Cyma Builders and Construction Managers were retained by DPT Laboratories to construct a new small volume parenteral (SVP) manufacturing suite and a new compounding suite at their Lakewood, NJ facility. The project was part of an ongoing master plan being executed at the facility that involves constructing individual SVP suites to fulfill the CDMO needs of their various clients
The 7,200 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 DPT’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. This system was to be integrated into the existing adjacent suite that used the same modular system. Since the existing suite was in production 7-days a week, Cyma had to perform the tie-in to the suite during a previously scheduled bi-yearly shutdown. Cyma successfully completed five separate integration points at this shutdown, when the overall suite construction was only approximately 35% complete. Using the aforementioned clean room temporary partitions, Cyma was able to ensure that the existing suite was adequately sealed and protected while the rest of the suite was completed. The suites also had a trowel applied epoxy floor system with integral cove base.
The project had a significant amount of support infrastructure. This included two custom AHU’s, a new process and HVAC chilled water system, as well as a custom AWFI heat exchanger skid for an AWFI 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. 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 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.
At 60% completion, Cyma was informed that the customer purchased filling line was approximately 4 months behind schedule. This delay proved devastating to the client’s overall schedule to get the suite into active production by the end of 2016. In order to help their client achieve their goal, Cyma worked with their critical subcontractors to revise the sequence of construction to minimize this impact. This allowed almost 80% of the suite to be constructed while the filling line was being completed. Once the filling line arrived, Cyma rigged the unit into place as quickly as possible so the rest of the suite could be completed. Cyma then connected all of the relevant utilities and supported the startup of the filling line.