Time-sensitive drugs often must be administered within days or even hours of manufacturing. Before they are administered to the patient, they must be manufactured, packaged, and inspected – a process that mandates checking for the presence of foreign particles in the drug after the manufacturing process.
To do this, Gerald Budd, president of Phoenix Imaging, and his colleagues, have now developed a robotic-based vision system that can automatically load and unload products onto a test stand and inspect for such particles in a fraction of the time required by human operators.
The so-called ParticleScope System was revealed in this month’s issue of the industry journal ‘Vision Systems Design’.
In the past, the inspection of particles within fluids was probabilistic in nature, one with human inspectors required to perform a statistical analysis on thousands of vials before a 1% confidence level in the batch quality could be determined.
But in today’s biopharmaceutical industry, where anticancer medications are manufactured in very small, expensive clinical-trial batches of less than 3000 vials, it is nearly impossible to approach the task with human inspectors.
Because the new ParticleScope is a deterministic method of measuring particles and not a probabilistic one, no such statistical measurements need to be made. “By analysing just one sample,” says Budd, “we can determine the quality of the sample-no probabilistic batch methods are required.”
Full details on the new system can be found here.