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class="vector-toc-list"> </ul> </li> <li id="toc-Cleanrooms_of_different_kinds" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Cleanrooms_of_different_kinds"> <div class="vector-toc-text"> <span class="vector-toc-numb">3.2</span> <span>Cleanrooms of different kinds</span> </div> </a> <ul id="toc-Cleanrooms_of_different_kinds-sublist" class="vector-toc-list"> </ul> </li> </ul> </li> <li id="toc-Operating_procedure" class="vector-toc-list-item vector-toc-level-1 vector-toc-list-item-expanded"> <a class="vector-toc-link" href="#Operating_procedure"> <div class="vector-toc-text"> <span class="vector-toc-numb">4</span> <span>Operating procedure</span> </div> </a> <button aria-controls="toc-Operating_procedure-sublist" class="cdx-button cdx-button--weight-quiet cdx-button--icon-only vector-toc-toggle"> <span class="vector-icon mw-ui-icon-wikimedia-expand"></span> <span>Toggle Operating procedure subsection</span> </button> <ul 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<span class="vector-icon mw-ui-icon-wikimedia-expand"></span> <span>Toggle Cleanroom classification and standardization subsection</span> </button> <ul id="toc-Cleanroom_classification_and_standardization-sublist" class="vector-toc-list"> <li id="toc-ISO_14644-1_and_ISO_14698" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#ISO_14644-1_and_ISO_14698"> <div class="vector-toc-text"> <span class="vector-toc-numb">5.1</span> <span>ISO 14644-1 and ISO 14698</span> </div> </a> <ul id="toc-ISO_14644-1_and_ISO_14698-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-US_FED_STD_209E" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#US_FED_STD_209E"> <div class="vector-toc-text"> <span class="vector-toc-numb">5.2</span> <span>US FED STD 209E</span> </div> </a> <ul id="toc-US_FED_STD_209E-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-EU_GMP_classification" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#EU_GMP_classification"> <div class="vector-toc-text"> <span class="vector-toc-numb">5.3</span> <span>EU GMP classification</span> </div> </a> <ul id="toc-EU_GMP_classification-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-BS_5295" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#BS_5295"> <div class="vector-toc-text"> <span class="vector-toc-numb">5.4</span> <span>BS 5295</span> </div> </a> <ul id="toc-BS_5295-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-USP_<800>_standards" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#USP_<800>_standards"> <div class="vector-toc-text"> <span class="vector-toc-numb">5.5</span> <span>USP <800> standards</span> </div> </a> <ul id="toc-USP_<800>_standards-sublist" class="vector-toc-list"> </ul> </li> </ul> </li> <li id="toc-Ramifications_and_further_applications" class="vector-toc-list-item vector-toc-level-1 vector-toc-list-item-expanded"> <a class="vector-toc-link" href="#Ramifications_and_further_applications"> <div class="vector-toc-text"> <span class="vector-toc-numb">6</span> <span>Ramifications and further applications</span> </div> </a> <ul id="toc-Ramifications_and_further_applications-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-See_also" class="vector-toc-list-item vector-toc-level-1 vector-toc-list-item-expanded"> <a class="vector-toc-link" href="#See_also"> <div class="vector-toc-text"> <span class="vector-toc-numb">7</span> <span>See also</span> </div> </a> <ul id="toc-See_also-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-References" class="vector-toc-list-item vector-toc-level-1 vector-toc-list-item-expanded"> <a class="vector-toc-link" href="#References"> <div class="vector-toc-text"> <span class="vector-toc-numb">8</span> <span>References</span> </div> </a> <ul id="toc-References-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-External_links" class="vector-toc-list-item vector-toc-level-1 vector-toc-list-item-expanded"> <a class="vector-toc-link" href="#External_links"> <div class="vector-toc-text"> <span class="vector-toc-numb">9</span> <span>External links</span> </div> </a> <ul id="toc-External_links-sublist" class="vector-toc-list"> </ul> </li> </ul> </div> </div> </nav> </div> </div> <div