Craig McCasland

STERRX, LLC

Founded in 2013 as a manufacturer of sterile liquid pharmaceuticals, SterRx is an innovative company with a new vision for 503B manufacturing: Eliminate virtually all human contact with both the manufacturing and packaging processes through the use of robotic automation. This novel approach makes sense, because the SterRx founders are industry leaders in aseptic packaging of pharmaceuticals and medical devices, where cGMP has always been the standard. In contrast, most companies hire pharmacists who must transition to stricter cGMP requirements. SterRx and all other Section 503B facilities operate under cGMP regulations and FDA guidance. 100+ The company has more than 100 employees, including pharmacists, quality operators, compound staff, process engineers and validation staff. SterRx currently occupies a Plattsburgh, New York, production facility comprising more than 50,000 square feet and with a production capacity of ~90-100 million units annually. Manufacturing is accomplished via four fully enclosed blow-fill-seal (BFS) machines, which eliminate the need for manual intervention in the manufacture and packaging processes and thus greatly reduces the risk of contamination and error.