Sterilization biological indicator ML6 series

medicallaboratoryfor the pharmaceutical industry

Product Introduction
Spore suspensions are designed to monitor the sterilization efficacy of moist heat sterilizers, especially for internal sterilization of liquid products in medical and pharmaceutical settings.

Key Product Statements
Self-developed medium formula, validated to withstand 134℃ for 2 h without fading. Available parameters and formulations for different 121℃ sterilization durations. Customization available for spore concentration and D-value to meet validation protocols.

Features

• Color-changing medium offering reliable readout within 48 hours.
• High-strength ampoules resistant to breakage during handling.
• Controlled production process ensures stable spore performance through shelf life.
• Capsule vial option provides compact packaging for monitoring medical devices and specific materials.

Compliance
Biological indicators directly monitor the lethality of sterilization processes. These spore suspensions meet relevant standards and guidance, and come with traceable spore batches and test reports including spore concentration and D-value.

• ISO 11138 — 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
Suitable for pharmaceutical manufacturers, medical device production, public health laboratories, biosafety laboratories and facilities requiring validation of internal liquid sterilization. Technical support and a range of types are available for validation workflows.

Download / Documentation
Product literature, validation guides and technical documentation are available in the product download section.

Technical specifications

• Intended use: monitoring moist heat (autoclave) sterilization, especially internal sterilization of liquid products.
• Medium: proprietary formula validated for stability under sterilization (tested: 134℃ for 2 h without fading).
• Result readout: color-changing medium with typical accurate results in 48 hours.
• Packaging: high-strength ampoules; capsule vial option for compact monitoring.
• Customization: spore concentration and D-value customizable per customer requirements.
• Traceability: traceable spore batches; test reports include spore concentration and D-value.
• Standards: ISO 11138, GB18281, GMP, PDA TR51, FDA 510(k), Pharmacopoeias (USP, EP, ChP).
• Supported sterilization conditions: parameters available for 121℃ sterilization durations; demonstrated stability after 134℃/2 h.