1. Accelerated Stability Testing
Arista Biologicals Inc.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. Heat Stress Conditions
Arista Biologicals Inc.

8. Typical Expected Results
Arista Biologicals Inc.

9. 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.

10. 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.

11. 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.

12. 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.

13. 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.