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04/06/2005 - LTS Formaldehyde Strips

SGM Biotech, Inc. is pleased to announce the release of its new SGMStrip for monitoring low-temperature steam formaldehyde processes. The product consists of the spores of Geobacillus stearothermophilus ATCC# 7953 inoculated onto the standard cellulose carrier used for the other SGMStrip BIs. These carriers are packaged in the blue sterilizable glassine used in SGM's other products.

This product meets all of the criteria addressed in ISO 11138-5 "Sterilization of healthcare products - biological indicators systems Part 5: Use in assessing low-temperature steam and formaldehyde sterilization processes". The spore population meets the ISO 11138-5 with a minimum of 1.0 x 10⁶ spores per unit. If the user desires to reconfirm this population, SGM has developed a Population Assay Kit including all the supplies necessary for performing this test. The kit includes the same media used by SGM which aids greatly in achieving the confirmation of results.

D-value testing is performed based on the method described in ISO 11138-5, Annex A. Performance results comply with the standard which requires a D₆₀-value of not less than 6 minutes. The resistance of the biological indicator is also expressed as FBIO which is the actual population determined multiplied by the measured D60-value. The survival-kill response characteristics are calculated according to ISO 11138-1, Annex E. The survival-kill response meets the ISO 11138-5 requirement of a survival time not less than 18 minutes and a kill time not more than 54 minutes.

More SGM News

02/03/2010 - Understanding Biological Indicator Grow-Out Times
An RIT study co-authored by SGM Biotech using Smart-Well technology was recently published in Pharmaceutical Technology.
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03/06/2008 - ISO 13485:2003 and 9001:2000 Certification
SGM Biotech has recently received ISO 13485:2003 and 9001:2000 certification.
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12/03/2006 - Announcing Releasat® for Steam!
SGM is pleased to introduce the Releasat Culturing Set for monitoring steam sterilization with 24 hour release.
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10/25/2006 - Introducing DriAmp®!
SGM Biotech, Inc. is pleased to announce the introduction of its new dry heat sterilization product, the DriAmp® Culturing Set with proprietary Releasat® medium.
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07/17/2006 - Montana SBA Exporter of the Year
The Montana District Office of the U.S. Small Business Administration named SGM Biotech, Inc. the 2006 Montana Small Business Exporter of the Year.
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03/23/2006 - Propylene Oxide EZTest BI
SGM Biotech, Inc. is pleased to announce the release of its EZTest® propylene oxide (PPO) self-contained biological indicator (SCBI) for use in monitoring and validating propylene oxide gas pasteurization of almonds, nuts and other dry food products.
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08/24/2005 - Population Assay Presentations
Presentations have been added with detailed instructions for performing population assays of MagnaAmp, SterilAmp, and paper carriers.

04/06/2005 - LTS Formaldehyde Strips
SGM Biotech, Inc. is pleased to announce the release of its new SGMStrip for monitoring low-temperature steam formaldehyde processes.
Read entire press release

02/14/2005 - Population Assay Kit
SGM is pleased to announce the release of its new Population Assay Kit. This kit provides users with the same supplies and culture medium used by SGM for the recovery of spores in our QC release test.
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