PS&S was tasked with designing a facility that would host small scale clinical manufacturing operations for a pharmaceutical client in New Jersey.
Since this facility would require the handling of solvents, there were DEA controlled substances considerations to address.
THE PS&S SOLUTION
The project involved small scale clinical formulation equipment and support areas. The support areas required the capacity to handle solvents and DEA controlled substances. This application was a research facility and it did not need to comply with GMP regulations; however the containment and cleanability of the formulation lab equipment created a similar small scale program.
The largest capacity equipment was a GPCG -5 Glatt unit, which involved a 36-liter working capacity. This lab also used intrinsically safe devices due to solvent use.
Various equipment included mills, coaters, tablet machines, blenders, dryers and wash equipment.
The other major support area of the facility was a 10,000 sf analytical lab, which included specialty labs for light sensitive products and radioactive materials. This lab had several rooms for vibration and noise isolation as well. The lab design was a combination of fixed casework and carts. Lab gases and utility stations were designed to receive the carts and create a plug and play environment.