Products and Services

SGM Biotech biological indicatorsSGM Biotech manufactures a wide array of self-contained and traditional biological indicators to monitor most common sterilization processes: steam, low temperature steam formaldehyde, ethylene oxide, propylene oxide, dry heat, chlorine dioxide, hydrogen peroxide, and gamma radiation.

We can also create custom indicators to meet your unique sterilization monitoring requirements. In addition, we have an entire laboratory dedicated to contract studies where we can perform D-value and SEM studies with your specific products.

All products with incubation times of less than 7 days meet the FDA protocol for Reduced Incubation Time (RIT).

Biological Indicators

Highlight biological indicators by process:
steam / flash - steam sterilization of liquids - EtO - formaldehyde
hydrogen peroxide - radiation - dry heat - propylene oxide - chlorine dioxide

Smart-Read EZTest System

Smart-Read™ EZTest® Biological Indicator Monitoring System

The Smart-Read system allows the release of sterile product with true biological confirmation faster and easier than ever before. This unique system uses a real biological indicator -- with no added enzyme or chemical integrator -- which is incubated, evaluated, and documented in one simple, automated operation. Based on familiar, proven technology, all results are 100% verifiable by the operator.

 

The Smart-Read system includes the Smart-Read EZTest self-contained biological indicator for steam which is specially designed for rapid evaluation in the advanced Smart-Well® incubator.

         
EZTest biological indicator

EZTest®

Self-contained color change biological indicators available for steam, flash, propylene oxide, hydrogen peroxide, and ethylene oxide sterilization.

  EZTest biological indicator test pack (PCD)

EZTest Test Pack PCD

Biological test packs (process challenge devices) featuring EZTest indicators for monitoring steam or ethylene oxide.

         
SterilAmp biological indicator

SterilAmp® II

Color change biological indicator ampoules for monitoring steam (121°C) sterilization of liquids.

  SterilAmp 5230 biological indicator

SterilAmp® II "5230"

Color change biological indicator ampoules for monitoring low temperature (115°C) steam sterilization of liquids.

         
MagnAmp biological indicator

MagnaAmp®

Snap-top color change biological indicator ampoules for monitoring steam sterilization of liquids.

  Releasat biological indicator culturing kit

Releasat®

Rapid readout color change culturing kit featuring SGMStrip for monitoring steam or ethylene oxide sterilization.

         
Vapor Hydrogen Peroxide Biological Indicators

SGMDisc™ for HPV

Biological indicators for monitoring hydrogen peroxide vapor sterilization.

  SGMStrip biological indicator

SGMStrip®

Paper spore strip biological indicators in glassine available for steam,LTS formaldehyde, ethylene oxide, chlorine dioxide, and radiation.

         
DriAmp Culturing Set

DriAmp® Culturing Set

The DriAmp Culturing Set with Releasat® Medium provides 72 hour biological release for high temperature dry heat sterilization of instruments and depyrogenation processes.

  Spore Suspensions

Spore Suspensions

Spore suspensions for creating custom biological indicators to monitor steam, ethylene oxide, dry heat, or radiation.

         
custom biological indicators

Custom Indicators

Custom biological indicators can be manufactured to meet your unique sterilization monitoring requirements.

   

 

         

Other Products

EZTest Biological Indicator Incubators

SGM Incubators

Fourteen cavity incubators available for convenient incubation of EZTest and MagnaAmp biological indicators.

  Biological Indicator Gaskets

BI Gaskets

Top loading or inline positioning of EZTest or SGMStrip biological indicators in sanitary process lines.

         
Population Assay Kit

Population Assay Kit

The population assay kit contains all the materials required to confirm the population of our biological indicators.

  Lethality Mapper Software

Lethality Mapper

Microsoft Excel Add-in creates 2D and 3D lethality charts of sterilization chambers from F-values calculated using your thermocouple data.

 

Smart-Read EZTest Biological Indicator Monitoring System
New Products!

DriAmp Culturing Set with Releasat Medium
The DriAmp Culturing Set with Releasat® Medium provides 72 hour biological release for high temperature dry heat sterilization of instruments and depyrogenation processes.

EZTest PPO
EZTest self-contained BI for monitoring propylene oxide pasteurization of almonds and other dry foods.

BI Gaskets
Insert EZTest or SGMStrip biological indicators directly into process lines.

SGMStrip for Formaldehyde
SGMStrip is now available for monitoring low temperature steam formaldehyde sterilization.


Contract Studies

Custom D-value studies can be performed on your pharmaceutical or medical devices. SGM has the full capacity to test liquid products as well as inoculated medical products. B.I.E.R vessels for steam and ethylene oxide that meet the AAMI performance standards are used. All studies are performed under strict compliance to cGMPs.

SEM Photo Scanning electron microscope (SEM) images are also available to supplement inoculated D-value studies. These micrographs will demonstrate the physical interaction between your product and the inoculated spores. They will also demonstrate what the product surface appears like in reference to particles as small as microbial spores.

More Information ...


SGM Bitoech, Inc. is FDA registered and ISO 9000:2000 and ISO 13485:2003 compliant. We adhere to strict US and International standards in the manufacture of our quality products.

United States Pharmacopeia

European Norms

International Standards Organization

Association for the Advancement of Medical Instrumentation

American National Standards Institute

Current Good Manufacturing Practice

Copyright 2005, SGM Biotech, Inc. All rights reserved.

SGM Biotech, Inc.
10 Evergreen Drive Suite E
Bozeman, MT 59718 USA
Phone: 406-585-9535
FAX: 406-585-9219
General Information: info@sgmbiotech.com
Customer Service: cust-service@sgmbiotech.com

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