Product Stability Issues

Feb 19, 2015
Book chapter - Steam Sterilization: A Practitioner’s Guide (Ch.23)
Author: Moldenhauer, Jeanne.
Chapter summary

BACKGROUND

STABILITY TESTING REQUIREMENTS

- Maximum Fo
- Methods to Reduce Thermal Degradation of Product
- Change in Sterilization Process
- Presterilization of Some Components or Difficult-to-Sterilize Areas of the Product
- Changes in the Sterilization Model Utilized
- Aseptically Filling the Product Prior to Terminal Sterilization
- Reduce the Allowable Presterilization Bioburden
- Change in the BI for the Process

HIGHER TEMPERATURE - SHORTER TIME CYCLE

CHANGES TO A COMBINATION OF PARAMETERS

CONCLUSION
When evaluating the effects of the sterilization cycle on product stability, it is important to recognize that Fo alone cannot be correlated to product stability.
For example, cycles using any of the sterilization models, any BI, and a variety of sterilization times and temperatures can all yield the same total
Fo for a cycle. The effect on the product for each variation of the cycle may yield vastly different product degradation profiles. It is useful to perform
some stability studies early in the product formulation development process to identify products that may be potentially subjected to a terminal sterilization
cycle.

Courtesy of DHI Publications.

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