Pharmaceutical freeze dryers are increasingly being equipped with automatic loading and unloading systems to improve productivity and better protect both the product and operator from contamination. Although the sophistication of automatic loading and unloading systems continues to develop, production irregularities pose certain challenges, such as vials with missing or incorrectly place stoppers, incorrect filling volumes or poorly sealed vials.
Such defects are often only detected during offline or post-quarantine inspections; and, although this procedure is accepted as safe, it does have limitations. First, systematic variations such as reproducible filling volumes can’t always be corrected during production and could lead to the loss of an entire batch. A missing stopper could lead to product contamination and operator safety issues if processing potent material.
To solve these issues, Baumer and GEA have been working on a solution that not only offers maximum product safety, but can also be retrofitted into existing lines, making 100% inspection between filling and packaging a real possibility.
Baumer was able to draw on its experience with vision sensor technology and light barriers, providing a simple image-based quality control solution that includes integrated position recognition. As such, out-of-specification vials can be detected and reliably rejected. Up to 32 different characteristics can be identified, all in real-time, and automatically adjusts to changes in vial size.
If a freeze dryer is loaded and unloaded on the same side, all the inspection criteria can be tested using a single unit. For a pass-through design, two inspection systems are required. Thus, 100% traceability and filling-to-packaging line inspection can be achieved. Additionally images of any rejected vials can be saved to facilitate troubleshooting. This system represents a simple, cost-effective performance monitoring system that further enhances the operational reliability of pharmaceutical freeze drying.
