Cyma Builders completely renovated an existing pharmaceutical production space for August Bioservices, helping to facilitate their future business goals. The client purchased the facility with the intent of developing an extensive CDMO capability located in the middle of the United States.
The initial step was to revamp the existing facility to enable manufacturing operations while the future buildings were being designed. This involved overhauling the mechanical and electrical systems, and installing new clean process utilities to support the filling process that was intended for the site.
Significant work was also done on the existing equipment mezzanine above the suites, which included removing of AHUs and installing of new ductwork. This was coordinated with other utilities and equipment to ensure clear maintenance access.
Additionally, Cyma assisted the client in arranging for a new electrical service from the public utility company, capable of supporting the increased power needs from the current renovation and future expansion projects.
This project was executed during the COVID-19 pandemic. As a result, the project suffered significant challenges related to supply chain issues which affected stainless steel piping, electrical breakers, and mechanical infrastructure.
Cyma Builders successfully completed the GMP production suites for one of our confidential clients! The purpose of this project was to expand upon the facility’s existing GMP production spaces with four new Grade B Gene Therapy suites as well as an additional freezer room.
We are proud to share that our team was not only able to accomplish the expansion successfully, but also overcome the project’s unique challenges in a seamless way.
Creating an Efficient, Workable and Easily Accesible Layout
One of Cyma’s initial tasks was to create an efficient and workable layout while also ensuring that all areas would be easily accessible from the GMP clean room’s walkable ceiling. There was an extensive effort to coordinate all trades in the ceiling and to ensure that all the ductwork, process piping, and mechanical system would be accessible from this ceiling. This was achieved utilizing BIM modeling and coordination sessions for a 10 week period at the onset of the project.
Overall, the client was very happy with the result as it is relatively easy to access anything from the walkable ceiling installed during this portion of the project!
Preventing Covid-Related Equipment Delays and Supply-Chain Disruptions
One of the main challenges of the project was dealing with supply chain disruptions and COVID related delays to the equipment. Cyma created a tracking matrix early in the job and coordinated with subs on all components to try and identify components that suffered delays as quickly as possible. Once they were identified, Cyma worked with the manufacturer to try and mitigate the delay and prevent the component from delaying the overall project.
In the end, Cyma was able to prevent any equipment related delays from affecting the overall delivery and integration of the production suites into the existing facility!
Expanding and Integrating New Infrastructure with Minimal Disruption
Another challenge on the project was actually segregating the project from the existing facility and ensuring there was no impact to existing GMP operations. This was achieved by creating a comprehensive utility shutdown matrix which allowed the facility to see when and how every project related shutdown was being performed on the project, and whether or not it would be disruptive to the facility.
The facility was then able to coordinate with their end users and Cyma to select a date that would have the least impact. During these critical shutdowns, Cyma would draft and circulate a method of procedures to further coordinate with the facilities maintenance team so they would know what tasks were being performed throughout the day of the shutdown.
This process was very helpful to both Cyma and the facility as it allowed the shutdowns to be well planned and adapt to unforeseen circumstances as needed.
Cyma Builders was selected as the construction manager by this Pharmaceutical company to implement their Capacity Expansion Masterplan. The project was driven by spatial constraint of multiple programs throughout the site, including offices, warehouse and manufacturing (not pictured). The project was design to accommodate the additional needs of all three spaces within a single building addition.
The overall project consisted of constructing a new 17,000 SF pre-engineered building structure to accommodate the new program, which was apportioned 3,500 SF office, 3,500 SF manufacturing and 10,000 SF warehouse. The project commenced with an expansive pile driving effort, which was required due to poor soil conditions and adjacency to the river, followed by concrete mat slab construction. A 2,500 SF modular Vault was then delivered and erected onsite to accommodate controlled substance storage capacity requirements. The pre-engineered metal building was subsequently delivered to site and full assembled in the field around the Vault. The design of the building was done in conjunction with Cyma’s PEMB Division and Nucor. The structure had two sections, a lower roof area to accommodate the offices and an elevated one to accommodate the manufacturing and warehouse programs. All equipment loads were coordinated heavily during the design phase so the building purchase could be expedited and comply with the critical path.
