Sterilization bioindicator SS6-121 series

for steam sterilizationfor the pharmaceutical industrymedical

Product overview
Self-contained biological indicators for autoclave steam (SS6 series) provide rapid verification of steam sterilization cycles at 121°C, 132°C and 134°C. Available in Rapid (SS6-121R) and Ultra-Rapid (SS6-121S) versions, they target applications in hospitals, central sterile services, pharmaceutical production, medical device manufacturing and biosafety laboratories.

Key features

• Self-contained design minimizes handling and contamination risk while allowing effective steam penetration via medical-grade dialysis paper.
• Two response times: Rapid (results within 3 hours) and Ultra-Rapid (results within 30 minutes).
• Compatible with HTY-RBIR100 Rapid BI Reader for fluorescence-based result interpretation.
• Traceable spore population and documented validation data for process control.

Specifications (table)
Rapid — Ultra-Rapid
Model: SS6-121R — Model: SS6-121S
Organism: Geobacillus stearothermophilus ATCC 7953 — Geobacillus stearothermophilus ATCC 7953
Spore population: 1×10^6–5×10^6 — 1×10^6–5×10^6
Storage: 2–25°C — 2–25°C
Shelf life: 12 months — 12 months
Packaging: 50 pcs/box — 50 pcs/box
Time to result: Within 3 hours — Within 30 minutes

Compliance
Biological indicators meet international standards and include traceable spore and validation data.

• ISO 11138 — Biological indicators
• GB18281 — Biological indicator
• USP <1229>, USP 55, USP 1035
• Ph. Eur. 5.1.2
• PDA TR51
• GMP and applicable FDA 510(k) statements as specified

Applications
Designed for rapid monitoring of steam sterilization effectiveness in operating rooms, CSSDs, pharmaceutical and medical device production, and biosafety laboratories where fast release decisions and routine sterilization validation are required.

Technical specifications

• Product type: Self-contained autoclave steam biological indicator
• Versions: Rapid (SS6-121R) and Ultra-Rapid (SS6-121S)
• Indicator organism: Geobacillus stearothermophilus ATCC 7953
• Spore population per indicator: 1×10^6 to 5×10^6
• Storage conditions: 2–25°C
• Shelf life: 12 months
• Packaging: 50 pieces per box
• Time to result: Rapid — within 3 hours; Ultra-Rapid — within 30 minutes
• Result detection: Incubation and fluorescence-based reading (HTY-RBIR100 Rapid BI Reader)
• Standards/compliances: ISO 11138, GB18281, USP, EP, GMP, PDA TR51, FDA 510(k) (as stated)