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一般描述
Sterility Indicator (Radiation Sterilization) consists of Bacillus pumilus (ATCC 27142) spores impregnated on paper strips, individually placed into envelopes. The number of spores present per strip: 1 million. Bacillus pumilus is a radiation resistance species. The spores are highly resistant and are used to monitor the efficiency of radiation sterilization. These indicators as specified by U.S. military specification MIL-S-36586 are GMP requirements of U.S. FDA.
包装
package of 25 strips
Dimension envelop (2 strips): 46x70 mm
Dimension strips: 33x7 mm
Dimension envelop (2 strips): 46x70 mm
Dimension strips: 33x7 mm
组分
Bacillus pumilus (ATCC 27142) spores impregnated on paper strips (1 mio. spores per strip)
储存分类代码
11 - Combustible Solids
WGK
WGK 3
闪点(°F)
Not applicable
闪点(°C)
Not applicable
个人防护装备
Eyeshields, Gloves, type N95 (US)
法规信息
新产品
Endospores as biological indicator for the validation of sterilization process
CHEUNG H Y
Pharmaceutical Technology, 158-158 (2013)
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