Name: failure of cleaning verification in pharmaceutical industry due to uncleanliness of stainless steel surface
Uploaded: 2017-08-11T15:00:00.000+00:00
Duration: 7 min
Description: Watch this Scientific Journal Video about Failure of Cleaning Verification in Pharmaceutical Industry Due to Uncleanliness of Stainless Steel Surface at JoVE.com

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1.样品溶液
<ol>
	<li>计算基础的最大允许结转 (MACO) 治疗剂量标准药物清洗极限 (CL)。 注意: 在这里，药物 A 的清洗限制 (CL) 已被计算为 2.4 微克每 50 厘米2的基础的最大允许结转 (MACO) 治疗剂量标准。清洁验证是在 50%、 100%和 150%清洗限制执行的。清洁验证被评定为两种制剂 （2.5%及 60 %w / w 药物负载）。</li>
</ol>
2.清洗程序优惠券
<ol>
	<li>最初的方法<ol>
		<li>通过冲洗和抹面为 10 ~ 15 秒两次水，两次与甲醇，以消除任何残余的存款清洁代用券。甲醇是有毒且极不稳定，在引擎盖执行此过程。</li>
	</ol>
	</li>
	<li>先进的方法<ol>
		<li>使用地方清洁解决方案<ol>
			<li>在室温下设置 sonicator。Sonicator 有没有权力设置调整，因此设置的时间给出足够的清洗结果。</li>
			<li>沉浸在高性能液相色谱法 (HPLC) 级水优惠券、 超声波几为 2 分钟。</li>
			<li>沉浸在 0.1%碱性洗涤剂溶液 HPLC 级水中优惠券、 超声波几为 2 分钟。</li>
			<li>沉浸在高效液相色谱法水优惠券、 超声波几为 2 分钟。</li>
			<li>沉浸在 0.1%酸性洗涤剂溶液在高效液相色谱法水优惠券、 超声波几为 2 分钟。</li>
			<li>沉浸在高效液相色谱法水优惠券、 超声波几为 2 分钟。</li>
		</ol>
		</li>
		<li>采用酸-基地-过氧化物 注意: 这是一种替代的方法，包括使用酸、 碱，、 过氧化氢而不是碱性和酸性洗涤剂。<ol>
			<li>在室温下设置 sonicator。Sonicator 有没有权力设置调整，因此设置的时间给出足够的清洗结果。</li>
			<li>沉浸在水中的优惠券、 超声波几为 2 分钟。</li>
			<li>沉浸在 0.1 M 氢氧化钠优惠券、 超声波几为 2 分钟。</li>
			<li>沉浸在水中的优惠券、 超声波几为 2 分钟。</li>
			<li>沉浸在 0.1 M 盐酸优惠券、 超声波几为 2 分钟。</li>
			<li>沉浸在水中的优惠券、 超声波几为 2 分钟。</li>
			<li>沉浸在 0.1 毫克/毫升 NaNo2 优惠券、 超声波几为 2 分钟。</li>
			<li>沉浸在水中的优惠券、 超声波几为 2 分钟。</li>
		</ol>
		</li>
	</ol>
	</li>
</ol>
3.抽汲过程
<ol>
	<li>装入不锈钢优惠券使用双面胶的带 250 毫升 （或 500 毫升） 的塑料烧杯底部。</li>
	<li>守住烧杯，使扣球和抽汲过程很容易。这也减少了一些不良的意外事故，如过度角时抽汲。</li>
	<li>在回旋在表面图案上的优惠券使用容积式移液管注入特定浓度和制订 （例如，为 12 微克/毫升 2.5 %w / w 药物 A 负荷 200 微升） 定义的体积块。</li>
	<li>等待，直到表面的优惠券是干 (~ 3-10 分钟，根据波动的样品)。</li>
	<li>蘸干拭子在用稀释剂 2 毫升的小瓶 (甲醇: 甲酸 100:0.2 音量)。</li>
	<li>按打击的小瓶里面拭子卸下多余的溶剂。</li>
	<li>坚定地擦表面的均匀、 重叠的一边到另一边笔画优惠券，直到总 50 厘米2试验区用湿棉棒一边擦干。</li>
	<li>重复擦拭的过程 （步骤 3.7） 使用拭子的同一侧。</li>
	<li>两次拭四个边的优惠券。</li>
	<li>翻转到另一边拭子和旋转 90 °，顺时针或逆时针旋转; 优惠券因此，旋转抽汲由 90 ° 的方向。</li>
	<li>重复详细步骤 3.7-3.9 的抽汲动议。后的表面采样，砍进溶剂瓶用剪刀的拭子头。</li>
	<li>旋转 90 ° 向同一方向前选择优惠券同时重复用第二个签抽汲过程。</li>
	<li>超声波几每小瓶含两个拖把头 5 分钟，然后 10 涡 s。</li>
	<li>将溶液转移到高效液相色谱法小瓶和标签作为工作液。</li>
</ol>
4.计算恢复
<ol>
	<li>追样<ol>
		<li>通过混合 200 µ L 每个优惠券扣用的稀释剂 1,800 微升解决方案编写控制解决方案。</li>
		<li>运行色谱系统根据表 1中列出的条件。</li>
		<li>计算基于工作解决方案峰下的相对面积拭子工作液复苏 (AW) 和控制解决方案 (C)。</li>
		<li>重复此过程三个优惠券和计算的平均回收率和相对标准偏差 (Srel)。 注: 在此处使用的所有分析方法根据 ICH Q2(R1) 准则进行了验证。材料一节中列出的色谱条件。</li>
	</ol>
	</li>
</ol>

