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Seal strength models for medical device trays.

机译:医疗器械托盘的密封强度模型。

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摘要

Seven empirical equations were developed for the prediction of seal strength for medical device trays. A new methodology was developed and used for identifying burst and peel locations and comparing burst pressure and peel force. Multiple linear regression was used to fit 76 models, selecting the best models based on the Akaike Information Criterion (AIC) and adjusted R2 (R 2adj) value of each model. The selected models have R2 adj and prediction R2(R2pred) values of .83 to .94.;Factors investigated for the peel force response were sealing pressure (3 levels), dwell time (3 levels), sealing temperature (3 levels), and adhesive. Additional factors investigated for the burst pressure response were restraining plate gap, and tray volume, height, length-to-width ratio and area. Polyethylene terephthalate-glycol (PETG) trays with Tyvek 1073B lids and two popular water-based adhesives were used. Trays were selected to yield three levels of area and three levels of length-to-width ratio, defining nine package configurations. Packages for burst testing were sealed under a fractional factorial design with 27 treatments. Packages for peel testing were sealed under a 17-point face-centered central composite design. Packages were tested using peel testing following the ASTM F88-07 standard and restrained burst testing with three gap distances following the ASTM F2054-00 standard.;All possible subsets of the factors were evaluated, with the best models selected based on AIC value. Equations were developed to predict peak and average peel force based on sealing process parameters (R2 pred =.94 and .92), burst pressure based on tray and sealing parameters and gap (R2pred =.94), and four peel force responses based on burst pressure and gap (R2pred =.83 to .86). Models were validated through cross-validation, using the prediction error sum of squares (PRESS) statistic. The R2pred was calculated to estimate the predictive ability of each model.
机译:开发了七个经验公式来预测医疗器械托盘的密封强度。开发了一种新的方法,用于识别破裂和剥离位置,并比较破裂压力和剥离力。多元线性回归用于拟合76个模型,根据Akaike信息准则(AIC)和调整后的每个模型的R2(R 2adj)值选择最佳模型。所选模型的R2调整值和R2(R2pred)预测值介于0.83至0.94之间;研究剥离力响应的因素包括密封压力(3个等级),保压时间(3个等级),密封温度(3个等级),和胶粘剂。研究的爆破压力响应的其他因素是限制板间隙,塔板体积,高度,长宽比和面积。使用了带有特卫强1073B盖的聚对苯二甲酸乙二醇酯(PETG)托盘和两种常用的水基粘合剂。选择托盘以产生三个级别的面积和三个级别的长宽比,从而定义了九种包装配置。用于爆破测试的包装采用27种处理方式,在分数分解设计下密封。用于剥离测试的包装在17点面心中央复合设计下密封。使用符合ASTM F88-07标准的剥离测试和根据ASTM F2054-00标准的三个间隙距离的限制性爆破测试对包装进行测试;评估了所有可能的因素子集,并根据AIC值选择了最佳模型。开发了基于密封过程参数(R2 pred = .94和.92)预测峰值和平均剥离力的方程,基于塔板和密封参数和间隙的爆破压力(R2pred = .94)以及基于以下四个方程的剥离力响应爆破压力和间隙(R2pred = .83至.86)。使用预测误差平方和(PRESS)统计量,通过交叉验证对模型进行验证。计算R2pred以估计每个模型的预测能力。

著录项

  • 作者

    Mays, Patricia.;

  • 作者单位

    Texas A&M University.;

  • 授予单位 Texas A&M University.;
  • 学科 Engineering Industrial.;Engineering Packaging.
  • 学位 Ph.D.
  • 年度 2008
  • 页码 115 p.
  • 总页数 115
  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类 一般工业技术;包装工程;
  • 关键词

  • 入库时间 2022-08-17 11:39:05

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