資金の機関には、この作業はサポートされていません。

1. サンプル ソリューション
<ol>
	<li>最大許容繰越 (マコ) 治療上の線量基準に基づく薬剤の洗浄の限界 (CL) を計算します。 注: ここでは、薬物 A の洗浄の限界 (CL) が計算された最大許容繰越 (マコ) 治療上の線量基準に基づいて 50 cm2あたり 2.4 μ g にします。50%、100%、150% の制限をクリーニングでクリーニングの検証が実行されます。2 製剤 (2.5%、60%/w 薬物負荷) のクリーニングの確認が評価されました。</li>
</ol>
2. クーポンの洗浄手順
<ol>
	<li>最初のアプローチ<ol>
		<li>きれいに洗浄し、水で二回と二度あらゆる残留の沈殿物を除去するためにメタノール 10-15 s の表面を拭くクーポン。メタノールは有毒で揮発性の高いフードでこのプロセスを実行します。</li>
	</ol>
	</li>
	<li>高度なアプローチ<ol>
		<li>きれい場所ソリューションを使用してください。<ol>
			<li>室温で、超音波発生装置を設定します。超音波発生装置は電源設定の調整、したがって時間の十分な洗浄効果を与えるに設定されます。</li>
			<li>高速液体クロマトグラフィー (HPLC) グレード水でクーポンの 2 分間超音波。</li>
			<li>HPLC グレードの水でアルカリ洗剤溶液を 0.1% のクーポンをつけるし、2 分間超音波。</li>
			<li>高速液体クロマトグラフィー水でクーポンの 2 分間超音波。</li>
			<li>HPLC 水の酸洗剤溶液を 0.1% クーポンの 2 分間超音波。</li>
			<li>高速液体クロマトグラフィー水でクーポンの 2 分間超音波。</li>
		</ol>
		</li>
		<li>酸基過酸化水素を使用してください。 注: これは酸、基盤、およびアルカリ性と酸性洗剤ではなく過酸化水素を使用して含まれている別の方法です。<ol>
			<li>室温で、超音波発生装置を設定します。超音波発生装置は電源設定の調整、したがって時間の十分な洗浄効果を与えるに設定されます。</li>
			<li>水でクーポンの 2 分間超音波。</li>
			<li>0.1 M 水酸化ナトリウムでクーポンの 2 分間超音波。</li>
			<li>水でクーポンの 2 分間超音波。</li>
			<li>0.1 M 塩酸でクーポンの 2 分間超音波。</li>
			<li>水でクーポンの 2 分間超音波。</li>
			<li>0.1 mg/mL NaNo2 のクーポンの 2 分間超音波。</li>
			<li>水でクーポンの 2 分間超音波。</li>
		</ol>
		</li>
	</ol>
	</li>
</ol>
3. 拭き取り手順
<ol>
	<li>両面テープを使用して 250 mL (500 mL) プラスチック ビーカーの底にステンレス鋼クーポンをマウントします。</li>
	<li>スパイクとプロセスを簡単に拭き取りにビーカーにホールドします。これはまた角を拭き取りときオーバー シュートなどいくつかの望ましくない事故を最小限に抑えます。</li>
	<li>肯定的な変位のピペットを使用してクーポンの表面に whirly パターンで特定濃度と定式化 (例えば2.5%/w 薬物 A の負荷で 12 μ g/mL の 200 μ L) で定義済みのボリュームを吹き込みます。</li>
	<li>クーポンの表面が乾燥するまで待ちます (〜 サンプルの変動に応じて 3 ~ 10 分)。</li>
	<li>希釈の 2 ml バイアルに乾いた綿棒を浸し (メタノール: ギ酸 100:0.2/ボリューム)。</li>
	<li>バイアルの中に綿棒を押すことによって過剰の溶媒を削除します。</li>
	<li>しっかりとウェット綿棒の片側で合計 50 cm2のテスト領域を一掃するまでも、オーバー ラップのサイド ・ ツー ・ サイド ストロークでクーポンの表面を拭いてください。</li>
	<li>(ステップ 3.7) 拭くを繰り返して綿棒の同じ側を使用します。</li>
	<li>クーポンの 4 つの端を 2 回綿棒します。</li>
	<li>反対側に綿棒を反転し、クーポン、時計回りまたは反時計回りに 90 ° 回転したがって、90 ° で拭き取りの方向を回転させます。</li>
	<li>3.7 3.9 の手順に示すとおり拭き取り動作を繰り返します。表面のサンプリング後溶剤のバイアルにはさみを使用して綿棒の頭をカットします。</li>
	<li>クーポンの前に選択した同じ方向へ 90 ° を回転させながら第 2 綿棒で拭き取り処理を繰り返します。</li>
	<li>5 分の 2 つの綿棒の頭、10 の渦のバイアルを超音波 s。</li>
	<li>高速液体クロマトグラフィー バイアルにソリューションを転送し、実用的なソリューションとしてラベルを付けます。</li>
</ol>
4. 回復の計算
<ol>
	<li>サンプル回復<ol>
		<li>200 μ L 各 1,800 μ L の希釈液を使用してソリューションをスパイク クーポンを混ぜて制御ソリューションを準備します。</li>
		<li>表 1に示す条件に従って、クロマトグラフィー システムを実行します。</li>
		<li>作業ソリューションのピークの下で相対的な面積に基づいて綿棒作業ソリューションの回復を計算 (AW) と制御ソリューション (C)。</li>
		<li>3 つのクーポンで手順を繰り返し、相対標準偏差 (Srel) と共に平均回収率を計算します。 注: ここで使用されるすべての分析法は、ICH Q2(R1) ガイドラインに従って検証されました。クロマトグラフィー条件は、材料のセクションに表示されます。</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>

