Patents & Publications
Apr 18, 2017

Game changer Biological Indicator cleared by FDA


 

Chandler, Arizona, April 18, 2017

        Taking sterility testing to higher levels, BCR Corp. offers a remarkably simple and rapid Biological Indicator (BI) containing spores of heat-resistant bacteria.

        The BCR-30-min BI™ is the first rapid BI that perfectly matches CDC’s definition of an ideal monitoring system.

 

 

Category: General
Posted by: boris123

CDC, Dec. 2009.       “An ideal biological monitor of the sterilization process should be easy to use, be inexpensive, not be subject to exogenous contamination, provide positive results as soon as possible after the cycle so that corrective action may be accomplished, and provide positive results only when the sterilization parameters (e.g., steam-time and temperature, and/or saturated steam; ETO-time, temperature, relative humidity and/or ETO concentration) are inadequate to kill microbial contaminates.”Technological basis

        Driven by public needs for safer and faster sterilizing procedures, the BI has evolved considerably over the past decades.  Despite the technological advances, present-day self-contained biological indicators (SCBIs) still have limitations: (1) relatively high cost compared to the traditional spore strips; (2) occurrence of “false negatives” caused by air trapped in the indicator; and (3) exclusion of extensive sterilization that can damage either the growth medium or the fluorogenic substrate.  False negatives are particularly significant because they may conceal contaminated surgical supplies in use.

        The unprecedented features of the BCR-30-min BI™ derive from a novel technology (patent pending) centered on phenotypically engineered spores (termed F-spores™) that function as self-reporters of germination.  F-spores™ have the unique property of being fluorogenic, i.e., they are non-fluorescent when dormant but produce intense fluorescence a few minutes after the onset of germination (PLoS ONE 5, e9283, 2010).  Measuring spore germination (instead of conventional spore outgrowth) enables extremely short readouts without sacrificing sterility assurance.  

        For testing the BCR-30-min BI™ after exposure to a sterilization cycle, the spore strip is introduced in the RBIP-ST30™, the readout accessory, for automatic processing.  No aseptic technique is required.  In the RBIP-ST30™, viable spore survivors are converted into F-spores™ producing intense fluorescence.  Dead spores, however, do NOT produce fluorescence.  The RBIP-ST30™ computes the spore’s fluorescence, calculates the sterility assurance level (SAL), and reports whether or not the sterility cycle is in compliance.


Features

    The figures below show the BCR-30-min BI™ together with a diagram of a self-contained BI (SCBI), currently the most used BI.

According to Dr. Boris Rotman, BCR’s Vice President and Chief Scientific Officer, “The low cost and the 30-min readout of the new biological indicator will permit for every load monitoring, which at present is considered the best practice since it improves patient’s safety and prevents costly recalls due to sterilization malfunction.  Also, the fact that the new indicator contains only spores, allows for extended sterilization, a feature not found in existing self-contained indicators.”

News
Apr 18, 2017
Category: General
Posted by: boris123

 

Chandler, Arizona, April 18, 2017

        Taking sterility testing to higher levels, BCR Corp. offers a remarkably simple and rapid Biological Indicator (BI) containing spores of heat-resistant bacteria.

        The BCR-30-min BI™ is the first rapid BI that perfectly matches CDC’s definition of an ideal monitoring system.

 

 

Oct 29, 2014
Category: General
Posted by: boris123

Simple Technology Could Reduce Cost of Fluorescence-based Instrumentation by More than Five-fold


Jan 14, 2011
Category: General
Posted by: boris123

BCR Diagnostics relocates to Chandler, Arizona

Nov 8, 2010
Category: General
Posted by: boris123

BCR Diagnostics awarded $204,630 grant under Qualifying Therapeutic Discovery Project (QTDP) program

Jun 16, 2006
Category: General
Posted by: boris123

BCR Corporation Presents An Innovative Breakthrough Biosensor Platform at National Institutes of Health "Life Sciences Showcase"