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美國SGM Biotech
SGM Biotech 公司是世界上專門生產(chǎn)和研發(fā)生物指示劑的獨立廠商。公司位于美國蒙大拿州，早在1988 年其產(chǎn)品就廣泛應(yīng)用于世界范圍的醫(yī)療和生物行業(yè)，用于監(jiān)測蒸汽、低溫甲醛蒸汽、環(huán)氧乙烷、環(huán)氧丙烷、干熱、過氧化氫、閃蒸汽殺菌過程。SGM 生產(chǎn)一系列自含式和傳統(tǒng)式生物指示劑，產(chǎn)品嚴格遵守QSR / GMP,ISO, 和EN 標(biāo)準(zhǔn)。SGM 也接受特殊指示劑的定制，以滿足獨特的滅菌監(jiān)視要求。另外，SGM 有規(guī)范的實驗室能完成特效產(chǎn)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.
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