FDA Stability Testing

The U.S. Food and Drug Administration (FDA) requires medical product manufacturers to test for quality over the lifespan of the product. Stability tests measure how products change over time when exposed to temperature, humidity and light.

Schedule

• Stability tests cover storage, shipment and subsequent uses of a product. Long-term tests last at least 12 months, while intermediate and accelerated testing last at least six months. Accelerated conditions tests examine a product for long-term stability over shorter spans. Testers pull samples at scheduled intervals to record measurements.

Temperature

• Temperatures and moisture affect the lifespan of products in storage. Testers must control these factors in storage testing chambers. Common temperature levels include room, refrigerated or frozen. Testers use different temperatures based on the product being tested.

Results

• Stability tests must determine the ideal quantity of a product and its ideal storage conditions and storage time in order to maximize its life. Tests should account for products used regularly as well as those stored long-term without interruptions.