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 up to the higher standards of the cGMP environment. While pharmacists and pharmacies typically operate under state law only, SterRx operates under FDA oversight and cGMP rules of compliance.
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.
Because safety in manufacturing is a primary goal at SterRx, the company uses the same production processes as those used for commercially available drugs, producing sterile compounds from nonsterile ingredients. These include sourcing API only from FDA-approved manufacturers to produce sterile products and employing 0.2-micron pharmaceutical-grade microfilters—validated to produce sterile products—to remove impurities from the API.