Archive for October, 2018

Confidential – CAR-T Cell Therapy Lab

Cyma Builders and Construction Managers were retained by a confidential client to construct a new pilot plant at their existing PA facility. This pilot plant was designed to support a new cell therapy suite that was being designed and constructed at another facility.  Due to the role of this new suite, it was imperative that it be completed and put into operation before the other facility was constructed.

The overall project consisted of the demolition of an existing suite that was renovated to accommodate the new program. The new suite included some new mechanical infrastructure while also re-purposing and modifying two existing packaged AHU’s that were used for the previous suite. The overall finishes installed in the suite included epoxy paint throughout, as well as a troweled epoxy floor. Cyma was also responsible for installing a number of bio safety cabinets and clean room pass thru’s as part of the project.

The original project schedule showed the suite being completed in early June of 2018, and was contingent on receiving funding for the project in November of 2017. Unfortunately, funding was not released for the project until late January of 2018. Due to the criticality of the suite to future operations, the client insisted that the early June completion date be maintained as much as possible. Once released, Cyma builders worked extensively with the design engineers and vendors to identify the long lead components on the critical path. Once identified, a methodical approach was taken to try to ensure that the long lead components were onsite when needed to achieve the project schedule. Using this strategy, Cyma was able to receive over 95% of the equipment on time, with the remaining 5% not arriving due to manufacturer related shortages.

Once the issue with the long lead equipment was resolved, Cyma began working on constructing the suite. The original construction schedule assumed 20 weeks of construction, but the work now had to be performed in 16 weeks due to constraints caused by the lead times of the materials and lack of funding. Cyma developed and implemented a construction plan to complete the work in the required time frame using a negotiated overtime allowance. The allowance was strictly managed to ensure that the money was being spent efficiently to allow the maximum amount of schedule to be recovered for each dollar spent.

During the project, Cyma was also able to use previous work experience in clean room environments to provide useful suggestions to the client. This included recommendations for clean room phones, various finish details, and materials of construction for the various signage that was installed as part of the project.

Confidential – Compounding & Filling Suite

Cyma Builders and Construction Managers were retained by a confidential client to construct a new manufacturing suite with a corresponding compounding suite at their New Jersey facility. The project was commissioned to fulfill the manufacturing needs of a new client that had recently been entered into a contract to manufacture certain products.

The 8,500 SF clean room was constructed to GMP EU classification and within the footprint of an active cGMP manufacturing facility. At the onset of the project, Cyma had to take extensive precautions to ensure the construction activities would not affect the active pharmaceutical manufacturing operations that were being conducted directly adjacent to the new suite. These precautions included clean room temporary partitions, strategic placement of negative air machines to ensure the control of dust and maintain pressure, as well as a diligent clean up effort to ensure that no dust or construction debris migrated into the plant. Cyma was also directly responsible for the flow of the contractors on site and ensuring they did not deviate from approved egress pathways. The FDA, EU, and the manufacturer’s clients conducted several routine and surprise audits during construction without having a single observation that could be attributed to the construction team.

The overall construction included a modular clean room system for all clean room walls, ceiling and doors. The construction team erected an independent structural steel support frame for the clean room within the existing building’s envelope. This construction strategy allowed the project to maintain the walk-ability of the modular clean room ceiling while not affecting the existing building’s structural integrity.

The project had a significant amount of support infrastructure. This included four custom AHU’s, four new chillers as well as a custom TWFI heat exchanger skid for a TWFI sub-loop that was being installed as part of the project. These systems were also tied in to the existing systems already in service at the plant. The project also included extensive modification to one of the two main WFI loops in the plant in order to reverse the flow of the loop to achieve a final design goal of their existing master plan. Throughout the installation of this infrastructure, Cyma worked with the engineering and production teams at the plant to schedule strategic shutdowns to allow the project to maintain schedule while almost completely negating the impact to production.

The project also required the retrofit of two existing Munter’s AHU’s that previously served the existing suite. The AHU’s were decontaminated, and then a thorough inspection process was performed to identify any potential failing parts for replacement. Cyma proceeded with replacing these parts in order to ensure the AHU’s fulfilled their designed role with minimal problems in the future.

The infrastructure was installed on a new two story rooftop/internal mezzanine platform system that was constructed immediately above the process space. This platform  was independently supported from the existing structure. It is important to note that Cyma also worked with the design team to ensure that this platform was completely walkable and unobstructed by any of the ductwork, piping, or other utilities being installed to support the suite below.

 

Newsletter Sign Up

  • This field is for validation purposes and should be left unchanged.

Additional Resources