加速稳定性的测定分析.ppt

Accelerated Stability Testing Timeline Progression进展，系列 of Your Test System Test Principle and Components构成 Be familiar with the test principle; know how it works. Identify the characteristics of the component parts, especially targeting the critical 关键components. Know how they interact in the system. Working Model Assemble a working model of your test system. Perform stress testing on the system as a whole as well as the independent stressing of key components. Perform accelerated stability testing; a guide will follow later. Experimental Manufacturing Experiment with available manufacturing methods with small batches. Conduct preliminary clinical trials. Perform accelerated and real-time stability testing. Arista Biologicals Inc. Timeline Progression of Your Test System Cont. Trial Manufacturing Make several trial or scale-up manufacturing runs to determine lot-to-lot variability. Conduct final clinical trials. Assess real-time stability. Full Scale manufacturing Full scale manufacturing runs can now be made. Arista Biologicals Inc. Stability testing - Questions and Concerns How can I determine if a product model in the RD stage will be stable enough to become a viable 可行的product with acceptable performance throughout its expected shelf life? Will my new product have stability similar to my other products? Can the same standards applied to the other products be applied to this one? How can I develop a set of accelerated stress conditions that will be a guide to real time stability data? Arista Biologicals Inc. In Research and Development We cannot wait for real time data in RD. We need a method to quickly and reliably predict shelf life that is validated. Gain experience with your type of test. Gather information where possible from the component manufacturers. Systems and reagents Types of reagents Drying and handling Components/membranes Double stick tapes Plastic backing Cassettes Desiccants Foil pouches/bottles etc. Remember: Formulate with stability in