SGM BIOTECH公司介绍


SGM BIOTECH公司介绍

简要描述: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。

详细介绍

产品咨询

公司:http://sgmbiotech.com/products/sgmstrip.php

美国SGM Biotech www.sgmbiotech.com
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*的灭菌监视要求。另外,SGM 有规范的实验室能完成*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.
 

美国SGM Biotech www.sgmbiotech.com
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*的灭菌监视要求。另外,SGM 有规范的实验室能完成*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.
 

美国SGM Biotech www.sgmbiotech.com
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*的灭菌监视要求。另外,SGM 有规范的实验室能完成*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. 
 

内毒素指示剂

内毒素指示剂

  • 产品特性
  • 相关资料
  • Q&A
  • 参考文献

内毒素指示剂内毒素指示剂

内毒素指示剂

对于内毒素检测使用的耗材,需要对其进行干热处理以去除热源。为确保干热灭菌设备(或其他灭菌设备)能有效地灭活、破坏内毒素,一般会在对热原去除过程的前后对耗材的内毒素含量进行比较,并测定细菌内毒素的对数下降值(通常不得少于3个对数单位),来评价热原去除的效果。

 

通常可利用内毒素指示剂对热源去除效果进行评价。美国药典(USP)中所描述的内毒素指示剂,其内毒素活性需至少为1000个内毒素活性单位(EU),以便在热原去除过程中能够证明内毒素水平至少下降了1000倍(3个对数单位)。

 

利用内毒素指示剂,证明在去除热原后内毒素水平至少降低3个对数单位,以确保干热灭菌设备对热源去除的有效性。

 


◆用途


验证干热灭菌设备(或其他灭菌设备)对热源的去除效果。

 


◆特点


● 内毒素指示剂含经纯化的脂多糖(来源:E.Coli 055:B5

● 该产品经冷冻干燥,不含稳定剂、填充剂。

 

保存条件:2~8℃,试剂溶解后请尽快使用。

※ 本页面产品仅供研究用,研究以外不可使用。


产品列表
产品编号 产品名称 产品规格 产品等级 备注
549-10291 ENDOTOXIN INDICATORS, >1000 EU/vial
 内毒素指示剂(>1000EU/瓶)
25 vials