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Gamma Wipe® 120洁净室湿巾

产品信息

  • Berkshire Gamma Wipe® 120 is a knife-cut, high-sorbency, cleanroom laundered wipe recommended for use in environments rated ISO Class 4 and above. It is composed of continuous filament polyester knit fabric. Each package is gamma irradiated sterile to a 10-6 Sterility Assurance Level. This combination of properties provides Gamma Wipe®120 with the high level of cleanliness, abrasion resistance and chemical compatibility required for cleaning critical sterile processing environments.

    The same wipe material can be provided in pre-wetted formats for reduced VOC emissions, increased convenience, increased productivity, improved solvent control and cleaning protocol repeatability and reduced costs. 

    ANSI/AAMI/ISO procedures have been followed for verification of irradiation dose with audits being performed to monitor bioburden levels and dose. The Sterility Assurance Level (SAL) or the probability of a viable organism being present on a product unit after sterilization is a SAL of 10-6 (which is the chance of 1 non-sterile unit in 1,000,000.
    Berkshire GammaWipe®120是一种刀形,高吸收性,无尘洗净的擦拭巾,推荐用于ISO 4级及以上等级的环境。它由100%连续长丝涤纶针织面料组成。每个包装均经过伽玛射线辐照灭菌,灭菌保证水平为10-6。这些特性的组合为GammaWipe®120提供了清洁关键的无菌加工环境所需的高度清洁度,耐磨性和化学相容性。

    可以以预润湿的形式提供相同的擦拭材料,以减少VOC排放,增加便利性,提高生产率,改善溶剂控制和清洁方案的可重复性并降低成本。

    遵循ANSI / AAMI / ISO程序来验证辐照剂量,并进行了审核以监测生物负荷水平和剂量。无菌保证水平(SAL)或灭菌后产品单元上存在活有机体的概率为10-6的SAL(这是在1,000,000中有1个非无菌单元的机会)。
    ISO Class Class 4-5
    Construction Knitted
    Material Polyester
    Edge Knife-Cut

    ISO Class 4-5级
    建设针织
    材质聚酯
    边刀,切
    Wipes laundered and packaged in Berkshire’s ISO Class 4 cleanroom with Lot Number on each pack. Gamma irradiated wipers and sterile validated to a 10-6 Sterility Assurance Level per AAMI guidelines.Header style packaging with Package Integrity testing. Radiation Dosage, Lot Information, Meets cGMP requirements for traceability. Chemically compatible with common cleaning and disinfecting solutions including isopropyl alcohol, phenols, bleaches and quarternary ammonium compounds. Designed for cleaning sterile surfaces and equipment during aseptic processing. Excellent for cleaning Medical Device. Applying and removing cleaning and disinfecting solutions. Excellent wipe for cleaning sterile laminar air flow units, barrier isolators and bio-containment units.
    在伯克希尔(Berkshire)的ISO 4级无尘室中洗涤和包装过的湿巾,每包都有批号。 根据AAMI指南,经伽玛射线辐照的擦拭布和无菌物品的无菌验证等级达到10-6.Header型包装以及包装完整性测试。 辐射剂量,批次信息,符合cGMP要求的可追溯性。 与常见的清洁和消毒溶液化学兼容,包括异丙醇,酚,漂白剂和季铵化合物。 设计用于在无菌处理过程中清洁无菌表面和设备。 非常适合清洁YL设备。 应用和去除清洁和消毒溶液。 出色的擦拭布,可用于清洁无菌层流气流单元,屏障隔离器和生物防护单元。
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