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Merck

05290

Sterility Indicator (Radiation Sterilization)

suitable for microbiology

Synonym(s):

Spore Strips (for Radiation Sterilization), Spore Strips Bioindicator (for Radiation Sterilization)

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About This Item

NACRES:
NA.85
UNSPSC Code:
41171621

Key Documents

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Product Name

Sterility Indicator (Radiation Sterilization), suitable for microbiology

shelf life

limited shelf life, expiry date on the label

application(s)

clinical
cosmetics
environmental
food and beverages
pharmaceutical
veterinary
microbiology

storage temp.

2-8°C

Quality Level

100

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General description

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.

Other Notes

Bacillus pumilus (ATCC 27142) spores impregnated on paper strips (1 mio. spores per strip)

Packaging

package of 25 strips
Dimension envelop (2 strips): 46x70 mm
Dimension strips: 33x7 mm

Storage Class

11 - Combustible Solids

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

ppe

Eyeshields, Gloves, type N95 (US)

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Certificates of Analysis (COA)

Lot/Batch Number
BCCL9658
BCCK6742
BCCJ5054
BCCF4108
BCCD5699

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Endospores as biological indicator for the validation of sterilization process
CHEUNG H Y
Pharmaceutical Technology, 158-158 (2013)

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