<ol>
	<li>. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=.">.</a> Validation of cleaning processes (7/93). Guide to inspections validation of cleaning processes. , (2004).</li><li>. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=.">.</a> Warning Letter: 320-12-08, Gulf Pharmaceuticals. , (2012).</li><li>. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=.">.</a> Warning Letter: 320-12-058, Novartis Internationsl AG. , (2012).</li><li>. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=.">.</a> Warning Letter: 05-10, Teva Parenterals Medicines, Inc. , (2009).</li><li>. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=.">.</a> Warning Letter: 320-14-09, Tianjin Zhongan Pharmaceutical Co., Ltd. , (2014).</li><li>Mantel, M., Wightman, J. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Influence+of+the+surface+chemistry+on+the+wettability+of+stainless+steel.">Influence of the surface chemistry on the wettability of stainless steel.</a> Surf Interface Anal. 21, 595-605 (1994).</li><li>Odaka, K., Ueda, S. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Dependence+of+outgassing+rate+on+surface+oxide+layer+thickness+in+type+304+stainless+steel+before+and+after+surface+oxidation+in+air.">Dependence of outgassing rate on surface oxide layer thickness in type 304 stainless steel before and after surface oxidation in air.</a> Vacuum. 47, 689-692 (1996).</li><li>Kerber, S. J., Tverberg, J. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Stainless+Steel+Surface+Analysis.">Stainless Steel Surface Analysis.</a> Adv. Mater. Processes. , 33-36 (2000).</li><li>Kusumaningrum, H. D., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Survival+of+foodborne+pathogens+on+stainless+steel+surfaces+and+cross-contamination+to+foods.">Survival of foodborne pathogens on stainless steel surfaces and cross-contamination to foods.</a> Int J Food Microbiol. 85, 227-236 (2003).</li><li>Liu, L., Pack, B. W. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Cleaning+verification+assays+for+highly+potent+compounds+by+high+performance+liquid+chromatography+mass+spectrometry:+Strategy,+validation,+and+long-term+performance.">Cleaning verification assays for highly potent compounds by high performance liquid chromatography mass spectrometry: Strategy, validation, and long-term performance.</a> J Pharmaceut. Biomed. 43, 1206-1212 (2007).</li><li>Lambropoulos, J., Spanos, G. A., Lazaridis, N. V. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Development+and+validation+of+an+HPLC+assay+for+fentanyl,+alfentanil,+and+sufentanil+in+swab+samples.">Development and validation of an HPLC assay for fentanyl, alfentanil, and sufentanil in swab samples.</a> J Pharmaceut. Biomed. 23, 421-428 (2000).</li><li>Chisti, Y., Moo-Young, M. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Clean-in-place+systems+for+industrial+bioreactors:+Design,+validation+and+operation.">Clean-in-place systems for industrial bioreactors: Design, validation and operation.</a> J. Ind. Microbiol. 13, 201-207 (1994).</li><li>Haidar Ahmad, I. A., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Cleaning+verification:+Exploring+the+effect+of+the+cleanliness+of+stainless+steel+surface+on+sample+recovery.">Cleaning verification: Exploring the effect of the cleanliness of stainless steel surface on sample recovery.</a> J Pharmaceut. Biomed. 134, 108-115 (2017).</li></ol>