金銭的な利益や利害の衝突が存在しません。

ステンレス鋼のクーポンから API 残基の低と変数の回復に大きく貢献は、クーポンの表面のクリーニングのための明確に定義されたプロシージャの欠如に由来しました。一貫性のある、正確なスパイクの回復と再現性のある結果となりましたクーポンの表面をクリーニングします。ステンレス鋼のクーポンから高回復のデモでは、検証メソッドを使用して製造装置から得られる実際のクリー?...

非専用装置の清浄度は、中間体の製造に使用するための後続のリリース前に検証すべき、クロス汚染を防ぐために製品に医薬原体 (Api) を変えます。再現性のある、効果的な方法で機器の種類ごとをきれいにするオペレーターを有効にするのに十分な詳細を含める必要がありますクリーニング手順と、これらの手順は、米国食品医薬品局 (FDA) の要件1によると検証されるべき。不十分なため多数の警告手紙2,3,4、洗浄の検証方法の検証に失敗したおよびクリーニングの手順5は、FDA によって発行されている障害のクリーニング。21 CFR §211.67 は、成功したクリーニングの確認のために必要な要件をについて説明します。
製造装置として同じ表面/仕上げステンレス鋼クーポンに対する検証を洗浄するための分析法の検証は実行こと業界のスタンダードです。ステンレス鋼のクーポン (例えば、50 cm2) を使用して、研究室での検証実験を洗浄するための装置の表面を表します。開発とこれらの分析法の検証は、目的 (すなわち装置の表面から回復させるべき残基) の標本が最大許容繰越 (マコ) 制限によって決まりますステンレス クーポンにターゲット残渣でスパイクです。このレベルは、健康への有害影響 (なし-観察-副作用-効果-レベル NOAEL) を患者が公開を取得制限として定義される許容暴露限界に基づいて決定されます。
アナリストや、拭き取りを行う製造者は、リカバリの誰が、拭き取りを行うに関係なく再現性を確実にする構造化された手順に従う必要があります。プロシージャする必要があります明示的に綿棒タイプの詳細、綿棒の数使用する希釈剤、溶剤の使用量、正確な抜本的なパターン、サンプル、検出 (紫外、蛍光、質量分析装置、全有機炭素、等) の方法、綿棒の頭から素材の抽出技術のかみ/抽出時間の量、サンプリング表面に適用されているストローク数、など。
サンプル回復、クーポンの表面およびこうして、機器の表面に影響を与えるすべての要因以外にも役割を果たします。表面上の材料の薄膜の蒸着又はステンレス鋼 (例えばFe、Cr、Ni) 内の要素の 1 つ以上の酸化状態の変化により、クーポンの表面を変更可能性があります6,7,8。元の状態に戻るステンレス クーポンの表面の再生は、定量的なスワップ ・ プロセスの成功に不可欠です。ステンレス鋼クーポンが正しく処理されなかった場合、研究は、アナリストにもう一つ、別の薬や様々 なスパイク レベル9,10,11を含む回復の変動を示した。1 枚のクーポンで 10 複製の回復で標準偏差はできます最大 14%、5 クーポン926% です。複製の数を増加または増加するクーポン使用時 (すなわち、同じクーポンでスパイクの 5 回ではなく 5 クーポン)11の数に相対標準偏差 (Srel) 値が増加したことに注意することが重要です。このような場合、ランダムなゆらぎとして変動を解釈できません。それにもかかわらず、その結果が私達の見つけることによって説明できるクーポンの表面の清浄度回復に影響すること。このペーパーで説明した結果回復結果の大幅な増加を示すし、正しくステンレス クーポンの表面を洗浄した後の変動の減少します。
きれい場所 (CIP) は、最小を含む装置の表面またはない装置の分解洗浄を自動化する手段です。CIP 洗浄プロセス、中に有機・無機の残基を削除する酸の順で連続洗浄の定義されているプロシージャが実行されます。界面活性剤、キレート化合物、又は錯化剤は通常機器の表面からすべての製品の洗浄の効率を高めるため CIP ソリューションに追加されます。洗浄の効率は、洗浄時間、温度 (通常 60-80 ° C)、汚染型、およびパーツ12をきれいにハードの存在、選択と (すなわち型、ベース、酸と界面活性剤の組成)、CIP 液の濃度を含むいくつかのパラメーターとは異なります。医薬品の種類に基づき、100 や 200 の CIP ソリューションは、製造装置の洗浄に使用される CIP プロセスをシミュレートするので、検証を洗浄に使用されるステンレス鋼クーポンをクリーニングに使用する選択されています。
本研究は、ステンレス鋼クーポンの表面から残留する医薬品の回収に影響を与えるさまざまな要因の影響を報告し、抗体・治療用タンパク質は、小分子分析の洗浄法開発のベスト プラクティスをお勧めします。クーポン表面きれいに一貫して明確に定義されたプロシージャの欠如は、低と変数の回復に大きく貢献として同定されました。クーポンの表面はきれいに正しく13時高で再現可能な回復が得られました。