The building erection was proceeded by receipt and rigging of major rooftop HVAC equipment. The office area was supported by a new 10,000 CFM packaged, DX AHU, while the manufacturing area was served by a 27,500 CFM custom Haakon AHU, inclusive of split condensing unit and heat pipe for energy recovery from the exhaust stream. Both units were installed on the roof over the office area, with the manufacturing system ducted over to the high-bay portion of the structure. A 16,000 CFM vertical air rotation unit was utilized for the warehouse and installed on an interior pad. Office construction included a new conference room, workstations and enclosed offices. The warehouse was design to accommodate 192 total pallet positions, with the Vault design to house an additional 192. All racking was installed to achieve this and a new epoxy coating installed across the warehouse floor.
The manufacturing area was designed to accommodate two (2) new Finishing Suites, only one of which was constructed and built out as part of the project. Additional support spaces included a Wash Room and Weigh/Dispense/Re-Pack Area. The proposed Finishing Suite included installation of existing mill and sifter equipment for bulk API processing; however, a new stack-up was required in order to accommodate their reuse. Cyma Builders led the procurement effort to purchase the new stack-up complete with new IBC’s, post lift, static butterfly valves, blender, and pack out equipment surrounded by a multi-tier stainless steel mezzanine. Additional process equipment purchases were also coordinated to accommodate the program including roller conveyors and floor scales.
The office and warehouse area were turned over on time and within budget in October 2015. the manufacturing suite is currently on schedule and within budget currently projected to conclude in the first quarter of 2016.
Cyma Builders & Construction Managers was selected by DPT Laboratories for a multi-component project to build a new Wash Prep Suite along with a Critical Utility Plant in support of ongoing operations and future expansion plans.
The Equipment Wash Prep Suite ($5,250,000.00/5,000 SF) involved the construction of a new wash room to support current and future filling operations as well as the construction of new utilities to support the future expansion needs of the facility. The wash room was constructed using the AES modular clean room system, and includes Grade C and D spaces. A new 13,500 CFM AHU was installed on roof level dunnage, along with all associated supply/seturn distribution and terminal HEPA filtration. Process utility distribution include new clean steam and WFI piping to points of use and washroom equipment connections. The challenges in constructing the suite involved installing a large amount of ductwork, re-circulation fans, and other HVAC & Process utilities in a mechanical space above the suite while maintaining a clearly designated walking path on the ceiling for maintenance and testing access. This effort required extensive coordination between the subcontractor, Cyma, architect and engineer to ensure an acceptable end product. Cyma also tied the new wash suite into an existing production suite during a compressed shutdown schedule to accommodate the client’s need to maintain production.
The new wash suite required the installation of several new pieces of equipment to allow for the proper operation of the room. Two Steris parts washers and Belimed Autoclaves were installed in the suite and integrated into the AES wall system and integrated with stainless steel closure panels.
The Critical Utility Infrastructure ($3,600,000/4,000 SF) upgrades to the production facility were extensive during the Equipment Prep & Wash project. Cyma performed a complete upgrade of two of the existing electrical services during this project, which served almost all of the major production and storage areas at the plant. This shutdown required an extensive, coordinated shutdown that was performed over a weekend. Cyma and the client worked together to ensure that all critical areas were supported with emergency power, and to make sure that the transfer of the loads from the old switchboards to the new substations were performed without issue.
Other infrastructure upgrades include major modifications to the plant’s water for injection (WFI) capabilities. A new 8,000 gallon Feldmeier holding tank was installed, along with a custom distribution skid to support the new WFI loop that was installed as part of this project as well as the existing loop that was currently in service. Cyma installed a new MECO Vapor Compression Still and Pretreatment system to perform the WFI generation on this new system. In addition to this infrastructure, Cyma also purchased and installed a new Digital Analysis Waste Neutralization system to treat any waste before releasing it to the township drainage system. All work was performed strategically to avoid impact to any active manufacturing operations. Architectural room construction followed equipment installation to define the boundaries of the newly complete Critical Utility Plant.
