CEKG Ultra-Clean Moisture-Heat Sterilization Bag is heat-sealed using Tyvek® non-woven material and ultra-clean PE film. It is suitable for moisture-heat sterilization packaging of tools, components, and other items in the pharmaceutical industry. The product is used in Grade C+A cleanroom environments and supports direct transfer to Grade A areas after sterilization. Manufactured in a fully Grade A facility, complying with ISO 9001 production standards.

Product Advantages

High Microbial Barrier Capability: Effectively blocks microorganisms, ensuring the sterile state of items after sterilization.

Low Particle Shedding: The number of 0.5μm particles generated during the opening process meets Grade A cleanroom requirements (＜600 when unopened, ＜1,000 when cut open).

Compatible with Multiple Sterilization Methods: Suitable for both moisture-heat sterilization and ethylene oxide (EO) sterilization.

Excellent Physical Strength: Provides tear resistance, puncture resistance, and drop resistance, effectively preventing damage during transport.

Stable Performance After Sterilization: Physical properties remain stable after high-temperature sterilization.

Transparent and Easy to Identify: The transparent and durable HDPE film allows for quick visual identification of the bag's contents.

Sterilization Status Visible: Built-in indicator changes color clearly to confirm that items have undergone the sterilization process.

Post-Sterilization Shelf Life: Can be stored for 6 to 24 months after sterilization.

Quality Validation

Quality Control Items: Including insoluble particulate matter, bacterial endotoxins, microbial limits, seal integrity, water vapor transmission rate, burst strength, non-volatile residue, etc.

Sterilization Tolerance Validation: Passed 121°C high-temperature tolerance testing to ensure no damage during the sterilization process.

Heat Penetration and Heat Distribution Validation: Includes empty load/full load heat penetration testing and empty load/full load heat distribution testing.

Microbial Challenge: Validated through microbial barrier performance testing to ensure long-term bacterial resistance.

Patented Technology: Utilizes patented whole-process clean treatment technology (MAC Multi-Effect AI Intelligent Dust Removal Treatment, MDS Multi-Effect AI Intelligent Sterilization Treatment), ensuring treatment effects meet and exceed regulatory requirements.

Production Environment: Manufactured in a fully Grade A cleanroom facility, complying with ISO 9001 production standards.

Specifications

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