class="mw-content-container"> <main id="content" class="mw-body"> <header class="mw-body-header vector-page-titlebar"> <nav aria-label="Contents" class="vector-toc-landmark"> <div id="vector-page-titlebar-toc" class="vector-dropdown vector-page-titlebar-toc vector-button-flush-left" > <input type="checkbox" id="vector-page-titlebar-toc-checkbox" role="button" aria-haspopup="true" data-event-name="ui.dropdown-vector-page-titlebar-toc" class="vector-dropdown-checkbox " aria-label="Toggle the table of contents" > <label id="vector-page-titlebar-toc-label" for="vector-page-titlebar-toc-checkbox" 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href="https://bn.wikipedia.org/wiki/%E0%A6%A8%E0%A6%BF%E0%A6%B0%E0%A7%8D%E0%A6%AE%E0%A6%B2_%E0%A6%95%E0%A6%95%E0%A7%8D%E0%A6%B7" title="নির্মল কক্ষ – Bangla" lang="bn" hreflang="bn" data-title="নির্মল কক্ষ" data-language-autonym="বাংলা" data-language-local-name="Bangla" class="interlanguage-link-target"><span>বাংলা</span></a></li><li class="interlanguage-link interwiki-bg mw-list-item"><a href="https://bg.wikipedia.org/wiki/%D0%A7%D0%B8%D1%81%D1%82%D0%B0_%D1%81%D1%82%D0%B0%D1%8F" title="Чиста стая – Bulgarian" lang="bg" hreflang="bg" data-title="Чиста стая" data-language-autonym="Български" data-language-local-name="Bulgarian" class="interlanguage-link-target"><span>Български</span></a></li><li class="interlanguage-link interwiki-ca mw-list-item"><a href="https://ca.wikipedia.org/wiki/Sala_blanca" title="Sala blanca – Catalan" lang="ca" hreflang="ca" data-title="Sala blanca" data-language-autonym="Català" data-language-local-name="Catalan" class="interlanguage-link-target"><span>Català</span></a></li><li class="interlanguage-link interwiki-de mw-list-item"><a href="https://de.wikipedia.org/wiki/Reinraum" title="Reinraum – German" lang="de" hreflang="de" data-title="Reinraum" data-language-autonym="Deutsch" data-language-local-name="German" class="interlanguage-link-target"><span>Deutsch</span></a></li><li class="interlanguage-link interwiki-et mw-list-item"><a href="https://et.wikipedia.org/wiki/Puhasruum" title="Puhasruum – Estonian" lang="et" hreflang="et" data-title="Puhasruum" data-language-autonym="Eesti" data-language-local-name="Estonian" class="interlanguage-link-target"><span>Eesti</span></a></li><li class="interlanguage-link interwiki-es mw-list-item"><a href="https://es.wikipedia.org/wiki/Sala_blanca" title="Sala blanca – Spanish" lang="es" hreflang="es" data-title="Sala blanca" data-language-autonym="Español" data-language-local-name="Spanish" class="interlanguage-link-target"><span>Español</span></a></li><li class="interlanguage-link interwiki-eo mw-list-item"><a href="https://eo.wikipedia.org/wiki/Pur%C4%89ambro" title="Purĉambro – Esperanto" lang="eo" hreflang="eo" data-title="Purĉambro" data-language-autonym="Esperanto" data-language-local-name="Esperanto" class="interlanguage-link-target"><span>Esperanto</span></a></li><li class="interlanguage-link interwiki-fa mw-list-item"><a href="https://fa.wikipedia.org/wiki/%D8%A7%D8%AA%D8%A7%D9%82_%D8%AA%D9%85%DB%8C%D8%B2" title="اتاق تمیز – Persian" lang="fa" hreflang="fa" data-title="اتاق تمیز" data-language-autonym="فارسی" data-language-local-name="Persian" class="interlanguage-link-target"><span>فارسی</span></a></li><li class="interlanguage-link interwiki-fr mw-list-item"><a href="https://fr.wikipedia.org/wiki/Salle_blanche" title="Salle blanche – French" lang="fr" hreflang="fr" data-title="Salle blanche" data-language-autonym="Français" data-language-local-name="French" class="interlanguage-link-target"><span>Français</span></a></li><li class="interlanguage-link interwiki-ko mw-list-item"><a href="https://ko.wikipedia.org/wiki/%EC%B2%AD%EC%A0%95%EC%8B%A4" title="청정실 – Korean" lang="ko" hreflang="ko" data-title="청정실" data-language-autonym="한국어" data-language-local-name="Korean" class="interlanguage-link-target"><span>한국어</span></a></li><li class="interlanguage-link interwiki-id mw-list-item"><a href="https://id.wikipedia.org/wiki/Kamar_bersih" title="Kamar bersih – Indonesian" lang="id" hreflang="id" data-title="Kamar bersih" data-language-autonym="Bahasa