Standardization News

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.

“While process understanding in pharmaceutical freeze-drying has improved, process design has seen little change since inception,” says Ganguly, technology manager of IMA Life North America Inc. “For example, there is no known standard related to use of process instrumentation applied to freeze drying.”

Development scientists, validation and operations engineers, technicians, and operators in the biopharmaceutical industry would benefit most from this new information.

To purchase standards, contact ASTM International customer relations (tel +1.877.909.ASTM).

ASTM welcomes participation in the development of its standards. Become a member at www.astm.org/JOIN.

The next meeting of ASTM International’s committee on the manufacture of pharmaceutical and biopharmaceutical products takes place October 22-24 at Purdue University, West Lafayette, Indiana, USA.