A sterilization indicator for testing the effectiveness of a sterilization procedure
comprises a source of an enzyme, a sterilant-resistant chemical associated with
the enzyme, and a substrate that reacts with the enzyme to form a detectable enzyme-modified
product that provides an indication of the failure of the sterilization procedure.
The sterilant-resistant chemical may be a polyglycerol alkyl ester, polyglycerol
alkyl ether, an ethoxylated polyhydric alcohol ester, or a polyhydric alcohol ether.
The indicator may be used to test the effectiveness of a hydrogen peroxide plasma
sterilization procedure and may be provided with a non-challenge test pack or a
lumen-challenge test pack.
