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Semi Self-Contained 48h Biological Indicator for Dry Heat

BIONOVA BT30 Semi Self-Contained Biological Indicator for Dry Heat Sterilization, 50 Sets

BT30

Price: $240.00

Product Code: BI-DH48

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Description

Technical Specs

Literature

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.

Yellow = Sterilization failed (spore growth)

Blue = Sterilization successful

Key Features

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.

Sold Separately:
SteriCheck Digital Incubator
Bionova Incubator
Bionova MiniBio Auto-Reader Incubator

Brand	Bionova (BT30)
Process	Dry Heat (160–180 ºC)
Packaging	50 units per box (25 Tube A + 25 Tube B)
Microorganism	Bacillus atrophaeus (ATCC® 9372)
Population	10^6 Spores/carrier D-Value: ≥ 2.0 minutes at 160 ºC Z-Value: ≥ 20 ºC
Read-Out Time	48 hour (Temperature: 37 ºC)
Regulations	IRAM 37102-1, ISO 11138-1, ISO 11138-4
Length	3 m
Shelf Life	50

Component	Material	Dimensions (mm)
Tube A	Nylon	45.0 H x 8.4 OD, 1.0 wall thickness
Tube B	Polypropylene copolymer	45.2 H x 8.5 OD, 0.5 wall thickness
Cap A	Nylon (with rod)	10.5 OD x 13.5 H, 1.2 wall; rod: 28.5 L
Cap B	Polypropylene	10.5 OD x 13.1 H, 1.2 wall
Filter Paper	—	5.0 x 25.0 (in Cap A rod groove)
Glass Ampoule	Glass	35.0–40.0 H x 6.8 OD, 0.2–0.3 wall
Product Label	Paper	17.0 x 33.0; 1.5 mm indicator line (brown)

Directions for Use

1. Preparation

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.

2. Placement

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.

3. Sterilization

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

4. Activation & Incubation

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.

5. Result Interpretation

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.

6. Disposal

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

Important Notes

Do not expose the BT30 indicator to steam, radiation, or any sterilization process other than Dry Heat.

Always read the full Instructions for Use provided by the manufacturer before using this product.

Avoid storing indicators near sterilizing agents to prevent premature exposure

Features

Q. What is the BIONOVA Semi Self-Contained 48h Biological Indicator used for?
A. designed specifically for monitoring Dry Heat sterilization processes between 150–180 ºC. It helps verify the effectiveness of the sterilization cycle by detecting the survival or inactivation of Bacillus atrophaeus (ATCC® 9372) spores.

Q. How do I use the two-tube system properly?
A. Tube A is exposed to the dry heat sterilization cycle. After the cycle is complete and once conditions are sterile (preferably in a laminar flow hood), transfer the metal coupon from Tube A to Tube B, which contains the culture medium. Avoid exposing Tube B to heat during sterilization, as this will compromise the medium. Proper microbiological conditions are critical to prevent cross-contamination.

Q. What does a positive or negative result look like?
A. After 48 hours of incubation at 37±2 ºC, check the culture medium in Tube B:

Yellow color: Indicates growth of viable spores — sterilization FAILED.
Blue color: No spore growth — sterilization successful.

Q. Can I incubate at a higher or lower temperature than 37°C?
A. No. For accurate results, the BT30 indicator must be incubated at 37±2 ºC. Incubation outside this range can delay or misrepresent the results.

Q. Can Tube B be placed in the sterilizer with Tube A?
A. No. Tube B contains a heat-sensitive culture medium and should never be exposed to sterilization temperatures. Only Tube A is meant for sterilizer exposure.

Q. What type of incubator should I use?
A. Use a dry incubator such as the BIONOVA® IC10/20, SteriCheck Digital Incubator, or any validated incubator that maintains 37±2 ºC and accommodates the BT30 vial dimensions. Incubators should be regularly calibrated for accurate performance.

Q. What precautions should I take to avoid contamination during the transfer?
A. Perform the transfer in a clean, controlled environment using sterile tools and gloves. Avoid touching the inner surfaces of either tube. Conduct the procedure in a laminar airflow cabinet when possible to ensure sterility.

Q. What is the shelf life and storage recommendation for the BI-DH48 (BT30)?
A. Has a 24-month shelf life from the manufacture date. Store it in a dark place at 10–30 ºC with 30–80% relative humidity. Do not store near sterilizing agents, and always keep the box closed and protected during transport.