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 5
• 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
应用范围:
• 胶塞、接口环和接口盖
• 西林瓶和容器
• 注射器组件
• 不锈钢工具和滤芯
• 医疗器械
• 洁净服
*The following content is generated by AI and is for reference only.
The BioCana™ SPS Super-Clean Wet Sterilization Bag, commonly known as a breathing bag, is a specialized medical packaging solution designed for the safe and effective sterilization of surgical instruments using steam autoclaving processes. Engineered with advanced breathable film technology, this product allows saturated steam to penetrate the pouch efficiently while simultaneously permitting air and moisture vapor to escape during the sterilization cycle. This unique "breathing" capability ensures complete sterilization without trapping residual air pockets, which could otherwise compromise the sterility of the contents. Once the cycle is complete, the bag forms an effective barrier against microbial recontamination, maintaining the sterile status of the instruments until the moment of use.
These bags are widely utilized in hospitals, dental clinics, and surgical centers for packaging a variety of rigid metal instruments, textiles, and other heat-stable items. The material is specifically formulated to withstand high temperatures and pressures typical of pre-vacuum or gravity displacement autoclaves without melting or losing structural integrity. A key feature of the BioCana™ SPS series is its superior clarity, allowing healthcare professionals to visually inspect the contents before opening, thereby reducing handling errors and improving workflow efficiency. Additionally, the packaging includes integrated chemical indicators that change color upon successful exposure to sterilization conditions, providing immediate visual confirmation of the process.
Critical safety precautions must be observed when utilizing these bags. Users should ensure the bags are not overloaded, as excessive weight can hinder steam penetration and lead to incomplete sterilization. It is imperative to verify that the bag size matches the instrument load to prevent tearing or leakage. Furthermore, the bags must be stored in a clean, dry environment away from direct sunlight and sharp objects to maintain their barrier properties. Improper sealing or reuse of single-use pouches is strictly prohibited, as it compromises the sterile field. Adhering to manufacturer guidelines regarding temperature settings, exposure time, and drying cycles is essential to guarantee patient safety and regulatory compliance. By combining robust protection with reliable sterilization performance, the BioCana™ SPS bag remains a vital component in modern infection control protocols.