Indonesia" data-language-local-name="Indonesian" class="interlanguage-link-target"><span>Bahasa Indonesia</span></a></li><li class="interlanguage-link interwiki-it mw-list-item"><a href="https://it.wikipedia.org/wiki/Camera_bianca" title="Camera bianca – Italian" lang="it" hreflang="it" data-title="Camera bianca" data-language-autonym="Italiano" data-language-local-name="Italian" class="interlanguage-link-target"><span>Italiano</span></a></li><li class="interlanguage-link interwiki-he mw-list-item"><a href="https://he.wikipedia.org/wiki/%D7%97%D7%93%D7%A8_%D7%A0%D7%A7%D7%99" title="חדר נקי – Hebrew" lang="he" hreflang="he" data-title="חדר נקי" data-language-autonym="עברית" data-language-local-name="Hebrew" class="interlanguage-link-target"><span>עברית</span></a></li><li class="interlanguage-link interwiki-lv mw-list-item"><a href="https://lv.wikipedia.org/wiki/T%C4%ABr%C4%81_telpa" title="Tīrā telpa – Latvian" lang="lv" hreflang="lv" data-title="Tīrā telpa" data-language-autonym="Latviešu" data-language-local-name="Latvian" class="interlanguage-link-target"><span>Latviešu</span></a></li><li class="interlanguage-link interwiki-hu mw-list-item"><a href="https://hu.wikipedia.org/wiki/Tisztat%C3%A9r" title="Tisztatér – Hungarian" lang="hu" hreflang="hu" data-title="Tisztatér" data-language-autonym="Magyar" data-language-local-name="Hungarian" class="interlanguage-link-target"><span>Magyar</span></a></li><li class="interlanguage-link interwiki-nl mw-list-item"><a href="https://nl.wikipedia.org/wiki/Cleanroom" title="Cleanroom – Dutch" lang="nl" hreflang="nl" data-title="Cleanroom" data-language-autonym="Nederlands" data-language-local-name="Dutch" class="interlanguage-link-target"><span>Nederlands</span></a></li><li class="interlanguage-link interwiki-ja mw-list-item"><a href="https://ja.wikipedia.org/wiki/%E3%82%AF%E3%83%AA%E3%83%BC%E3%83%B3%E3%83%AB%E3%83%BC%E3%83%A0" title="クリーンルーム – Japanese" lang="ja" hreflang="ja" data-title="クリーンルーム" data-language-autonym="日本語" data-language-local-name="Japanese" class="interlanguage-link-target"><span>日本語</span></a></li><li class="interlanguage-link interwiki-pl mw-list-item"><a href="https://pl.wikipedia.org/wiki/Clean_room" title="Clean room – Polish" lang="pl" hreflang="pl" data-title="Clean room" data-language-autonym="Polski" data-language-local-name="Polish" class="interlanguage-link-target"><span>Polski</span></a></li><li class="interlanguage-link interwiki-pt mw-list-item"><a href="https://pt.wikipedia.org/wiki/Sala_limpa" title="Sala limpa – Portuguese" lang="pt" hreflang="pt" data-title="Sala limpa" data-language-autonym="Português" data-language-local-name="Portuguese" class="interlanguage-link-target"><span>Português</span></a></li><li class="interlanguage-link interwiki-ru mw-list-item"><a href="https://ru.wikipedia.org/wiki/%D0%A7%D0%B8%D1%81%D1%82%D0%BE%D0%B5_%D0%BF%D0%BE%D0%BC%D0%B5%D1%89%D0%B5%D0%BD%D0%B8%D0%B5" title="Чистое помещение – Russian" lang="ru" hreflang="ru" data-title="Чистое помещение" data-language-autonym="Русский" data-language-local-name="Russian" class="interlanguage-link-target"><span>Русский</span></a></li><li class="interlanguage-link interwiki-sr mw-list-item"><a href="https://sr.wikipedia.org/wiki/%D0%A7%D0%B8%D1%81%D1%82%D0%B0_%D1%81%D0%BE%D0%B1%D0%B0" title="Чиста соба – Serbian" lang="sr" hreflang="sr" data-title="Чиста соба" data-language-autonym="Српски / srpski" data-language-local-name="Serbian" class="interlanguage-link-target"><span>Српски / srpski</span></a></li><li class="interlanguage-link interwiki-fi mw-list-item"><a href="https://fi.wikipedia.org/wiki/Puhdastila" title="Puhdastila – Finnish" lang="fi" hreflang="fi" data-title="Puhdastila" data-language-autonym="Suomi" data-language-local-name="Finnish" class="interlanguage-link-target"><span>Suomi</span></a></li><li class="interlanguage-link interwiki-sv mw-list-item"><a href="https://sv.wikipedia.org/wiki/Renrum" title="Renrum – Swedish" lang="sv" hreflang="sv" data-title="Renrum" data-language-autonym="Svenska" data-language-local-name="Swedish" class="interlanguage-link-target"><span>Svenska</span></a></li><li class="interlanguage-link interwiki-ta mw-list-item"><a