Automated technology for sterile compounding
Sterile compounding is already occurring at point-of-care facilities, some of which are regulated by FDA as 503B outsourcing facilities under strict quality and safety guidelines. James Rorke, vice-president of North American Operations at Steriline, predicts that this rigor will, in the future, extend to some or all patient-specific 503A sterile compounding, which often takes place in pharmacies, hospitals, and institutional settings. Steriline’s Intelligent Compounding System (ICS) meets the need for aseptic patient-specific compounding in a compact footprint, Rorke says.
In the ICS, check-weighing provides the data to prove that every single container has been filled to the optimal volume, explains Rorke. “Incorporating 100% check weighing while filling allows us to target the primary fill volume to the lower end of the acceptable fill range, such that variances in the fill volume are more likely to fall in the nominal range or under filled. If under filled, we add the additional volume of product to meet the requirement. This function practically eliminates over-filled rejects, and it tightens the process window to eliminate waste.”