Cyma Builders was selected as the construction manager for a Weigh/Dispense/Blend Suite to facilitate relocation of OSD manufacturing operations to a California facility location.
Working with CRB as the design lead, the client considered the numerous approaches and technology to achieve the throughput required for the space. Cyma Builders assisted in cost analysis of the options and coordinated the bid process for all process equipment , specifically Downflow Booth and Blender equipment, and assisted with management of the submittal process.
The footprint of the new Weigh/Dispense/Blend Suite was carved out of an existing TSA Warehouse, requiring heavy coordination with daily operations. Concrete pits were sunk into the existing slab at three (3) locations to allow flush mounted scales to be installed for tote weighing. A new steel frame was erected to support an AHU platform and process equipment structural requirements, while the remainder of the Suite was built with structural/seismic considerations using cold formed metal framing. The walls/lid of the Suite were rated to provide a walkable surface for maintenance of MEP systems serving the space. A new Buffalo air handling unit was installed, along with air valves and terminal HEPA filters to comprise the HVAC system. Plumbing utilities were extended off existing site distribution and infrastructure, including Purified Water, Compressed Air and Potable Water. A new 200 A bus duct plug was installed to support the new HVAC, process and general distribution electrical loads for the space. All shutdowns of plumbing and electrical systems were carefully coordinated with the active site to avoid any impact to active manufacturing operation and production schedules.
In addition to the Weigh/Dispense/Blend upgrades, modifications were required to a second floor tablet press dump stations to accommodate installation of new compression equipment. The existing second floor space was a combination of charging suites, ovens and staging areas, making the unification difficult from and architectural and HVAC standpoint. Also, temporary protections had to be devised to isolate an existing dump station that had to remain active for portions of construction due to ongoing qualification runs. Following demolition of all existing equipment and architectural components, a new HVAC system was installed served by a roof mounted Buffalo air handling unit. Electrical and plumbing utilities were extended off existing site distribution/infrastructure. Heavy coordination was required with the two (2) new tablet presses being installed on the first floor. The second floor slab was cored at strategic locations for installation of new stainless steel dump chutes and process control panels. Finishes were then patched at the suite below to restore them to original condition.
Both spaces were finished with DensArmor walls/ceilings, epoxy paint, Stonhard epoxy floors and stainless steel bumper/corner guards. Chase SS sliding doors were installed at most new airlocks and suite, while ASI high speed roll-ups were installed for access to the Downflow Booth and Warehouse airlock. Specialty systems installed for the space included door interlock/security controls, PA system and fire alarm system.
Cyma Builders & Construction Managers have been retained by Jacobus Pharmaceuticals, Inc. to provide Pre-Construction, Construction, and Post-Construction services for their Oral Solid Dosage production facility upgrades in Plainsboro, NJ. The overall facility upgrade program includes complete renovation of (2) existing drug production processes from raw material entry and bulk API generation through final tableting and coating. In addition, several of the overall facility support functions will be renovated and expanded to support expanded capacity and improved circulation, as well as replacement and upgrade of existing building infrastructure. The facility is to remain operational throughout construction, including manufacturing areas, requiring a strategically planned approach to phasing to minimize operational shutdowns.
Construction scope includes renovation and expansion of existing API generation, processing, and tableting suites to improve manufacturing efficiency and production environment quality. Non-GMP and cGMP corridors and air locks will be modified to allow for better facility circulation. New non-GMP and GMP staging areas will be created. Replacement and upgrades of HVAC, Electrical, and non-process utility systems will be completed as necessary to support the renovations. Upgrades to process utility systems and controls will be completed to support the new manufacturing equipment. A central cold storage box will be installed to support all OSD functions. A new receiving dock will be constructed for receipt of raw materials, along with a new hazardous material storage containment area. Removal and modifications of existing process equipment to improve efficiency in loading and transfer of materials. Installation of new process equipment will includes Reactors, Centrifuges, Charcoal Settlers, Dryers, Presses, Coaters, Mixers and Misc. Production and Packaging Equipment. Final installation of interconnecting process utilities and controls for material transfer will complete the project.
