Hydrogen peroxide sterilization biological indicator HS4-600

medicallaboratoryfor the pharmaceutical industry

Product Overview
Tailin VH2O2 Biological Indicators are self-contained biological indicators designed to verify the microbial lethality of vaporized hydrogen peroxide sterilization and biodecontamination cycles in pharmaceutical, medical device, biosafety, and cleanroom environments.

Suitable for sterilization validation of vaporized & atomized hydrogen peroxide. Biological indicators are the ideal process indicators that directly monitor the lethality of a given sterilization process. The spores used are traceable and the test report includes spore concentration, D-value, and other relevant data.

Features

• Self-contained BIs, easy to use, press for instant inoculation.
• Patented structure, less than 10% evaporation during incubation.
• Tyvek® packaged to meet the requirements for hydrogen peroxide penetration while avoiding external contamination.
• Waterproof design to ensure functionality in high humidity environments.

Compliance
Tailin’s biological indicators meet the requirements of ISO 11138, GB18281, GMP, PDA TR51, FDA 510(k) and Pharmacopoeia (USP, EP, ChP).

• ISO11138 — Sterilization of health care products - Biological indicator
• GB18281 — Sterilization of health care products - Biological indicator
• USP 1229 — Sterilization of Compendial Articles
• USP 55 — Biological Indicators - Resistance Performance Tests
• USP 1035 — Biological Indicators for Sterilization
• Ph.Eur 5.1.2 — Biological Indicators and related microbial preparations used in the manufacture of sterile products
• PDA TR51 — Biological Indicator for Gas and Vapor-Phase Decontamination Processes: Specification, Manufacture, Control and Use

Applications
Biological indicators are suitable for pharmaceutical enterprises, medical device industries, CDC, biosafety laboratories and similar environments. Tailin’s biological indicators provide a range of types with professional technical support.

Technical specifications

• Intended use: Sterilization validation for vaporized & atomized hydrogen peroxide decontamination processes.
• Product form: Self-contained biological indicators (BIs) with instant inoculation mechanism.
• Spore preparation: Mature spore preparation process with spore purity higher than 99%.
• Packaging: Tyvek® packaging designed to allow hydrogen peroxide penetration while preventing external contamination.
• Performance: Patented design to minimize evaporation during incubation (less than 10%).
• Environmental resistance: Waterproof design to ensure functionality in high humidity environments and high temperature resistant culture materials.
• Traceability & reporting: Spores used are traceable; test report includes spore concentration, D-value and other relevant quality data.
• Standards & regulatory: Compliant with ISO 11138, GB18281, USP, EP, ChP, PDA TR51, GMP, and FDA 510(k) guidance as applicable.