Fruh Packaging, Inc. – U.S. Expansion
Fruh Packaging, Inc. opened its new, state-of-the-art production facility in Exton, Pennsylvania. Früh Verpackungstechnik, located in Fehraltorf, Switzerland, is a leading Swiss industrial company that develops solutions for complex packaging needs. This expansion into the U.S. marked a significant milestone, supporting the company’s contract packaging services for medical devices and replicating the high standards and comprehensive service catalog available at the Switzerland location.
Working closely with the teams at Fruh and developer, Hankin Group, Precis assisted in designing the new 42,900-sf facility, with an additional 21,100 sf planned for future expansion. The facility includes an ISO 7 primary packaging cleanroom, ISO 8 final rinsing and material airlock and gowning rooms, and a CNC incoming inspection and final packaging area. The cleanrooms feature modular construction with a viewing corridor and ample exterior daylight.
Eisai Co., Ltd. – Pilot Plant
Eisai Co., Ltd. (formerly Morphotek) is a biopharmaceutical company focused on research and development for the treatment of cancer and infectious diseases. The award-winning building was designed for the production of biologics to support early-stage clinical trials. The project involved master planning, architecture, and engineering design services for the 60,000-sf cGMP pilot plant to support manufacturing of advanced therapeutics. The use of BIM software enabled advanced coordination, team communication, and project organization.
The project began with demolition of three existing buildings and construction of the new facility, which includes the pilot plant, laboratories, and office space. Integrated architecture and engineering yielded a facility that marries form and function. A unidirectional circulation and viewing corridor maximizes building area dedicated to production. A mechanical catwalk rings the production core and provides access to all building systems for ventilation and maintenance. Dual fixed and disposable technology offer flexibility in manufacturing. Natural light permeates most of the building, including office and laboratory areas. The building offers 85.2 percent efficiency, with full systems redundancy, and enables complete segregation of production spaces in the event of a failure or contamination.
Sustainable design and operational features of the project resulted in LEED Gold Certification, and the project was recognized as an ISPE Facility of the Year Sustainability Category winner. The plant is 30 percent more water efficient, 33.2 percent more energy efficient, and offers a 90 percent more efficient HVAC system compared to a standard pharmaceutical facility. A rooftop solar array includes 330 photovoltaic panels that generate enough annual electricity to power six U.S. houses for a year.
The award-winning project was completed $3 million under budget in 18 months.
Images © Don Pearse Photographers, Inc.
Center for Breakthrough Medicines – 411 Innovations Labs Complex
Precis was tasked with programming multiple buildings within the Center for Breakthrough Medicines (CBM) 411 Innovations Labs complex in King of Prussia, Pennsylvania. The CBM is an advanced therapy-focused contract development manufacturing organization (CDMO) dedicated to delivering life-changing patient treatments.
Precis provided programming for viral vector, cell therapy, filling, plasmid, and mRNA manufacturing; myco, molecular, quality control (QC), next-generation sequencing (NGS), virology, flow cytometry, and environmental monitoring testing labs; and warehouse and support areas.
Precis was responsible for defining user requirements to be able to develop a conceptual floor plan and equipment layout. Tasks included participating in programming meetings with the users to walk through the process and define space requirements. In addition to the floor plan, room cards were developed to define equipment, utilities, and other design requirements needed within each room. Deliverables included a programming questionnaire, programming layout, equipment list with consumption requirements, and the development of room cards. After completing concept design, Precis continued to provide design support to the architectural and mechanical, electrical, and plumbing teams along with providing GMP expertise.
Piramal Pharma Solutions – Fill/Finish Manufacturing Facility Expansion
Piramal Pharma Solutions is a leading global contract development and manufacturing organization (CDMO). Precis provided architecture, process architecture, and mechanical, electrical, plumbing, fire protection, and process engineering design services for interior renovations and facility expansion of Piramal’s Lexington fill/finish manufacturing facility. Situated on a 12-acre site, the facility had sufficient land area to expand the existing building’s footprint and site features to meet the current need for expanded fill/finish capacity.
The 24,000-sf expansion included a Grade C fill/finish suite with associated Grade C support areas and Grade D equipment staging and clean-in-place (CIP) and sterilize-in-place (SIP) rooms. Renovations to the existing building included a 2,600-sf microbiology lab suite with CNC laboratory and support areas, Grade D gowning rooms, and a Grade C sterility testing room.
Additional support spaces included a new production staff office suite, new toilet areas, and upgrades to the existing unisex changing rooms. New mechanical equipment and building utilities were provided on a new mechanical mezzanine above the production area expansion, within the existing mechanical rooms, clean utility room, and outside adjacent to the building.