没有金融利益冲突的存在。

从不锈钢优惠券 API 残留量低和可变的经济复苏所作的主要贡献被追溯到缺乏明确规程的优惠券表面清理。清洁表面的优惠券导致一致、 准确的加标的回收和重复性好的结果。从不锈钢优惠券回收率高的示威，从制造设备使用经过验证的方法获得的实际清洗验证结果应该是准确和精确，反光的设备上的残留水平以最低风险的假阴性率为可能危及病人安全的产品的结转。
其次?...

应在用于制造的中间体及其后续版本之前验证非专用设备的清洁和在产品的活性药物成分 (Api)，改变以防止交叉污染。清洁程序应包含足够的细节，以使操作者能以重现性好和有效的方式，每种类型的设备，这些程序应根据美国食品和药物管理局 (FDA) 要求1验证。无数的警告信，由于不足清洗2，，34、 未能验证清洗的验证方法，以及未能遵循 FDA 已发出5的清洗程序。21 CFR §211.67 概述了成功的清洗验证所需的要求。
它是清洁验证分析方法的验证上不锈钢优惠券与同一表面/完成作为制造设备的行业标准。不锈钢优惠券 （例如，50 厘米2） 用于表示设备表面的清洁验证实验在实验室里。期间的发展，这些分析方法验证的利益 （即，应恢复从设备表面的残留） 样本被涨到了目标残留测定的最大允许结转 (MACO) 限制的不锈钢优惠券上。基于接受曝光极限的定义为，病人可以得到接触过，没有健康的不良影响 （没有观察到不良-影响-级，NOAEL） 的限制，确定了这一级别。
分析师或进行抽汲的制造经营必须遵循结构化的程序，以确保经济复苏是可再生的无论由谁进行抽汲。程序应明确详细说明拭子类型、 使用数量的拭子，稀释剂，溶剂用量，精确的扫描模式，适用于采样表面，所花费的时间抽汲、 提取样品，检测（紫外、 荧光、 质谱、 总有机碳等）的方法，萃取技术从拭子头的物质数量的笔画数等。
此外影响样品回收的优惠券，表面、 因此，在设备表面的所有上述因素也发挥了作用。沉积的薄膜材料表面上的或由于一个或多个不锈钢 （如、 铁、 铬和镍） 中的元素的氧化态的变化，可能修改表面的优惠券6，，78。再生的表面的不锈钢优惠券回其原始状态的定量的交换过程的成功至关重要。研究，不锈钢优惠券不被恰当地清洁，表明恢复包括分析师到另一个，不同的药物或各种穗水平9，，1011，变异性。上一张优惠券十复制恢复中的标准偏差可达 14%和 26%五优惠券9日。它是重要的是注意到，相对标准偏差 (Srel) 值增加随着越来越多的复制或随着越来越多的使用优惠券 （即，而不是在相同的优惠券上扣五次五优惠券）11。在这种情况下，变化不能解释为随机波动。尽管如此，他们的研究结果可以解释我们的清洁表面的优惠券会影响经济复苏。在本文中描述的结果说明恢复结果显著增加和减少变异性正确清洁表面的不锈钢优惠券后。
清洁--就地 (CIP) 是设备的清洁表面，包括最小或没有拆卸设备自动化的方式。在 CIP 清洗过程，期间连续洗与其后酸基地定义的过程执行删除有机和无机残留物。表面活性剂、 螯合的化合物或络合剂通常添加到 CIP 解决方案提高效率的清洗设备表面的任何产品。清洗效率取决于几个参数，包括选择和浓度的 CIP 解决方案 （即，类型和组成基地、 酸及表面活性剂），清洗时间、 温度 (通常为 60-80 ° C)、 污染类型和难清洁部分12的存在。基于类型的药物产品，CIP 解决方案 100 和 200 已选择要用于清洗不锈钢优惠券用于清洁验证，因为它模拟的 CIP 过程用于清洗生产设备。
这项研究报告影响药物残留回收不锈钢优惠券的表面的不同因素的影响，并建议为小分子、 治疗蛋白和抗体分析清洗方法开发的最佳做法。一贯地打扫优惠券表面良好定义过程缺乏被确定为低和可变的经济复苏的主要原因。当表面的优惠券正确清洗13得到高、 重现性好的恢复。

