BT96 Self-Contained Biological Indicator

Advanced Monitoring for VH₂O₂ Sterilization Processes

The 30min Biological Indicator for Hydrogen Peroxide is a high-performance solution designed for rapid and reliable verification of sterilization processes involving Plasma or Vaporized Hydrogen Peroxide (VH₂O₂). This indicator ensures accurate detection of sterilization efficacy in healthcare, pharmaceutical, food, and medical device industries.

Product Description

The 30min Biological Indicator is a self-contained device comprising a spore carrier inoculated with Geobacillus stearothermophilus spores and a sealed ampoule containing a special culture medium. Designed for use with Vaporized Hydrogen Peroxide sterilization systems, it provides reliable results in a significantly reduced timeframe.

Key Features

Rapid Readout:

Final fluorescence detection in just 30 minutes, allowing faster validation of sterilization cycles.

Exceptional Sensitivity:

Reliable detection of sterilization failures to ensure compliance with stringent sterilization standards.

Visual Confirmation:

After incubation, culture medium colour changes confirm sterilization success or failure.

Regulations & Compliance

Manufactured under ISO13485:2016 and related international quality standards.

Complies with FDA 510(k) guidelines.

Classified as a Class 1 device according to international risk standards.

Technical Specifications

Spore Strain: Geobacillus stearothermophilus

Readout Time: Fluorescence results available in 30 minutes.

Culture Medium: Purple-to-yellow colour change for positive sterilization failure detection.

Environmental Conditions During Manufacture

Temperature: 15–30 °C

Relative Humidity (RH): 30–80%

Storage Conditions

Temperature: 10–30 °C

Relative Humidity (RH): 30–80%

Light Exposure: Store in a dark place to maintain product integrity.

Transport Conditions

Products should be transported within the recommended storage conditions to prevent damage.

Acceptable temperature excursions:

2–10 °C or 30–37 °C for no longer than 7 days.

Shelf Life

The 30-minute Biological Indicator has a shelf life of 2 years from the date of manufacture when stored under recommended conditions.

Precautions

• Designed for indoor use only.
• Avoid pouring or immersing the product in liquids.
• Do not expose to direct sunlight or sterilising agents during storage.
• Handle ampoules carefully to avoid breakage.

Packaging & Labeling

Packaging:

Individually packaged to ensure sterility and prevent contamination.

Labelling:

Each unit is labelled with a product code, batch number, serial number, storage instructions, and expiration date.

Applications

Ideal for use in:

• Hospitals and healthcare facilities
• Pharmaceutical manufacturing
• Food processing industries
• Medical device sterilization validation

Why Choose the 30min Biological Indicator?

The 30min Biological Indicator for Hydrogen Peroxide combines rapid detection capabilities with stringent quality assurance to deliver unparalleled reliability. Its ease of use and compliance with international standards make it an essential tool for monitoring sterilization processes.