Additionally, Piramal requested the design of 12 new, temporary cold boxes and a connecting corridor as well as design for a new building connection from their existing building to the temporary cold box corridor.
cGMP Warehouse
Precis provided full architecture, mechanical, electrical, plumbing, fire protection, and process engineering services for the multi-phase design and engineering of a new off-site cGMP warehouse and storage facility for a global contract research development and manufacturing organization (CRDMO) in New Jersey.
Supporting services for the client’s existing facility in a nearby town were also provided. The remaining shell space fit-out will include a new modular-construction drug product fill/finish suite, cell bank suite, product sample suite, and various cold storage amenities. The existing two-story 14,000-sf front office underwent minor renovations to accommodate a new workspace, which required a new 650-sf quality control (QC) laboratory.
Renaissance Pharma, Inc. – Grade C Compounding + Filling Suites
Precis supported expansion of the existing Grade C filling capabilities to support a manufacturing contract for compounding, filling, and packaging a bio-dosage nasal product with a potent active pharmaceutical ingredient (API). The project renovated existing process areas to create two new filling suites and one compounding suite, with associated technical support spaces. In addition, an existing secondary packaging area was enclosed to control access to new secondary packaging equipment.
Two compounding scale stations were incorporated into the design, each equipped with a pit scale and utility panel with process vent, vacuum, water for injection (AWFI), clean steam, clean steam condensate, compressed air (30 psig and 90 psig), nitrogen (two at 30 psig), process waste, tempered chilled water supply and return from a telematics control unit (TCU) (one with chilled water supply and return), and a local human-machine interface (HMI) for TCU control to support compounding in vessels up to 250L. One of the two compounding stations was designed for future use of solvents.
The project utilized pre-engineered modular wall and ceiling panels with honeycomb core and PVC coating and an epoxy urethane floor system with an integral cove base integrated with the modular wall panels. The cleanroom walkable ceiling is connected to the existing mezzanine about this area. An elevated steel-framed system was provided to support a mezzanine extension or catwalk system. An elevated steel dunnage platform extension above the existing roof was provided to house the new chilled water, process chilled water, and air systems infrastructure.
DSM Biomedical – New Headquarters Building
Kensey Nash, acquired by DSM Biomedical, is a worldwide leader in the medical device industry known for novel product development and advanced technology in the field of biomaterials for vascular and embolic protection. The new headquarters building includes corporate offices, research and development laboratories, along with manufacturing and warehousing totaling 200,000 sf.
The project scope included programming, assistance with site selection and land development, site master planning, building design, construction administration, and furniture procurement for a phased project, constructed on a 23-acre greenfield site.
Design-Build Biomedical Manufacturing Facility
Precis worked as part of a design-build project team on the design of a 40,000-sf biomedical manufacturing facility related to the manufacture of human biologic products.
The design involved the build-out of an existing warehouse shell space. The scope included office, laboratory, manufacturing, and utility areas, including modular clean room construction. Full mechanical, electrical, plumbing, and fire protection engineering design was included in the build-out with consideration for future expansion into adjacent warehouse space.
Eisai, Inc. – Biopharmaceutical Facility
Eisai, Inc. is a biopharmaceutical company focused on the discovery and development of therapeutic monoclonal antibodies for the treatment of cancer and inflammatory and infectious diseases.
Precis provided architectural and engineering services to facilitate the master plan, design, and two phases of construction. In Phase 1, 16,000 sf of the existing 40,000-sf building were renovated, providing administrative offices and research and development (R&D) laboratories. A second phase included full architecture and engineering services for a 19,400-sf building addition along with renovation of the building’s remaining 24,000 sf.
The program included research and development laboratories, a vivarium, a data center, and an employee lunchroom with the capability to convert to a corporate meeting room for 100 people. Infrastructure included a complete upgrade of existing lab HVAC and utility systems, and design of all new building utilities including high pressure steam, heating hot water, chilled water, preheat glycol water, and a new main electrical service.
Image © Don Pearse Photographers, Inc.
Terumo Medical Corporation – FemoSeal Cleanroom Renovation
Precis provided architecture and full mechanical, electrical, plumbing, and fire protection engineering services to facilitate interior renovations to provide production space for Terumo Medical Corporation’s FemoSealTM vascular closure system. Production operations for this product were being relocated to Elkton, Maryland, from Costa Rica.
The renovations included the addition of an ISO 8 assembly area, an ISO 8 gowning area, and an ISO 8 material airlock, a drying oven and final packaging area, a sterile prep area, siliconization washing, and an analytical lab. The project required strategic re-distribution and re-balancing of existing air-handling systems to maintain production in the adjacent manufacturing suites during construction.
New mechanical systems included a 37,000-CFM custom rooftop dunnage-mounted air-handling unit (AHU) with desiccant wheel dehumidification and associated air distribution to support the low humidity requirement of the manufacturing space, as well as new compressed air drying and heating equipment to support the device assembly process. The siliconization washing space also required a dedicated hazardous exhaust system with lower explosive limit (LEL) monitoring and in-duct sprinkler protection.