<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

この作業の目的は、残留する医薬品のステンレス鋼クーポンの表面からの回復に影響するパラメーターを識別するためにです。薬物製品スパイク レベル、スパイキング プロシージャ、医薬品賦形剤比、アナリストのアナリストの変動、日中変動およびクーポンのクリーニング手順を含む、一連の要因を評価しました。クーポン表面きれいに一貫して明確に定義されたプロシージャの欠如は、低と変数の回復に大きく貢献として同定されました。ソリューションきれい場所 (CIP) クーポンの表面を洗浄の評価を与えた高回収率 (&#62; 90%)、以前評価した条件に関係なく再現性のある結果 (Srel≤4%)。小分子の検証をクリーニングに応用されたアプローチ (MW &#60; 1,000 Da) (50,000 Da まで MW) の巨大生体分子だけでなく。

代表的な起因薬物に対する検証を洗浄するための初期の試みは表 2にまとめて。実験セクションで詳細な手順に従ってクーポンを洗浄した前に API/賦形剤、別のアナリストの様々 な比率と同じのアナリストは別の日、別のスパイク レベルで一貫性のない結果が得られました。検証の要件を失敗の結果の一部として、回収率で観測された変動は、対処する?...

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

一貫してクーポンの表面を掃除する明確に定義されたプロシージャの欠如は、検証のクリーニングで低と変数の回復に大きく貢献として同定されました。本稿では、ステンレス鋼のクーポンを洗浄の適切なプロトコルについて説明します。

クリーニング ステンレス鋼表面の不潔による医薬品業界における検証の失敗

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 ビュー.  Novartis Pharmaceuticals Corporation. 一貫してクーポンの表面を掃除する明確に定義されたプロシージャの欠如は、検証のクリーニングで低と変数の回復に大きく貢献として同定されました。本稿では、ステンレス鋼のクーポンを洗浄の適切なプロトコルについて説明します。

ビデオ: 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;

蛍光粉を使用した小売環境における微生物汚染を追跡する - 小売デリカ環境の例

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

環境学

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.

大面積自立超薄ポリマーフィルムの作製

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.

バイオフィルム除去窒素パージすることなく、二酸化炭素エアロゾルを使用します

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.

ポータブル化学殺菌（PCS）、D-FENSおよびD-FEND ALL：小説二酸化塩素除染技術の軍事用

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 ...

生物工学

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.

ライト強化フッ酸不動態化：バルクシリコン欠陥を検出するための高感度テクニック

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 ...

工学

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.

ステンレス鋼の滑りやすい表面の作製と高温の反付着挙動

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.

培養およびメンテナンス<em&gt;クロストリジウム·ディフィシル</em&gt;嫌気性環境での

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

免疫・感染学

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).

