SGM Biotech was acquired by Mesa Labs (Nasdaq: MLAB) on April 27, 2010 and is now known as Mesa Labs, Bozeman Manufacturing Facility. The acquisition expands and compliments Mesa's existing offering
of biological indicators through its Omaha Manufacturing Facility (formerly Raven Labs).
The Bozeman facility 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.
Originally established in 1988, the Bozeman organization has expanded to more than 22,000 square feet of state-of-the-art facility. Mesa Labs 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, Mesa Labs markets a full line of standard biological indicator products. Click here to visit our products page.
Industry Involvement
Mesa Labs maintains an active role within the sterilization community to promote the use and advancement of biological indicators for sterilization monitoring.
Garrett Krushefski, Manager International Sales - AAMI/ST/WG 04 Biological Indicators Committee member. AAMI/ST/WG 91 Resistometer Committee member.
Kurtis McCauley, Director of Laboratory Production - Institute For Thermal Processing Specialists (IFTPS) member.
The Mesa Labs, Bozeman Manufacturing Facility 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