href="https://ta.wikipedia.org/wiki/%E0%AE%A4%E0%AF%82%E0%AE%AF%E0%AF%8D%E0%AE%AE%E0%AF%88%E0%AE%AF%E0%AE%BE%E0%AE%A9_%E0%AE%85%E0%AE%B1%E0%AF%88" title="தூய்மையான அறை – Tamil" lang="ta" hreflang="ta" data-title="தூய்மையான அறை" data-language-autonym="தமிழ்" data-language-local-name="Tamil" class="interlanguage-link-target"><span>தமிழ்</span></a></li><li class="interlanguage-link interwiki-uk mw-list-item"><a href="https://uk.wikipedia.org/wiki/%D0%A7%D0%B8%D1%81%D1%82%D1%96_%D0%BF%D1%80%D0%B8%D0%BC%D1%96%D1%89%D0%B5%D0%BD%D0%BD%D1%8F" title="Чисті приміщення – Ukrainian" lang="uk" hreflang="uk" data-title="Чисті приміщення" data-language-autonym="Українська" data-language-local-name="Ukrainian" class="interlanguage-link-target"><span>Українська</span></a></li><li class="interlanguage-link interwiki-ur mw-list-item"><a href="https://ur.wikipedia.org/wiki/%D8%B5%D8%A7%D9%81_%DA%A9%D9%85%D8%B1%DB%81" title="صاف کمرہ – Urdu" lang="ur" hreflang="ur" data-title="صاف کمرہ" data-language-autonym="اردو" data-language-local-name="Urdu" class="interlanguage-link-target"><span>اردو</span></a></li><li class="interlanguage-link interwiki-zh mw-list-item"><a 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id="siteSub" class="noprint">From Wikipedia, the free encyclopedia</div> </div> <div id="contentSub"><div id="mw-content-subtitle"><span class="mw-redirectedfrom">(Redirected from <a href="/w/index.php?title=Clean_room&redirect=no" class="mw-redirect" title="Clean room">Clean room</a>)</span></div></div> <div id="mw-content-text" class="mw-body-content"><div class="mw-content-ltr mw-parser-output" lang="en" dir="ltr"><div class="shortdescription nomobile noexcerpt noprint searchaux" style="display:none">Dust-free room for research or production</div> <style data-mw-deduplicate="TemplateStyles:r1236090951">.mw-parser-output .hatnote{font-style:italic}.mw-parser-output div.hatnote{padding-left:1.6em;margin-bottom:0.5em}.mw-parser-output .hatnote i{font-style:normal}.mw-parser-output .hatnote+link+.hatnote{margin-top:-0.5em}@media print{body.ns-0 .mw-parser-output .hatnote{display:none!important}}</style><div role="note" class="hatnote navigation-not-searchable">This article is about the manufacturing or research environment. For the method used to avoid copyright infringement, see <a href="/wiki/Clean_room_design" class="mw-redirect" title="Clean room design">Clean room design</a>. For the software project methodology, see <a href="/wiki/Cleanroom_software_engineering" title="Cleanroom software engineering">Cleanroom software engineering</a>. For the TV episode, see <a href="/wiki/The_Clean_Room" title="The Clean Room">The Clean Room</a>.</div> <figure class="mw-default-size mw-halign-right" typeof="mw:File/Thumb"><a href="/wiki/File:Clean_room.jpg" class="mw-file-description"><img src="//upload.wikimedia.org/wikipedia/commons/thumb/5/50/Clean_room.jpg/220px-Clean_room.jpg" decoding="async" width="220" height="171" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/5/50/Clean_room.jpg/330px-Clean_room.jpg 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/5/50/Clean_room.jpg/440px-Clean_room.jpg 2x" data-file-width="2247" data-file-height="1742" /></a><figcaption>Cleanroom used for the production of microsystems. The <a href="/wiki/Yellow" title="Yellow">yellow</a> (red-green) lighting is necessary for <a href="/wiki/Photolithography" title="Photolithography">photolithography</a>, to prevent unwanted exposure of <a href="/wiki/Photoresist" title="Photoresist">photoresist</a> to light of shorter wavelengths.</figcaption></figure> <figure class="mw-default-size mw-halign-right" typeof="mw:File/Thumb"><a href="/wiki/File:Cleanroom_outside.jpg" class="mw-file-description"><img src="//upload.wikimedia.org/wikipedia/commons/thumb/c/c5/Cleanroom_outside.jpg/220px-Cleanroom_outside.jpg" decoding="async" width="220" height="165" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/c/c5/Cleanroom_outside.jpg/330px-Cleanroom_outside.jpg 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/c/c5/Cleanroom_outside.jpg/440px-Cleanroom_outside.jpg 2x" data-file-width="2048" data-file-height="1536" /></a><figcaption>Cleanroom from outside</figcaption></figure> <figure class="mw-default-size