加法で製造された17-4 PHステンレス鋼の標本のマイクロメカニカルテンション試験

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

Determining Viral Disinfection Efficacy of Hot Water Laundering

This protocol provides an example of a laboratory process for conducting laundering studies that generate data on viral disinfection. While the protocol was developed for research during the coronavirus disease 2019 (COVID-19) pandemic, it is intended to be a framework, adaptable to other virus disinfection studies; it demonstrates the steps for preparing the test virus, inoculating the test material, assessing visual and integrity changes to the washed items due to the laundering process, and quantifying the reduction in viral load. Additionally, the protocol outlines the necessary quality control samples for ensuring the experiments are not biased by contamination and measurements/observations that should be recorded to track the material integrity of the personal protective equipment (PPE) items after multiple laundering cycles. The representative results presented with the protocol use the Phi6 bacteriophage inoculated onto cotton scrub, denim, and cotton face-covering materials and indicate that the hot water laundering and drying process achieved over a 3-log (99.9%) reduction in viral load for all samples (a 3-log reduction is the disinfectant performance metric in U.S. Environmental Protection Agency's Product Performance Test Guideline 810.2200). The reduction in viral load was uniform across different locations on the PPE items. The results of this viral disinfection efficacy testing protocol should help the scientific community explore the effectiveness of home laundering for other types of test viruses and laundering procedures.

In response to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, a laboratory protocol was developed to test the viral disinfection efficacy of hot water laundering of cloth face coverings, cotton scrubs, and denim pants. The Phi6 virus (bacteriophage) was used as the organism to test disinfection efficacy.

温水洗浄のウイルス消毒効果の決定

This protocol provides an example of a laboratory process for conducting laundering studies that generate data on viral disinfection. While the protocol ...

クリーンルーム環境における微生物制御およびモニタリング戦略

Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

A well-validated and holistic program that incorporates robust gowning, cleaning, environmental monitoring, and personnel monitoring measures is critical for minimizing the microbial bioburden in cellular therapy manufacturing suites and the corresponding testing laboratories to ensure that the facilities are operating in a state of control. Ensuring product safety via quality control measures, such as sterility testing, is a regulatory requirement for both minimally manipulated (section 361) and more than minimally manipulated (section 351) human cells, tissues, and cellular and tissue-based products (HCT/Ps). In this video, we provide a stepwise guide for how to develop and incorporate the best aseptic practices for operating in a cleanroom environment, including gowning, cleaning, staging of materials, environmental monitoring, process monitoring, and product sterility testing using direct inoculation, provided by the United States Pharmacopeia (USP&lt;71&gt;) and the National Institutes of Health (NIH) Alternative Sterility Testing Method. This protocol is intended as a reference guide for establishments expected to meet current good tissue practices (cGTP) and current good manufacturing practices (cGMP).

著者スポットライト:クリーンルーム環境と細胞療法のための微生物制御およびモニタリング戦略  

The protocol summarizes the best practices to minimize microbial bioburden in a cleanroom environment and includes strategies such as environmental monitoring, process monitoring, and product sterility testing. It is relevant for manufacturing and testing facilities that are required to meet current good tissue practice standards and current good manufacturing practice standards.

クリーンルーム環境と細胞療法のための微生物制御およびモニタリング戦略

A well-validated and holistic program that incorporates robust gowning, cleaning, environmental monitoring, and personnel monitoring measures is critical ...

クリーニングステンレス鋼表面の不潔による医薬品業界における検証の失敗

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この動画の章

蛍光粉を使用した小売環境における微生物汚染を追跡する - 小売デリカ環境の例

大面積自立超薄ポリマーフィルムの作製

バイオフィルム除去窒素パージすることなく、二酸化炭素エアロゾルを使用します

ポータブル化学殺菌（PCS）、D-FENSおよびD-FEND ALL：小説二酸化塩素除染技術の軍事用

ライト強化フッ酸不動態化：バルクシリコン欠陥を検出するための高感度テクニック

ステンレス鋼の滑りやすい表面の作製と高温の反付着挙動

培養およびメンテナンス

加法で製造された17-4 PHステンレス鋼の標本のマイクロメカニカルテンション試験

温水洗浄のウイルス消毒効果の決定

クリーンルーム環境と細胞療法のための微生物制御およびモニタリング戦略

クリーニング ステンレス鋼表面の不潔による医薬品業界における検証の失敗

要約

さらに動画を探す

この動画の章

蛍光粉を使用した小売環境における微生物汚染を追跡する - 小売デリカ環境の例

大面積自立超薄ポリマーフィルムの作製

バイオフィルム除去窒素パージすることなく、二酸化炭素エアロゾルを使用します

ポータブル化学殺菌（PCS）、D-FENSおよびD-FEND ALL：小説二酸化塩素除染技術の軍事用

ライト強化フッ酸不動態化：バルクシリコン欠陥を検出するための高感度テクニック

ステンレス鋼の滑りやすい表面の作製と高温の反付着挙動

培養およびメンテナンス

加法で製造された17-4 PHステンレス鋼の標本のマイクロメカニカルテンション試験

温水洗浄のウイルス消毒効果の決定

クリーンルーム環境と細胞療法のための微生物制御およびモニタリング戦略

クリーニングステンレス鋼表面の不潔による医薬品業界における検証の失敗