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超净湿热灭菌袋(呼吸袋)

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Other Packaging Materials

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Biocana Lifesciences (Shanghai) Co.,Ltd

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YES

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Product Description

GMP要求无菌洁净器具和物料在跨级别转运时必须保持无菌传递，超净湿热灭菌袋系采用经FDA认可的Tyvek与HDPE膜两种材料制成，可以耐受多种灭菌方法，满足了监管法规对洁净区物品跨区域无菌转运的要求。

产品优势：

• 生产环境 ISO Class 5 (A级)
• 每个Tyvek袋均配有灭菌指示剂
• HDPE膜采用无添加剂树脂
• 经包装完整性的染色测试(甲基蓝)
• 可蒸汽、EO、VHP和伽玛射线灭菌
• 极高的无菌保障水平
• 优良的微生物阻隔性
• 每批货物提供洁净度报告
• 规格可依据客户要求生产
• 可以轻易地热封口

AI Product Description

*The following content is generated by AI and is for reference only.

The Sterile Wet Heat Bag, commonly known as a breathing bag, is a specialized medical packaging solution designed for the terminal sterilization of heat-sensitive and moisture-tolerant items using saturated steam. These bags feature a unique semi-permeable membrane that allows steam to penetrate the package during the sterilization cycle while simultaneously preventing microbial ingress post-sterilization. This "breathing" capability ensures rapid heat transfer and effective sterilization without the risk of package rupture or steam condensation pooling inside, which could compromise sterility. They are widely utilized in healthcare settings, laboratories, and dental clinics to sterilize surgical instruments, textiles, glassware, and various reusable devices that can withstand high temperatures and humidity. Proper usage is critical to maintaining the integrity of the sterile barrier. Users must ensure the bags are loaded correctly within autoclaves, avoiding over-packing which restricts steam flow. The orientation of the bag should allow for optimal steam circulation, typically with the open end facing upwards or according to manufacturer guidelines. It is imperative to verify that the specific bag type matches the autoclave parameters, including temperature and exposure time, to achieve the required Sterility Assurance Level (SAL). After the cycle completes, the bags must be handled with care; any signs of wetness, tears, or compromised seals indicate a failed sterility barrier, rendering the contents non-sterile and requiring reprocessing or disposal. Storage conditions should remain dry and cool to prevent degradation of the breathable material. Additionally, these bags are generally single-use only and must not be reused under any circumstances. Adherence to strict handling protocols and regular quality control checks ensures patient safety and operational efficiency. By selecting the appropriate breathing bag for specific instrumentation needs, medical facilities can guarantee reliable sterilization outcomes while minimizing the risk of cross-contamination.