mw-halign-right" typeof="mw:File/Thumb"><a href="/wiki/File:Cleanroom_entrance.jpg" class="mw-file-description"><img src="//upload.wikimedia.org/wikipedia/commons/thumb/c/c3/Cleanroom_entrance.jpg/220px-Cleanroom_entrance.jpg" decoding="async" width="220" height="268" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/c/c3/Cleanroom_entrance.jpg/330px-Cleanroom_entrance.jpg 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/c/c3/Cleanroom_entrance.jpg/440px-Cleanroom_entrance.jpg 2x" data-file-width="1536" data-file-height="1870" /></a><figcaption>Entrance to a cleanroom with no air shower</figcaption></figure> <figure class="mw-default-size mw-halign-right" typeof="mw:File/Thumb"><a href="/wiki/File:Cleanroom1.jpg" class="mw-file-description"><img src="//upload.wikimedia.org/wikipedia/commons/thumb/1/16/Cleanroom1.jpg/220px-Cleanroom1.jpg" decoding="async" width="220" height="132" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/1/16/Cleanroom1.jpg/330px-Cleanroom1.jpg 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/1/16/Cleanroom1.jpg/440px-Cleanroom1.jpg 2x" data-file-width="945" data-file-height="566" /></a><figcaption>Cleanroom for <a href="/wiki/Microelectronics" title="Microelectronics">microelectronics</a> manufacturing with <a href="/wiki/Fan_filter_unit" title="Fan filter unit">fan filter units</a> installed in the ceiling grid</figcaption></figure> <figure class="mw-default-size mw-halign-right" typeof="mw:File/Thumb"><a href="/wiki/File:Cleanroom-Cabin.JPG" class="mw-file-description"><img src="//upload.wikimedia.org/wikipedia/commons/thumb/2/25/Cleanroom-Cabin.JPG/220px-Cleanroom-Cabin.JPG" decoding="async" width="220" height="190" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/2/25/Cleanroom-Cabin.JPG/330px-Cleanroom-Cabin.JPG 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/2/25/Cleanroom-Cabin.JPG/440px-Cleanroom-Cabin.JPG 2x" data-file-width="1220" data-file-height="1056" /></a><figcaption>Cleanroom cabin for precision measuring tools</figcaption></figure> <figure class="mw-default-size" typeof="mw:File/Thumb"><a href="/wiki/File:Cleanroom_Garment2.JPG" class="mw-file-description"><img src="//upload.wikimedia.org/wikipedia/commons/thumb/b/b6/Cleanroom_Garment2.JPG/220px-Cleanroom_Garment2.JPG" decoding="async" width="220" height="250" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/b/b6/Cleanroom_Garment2.JPG/330px-Cleanroom_Garment2.JPG 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/b/b6/Cleanroom_Garment2.JPG/440px-Cleanroom_Garment2.JPG 2x" data-file-width="2709" data-file-height="3074" /></a><figcaption>Typical cleanroom head garment</figcaption></figure> <p>A <b>cleanroom</b> or <b>clean room</b> is an engineered space that maintains a very low concentration of airborne <a href="/wiki/Particulates" title="Particulates">particulates</a>. It is well isolated, well controlled from <a href="/wiki/Contamination" title="Contamination">contamination</a>, and actively cleansed. Such rooms are commonly needed for scientific research and in industrial production for all nanoscale processes, such as <a href="/wiki/Semiconductor" title="Semiconductor">semiconductor</a> manufacturing. A cleanroom is designed to keep everything from dust to airborne organisms or vaporised particles away from it, and so from whatever material is being handled inside it. </p><p>A cleanroom can also prevent the escape of materials. This is often the primary aim in hazardous <a href="/wiki/Biological_engineering" title="Biological engineering">biology</a>, <a href="/wiki/Nuclear_engineering" title="Nuclear engineering">nuclear work</a>, <a href="/wiki/Pharmaceutical_industry" title="Pharmaceutical industry">pharmaceutics</a> and <a href="/wiki/Virology" title="Virology">virology</a>. </p><p>Cleanrooms typically come with a cleanliness level quantified by the number of particles per cubic meter at a predetermined molecule measure. The ambient outdoor air in a typical urban area contains 35,000,000 particles for each cubic meter in the size range 0.5 μm and bigger, equivalent to an ISO 9 certified cleanroom. By comparison, an <a href="/wiki/ISO_14644" title="ISO 14644">ISO 14644</a>-1 level 1 