Hydrogen peroxide sterilization biological indicator HS4-600

medicallaboratoryfor the pharmaceutical industry

Introduction
Specially designed to meet the needs of the pharmaceutical, food, and medical device industries using vaporized & atomized hydrogen peroxide decontamination.

Product Overview
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.