Stability Express Overview

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A stability study typically consists of placing a number of containers from a batch of product into a series of environmental storage chambers (also known as conditions). Then at pre-determined times or every pull periods, a number of containers are taken from each storage chambers and sent to the lab for a variety of tests. These conditions, pull periods and tests to be performed are all pre-determined using a defined protocol.

Once the protocol has been completed, the results from those tests are graphed against time for each storage conditions and this permits calculations to be made to predict product shelf life at each conditions. Generally, using elevated temperatures and humidity will usually accelerate the degradation of a product and this can be used to predict the likely shelf life under normal conditions.

Stability Study Management Workflow

Stability Study Management Workflow:

  • Creating a new stability protocol, or copy from an existing study template
  • Approving the protocol then start the study
  • Confirm placement of containers into storage rooms (this is the actually time when the study starts)
  • Confirm movement (cycling) of containers - optional
  • Confirm staging - optional
  • Confirm pull of containers from storage rooms
  • Registering stability samples into LIMS as required
  • Perform and record laboratory testing
  • Confirm scrapping of unused containers
  • Archiving stability protol and/or samples
  • Relocation of all containers from specific storage room/area - optional
  • Pull of "extra" containers - optional
  • Re-placement of containers used for non-destructive tests - optional
  • Report generation are generated throughout the process to show both preliminary and final informations

One of the main advantage of Matrix Stability Express is that each study or protocol design can include a number of batches, the different conditions in which they are to be stored and tests to be performed at specified intervals. Furthermore, it can also include more advanced features such as the recording of cycling and staging informations.