<table><tbody><tr><td>stainless steel coupons</td><td>&amp;nbsp;GlobePharma (New Brunswick, NJ &lt;span class=&quot;font6&quot;&gt;).&amp;nbsp;&lt;/span&gt;</td><td>SS316-20RA-50cm2</td><td></td></tr><tr><td>Clean in place solutions (CIP100 and CIP200)&amp;nbsp;</td><td>were obtained from Steris Corporation (Mentor, OH)</td><td>1D10BG</td><td>Alkaline detergent and acid detergent, respectively</td></tr><tr><td>Positive displacement pipettes</td><td>Gilson (Middleton, WI).&amp;nbsp;</td><td></td><td></td></tr><tr><td>HPLC grade water</td><td>Millipore Milli-Q Advantage Water Purification System (Darmstadt, Germany)&amp;nbsp; or from Honeywell Burdick &amp;amp; Jackson (Muskegon, Michigan)</td><td>7732-18-5</td><td></td></tr><tr><td>HPLC grade Methanol</td><td>EMD</td><td>MX0475-1</td><td></td></tr><tr><td>glacial acetic acid&amp;nbsp;</td><td>EMD</td><td>MAX0073P5</td><td></td></tr><tr><td>HPLC grade Acetonitrile&amp;nbsp;</td><td>J.T. Baker (Avantor Performance Materials, Center Valley, PA)</td><td>75-05-8</td><td></td></tr><tr><td>Trifluoroacetic acid</td><td>J.T. Baker (Avantor Performance Materials, Center Valley, PA)</td><td>75-05-8</td><td></td></tr><tr><td>Chromatography column Zorbax Eclipse</td><td>&amp;nbsp;XDB-C18, 4.6 x 100 mm, 3.5 &amp;micro;m HPLC column</td><td>UNSPSC &amp;ndash; 41115709</td><td></td></tr><tr><td>Vanquish UHPLC system&amp;nbsp;</td><td>Thermo Fisher Scientific, Germering, Germany</td><td></td><td></td></tr><tr><td>Branson B8510 Ultrasonic cleaner&amp;nbsp;</td><td>Branson Ultrasonics (Danbury, CT, USA)</td><td>model (8510-D7H)</td><td></td></tr></tbody></table>

failure of cleaning verification in pharmaceutical industry due to uncleanliness of stainless steel surface

这项工作的目的是找出影响医药残留回收表面的不锈钢优惠券的参数。一系列因素进行评估，包括药物产品穗水平、 扣过程、 药物辅料比率，分析师向分析师变异性、 盘中变异性和清洁程序的优惠券。一贯地打扫优惠券表面良好定义过程缺乏被确定为低和可变的经济复苏的主要原因。评估的清洁表面的地方清洁解决方案 (CIP) 优惠券给高价回收 (&#62; 90%) 和可重复性 （Srel≤ 4%） 无论以前评估的条件。该方法已成功应用的清洁验证的小分子 (MW &#60; 1,000 Da) 以及大分子 (MW 到 50,000 Da)。

从最初的尝试清洗验证药物代表结果都列在表 2。优惠券洗干净根据实验部分中的详细步骤之前，不一致的结果得出不同穗层面，对于不同比例的 API/辅料，不同分析师，甚至在不同的日子同样的分析师。观察到的变异性的复苏中需要加以解决，为一些结果失败的验证要求 (60%&#60; 恢复 &#60; 150%)，如为 60%的药物恢复负载限制，在所有清洗。
<p class="jove_content"...

Watch this Scientific Journal Video about Failure of Cleaning Verification in Pharmaceutical Industry Due to Uncleanliness of Stainless Steel Surface at JoVE.com

Failure of Cleaning Verification in Pharmaceutical Industry Due to Uncleanliness of Stainless Steel Surface

一贯地打扫优惠券表面良好定义过程缺乏被确定为低和可变的经济复苏，在清理核查的主要贡献。这份手稿描述的清洗不锈钢优惠券正确的协议。

清洁验证在不锈钢表面脏制药行业中的失败

The aim of this work is to identify the parameters that affect the recovery of pharmaceutical residues from the surface of stainless steel coupons. A ...

