美国SGM Biotech
SGM Biotech 公司是世界上专门生产和研发生物指示剂的独立厂商。公司位于美国蒙大拿州,早在1988 年其产品就广泛应用于世界范围的医疗和生物行业,用于监测蒸汽、低温甲醛蒸汽、环氧乙烷、环氧丙烷、干热、过氧化氢、闪蒸汽杀菌过程。SGM 生产一系列自含式和传统式生物指示剂,产品严格遵守QSR / GMP,ISO, 和EN 标准。SGM 也接受特殊指示剂的定制,以满足独特的灭菌监视要求。另外,SGM 有规范的实验室能完成特效产品的D 值和SEM 研究。
SGM Biotech 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 ServedOur 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 ProductsThrough 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.