Steam Sterilization Biological Indicator<br/>(Self Contained)-MicroDome Labs，Biological Indicator

Steam Sterilization Biological Indicator
(Self Contained)

USP<1229.1>Steam Sterilization by Direct contact

Classification： Biological Indicators
Organism: G.stearothermophilus
Item No:
SDSG7-3/SDSG7-4/SDSG7-5/SDSG7-6

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Classification:

Keyword： Steam Sterilization Biological Indicator<br/>(Self Contained)

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Details

Additional information:
Brand: Microdome Labs	Process: Steam sterilization by direct contact
Storage: 2-8 ℃, protected from light, < 50% relative humidity	Expiration: 24 months from date of manufacture
Negative result: Recovery medium remains purple/clear	Positive result: Recovery medium turns yellow/turbid
Regulations: ISO 11138-1	Field of activity: Healthcare, Pharmaceutical
Description: MicroDome Labs' Steam Sterilization Biological Indicator (Self-Contained ) consists of: ① A plastic culture tube. ② Perforated tube cap with bacterial barrier/breathable membrane. ③ Fiber paper spore carrier (impregnated with high-purity Geobacillus stearothermophilus). 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 biological indicator (self contained) is applicable to the validation and monitoring of steam direct-contact sterilization cycles (USP <1229.1> Steam Sterilization by Direct Contact), as well as the validation of moist heat sterilization processes and equipment. The product is strictly manufactured in accordance with the principles of ISO 11138 and complies with the requirements of the current edition of the Chinese Pharmacopoeia.

Product Specifications

Produce Name	Organism	Item No.	Spore Count	Package
Steam Sterilization Biological Indicator (Self Contained)	G.stearothermophilus Cell Line#7953	SDSG7-3	10³	48 vials/box
		SDSG7-4	10⁴
		SDSG7-5	10⁵
		SDSG7-6	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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