BT93/6 Spore Coupons for H2O2 Sterilization

Designed for the precise monitoring of Plasma or Vaporized Hydrogen Peroxide sterilization processes, BT93/6 Spore Coupons are essential tools in ensuring the efficacy of sterilization, crucial for high-quality infection control.

BT93/6 Spore Coupons – Key Features:

Usage: Ideal for monitoring Plasma/Vaporized Hydrogen Peroxide (H2O2) Sterilization Processes.

Compliance: Adheres to ISO 13485:2016, ISO 11138-1:2017, and IRAM 37102-1:1999 standards.

Classification: Classified as Class 1 (low risk) according to regulatory guidelines.

Authorization: Approved by ANMAT (PM 1614-1) for use in healthcare settings.

Product Specifications:

• Dimensions: Coupons measure 25 mm x 70 mm, with a stainless steel coupon size of 34.0 mm x 7.0 mm x 0.8 mm.
• Spore Count: Contains 10^6 Geobacillus stearothermophilus ATCC 7953 spores per coupon.
• Suggested Culture Medium: Bionova® MC1020-2, with incubation conditions of 24 hours at 55-62 °C. For TSB, a 7-day incubation is recommended.

Manufacturing and Handling:

• Environmental Conditions: Produced under strict environmental conditions (15-30 ºC, RH= 30-80%) to maintain sterility.
• Storage Guidelines: Should be stored at 10-30 °C with a relative humidity of 30-80%.
• Transportation: Ensure the product is transported in closed, reinforced boxes to prevent damage, without posing any risk to human health.

Durability and Packaging:

Shelf Life: Guaranteed 2-year shelf life.

Packaging: Supplied in packs of 100 units, sealed in aluminum foil bags for protection.

Labeling and Identification:

• Product Envelope: Includes product code and description, process for
  intended use, bacterial strain, batch number, expiration date and
  datamatrix code.
• Packing Details: product code and description, bacterial strain,
  process for intended use, bacterial load, batch number, manufacture
  date, expiration date, presentation, classification according to
  regulation, storage conditions, manufacturer information, barcode and
  datamatrix code.

Application Areas:

Suitable for use across healthcare and industry sectors, providing a reliable method for validating sterilization processes.

Usage Precautions:

• Avoid storage near sterilizing agents and exposure to radiation, EO, or sterilization methods other than H2O2.
• It’s recommended to incubate at 60 °C using a Bionova® IC10/20 incubator for optimal results.
• Always read the product’s directions thoroughly before use to ensure correct application and handling.