Accelerated Stability Testing Arista Biologicals Inc.

Timeline Progression of Your Test System Test Principle and Components Be familiar with the test principle; know how it works. Identify the characteristics of the component parts, especially targeting the critical 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 R&D stage will be stable enough to become a viable 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 R&D. 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 mind. Arista Biologicals Inc.

Accelerated Stability Testing What is it? Any environmental condition that may affect performance of your test system. Stress Testing Heat Humidity Light Know: Factors that affect stability: Inherent stability of key components of test Membranes, paper, tapes, and other structural materials Stabilizers, wetting agents, blocking agents Packaging and desiccating agents and their capabilities Ideal and actual moisture contents of packaged test Arista Biologicals Inc.

Heat Stress Conditions Arista Biologicals Inc.

Typical Expected Results Arista Biologicals Inc.

Where Do Guidelines Come From? Experience Test systems similar to yours; how they perform under same conditions of stress Knowing the chemistry/immunochemistry of the system Borrowing some basic principles from the pharmaceutical industry Regulatory Sources FDA and similar regulatory bodies Professional consultants Arista Biologicals Inc.

What to Look for After Stress Physical Appearance Look at the product Take it apart Check the color of the immobilized detector reagent Check the condition and color of the sample pad, membrane Performance Test the following parameters Sensitivity Specificity Running time of the test Arista Biologicals Inc.

What to Look for After Stress Cont. Performance Cont. Component assays Sample pad buffer pH Release characteristics of the conjugate pad Wetability of the sample and conjugate pads, membrane Detector reagent migration patterns Examine the quality and color of the test and control lines Packaging components Integrity of the foil pouch Effectiveness of the desiccating agent Arista Biologicals Inc.

What to do if Product Fails Stress Testing Determine which component(s) failed Interchange components with a working test to isolate the source of the problem Change in components may be necessary May need to change stabilizers May need to change surfactants Consider other types of adhesives, tapes and cover tapes, even membranes and plastic supports Arista Biologicals Inc.

Additional Information Accelerated stability predictions are only useful as a guide, particularly data generated in high temperature stress tests It may be informative to test a competitor’s product alongside yours during stress testing Actual stability claims should be about 25% less than predicted by your data For example Predict 2 years, claim 18 months Predict 3 years, claim 2 years This will reduce the number of lawsuits and losses, and allow for a certain degree of mishandling by the customer Arista Biologicals Inc.