Lyophilization Cycle Scale-up and Transfer with Tempris Technology
The Tempris technology, designed explicitly for Lyophilization Cycle Scale-Up and Transfer, is applicable on all scales of freeze-dryers, even in production units with automatic loading and unloading systems, and thereby allows comparison of consistent product temperature profiles over the scale-up and transfer process. A process developed in a laboratory scale can directly correlate to subsequent pilot scale batches used for clinical supply, up to validation and routine batches in manufacturing scale equipment. This way, Tempris sensors supply data for the most important critical quality attribute, product temperature, throughout the product life cycle with identical measurement technology. In addition, the product temperature profiles allow early detection of equipment-related differences between freeze-dryers, including the extension of freezing and primary drying times, which require compensation. This way, process conditions can be more easily adapted to achieve an acceptable product with a high degree of assurance in product quality.