OSD Manufacturing Facility

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.

Jacobus – OSD Manufacturing Facility

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.

DPT Laboratories – SVP Suite

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.

Isogen – Aseptic Filling Facility

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.

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