, and a single-story mechanical building. The design accommodates a full fit-out with segregated cell therapy and viral vector suites, and logistics and material management to support operation. The design layout incorporated modular construction in order to be flexible and maximize equipment efficiency with room for future expansion.
Precis provided basis of design for cGMP compliance to handle T-cell therapy and clinical-grade to commercial-scale materials to support viral vectors for cell and gene therapy; process development (PD) laboratories; analytical laboratories to support manufacturing and PD; and logistics, support, and office spaces. A preliminary building area diagram was developed and adopted in concept by WuXi AppTec.
Precis was re-engaged to perform the detailed design and provide support during construction for Phases 3 and 4.