TABLE I

The Experimental Conditions Used for Each Study

Sample No.StoppersDrying Time of the StoppersStorage Conditions of the Lyophilized Products
Impact of stopper elastomer formulations on the moisture content inside lyophilized vials
    A1HM stopper2 h30°C/65% RH
    A2LM stopper2 h30°C/65% RH
    A3HM stopper24 h30°C/65% RH
    A4LM stopper24 h30°C/65% RH
Effect of stopper drying time on moisture permeation through the stopper
    B1HM stopper1 h 50 min30°C/65% RH
    B2HM stopper3 h 10 min30°C/65% RH
    B3HM stopper5 h 20 min30°C/65% RH
    B4HM stopper11 h 20 min30°C/65% RH
    B5HM stopper25 h 30 min30°C/65% RH
Effect of the stopper elastomer formulations on moisture permeation through the stopper
    C1HM stopper2 h30°C/0% RH
    C2HM stopper24 h30°C/0% RH
    C3HM stopper2 h30°C/65% RH
    C4HM stopper24 h30°C/65% RH
    C5HM stopper2 h30°C/97% RH
    C6HM stopper24 h30°C/97% RH
    D1LM stopper2 h30°C/0% RH
    D2LM stopper24 h30°C/0% RH
    D3LM stopper2 h30°C/65% RH
    D4LM stopper24 h30°C/65% RH
    D5LM stopper2 h30°C/97% RH
    D6LM stopper24 h30°C/97% RH