Semi Self-Contained 48h Biological Indicator for Dry Heat

Bionova Semi Self-Contained 48h Biological Indicator with Culture Media Tubes for Dry Heat sterilization, 50/box (25 Tube A + 25 Tube B).
(Non-Medical only)


Product code: BI-DH48
Mfr: BT30


For monitoring Dry Heat sterilization processes at 150–180 ºC, each vial contains 10⁶ Bacillus atrophaeus (ATCC® 9372) spores with built-in culture media for a visual readout within 48 hours at 37±2 ºC. If sterilization is unsuccessful, the medium changes from blue to yellow, indicating viable spores.

The system consists of Tube A (exposed to heat) and Tube B (contains culture medium, not heat-tolerant). After sterilization, the metal coupon from Tube A is transferred to Tube B under microbiological conditions to prevent contamination.

• Designed for Dry Heat Sterilization
  • Specifically developed to monitor sterilization cycles between 160–180 ºC.
• High-Performance Spore Indicator
  • Contains 1.0 x 10⁶ Bacillus atrophaeus ATCC 9372 spores per vial for accurate validation.
• Rapid, Clear Visual Results
  • Color change from blue to yellow indicates microbial growth (sterilization failure) after incubation at 37 ºC for up to 48 hours.
• Semi Self-Contained System
  • Easy to use with integrated glass ampoule and culture medium inside polypropylene tubing.
• Meets International Standards
  • Manufactured in compliance with ISO 13485:2016, ISO 11138-1 & -4, and IRAM 37102-1 standards.
• Regulatory Approval
  • Authorized by ANMAT (Argentina) – PM 1614-1
  • Classified as Class 1 risk product under ANMAT guidelines.
• Robust Construction
  • Durable nylon and polypropylene components ensure structural integrity under high temperatures.
• Built-In Chemical Indicator Line
  
  • Visual verification with a 1.5 mm line that changes color (to brown) when exposed to Dry Heat.
• Long Shelf Life
  • 24-month shelf life under proper storage conditions (10–30 ºC, dark, 30–80% RH).
• Convenient Packaging
  • Supplied in boxes of 50 units (25 Tube A + 25 Tube B) with complete labeling for traceability.

Type: Sterilizer

• Ensure the indicator is stored according to recommended conditions (10–30 ºC, 30–80% RH, protected from light).
• Do not use if the indicator is expired or shows any physical damage.
• Handle the indicator under clean conditions to avoid contamination.

• Place the BT30 indicator inside the sterilizer chamber in the area most difficult for the dry heat to reach (worst-case location).
• Do not place the indicator in direct contact with sterilizing agents or surfaces that may alter its function.

• Run the dry heat sterilization cycle as required (typically 160–180 ºC).
• After completion, allow the indicator to cool before handling.

• Gently crush the glass ampoule inside Tube B to release the culture medium.
• Shake lightly to ensure full contact between the medium and the spores.
• Place the activated indicator into an incubator set at 37 ºC.
• Incubate for up to 48 hours.

• Positive Result (Failed Sterilization): The culture medium will change from blue to yellow, indicating microbial growth.
• Negative Result (Successful Sterilization): The medium will remain blue, confirming no growth and effective sterilization.

• Dispose of all used indicators as biohazardous waste according to your facility’s protocol.
• Do not reuse the indicator.