certified cleanroom permits no particles in that size range, and just 12 particles for each cubic meter of 0.3 μm and smaller. Semiconductor facilities often get by with level 7 or 5, while level 1 facilities are exceedingly rare. </p> <meta property="mw:PageProp/toc" /> <div class="mw-heading mw-heading2"><h2 id="History">History</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Cleanroom&action=edit&section=1" title="Edit section: History"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>The modern cleanroom was invented by American <a href="/wiki/Physicist" title="Physicist">physicist</a> <a href="/wiki/Willis_Whitfield" title="Willis Whitfield">Willis Whitfield</a>.<sup id="cite_ref-nkwes_1-0" class="reference"><a href="#cite_note-nkwes-1"><span class="cite-bracket">[</span>1<span class="cite-bracket">]</span></a></sup> As an employee of the <a href="/wiki/Sandia_National_Laboratories" title="Sandia National Laboratories">Sandia National Laboratories</a>, Whitfield created the initial plans for the cleanroom in 1960.<sup id="cite_ref-nkwes_1-1" class="reference"><a href="#cite_note-nkwes-1"><span class="cite-bracket">[</span>1<span class="cite-bracket">]</span></a></sup> Prior to Whitfield's invention, earlier cleanrooms often had problems with particles and unpredictable <a href="/wiki/Airflow" title="Airflow">airflows</a>. Whitfield designed his cleanroom with a constant, highly filtered airflow to flush out impurities.<sup id="cite_ref-nkwes_1-2" class="reference"><a href="#cite_note-nkwes-1"><span class="cite-bracket">[</span>1<span class="cite-bracket">]</span></a></sup> Within a few years of its invention in the 1960s, Whitfield's modern cleanroom had generated more than US$50 billion in sales worldwide (approximately $483 billion today).<sup id="cite_ref-kwes_2-0" class="reference"><a href="#cite_note-kwes-2"><span class="cite-bracket">[</span>2<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-3" class="reference"><a href="#cite_note-3"><span class="cite-bracket">[</span>3<span class="cite-bracket">]</span></a></sup> </p><p>By mid-1963, more than 200 U.S. industrial plants had such specially constructed facilities—then using the terminology “White Rooms,” “Clean Rooms,” or “Dust-Free Rooms”—including the Radio Corporation of America, McDonnell Aircraft, Hughes Aircraft, Sperry Rand, Sylvania Electric, Western Electric, Boeing, and North American Aviation.<sup id="cite_ref-4" class="reference"><a href="#cite_note-4"><span class="cite-bracket">[</span>4<span class="cite-bracket">]</span></a></sup> RCA began such a conversion of part of its Cambridge, Ohio facilities in February 1961. Totalling 70,000 square feet, it was used to prepare control equipment for the Minuteman ICBM missiles.<sup id="cite_ref-5" class="reference"><a href="#cite_note-5"><span class="cite-bracket">[</span>5<span class="cite-bracket">]</span></a></sup> </p><p>The majority of the integrated circuit manufacturing facilities in <a href="/wiki/Silicon_Valley" title="Silicon Valley">Silicon Valley</a> were made by three companies: MicroAire, PureAire, and Key Plastics. These competitors made laminar flow units, glove boxes, cleanrooms and <a href="/wiki/Air_shower_(room)" title="Air shower (room)">air showers</a>, along with the chemical tanks and benches used in the "wet process" building of integrated circuits. These three companies were the pioneers of the use of <a href="/wiki/Polytetrafluoroethylene" title="Polytetrafluoroethylene">Teflon</a> for airguns, chemical pumps, scrubbers, water guns, and other devices needed for the <a href="/wiki/Semiconductor_device_fabrication" title="Semiconductor device fabrication">production of integrated circuits</a>. William (Bill) C. McElroy Jr. worked as an engineering manager, drafting room supervisor, QA/QC, and designer for all three companies, and his designs added 45 original patents to the technology of the time. McElroy also wrote a four-page article for MicroContamination Journal, wet processing training manuals, and equipment manuals for wet processing and cleanrooms.