Standardization News

A new ASTM International standard will aid the pharmaceutical industry by describing best practices in monitoring process and product condition during freeze-drying. ASTM’s committee on manufacture of pharmaceutical and biopharmaceutical products (E55) developed the standard, which focuses on methods that apply to both laboratory and production environments.

“The new standard provides guidance on product temperature and pressure measurement during freeze-drying,” says ASTM International member Arnab Ganguly. “This will promote a deeper understanding of the science and engineering of pharmaceutical freeze-drying, which is a fundamental component of the quality by design paradigm.”  

Ganguly, technology manager, IMA Life North America, says that the new standard, soon to be published as E3250, will help to minimize uncertainty that can lead to delays in what constitutes best practices for freeze-drying in the development of pharmaceuticals. Developers, validation engineers, technicians, and operators will all find the new standard useful.  

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