Use of Overkill Half-Cycle Qualification Data to Support Reduction of Exposure Time in Validated Ethylene Oxide Sterilization Cycles [0.03%]
过度杀灭半周期验证数据在乙烯灭菌周期减少暴露时间中的应用支持
Scott Weiss,Phil Cogdill,Joyce M Hansen
Scott Weiss
This article details the evaluation conducted for the potential to reduce ethylene oxide (EO) exposure times using data from currently validated EO sterilization cycles. The candidate cycles used the overkill half-cycle approach detailed in...
Vu Le,Andre Tuggles
Vu Le
Due to its complexity, sterilization has been perceived by some professionals who lack sterility assurance expertise as a "black box" process. Historically, medical device manufacturers have selected one of the available industrial steriliz...
Potential Induced Radioactivity in Materials Processed with X-ray Energy Above 5 MeV [0.03%]
利用5MeV以上X射线能量加工的材料可能引起的放射性现象
Hervé Michel,Thomas Kroc,Brian J McEvoy et al.
Hervé Michel et al.
Section 5.1.2 of ANSI/AAMI/ISO 11137-1 states that "the potential for induced radioactivity in product shall be assessed." This article describes how compliance with this requirement may be achieved using qualified test methods. Materials o...
Advancing the Sustainable Use of Ethylene Oxide through Process Validation [0.03%]
通过工艺验证促进环氧乙烷的可持续利用
Brian McEvoy,Stacy Bohl Wiehle,Ken Gordon et al.
Brian McEvoy et al.
Based on excellent material compatibility and ability for scale, ethylene oxide (EO) sterilization constitutes approximately 50% of single-use medical device sterilization globally. Epidemiological considerations have elevated focus toward ...
Christiane Beerlage,Bjoern Wiese,Annemie Rehor Kausch et al.
Christiane Beerlage et al.
The terminal sterilization of sterile orthopedic implants is a key process that, in addition to providing sterility, changes the material properties of the product and packaging. These changes might be observed during functionality testing ...
Connecting Across Competencies: Leveraging Best Practices for Processing [0.03%]
跨越职能的能力培养：利用最佳实践进行处理培训
Terra A Kremer,Kaumudi Kulkarni,Christopher Ratanski et al.
Terra A Kremer et al.
The AAMI working group ST/WG 93 is finalizing a standard (AAMI ST98) for the cleaning validation of reusable medical devices based on guidance from the technical information report AAMI TIR30:2011/(R)2016. A number of analytical best practi...
Regulatory Approach for Transitioning from Gamma Ray to X-ray Radiation Sterilization [0.03%]
从γ射线灭菌向X射线辐射灭菌转换的监管方法研究
Alan Montgomery,Romain Bolle-Reddat,Shari Formica et al.
Alan Montgomery et al.
When investing in X-ray irradiation facilities around the world, an opportunity exists for defining a regulatory framework for assessing the transition from current gamma irradiation processes. Historically, regulatory strategies for changi...
The Ethylene Oxide Product Test of Sterility: Limitations and Interpretation of Results [0.03%]
环氧乙烷灭菌产品检测：限制及结果解读
Michael Sadowski,Clark Houghtling,Sopheak Srun et al.
Michael Sadowski et al.
The ethylene oxide (EO) product test of sterility (ToS) can be conducted to comply with ANSI/AAMI/ISO 11135:2014 for the generation of data to demonstrate the appropriateness of the biological indicator (BI) that is used to develop and qual...
Enhancing Service Capabilities by Adding Electron-Beam Irradiator to Gamma Irradiation Facility [0.03%]
通过添加电子束辐照装置增强辐照设施服务能力
Gilmara C de Luca,John Schlecht,Bart Croonenborghs
Gilmara C de Luca
In 2013, Sterigenics undertook the addition of a 10-MeV electron beam (e-beam) accelerator at its facility in Jarinu, Brazil. A gamma irradiator was already located at this facility, which processed materials and provided irradiation servic...
Application of Processing Guidance: Case Study of Cleaning Validations on Flexible Endoscopes [0.03%]
处理指导原则的应用：基于内镜清洗效果的案例研究
Nupur Jain,S Darbi Chavez,Alpa Patel
Nupur Jain
In 2015, the Food and Drug Administration (FDA) updated its guidance on test methods for cleaning validations for reusable medical devices. The changes include the condition and contamination of devices, test samples and controls, cleaning ...