<sup id="cite_ref-6" class="reference"><a href="#cite_note-6"><span class="cite-bracket">[</span>6<span class="cite-bracket">]</span></a></sup><sup class="noprint Inline-Template Template-Fact" style="white-space:nowrap;">[<i><a href="/wiki/Wikipedia:Citation_needed" title="Wikipedia:Citation needed"><span title="This claim needs references to reliable sources. (April 2024)">citation needed</span></a></i>]</sup> </p> <div class="mw-heading mw-heading2"><h2 id="Overview">Overview</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Cleanroom&action=edit&section=2" title="Edit section: Overview"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>A cleanroom is a necessity in the manufacturing of <a href="/wiki/Fabrication_(semiconductor)" class="mw-redirect" title="Fabrication (semiconductor)">semiconductors</a> and <a href="/wiki/Rechargeable_battery" title="Rechargeable battery">rechargeable batteries</a>, the <a href="/wiki/Life_sciences" class="mw-redirect" title="Life sciences">life sciences</a>, and any other field that is highly sensitive to environmental contamination. </p><p>Cleanrooms can range from the very small to the very large. On the one hand, a single-user laboratory can be built to cleanroom standards within several square meters, and on the other, entire manufacturing facilities can be contained within a cleanroom with factory floors covering thousands of square meters. Between the large and the small, there are also modular cleanrooms.<sup id="cite_ref-7" class="reference"><a href="#cite_note-7"><span class="cite-bracket">[</span>7<span class="cite-bracket">]</span></a></sup> They have been argued to lower costs of scaling the technology, and to be less susceptible to catastrophic failure. </p><p>With such a wide area of application, not every cleanroom is the same. For example, the rooms utilized in semiconductor manufacturing need not be <a href="/wiki/Sterilization_(microbiology)" title="Sterilization (microbiology)">sterile</a> (i.e., free of uncontrolled microbes),<sup id="cite_ref-8" class="reference"><a href="#cite_note-8"><span class="cite-bracket">[</span>8<span class="cite-bracket">]</span></a></sup> while the ones used in biotechnology usually must be. Vice versa, <a href="/wiki/Operating_room" class="mw-redirect" title="Operating room">operating rooms</a> need not be absolutely pure of nanoscale inorganic salts, such as <a href="/wiki/Rust" title="Rust">rust</a>, while nanotechnology absolutely requires it. What then is common to all cleanrooms is strict control of airborne <a href="/wiki/Particulates" title="Particulates">particulates</a>, possibly with <a href="/w/index.php?title=Secondary_decontamination&action=edit&redlink=1" class="new" title="Secondary decontamination (page does not exist)">secondary decontamination</a> of air, surfaces, workers entering the room, implements, chemicals, and machinery. </p><p>Sometimes particulates exiting the compartment are also of concern, such as in <a href="/wiki/Virology" title="Virology">research</a> into dangerous <a href="/wiki/Virus" title="Virus">viruses</a>, or where <a href="/wiki/Ionizing_radiation" title="Ionizing radiation">radioactive materials</a> are being handled. </p> <div class="mw-heading mw-heading2"><h2 id="Basic_construction">Basic construction</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Cleanroom&action=edit&section=3" title="Edit section: Basic construction"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>First, outside air entering a cleanroom is <a href="/wiki/Filter_(air)" class="mw-redirect" title="Filter (air)">filtered</a> and cooled by several outdoor <a href="/wiki/Air_handler" title="Air handler">air handlers</a> using progressively finer filters to exclude dust. </p><p>Within, air is constantly recirculated through fan units containing high-efficiency particulate absorbing filters (<a href="/wiki/HEPA" title="HEPA">HEPA</a>), and/or ultra-low particulate air (<a href="/wiki/ULPA" class="mw-redirect" title="ULPA">ULPA</a>) filters to remove internally generated contaminants. Special lighting fixtures, walls, equipment and other materials are used to minimize the generation of airborne particles. Plastic sheets can be used to restrict air turbulence if the cleanroom design is of the laminar airflow type.