Conclusion
The study indicates that safety margins for shelf temperature and chamber pressure for a given product can be pre-evaluated
in a laboratory using advanced PAT tools and therefore may allow for a rational QbD approach in the future. In addition, product
resistance data obtained from MTM may provide valuable information about microcollapse in the product ("benchmark" properties).
This information can be very useful in interpreting the effect of temperature or pressure deviations on a product.
Henning Gieseler, PhD,* and Stefan Schneid work in the Division of Pharmaceutics at the University of Erlangen, Erlangen, Germany 91058, tel. +49 9131 85 29545, gieseler@freeze-drying.eu
Tony Kramer works at the Ecolab Research Center in Eagan, Michigan.
*To whom all correspondence should be addressed. Submitted: Jan. 23, 2008. Accepted. Apr. 23, 2008.
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