Impact of stopper elastomer formulations on the moisture content inside lyophilized vials |
A1 | HM stopper | 2 h | 30°C/65% RH |
A2 | LM stopper | 2 h | 30°C/65% RH |
A3 | HM stopper | 24 h | 30°C/65% RH |
A4 | LM stopper | 24 h | 30°C/65% RH |
Effect of stopper drying time on moisture permeation through the stopper |
B1 | HM stopper | 1 h 50 min | 30°C/65% RH |
B2 | HM stopper | 3 h 10 min | 30°C/65% RH |
B3 | HM stopper | 5 h 20 min | 30°C/65% RH |
B4 | HM stopper | 11 h 20 min | 30°C/65% RH |
B5 | HM stopper | 25 h 30 min | 30°C/65% RH |
Effect of the stopper elastomer formulations on moisture permeation through the stopper |
C1 | HM stopper | 2 h | 30°C/0% RH |
C2 | HM stopper | 24 h | 30°C/0% RH |
C3 | HM stopper | 2 h | 30°C/65% RH |
C4 | HM stopper | 24 h | 30°C/65% RH |
C5 | HM stopper | 2 h | 30°C/97% RH |
C6 | HM stopper | 24 h | 30°C/97% RH |
D1 | LM stopper | 2 h | 30°C/0% RH |
D2 | LM stopper | 24 h | 30°C/0% RH |
D3 | LM stopper | 2 h | 30°C/65% RH |
D4 | LM stopper | 24 h | 30°C/65% RH |
D5 | LM stopper | 2 h | 30°C/97% RH |
D6 | LM stopper | 24 h | 30°C/97% RH |