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Key Documents

05290

Millipore

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

UNSPSC Code:
41171621
NACRES:
NA.85

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

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.

Packaging

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

Components

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

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Personal Protective Equipment

dust mask type N95 (US), Eyeshields, Gloves

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Certificates of Analysis (COA)

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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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