webinar will summarize and clarify terms and issues concerning the vacuum
integrity testing of freeze dryers. Because the lyophilization process occurs in an
evacuated vessel, users
of freeze dryers face
unique challenges in maintaining the sterility of the product in a system under a vacuum. Among these challenges are the
measurement of system
"tightness" and the establishment of an inleakage criterion that maintains a reasonable assurance of product sterility.
System tightness also is important for laboratory dryers to ensure accurate
data required for cycle development. With this in mind, the Vacuum Integrity Test is an
important part of any
Factory Acceptance Test (FAT), Site Acceptance Test (SAT), and/or Operation Qualification (OQ).