Statistical evaluation comparing strength of new and aged nuclear grade HEPA filters
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Engineering topics
Publications and source records attributed to Cooley, Scott K..
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(Part of the data collected for this work and discussed in this report was subject to data quality and bias issues. All the affected tests have subsequently been repeated, as directed by the Waste Treatment Plant Project, and new statistical analyses have been performed on the revised data set. A subsequently-issued report supercedes this report and describes the revised data, together with the revised composition-property models (Kot et al. 2004). The reader should refer to the new report for discussion of the revised data set and composition-property (TCLP cadmium release) models. None of the data for the spike glasses, designed for Case 1 and Case 2 COPCs testing, were affected by this issue.)
The medical device industry has been investigating ways to increase the use of alternatives to cobalt-60 gamma radiation and ethylene-oxide gas sterilization, such as electron beam (E-beam) and X-ray radiation, due to regulatory and market pressures. One impediment to switching to E-beam or X-ray technology for sterilization is the lack of data on the effects of these radiation sources on medical device polymers. To provide such data this work considers irradiation and testing of a common single-use medical bone cement mixing system, the Stryker Advanced Cement Mixer (ACM®), that is composed of seven polymer materials. The ACM® devices considered here were processed to sterilization-relevant doses (15, 25, 50, and 70 kGy) using three radiation technologies: gamma, E-beam, and X-ray. The system and its polymer components were tested for product functionality, as well as mechanical and visual properties to determine how exposure effects may be influenced by radiation technology and dose level. We found that although there were instances of statistically significant differences in effects between the gamma-irradiated products and those irradiated with E-beam and X-ray, those effects were negligible in terms of retained functionality of the product and retained mechanical properties of the polymer components. Overall, results of this study demonstrate that, for of the effects studied, E-beam and X-ray are viable alternatives to cobalt-60 gamma radiation for sterilization of the polymer-based device investigated.
The primary goal of the testing described in this report was to collect data to demonstrate compliance of the immobilized high-level waste (IHLW) glasses with delisting requirements. The collected data will be used to support a petition to delist the IHLW glasses destined for the national disposal facility. The Delisting Data Quality Objectives (DQO) (Cook and Blumenkranz 2003) identified a list of (16) inorganic constituents of potential concern (COPCs) and their associated limits for delisting. These COPCs can be divided into three groups, Cases 1, 2, and 3, based on their Toxicity Characteristic Leaching Procedure (TCLP) responses versus their respective delisting limits. To briefly summarize, Case 1 COPCs are those that, when loaded at their highest expected concentration in Waste Treatment Plant (WTP) glasses, are not expected to leach at their respective delisting limits when the glasses are exposed to the TCLP. Case 2 COPCs may reach the delisting limits in TCLP leachates of WTP glasses if loaded to concentrations near their maximum expected concentrations in glass. Finally, Case 3 COPCs are components that are likely to be present in concentrations sufficient to exceed their respective delisting limits in TCLP leachates of some possible glasses. The test objective was to show that, for (i) the expected range of inorganic contents in the waste feed to the Hanford WTP high level waste (HLW) vitrification facility, (ii) the expected range of glass product compositions, and (iii) the Case 1 and Case 2 COPCs identified by the DQO, the IHLW glasses meet all the relevant requirements for delisting. For Case 3 COPCs (i.e., Cd), the testing was to demonstrate the relationship between glass composition and TCLP cadmium (Cd) release, and then employ the results to develop TCLP-composition response models. During WTP operations, TCLP-composition models can be used to predict, within the required statistical uncertainties, TCLP responses of IHLW production glasses that are within the compositional region used to develop the model.
Due to market and regulatory pressures, many healthcare manufacturers are considering alternatives to cobalt-60 gamma radiation, including accelerator-based electron beam (E-beam) and X-ray radiation for product sterilization. In this work, the effects of irradiation on a representative medical product, comprised of eight distinct polymer materials, were directly compared for three radiation technologies – cobalt-60 gamma, E-beam, and X-ray – at four dose levels (15, 25, 50, and 70 kGy). The objective was to determine how radiation effects (deleterious or beneficial) are influenced by source and dose level, with the specific goal of determining whether E-beam radiation and/or X-ray radiation could be viable alternatives to gamma radiation for device sterilization. Here, the specific product considered is a single-use medical device for orthopedic surgery, the Stryker Instruments MixeVac III bone cement mixer, which is currently sterilized using gamma radiation from cobalt-60 sources. Following ASTM International standards and input from the manufacturer, we characterized the effects of the three radiation sources on product functionality as well as on the mechanical and optical properties of the constituent polymers. Results indicate that although measurable differences in properties between the standard gamma irradiated materials and the alternative E-beam and X-ray irradiated materials were observed, those differences were small. Statistically significant differences were noted in the case of yellowness index for polyvinyl chloride, high-density polyethylene, and polycarbonate, and in the case of tensile elongation at break for high impact polystyrene and polyvinyl chloride. In general, the results of this study support the viability of E-beam and X-ray radiation as alternative options to cobalt-60 gamma radiation for sterilization of Stryker single-use universal bone cement mixer medical devices.
Method and system for displaying information on one or more aircraft flights, where at least one flight is determined to have at least one atypical flight phase according to specified criteria. A flight parameter trace for an atypical phase is displayed and compared graphically with a group of traces, for the corresponding flight phase and corresponding flight parameter, for flights that do not manifest atypicality in that phase.
Method and system for analyzing aircraft data, including multiple selected flight parameters for a selected phase of a selected flight, and for determining when the selected phase of the selected flight is atypical, when compared with corresponding data for the same phase for other similar flights. A flight signature is computed using continuous-valued and discrete-valued flight parameters for the selected flight parameters and is optionally compared with a statistical distribution of other observed flight signatures, yielding atypicality scores for the same phase for other similar flights. A cluster analysis is optionally applied to the flight signatures to define an optimal collection of clusters. A level of atypicality for a selected flight is estimated, based upon an index associated with the cluster analysis.