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8.1K 次观看.  Novartis Pharmaceuticals Corporation. 一贯地打扫优惠券表面良好定义过程缺乏被确定为低和可变的经济复苏，在清理核查的主要贡献。这份手稿描述的清洗不锈钢优惠券正确的协议。

视频: Failure of Cleaning Verification in Pharmaceutical Industry Due to Uncleanliness of Stainless Steel Surface

Tracking Microbial Contamination in Retail Environments Using Fluorescent Powder - A Retail Delicatessen Environment Example

Cross contamination of foodborne pathogens in the retail environment is a significant public health issue contributing to an increased risk for foodborne illness. Ready-to-eat (RTE) processed foods such as deli meats, cheese, and in some cases fresh produce, have been involved in foodborne disease outbreaks due to contamination with pathogens such as Listeria monocytogenes. With respect to L. monocytogenes, deli slicers are often the main source of cross contamination. The goal of this study was to use a fluorescent compound to simulate bacterial contamination and track this contamination in a retail setting. A mock deli kitchen was designed to simulate the retail environment. Deli meat was inoculated with the fluorescent compound and volunteers were recruited to complete a set of tasks similar to those expected of a food retail employee. The volunteers were instructed to slice, package, and store the meat in a deli refrigerator. The potential cross contamination was tracked in the mock retail environment by swabbing specific areas and measuring the optical density of the swabbed area with a spectrophotometer. The results indicated that the refrigerator (i.e. deli case) grip and various areas on the slicer had the highest risk for cross contamination. The results of this study may be used to develop more focused training material for retail employees. In addition, similar methodologies could also be used to track microbial contamination in food production environments (e.g.&#160;small farms), hospitals, nursing homes, cruise ships, and hotels.

The overall goal of this study was to demonstrate the potential cross contamination mechanism of foodborne pathogen Listeria monocytogenes in a retail deli setting. This methodology may be applied to a variety of different environments to track pathogen contamination. &#160;

跟踪微生物污染在零售环境中使用荧光粉 - 零售熟食店环境范例

Cross contamination of foodborne pathogens in the retail environment is a significant public health issue contributing to an increased risk for foodborne ...

科研

环境科学

Fabrication of Large-area Free-standing Ultrathin Polymer Films

This procedure describes a method for the fabrication of large-area and ultrathin free-standing polymer films. Typically, ultrathin films are prepared using either sacrificial layers, which may damage the film or affect its mechanical properties, or they are made on freshly cleaved mica, a substrate that is difficult to scale. Further, the size of ultrathin film is typically limited to a few square millimeters. In this method, we modify a surface with a polyelectrolyte that alters the strength of adhesion between polymer and deposition substrate. The polyelectrolyte can be shown to remain on the wafer using spectroscopy, and a treated wafer can be used to produce multiple films, indicating that at best minimal amounts of the polyelectrolyte are added to the film. The process has thus far been shown to be limited in scalability only by the size of the coating equipment, and is expected to be readily scalable to industrial processes. In this study, the protocol for making the solutions, preparing the deposition surface, and producing the films is described.

We describe a method for the fabrication of large-area (up to 13 cm diameter) and ultrathin (as thin as 8 nm) polymer films. Instead of using a sacrificial interlayer to delaminate the film from its substrate, we use a self-limiting surface treatment suitable for arbitrarily large areas.

大面积的制造自立性的超薄聚合物薄膜

This procedure describes a method for the fabrication of large-area and ultrathin free-standing polymer films.  Typically, ultrathin films are prepared ...

化学

Biofilm Removal Using Carbon Dioxide Aerosols without Nitrogen Purge

Biofilms can cause serious concerns in many applications. Not only can they cause economic losses, but they can also present a public health hazard. Therefore, it is highly desirable to remove biofilms from surfaces. Many studies on CO2 aerosol cleaning have employed nitrogen purges to increase biofilm removal efficiency by reducing the moisture condensation generated during the cleaning. However, in this study, periodic jets of CO2 aerosols without nitrogen purges were used to remove Pseudomonas putida biofilms from polished stainless steel surfaces. CO2 aerosols are mixtures of solid and gaseous CO2 and are generated when high-pressure CO2 gas is adiabatically expanded through a nozzle. These high-speed aerosols were applied to a biofilm that had been grown for 24 hr. The removal efficiency ranged from 90.36% to 98.29% and was evaluated by measuring the fluorescence intensity of the biofilm as the treatment time was varied from 16 sec to 88 sec. We also performed experiments to compare the removal efficiencies with and without nitrogen purges; the measured biofilm removal efficiencies were not significantly different from each other (t-test, p &gt; 0.55). Therefore, this technique can be used to clean various bio-contaminated surfaces within one minute.

