| 摘要 |
Described is a leak testing method for disposable sterile syringes (1) prefilled with a medicinal product, each of which comprises a barrel (2) for containing the medicinal product and a plunger (7) which slides inside the barrel (2) and forms a seal with the latter's inside surface. The method comprises the steps of fixing the position of the plunger (7) relative to the barrel (2) of each syringe (1) to be tested; exposing the syringes (1) to an outside pressure that is different from atmospheric pressure; exposing the syringes (1) to an outside pressure equal to atmospheric pressure; releasing the position of the plunger (7) relative to the barrel (2) of the syringe (1); and detecting any change in the position of the plunger (7) relative to the barrel (2) of the syringes (1). |
