Proposed ASTM International Standard Promotes Better Understanding of Pharmaceutical Freeze Drying

A proposed ASTM International standard aims to promote a shared understanding of the science and engineering behind pharmaceutical freeze-drying. The proposed standard (WK63507) is being developed by ASTM’s committee on the manufacture of pharmaceutical and biopharmaceutical products (E55). 

According to ASTM member Arnab Ganguly, uncertainty over the best practices in these areas of freeze-drying operations can lead to delays resulting from lengthy internal debate over what constitutes best methods. Industry-wide standards can reduce time lost in unnecessary debate over best practice protocols.



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