Biofilms on surfaces can be effectively and rapidly removed by using a periodic jet of carbon dioxide aerosols without a nitrogen purge.

去除生物膜使用二氧化碳气溶胶没有氮气吹扫

Biofilms can cause serious concerns in many applications. Not only can they cause economic losses, but they can also present a public health hazard. ...

The Portable Chemical Sterilizer (PCS), D-FENS, and D-FEND ALL: Novel Chlorine Dioxide Decontamination Technologies for the Military

There is a stated Army need for a field-portable, non-steam sterilizer technology that can be used by Forward Surgical Teams, Dental Companies, Veterinary Service Support Detachments, Combat Support Hospitals, and Area Medical Laboratories to sterilize surgical instruments and to sterilize pathological specimens prior to disposal in operating rooms, emergency treatment areas, and intensive care units. The following ensemble of novel, &#8216;clean and green&#8217; chlorine dioxide technologies are versatile and flexible to adapt to meet a number of critical military needs for decontamination6,15. Specifically, the Portable Chemical Sterilizer (PCS) was invented to meet urgent battlefield needs and close critical capability gaps for energy-independence, lightweight portability, rapid mobility, and rugged durability in high intensity forward deployments3. As a revolutionary technological breakthrough in surgical sterilization technology, the PCS is a Modern Field Autoclave that relies on on-site, point-of-use, at-will generation of chlorine dioxide instead of steam. Two (2) PCS units sterilize 4 surgical trays in 1 hr, which is the equivalent throughput of one large steam autoclave (nicknamed &#8220;Bertha&#8221; in deployments because of its cumbersome size, bulky dimensions, and weight). However, the PCS operates using 100% less electricity (0 vs. 9 kW) and 98% less water (10 vs. 640 oz.), significantly reduces weight by 95% (20 vs. 450 lbs, a 4-man lift) and cube by 96% (2.1 vs. 60.2 ft3), and virtually eliminates the difficult challenges in forward deployments of repairs and maintaining reliable operation, lifting and transporting, and electrical power required for steam autoclaves.

The Portable Chemical Sterilizer PCS, D-FENS, and D-FEND ALL: Novel Chlorine Dioxide Decontamination Technologies for the Military

The Portable Chemical Sterilizer (PCS) is a revolutionary, energy-independent, almost waterless sterilization technology for Army medical units. The PCS generates chlorine dioxide from dry reagents mixed with water on-site, at-will, and at point-of-use (PoU) in a plastic suitcase. The Disinfectant-sprayer for Foods and ENvironmentally-friendly Sanitation (D-FENS) and the Disinfectant for ENvironmentally-friendly Decontamination, All-purpose (D-FEND ALL) produce aqueous chlorine dioxide in a collapsible spray bottle and other potential embodiments. These versatile decontamination technologies kill microbes in myriad diverse Dual-use applications for military and civilian consumers.

便携式化学消毒（PCS），D-沼泽，和D-FEND ALL：新型二氧化氯去污技术用于军事

There is a stated Army need for a field-portable, non-steam sterilizer technology that can be used by Forward Surgical Teams, Dental Companies, Veterinary ...

生物工程

Light Enhanced Hydrofluoric Acid Passivation: A Sensitive Technique for Detecting Bulk Silicon Defects

A procedure to measure the bulk lifetime (&#62;100 &#181;sec) of silicon wafers by temporarily attaining a very high level of surface passivation when immersing the wafers in hydrofluoric acid (HF) is presented. By this procedure three critical steps are required to attain the bulk lifetime. Firstly, prior to immersing silicon wafers into HF, they are chemically cleaned and subsequently etched in 25% tetramethylammonium hydroxide. Secondly, the chemically treated wafers are then placed into a large plastic container filled with a mixture of HF and hydrochloric acid, and then centered over an inductive coil for photoconductance (PC) measurements. Thirdly, to inhibit surface recombination and measure the bulk lifetime, the wafers are illuminated at 0.2 suns for 1 min&#160;using a halogen lamp, the illumination is switched off, and a PC measurement is immediately taken. By this procedure, the characteristics of bulk silicon defects can be accurately determined. Furthermore, it is anticipated that a sensitive RT surface passivation technique will be imperative for examining bulk silicon defects when their concentration is low (&#60;1012 cm-3).

