Search Results

The TST Control Integrator for Steam Autoclave is a steam sterilization process indicator designed to indicate, through a yellow to blue color change, when a combination of parameters necessary for sterilization (270°F for 3 minutes) have been achieved.

Albert Browne Ltd. received clearance for a TST Control Integrator for Steam Autoclave, K902958, which monitored sterilization cycles with a holding temperature/time combinations of 250°F (121°C)/15 min. The purpose of this submission is to expand the process parameter combinations to include a cycle of 270°F/3 min. Like the integrator described in K902958, the TST steam integrator discussed in this amendment changes color from yellow to blue when a specific set of process parameters required for steam sterilization to occur have been met. The parameters of the sterilization cycle monitored by the proposed integrator - time, temperature and the presence of steam - are equivalent to those monitored by the integrators described in K902958. Albert Browne Ltd. is amending K902958 in order to increase the combinations of parameters which produce a color change to include additional temperatures. The time-temperature combinations in sterilization cycles which will induce TST Control Integrators to change color from vellow to blue are presented in Table 1. The TST steam integrator consists of a paper strip with the chemical indicator ink located on one end. The color change is pH based. The time and temperature required for the color change to occur is precisely controlled through manipulation of the chemical composition of the ink.

SteriTer CROSS-CHECKS sterilization chemical monitoring strips are designed to be utilized in steam sterilizers operating at 132" (270°F to 276°F to 276°F). When used as directed, the SteriToc Cross.Checks indicator strips give visible indication that sterilizing conditions were met. During steritization, the check mark at the end of the strip changes from white to black, becoming as dark or darker in intensity than the black reference arrow printed on the strip.

The basic formula and concept of black to white chemical steam sterilization indicators has not changed dramatically since they were invented in 1932.