Biological Indicator (Self-Contained)-MicroDome Labs，Biological Indicator

Biological Indicator
(Self-Contained)

USP<1229.2>Moist Heat Sterilization of Aqueous Liquids

Classification： Biological Indicators
Organism: Bacillus subtilis
Item No:
SLSLSB3-3/SLSLSB3-4/SLSLSB3-5/SLSLSB3-6
More into about the product:

Key words:

Classification:

Biological Indicator & Accessories

Biological Indicator (self-contained) for moist heat sterilization

Keyword： Biological Indicator (Self-Contained)

Agency:

sales@lotustech.com.au

Manufacturer:

info@microdome.com.au

Message

Details

Additional information:

Brand: Microdome Labs
Process: Moist heat
Packing: 48 vial per box
Microorganism:Bacillus subtilis
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 Liquid Type).
① Polypropylene culture tube with perforated cap.
② Bacteria-retentive breathable membrane.
③ Cellulose-based spore carrier strip.
④Crushable glass ampoule containing sterile recovery growth medium and pH indicator.

Biological Indicator Microorganism:
High-purity Bacillus subtilis spores (Cell Line #35021)
Patented Design Features:
①Eliminates F-value variations caused by orientation (upright/horizontal/inverted) during use.
②Prevents compression of paper carrier by crushable ampoule in traditional upright positioning (which may compromise sterilization efficacy).

Applications:
①Validation and monitoring of direct steam contact sterilization cycles (per USP <1229.1>).
②Process validation for moist heat sterilization (e.g., liquid reagents/products).
③Performance qualification (PQ) of moist heat sterilization equipment.

Compliance:
①Manufactured in strict accordance with ISO 11138-1/3 standards.
②Meets current Chinese Pharmacopoeia (ChP) requirements.

Key Technical Notes:

①Self-contained system: Integrates spores, recovery medium, and pH indicator in a single unit.
②Crush ampoule mechanism: Ensures aseptic release of growth medium upon activation.
③Orientation-independent performance: Validated FBio consistency across all operational positions (D-value: 1.0-5.0 min at 121℃).

Product Specifications

Produce Name	Organism	Item No.	Spore Count	Package
Biological Indicator for Moist Heat Sterilization for Aqueous Liquid (self-contained liquid biological indicator)	Bacillus subtilis(Glass tube)	SLSLSB3-3	10³	48 vials/box
		SLSLSB3-4	10⁴
		SLSLSB3-5	10⁵
		SLSLSB3-6	10⁶
Biological indicator spore counting kit	N/A	MD-PF	N/A	1 set/box