Dry heat sterilization biological indicator

medicallaboratoryfor the pharmaceutical industry

Product Introduction
Biological indicators (BIs) for dry heat sterilization designed to confirm the performance of dry heat sterilizers and to monitor sterilization effectiveness. Suitable for use in pharmaceutical production, scientific institutions and medical device manufacturing.

Features

• Ampoule-type carriers with high mechanical strength to resist breakage during handling.
• Carriers and formulations resistant to dry heat sterilization temperatures.

Compliance
These biological indicators are intended as direct process indicators for lethality assessment and support sterilization validation. Tailin BIs conform to recognized standards and guidance. Test reports include spore concentration, D-value and other traceable quality data.

• ISO 11138 – Sterilization of health care products: Biological indicators
• GB 18281 – Sterilization of health care products: Biological indicators
• USP chapters (including USP 1229, USP 55, USP 1035)
• Ph. Eur. 5.1.2 – Biological indicators and related microbial preparations
• PDA TR51 – Biological Indicator for Gas and Vapor-Phase Decontamination Processes
• FDA 510(k) references where applicable

Applications
Used for routine performance checks and validation of dry heat sterilizers in controlled production and laboratory environments.

• Pharmaceutical manufacturing
• Medical device production
• Biosafety laboratories and public health institutions (CDC-type)

Packaging / Storage

• Carrier format: ampoule type
• Storage temperature: 2-25°C
• Shelf life: 12 months

Additional information
Spore preparations are fully traceable. Supplied test reports contain spore concentration, D-value and other quality control parameters to support sterilization validation protocols.

Technical specifications

• Product type: Biological indicators (BIs) for dry heat sterilization
• Carrier format: ampoule type
• Carrier properties: high mechanical strength; heat-resistant
• Intended use: confirm performance and monitor effectiveness of dry heat sterilizers
• Standards: ISO 11138, GB18281, USP (relevant chapters), Ph. Eur., PDA TR51, FDA 510(k) references
• Traceability: spores traceable; test report includes spore concentration and D-value
• Storage conditions: 2-25°C
• Shelf life: 12 months