Work Item
ASTM WK80172
New Guide for Lyophilization Process Validation
1. Scope
Provide a standard guide for lyophilization process validation
Keywords
freeze drying
Rationale
No standards currently exist for this topic
The title and scope are in draft form and are under development within this ASTM Committee.
Work Item Status
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