An automated method for vacuum testing pharmaceutical vials

A new automated vacuum tester which applies a high voltage, high frequency electric field and a stroboscopic flash to conveyorized vials was found to yield zero percent false rejections of lyophilized vials with internal pressures of less than 62 Torr. The hand-held testing device used until now was found to produce, on extended contact with vials containing sensitive protein product, excessively high numbers of particulates upon drug reconstitution. In the automated machine operating at rates between 150 and 30 vials per minute, each vial is exposed for only 0.3 to 1.4 seconds and sensitive products emerge undamaged.