Create a custom worksheet for stability study data collection, and analyze the stability of a product to predict its shelf life.

Purpose

This App provides a tool to create a custom worksheet for stability study data collection, and another tool to fit a general linear model against time and batch, which can be used to predict shelf life.

Installation

Download the file "Stability_Study.opx", and then drag-and-drop onto the Origin workspace. An icon will appear in the Apps gallery window.

Require Packages
This app requires orgutils app.

Operation

Click the App icon to open a toolbar.

• Create Stability Study Worksheet
  • Test Times Format: Time format can be Numeric (0, 1, 2...), Date/Time(1/1/2026, 3/1/2026...), or user-defined data.
  • Number of Test Times: Enter a number for test times.
  • Start Time: Specify time to start with.
  • Interval: Enter an interval for test times.
  • Unit of Time: Choose a unit for test times.
  • Batch: Enter space-separated text label for batches and number of replicates.
  • Randomize Runs: Select a method to randomize the batches.
• Stability Study
  • Input: Select a column for Response, Time and Batch. Specify at least one specification limit (lower or upper).
  • Settings:
    • Model Type: Specify whether data of samples come from every batch (Batch is a fixed factor) or from a random sample of batches (Batch is a random factor).
    • Percent  of response within specification limits: Calculate the shelf life based on the percentile.
    • Confidence Level: Confidence level of the estimated shelf life.
    • Alpha for Pooling Batches: Variable with Prob<alpha is excluded.
    • Use One Specification Limit to Calculate Shelf Life: Adjust the confidence level to produce a one-sided bound when there are two specification limits.
    • Initial Estimates for Variance Components: If batch is a random factor, you can optionally enter initial estimates for variance components. If empty, use default values.
  • Select Quantities, Diagnostics and Plots etc. to output.

Sample OPJU File
This app provides a sample OPJU file.  Right click the App icon in the Apps Gallery window, and choose Show Samples Folder from the short-cut menu. A folder will open. Drag-and-drop the project file StabilityStudySample.opju from the folder onto Origin. The Notes window in the project shows detailed steps.
Note: If you wish to save the OPJU after changing, it is recommended that you save to a different folder location (e.g. User Files Folder).

REFERENCE

1. nag_reml_hier_mixed_regsn (g02jdc)

v1.11:11/03/2026 Support random batch factor.