Description
The US Food and Drug Administration (FDA) is seeking a quote for a GEA North America LLC ConsiGma standalone Process Analytical Technology (PAT) Rig, or an equivalent product. The PAT rig will be used to support the modernization of pharmaceutical manufacturing by conducting regulatory science research on emerging technologies. The rig must meet certain minimum requirements, including being constructed from stainless steel and FDA-compliant materials, and being adaptable to continuous manufacturing operation. The contractor will be responsible for delivering, installing, and testing the equipment, as well as providing training and maintenance services.
Key features of the required equipment include:
• A vertical tube or chute through which pharmaceutical powders can flow with minimal to no mixing or turbulence
• A sealable insertion point in the vertical tube or chute into which an NIR measurement probe can be inserted
• The ability to permit continuously adjustable speed at which powder exits the bottom of the vertical tube or chute
• The ability to permit flow of cohesive powder through the tube or chute without impacting the accuracy or precision of an NIR spectrometer
• A minimum of one year parts and labor warranty from date of installation/commissioning