SGM Biotech, Inc.

SGM Biotech, Inc. is dedicated solely to the manufacture of biological indicators and supporting services for the evaluation of sterilization processes throughout the pharmaceutical and medical-device industries.

Established in 1988, SGM Biotech has expanded to more than 22,000 square feet of state-of-the-art facility. SGM Biotech manufactures product in strict compliance with QSR / GMP, ISO, and EN regulations where applicable.

FDA Registration #3026-231
ISO 9001:2000 Certified
ISO 13485:2003 Certified

Markets Served

Our biological indicators are used throughout the world by medical and industrial facilities to monitor steam, low temperature steam formaldehyde, ethylene oxide gas, hydrogen peroxide vapor, dry heat, and radiation sterilization processes. We serve customers directly and through a vast network of distributors across the globe.

Major Products

Through our innovative efforts over the past decade, we now offer more than 40 biological indicator suspension and packaging capabilities. A few of these innovations include stainless steel disks with and without holes for hanging inside isolators; woven stainless steel wire; paper in sizes from 10 to 64mm long and 1 to 7mm wide; and much more. In addition to custom products and studies, SGM Biotech markets a full line of standard biological indicator products. Click here to visit our products page.

Industry Involvement

SGM Biotech maintains an active role within the sterilization community to promote the use and advancement of biological indicators for sterilization monitoring.

Dr. John R. Gillis, President - ISO/TC 198/WG 04 Biological Indicators Committee expert member; AAMI/ST/WG 04, Biological Indicators Committee member; AAMI/ST/WG 91 Resistometer Committee member.

Garrett Krushefski, Scientific & Technical Services Manager - AAMI/ST/WG 04 Biological Indicators Committee member. AAMI/ST/WG 91 Resistometer Committee member.

Kurtis McCauley, Contract Studies Manager - Institute For Thermal Processing Specialists (IFTPS) member.

Business Awards

United States Small Business Administration Small Business Exporter of the Year. Montana, 2006.

State of Montana Governor's Excellence in Exporting, 1999 Export Marketing Program Award.

The SGM Advantage

Highly trained staff of professional microbiologists
Extensive offering of standard biological indicator packaging solutions
Flexible operations designed to provide reliable custom biological indicator studies and solutions
Established track record of testing and evaluating a wide array of sterilization processes
High-quality spores - clean, pure spores yeild product uniformity and precise populations
Reliable, high-quality D-value studies
Wide variety of spores, enabling us to readily test numerous sterilization processes
Strong technical leadership in the industry - active participation on national and international standards committees
Certified and audited facilities, operating procedures, and protocols
FDA-registered manufacturer of biological indicators
ISO 13485 and 9001 certified