Biological Indicator
(Self-Contained)
USP<1229.7>Gaseous Sterilization
Classification: Biological Indicators
Organism: Bacillus atrophaeus
Item No:
SDEB9-3/SDEB9-4/SDEB9-5/SDEB9-6
More into about the product:

Key words:

Keyword: Biological Indicator<br>(Self-Contained)

Details

Additional information:

Brand: Microdome Labs

Process: EO Sterilization

Packing: 48 vial per box

Microorganism:Bacillus atrophaeus

Regulations: ISO 11138-1

Initial Color:Red

Final Color: Yellow

Field of activity: 
Healthcare, Pharmaceutical

Description:

MicroDome Labs Moist Heat Sterilization Biological Indicator (Self-Contained ) consists of:

①  A plastic culture tube; 
②Perforated tube cap with bacterial barrier/breathable membrane; 
③ Fiber paper spore carrier (impregnated with high-purity Bacillus atrophaeus spores). 
④ Crushable glass tube containing sterile growth recovery medium with pH indicator. 
The patented tube design eliminates F-value (lethality) variations caused by indicator orientation (upright/horizontal/inverted).

Conventional designs may compromise sterilization efficacy when upright positioning compresses the paper carrier against the glass tube.

The ethylene oxide sterilization biological indicator (self-contained) is used for the verification and monitoring of ethylene oxide sterilization cycles, the validation of ethylene oxide sterilization processes, and the validation of ethylene oxide sterilization equipment. 
The product is strictly produced in accordance with the principles of ISO 11138 and meets the requirements of the current edition of the Chinese Pharmacopoeia.

The ATCC trademark and trade name and any and all ATCC catalog marks are trademarks  
of the American Type Culture Collection.

 

Product Specifications

 

Produce Name

Organism

Item No.

Spore Count

Package

EO Sterilization Biological Indicator(Self-contained)

Bacillus atrophaeus#9372

SDEB9-3

103

48 vials/box

SDEB9-4

104

SDEB9-5

105

SDEB9-6

106

Spore Elution Solution

N/A

MD-WF

N/A

5 bottles/box

Biological Indicator Spore Counting Kit

N/A

MD-PF

N/A

1 set/box

Crushing Clip

N/A

MD-BC

N/A

1 per box

 

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