Patent ID: 8173389

Claim:
A process for determining the effectiveness of sterilization, comprising: exposing at least one article to be sterilized and a sterilization indicator to a sterilization medium to effect a sterilization, the sterilization indicator, comprising: a carrier, the carrier having a first surface and a second surface; a support, the support having a first section and a second section, the carrier overlying the first section of the support, the second surface of the carrier being adhered to the first section of the support; and a biological indicator supported by the carrier, the first section having a length and the second section having a length, the ratio of the length of the second section to the length of the first section being in the range from about 2:1 to about 12:1, the second section of the support being of sufficient dimension to permit handling the sterilization indicator without contacting the biological indicator, the carrier having a surface area in the range from about 1 to about 80 mm 2 ; the biological indicator comprising at least one enzyme; the sterilization indicator being formed by applying the biological indicator to the carrier and then adhering the carrier to the support using sonic welding, wherein the sonic welding, when applied to the carrier with the biological indicator applied, exhibits no significant difference in the biological indicator following the sonic welding as compared to prior to the sonic welding, and contacting the biological indicator with at least one enzyme substrate following sterilization in a volume of incubation medium in the range from about 0.1 to about 1.5 ml to determine whether the sterilization is effective, the enzyme substrate comprising a substance which when acted upon by the enzyme produces an enzyme-modified product, the time required to produce a detectable amount of enzyme-modified product when the sterilization is not effective being from about 0.1 to about 12 hours.