A RT liquid surface passivation technique to investigate the recombination activity of bulk silicon defects is described. For the technique to be successful, three critical steps are required: (i) chemical cleaning and etching of silicon, (ii) immersion of silicon in 15% hydrofluoric acid and (iii) illumination for 1 min.

光增强氢氟酸钝化:一个敏感的技术检测散装硅缺陷

A procedure to measure the bulk lifetime (&#62;100 &#181;sec) of silicon wafers by temporarily attaining a very high level of surface passivation when ...

工程学

Measurement of Outgassing Rates of Steels

Steels are commonly used materials in the fabrication of vacuum systems because of their good mechanical, corrosion, and vacuum properties. A variety of steels meet the criterion of low outgassing required for high or ultrahigh vacuum applications. However, a given material can present different outgassing rates depending on its manufacturing process or the various pretreatment processes involved during the fabrication. Thus, the measurement of outgassing rates is highly desirable for a specific vacuum application. For this reason, the rate-of-pressure rise (RoR) method is often used to measure the outgassing of hydrogen after bakeout. In this article, a detailed description of the design and execution of the experimental protocol involved in the RoR method is provided. The RoR method uses a spinning rotor gauge to minimize errors that stem from outgassing or the pumping action of a vacuum gauge. The outgassing rates of two ordinary steels (stainless steel and mild steel) were measured. The measurements were made before and after the heat pretreatment of the steels. The heat pretreatment of steels was performed to reduce the outgassing. Extremely low rates of outgassing (on the order of 10&#8722;11 Pa m3 sec&#8722;1 m&#8722;2) can be routinely measured using relatively small samples.

A protocol for the measurement of outgassing rates of hydrogen from ordinary steel vacuum chambers using the rate-of-pressure rise method is presented.

钢的出气率的测量

Steels are commonly used materials in the fabrication of vacuum systems because of their good mechanical, corrosion, and vacuum properties. A variety of ...

Preparation and High-temperature Anti-adhesion Behavior of a Slippery Surface on Stainless Steel

Anti-adhesion surfaces with high-temperature resistance have a wide application potential in electrosurgical instruments, engines, and pipelines. A typical anti-wetting superhydrophobic surface easily fails when exposed to a high-temperature liquid. Recently, Nepenthes-inspired slippery surfaces demonstrated a new way to solve the adhesion problem. A lubricant layer on the slippery surface can act as a barrier between the repelled materials and the surface structure. However, the slippery surfaces in previous studies rarely showed high-temperature resistance. Here, we describe a protocol for the preparation of slippery surfaces with high-temperature resistance. A photolithography-assisted method was used to fabricate pillar structures on stainless steel. By functionalizing the surface with saline, a slippery surface was prepared by adding silicone oil. The prepared slippery surface maintained the anti-wetting property for water, even when the surface was heated to 300 &#176;C. Also, the slippery surface exhibited great anti-adhesion effects on soft tissues at high temperatures. This type of slippery surface on stainless steel has applications in medical devices, mechanical equipment, etc.

Slippery surfaces provide a new way to solve the adhesion problem. This protocol describes how to fabricate slippery surfaces at high temperatures. The results demonstrate that the slippery surfaces showed anti-wetting for liquids and a remarkable anti-adhesion effect on soft tissues at high temperatures.

不锈钢滑面的制备及高温抗粘接性能研究

Anti-adhesion surfaces with high-temperature resistance have a wide application potential in electrosurgical instruments, engines, and pipelines. A ...

Culturing and Maintaining Clostridium difficile in an Anaerobic Environment

Clostridium difficile is a Gram-positive, anaerobic, sporogenic bacterium that is primarily responsible for antibiotic associated diarrhea (AAD) and is a significant nosocomial pathogen. C. difficile is notoriously difficult to isolate and cultivate and is extremely sensitive to even low levels of oxygen in the environment. Here, methods for isolating C. difficile from fecal samples and subsequently culturing C. difficile for preparation of glycerol stocks for long-term storage are presented. Techniques for preparing and enumerating spore stocks in the laboratory for a variety of downstream applications including microscopy and animal studies are also described. These techniques necessitate an anaerobic chamber, which maintains a consistent anaerobic environment to ensure proper conditions for optimal C. difficile growth. We provide protocols for transferring materials in and out of the chamber without causing significant oxygen contamination along with suggestions for regular maintenance required to sustain the appropriate anaerobic environment for efficient and consistent C. difficile cultivation.

