This cGMP pharmaceutical production facility was designed and built in under 8 months to support the confidential client’s new product launch. The facility incorporates numerous measures to prevent the contamination or release of the product and the potent compounds used to make it.
This facility houses QC Labs, R&D Labs, a GMP raw materials warehouse, a finished products warehouse, ISO 6, 7, 8 spaces that support multiple ISO5/Class 100 transfer rooms where raw product is loaded into the barrier isolation filling rooms.
Syserco closely collaborated with the validation team by delivering comprehensive functional specifications, software and hardware design specifications, and cGMP level engineering. This cooperation extended to the commissioning/SAT phase in which Syserco produced customized cGMP commissioning deliverables to allow these Test Procedures and Test Forms to be fully leveraged for the validation of the facility, greatly reducing the time and cost of the BAS validation effort.
The fully validated Alerton BAS was delivered by Syserco using a design / build / validate model. It controls, monitors, trends, and alarms all aspects of the utility and support systems including Laboratory AHUs, Makeup AHUs, ISO Recirculation Units, Office AHU, multiple headered EFs, Heating Water, Chilled Water, Process Chilled Water, and Steam Boiler Control. In addition to the above standard control features, the BAS also monitors explosive and hazardous gases, laboratory equipment and critical room differential pressures.