New cGxP formulation unit
Akorn Pharmaceuticals, a pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals, wanted to scale up their TheraTears formulation production. They confided in Agidens, and we did not disappoint. Our multidisciplinary teams came together and provided a turnkey solution existing of two 2000 L vessels and one 400 L solution vessel, both integrated and automated in the new process. To top it off, Akorn adopted the Agidens Safety Plan as the new Master Safety Plan.
As Akorn’s existing filling device for TheraTears – eyedrops to restore, cleanse and nourish the eyes – was unable to get a higher output, they asked Agidens to deliver a solution to expand the Thera Tears formulation production to 4000 litres. We integrated a completely new cGxP compliant formulation unit, with in-line SIP station, that fully fitted the requirements, established a new SCADA standard at the Hettlingen site, and reinforced the CIP capacity with an additional parallel installation – all this with an eye on IoT implementation.
A complex but rewarding project that fits our turnkey portfolio.