11/10/2005

SGM Biotech, Inc.

New Biological indicator system allows recognition of steam steriliser failure

A new EZTest® incubator/reader from SGM Biotech Inc. will automatically detect a pH shift due to spore survival in as little as 3 hours incubation without technician intervention. This is a true biological test based solely on live bacterial spores. Once alerted by an audio alarm, a flashing LED and a printed report, remedial actions may be initiated far earlier than previously possible.

The use of biological indicators has in recent years increased substantially as manufacturers of sterile products have recognised their value in detecting sterilisation failures that thermocouples and other physical instruments fail toobserve. From a manufacturing aspect, minimising delay in recognising steriliser failures has been critical to allow remedial actions to be initiated and preventing suspect product from being released. The early use of spore strips as biological indicators, although valuable quality control, had the disadvantage of a 7 day incubation. EZTest are self contained and convenient biological indicators but more importantly have also reduced incubation times dramatically and the introduction of the Smartwell® incubator is the progression of this advantage.

EZTest® is a true biological indicator as defined by the USP, ISO and EP, conforming to all regulatory requirements and is already an established preference in many locations throughout the international medical community. The Smart-Well® units incubate activated BIs and continually monitor colour change for each cavity. A status light for each cavity shows the operator the following: running (yellow), failed (red), and green (passed).

The instrument is self calibrating and is easy to operate. The Smart–Well® allows temporary removal to visually confirm the BI status or a steriliser failure. Working unit at MEDICA 2005