WK80172 - New Guide for Lyophilization Process Validation

Work Item

ASTM WK80172

New Guide for Lyophilization Process Validation

Provide a standard guide for lyophilization process validation

freeze drying

No standards currently exist for this topic

Developed by Subcommittee: E55.05

Committee: E55

Staff Manager: Travis Murdock

Date Initiated: 12-10-2021

Technical Contact: Arnab Ganguly

Item: 002

Ballot: E55 (23-03)

Status: Will Reballot Item

Item: 002

Ballot: E55 (23-07)

Status: Will Reballot Item

Item: 001

Ballot: E55 (24-01)

Status: Will Reballot Item

Item: 001

Ballot: E55 (24-06)

Status: Negative Votes Need Resolution