ALK's 20mm 20ml, 30ml, 50ml and 100ml sterile, empty vials are certified depyrogenated and sealed and are:
Type 1 borosilicate assembled with butyl stoppers.
The sterilization process is performed in an FDA inspected facility, operating to cGMP compliance and the sterilization processes are carried out under strict Class 100 regulations.
Assembled units are free of all endotoxins and meet the FDA's mandated 14-day sterility testing protocol.