Abstract: A permanent record test device tests the efficiency of a steam sterilizer apparatus to create a vacuum satisfying the Bowie-Dick test procedure. A sheet of selectively porous material such as one hundred pound blotter paper having a steam sensitive indicator ink printed thereon is laminated between layers of steam and air impermeable polymeric material to substantially occlude the sheet from ambient atmosphere, except for a small metering region. The small metering region may include a hole punched through the laminated sheet. Two parallel and spaced apart strips can be used with a metering hole punched at one end of each of the strips or, alternatively, a metering hole is punched at one end of any one of the strips and the strips can be connected with a fluid passageway at the opposite end of the strips. Strips other then straight strips can be used, e.g., an L-shaped strip can be used with a V-shaped strip.

Abstract: A biological test pack adapted for use in testing the efficacy of an ethylene oxide sterilization process is described. The test pack is a clear plastic tray containing an sterilization sensitive ink which has been imprinted on a card which faces out of the bottom of the plastic tray. In addition, the tray contains a plastic syringe which holds a biological indicator. On top of the plastic syringe, absorbent paper is placed. The entire pack has a Tyvek sheet which seals it until it is used. The plastic tray is molded into a shape for holding the various items in particularly desirable locations. Accordingly, a disposable test pack which is uniformly manufactured and which should yield consistent results, is described. It can be used either as a general purpose routine test pack or as a validation challenge test pack.

Abstract: A biological indicator is made of a vial which contains a "spore dot", a nutrient solution in a frangible ampoule, and means for positioning the spore dot and for breaking the ampoule to release the nutrient solution when the cap of the vial is fully pressed on. The nutrient solution typically contains a pH indicator to determine whether all active spores on the strip were killed by a sterilization process which takes place prior to breaking the ampoule.