Cyma Builders & Construction Managers was retained to provide pre-construction and construction management services for DPT Laboratories new Small Volume Parenterals manufacturing suite at their Lakewood, NJ Facility. The SVP Suite was the first phase of a multi-phase manufacturing expansion and capacity upgrade. The program was constructed within an existing cGMP manufacturing area, requiring strategic implementation of construction and interface with existing utilities.
Work commenced with construction of temporary containment systems with negative air equipment to ensure adjacent manufacturing operations would not be compromised, followed by demolition of the existing program. A new concrete vault was constructed below the existing concrete slab to hold a process waste collection tank, cooling system, and transfer pump assembly. A network of Stainless steel process waste collection pipe and drain points were installed to support the manufacturing waste. In order to accommodate process support and HVAC equipment a structural steel mezzanine was constructed in the interstitial space and a platform was constructed at the roof level.
Modular construction was chosen for all clean room walls, ceilings, and doors. A ¼” troweled applied epoxy floor system with integral cove base was used throughout as a common floor finish.
Two custom air handling units were installed at the roof level and were supported by a common make up air unit to pre-condition the intake of outside air. Several custom exhaust fans were provided to relieve excess air. An HVAC chiller plant was implemented , consisting of an air cooled chiller, holding tank, and circulation pump. A humidification steam boiler was installed at the roof level with a series of humidification coils placed strategically in the supply duct stream. Supply, return, and exhaust ductwork was distributed and constructed in accordance with each room’s ISO classification. A new BAS control systems instituted to support all new HVAC equipment.
Clean utilities for the new process consisted of USP water, process chilled water, compressed air, and nitrogen. With the exception of process chilled water all clean utilities existed at the site, but required a very strategic approach for tie-ins and distribution to the SVP suite, due to the fact they supported business critical manufacturing. A new process chiller was installed at the roof level to support the process cooling. Utility panels were utilized to serve as centralized use points for all clean utilities with stainless steel hoses from panels to equipment.
The main substation had adequate capacity to support the new manufacturing program, however a new breaker was required to feed secondary 480V distribution gear. Several transformers and power panels were installed at the mezzanine level for process, HVAC, lighting, and general loads. A UPS was provided for back up of critical loads. All new lighting was clean room grade.
This project consisted of the renovation of an existing 19,000 SF non-GMP research and development facility to a new cGMP Aseptic Filling Facility within Dupont’s Stine Haskel Facility in Newark, DE. Cyma Builders and Construction Managers were the first consultant retained during the lease due diligence period under a Pre-Construction agreement to help determine the feasibility of utilizing the existing building to create the proposed program. Cyma played a key role in evaluating the building infrastructure and determining if it could support the requirements of the filling operations. Upon negotiation of the lease, Cyma was selected as the construction manager to guide design development, assist with procurement of process and process utility systems, construct the program, and support the commissioning and qualification process. The project was constructed on an extremely fast track basis with a constrained budget. All interrelated goals of budget, schedule, quality, and safety were attained allowing for development of a sterile filling facility ready for product in record time relative to industry standards. The new program included material and personnel air locks, fill/finish suite, component prep areas, microbiology, chemistry, metrology and materials laboratories, cold storage spaces.New toilet rooms and a new mechanical and electrical system were also part of the project.
The scope of work included the complete demolition of existing lab and office areas, including MEP utility distribution. The fill/finish and component prep suites were created, utilizing a modular clean room construction approach. New process support equipment included an autoclave, clean steam generator, WFI generation system, process chiller, process humidifiers, air compressor, and process air handling unit. Utility distribution included compressed air, nitrogen, clean steam, WFI, chilled water, plant steam and condensate, condensate, chilled water, process chilled water, process waste and vent, process ductwork, lab ductwork, and office ductwork, as well as electrical systems. The existing electrical infrastructure was expanded to accommodate new loads. The existing lab and office air handling unit was overhauled and the capacities were increased. A new loading dock was constructed to accommodate product delivery. New finishes to match specific programs (clean room, labs, and offices) were implemented throughout.