Culturing and Maintaining Clostridium difficile in an Anaerobic Environment

Clostridium difficile is a pathogenic bacterium that is a strict anaerobe and causes antibiotic associated diarrhea (AAD). Here, methods for isolating, culturing and maintaining C. difficile vegetative cells and spores are described. These techniques necessitate an anaerobic chamber, which requires regular maintenance to ensure proper conditions for optimal C. difficile cultivation.

培养和维护<em&gt;难辨梭状芽孢杆菌</em&gt;在厌氧环境

Clostridium  difficile is a Gram-positive, anaerobic, sporogenic bacterium  that is primarily responsible for antibiotic associated diarrhea (AAD) and is ...

免疫与感染

Surface Potential Measurement of Bacteria Using Kelvin Probe Force Microscopy

Surface potential is a commonly overlooked physical characteristic that plays a dominant role in the adhesion of microorganisms to substrate surfaces. Kelvin probe force microscopy (KPFM) is a module of atomic force microscopy (AFM) that measures the contact potential difference between surfaces at the nano-scale. The combination of KPFM with AFM allows for the simultaneous generation of surface potential and topographical maps of biological samples such as bacterial cells. Here, we employ KPFM to examine the effects of surface potential on microbial adhesion to medically relevant surfaces such as stainless steel and gold. Surface potential maps revealed differences in surface potential for microbial membranes on different material substrates. A step-height graph was generated to show the difference in surface potential at a boundary area between the substrate surface and microorganisms. Changes in cellular membrane surface potential have been linked with changes in cellular metabolism and motility. Therefore, KPFM represents a powerful tool that can be utilized to examine the changes of microbial membrane surface potential upon adhesion to various substrate surfaces. In this study, we demonstrate the procedure to characterize the surface potential of individual methicillin-resistant Staphylococcus aureus USA100 cells on stainless steel and gold using KPFM.

Here, we present a protocol explaining the use of Kelvin probe force microscopy as a tool for generating high resolution nano-scale surface potential maps. This tool was applied to assess the role of surface potential on the binding capacity of microorganisms to substrate surfaces.

细菌表面电位测量用开尔文探针力显微镜

Surface potential is a commonly overlooked physical characteristic that plays a dominant role in the adhesion of microorganisms to substrate surfaces. ...

Micromechanical Tension Testing of Additively Manufactured 17-4 PH Stainless Steel Specimens

This study presents a methodology for the rapid fabrication and micro-tensile testing of additively manufactured (AM) 17-4PH stainless steels by combining photolithography, wet-etching, focused ion beam (FIB) milling, and modified nanoindentation. Detailed procedures for proper sample surface preparation, photo-resist placement, etchant preparation, and FIB sequencing are described herein to allow for high throughput (rapid) specimen fabrication from bulk AM 17-4PH stainless steel volumes. Additionally, procedures for the nano-indenter tip modification to allow tensile testing are presented and a representative micro specimen is fabricated and tested to failure in tension. Tensile-grip-to-specimen alignment and sample engagement were the main challenges of the micro-tensile testing; however, by reducing the indenter tip dimensions, alignment and engagement between the tensile grip and specimen were improved. Results from the representative micro-scale in situ SEM tensile test indicate a single slip plane specimen fracture (typical of a ductile single crystal failure), differing from macro-scale AM 17-4PH post-yield tensile behavior.

Presented here is a procedure for measuring fundamental material properties through micromechanical tension testing. Described are the methods for micro-tensile specimen fabrication (allowing rapid micro-specimen fabrication from bulk material volumes by combining photolithography, chemical etching, and focused ion beam milling), indenter tip modification, and micromechanical tension testing (including an example).

增材制造的17-4 PH不锈钢试样的微机械张力测试

This study presents a methodology for the rapid fabrication and micro-tensile testing of additively manufactured (AM) 17-4PH stainless steels by combining ...