<sup id="cite_ref-9" class="reference"><a href="#cite_note-9"><span class="cite-bracket">[</span>9<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-10" class="reference"><a href="#cite_note-10"><span class="cite-bracket">[</span>10<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-11" class="reference"><a href="#cite_note-11"><span class="cite-bracket">[</span>11<span class="cite-bracket">]</span></a></sup> </p><p>Air temperature and <a href="/wiki/Humidity" title="Humidity">humidity</a> levels inside a cleanroom are tightly controlled, because they affect the efficiency and means of air filtration. If a particular room requires low enough humidity to make <a href="/wiki/Static_electricity" title="Static electricity">static electricity</a> a concern, it too will be controlled by, e.g., introducing controlled amounts of charged ions into the air using a <a href="/wiki/Corona_discharge" title="Corona discharge">corona discharge</a>. Static discharge is of particular concern in the electronics industry, where it can instantly destroy components and circuitry. </p><p>Equipment inside any cleanroom is designed to generate minimal air contamination. The selection of material for the construction of a cleanroom should not generate any particulates; hence, <a href="/w/index.php?title=Monolithic_epoxy&action=edit&redlink=1" class="new" title="Monolithic epoxy (page does not exist)">monolithic epoxy</a> or <a href="/wiki/Polyurethane" title="Polyurethane">polyurethane</a> floor coating is preferred. Buffed stainless steel or <a href="/w/index.php?title=Powder-coated_mild_steel_sandwich_partition_panels&action=edit&redlink=1" class="new" title="Powder-coated mild steel sandwich partition panels (page does not exist)">powder-coated mild steel sandwich partition panels</a> and ceiling panel are used instead of iron alloys prone to rusting and then <a href="/w/index.php?title=Flaking&action=edit&redlink=1" class="new" title="Flaking (page does not exist)">flaking</a>. Corners like the wall to wall, wall to floor, wall to ceiling are avoided by providing <a href="/w/index.php?title=Coved_surface&action=edit&redlink=1" class="new" title="Coved surface (page does not exist)">coved surface</a>, and all joints need to be sealed with <a href="/w/index.php?title=Epoxy_sealant&action=edit&redlink=1" class="new" title="Epoxy sealant (page does not exist)">epoxy sealant</a> to avoid any deposition or generation of particles at the joints, by vibration and <a href="/wiki/Friction" title="Friction">friction</a>. Many cleanrooms have a "tunnel" design in which there are spaces called "service chases" that serve as air plenums carrying the air from the bottom of the room to the top so that it can be recirculated and filtered at the top of the cleanroom.<sup id="cite_ref-12" class="reference"><a href="#cite_note-12"><span class="cite-bracket">[</span>12<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Airflow_principles">Airflow principles</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Cleanroom&action=edit&section=4" title="Edit section: Airflow principles"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <style data-mw-deduplicate="TemplateStyles:r1237032888/mw-parser-output/.tmulti">.mw-parser-output .tmulti .multiimageinner{display:flex;flex-direction:column}.mw-parser-output .tmulti .trow{display:flex;flex-direction:row;clear:left;flex-wrap:wrap;width:100%;box-sizing:border-box}.mw-parser-output .tmulti .tsingle{margin:1px;float:left}.mw-parser-output .tmulti .theader{clear:both;font-weight:bold;text-align:center;align-self:center;background-color:transparent;width:100%}.mw-parser-output .tmulti .thumbcaption{background-color:transparent}.mw-parser-output .tmulti .text-align-left{text-align:left}.mw-parser-output .tmulti .text-align-right{text-align:right}.mw-parser-output .tmulti .text-align-center{text-align:center}@media all and (max-width:720px){.mw-parser-output .tmulti .thumbinner{width:100%!important;box-sizing:border-box;max-width:none!important;align-items:center}.mw-parser-output .tmulti .trow{justify-content:center}.mw-parser-output .tmulti .tsingle{float:none!important;max-width:100%!important;box-sizing:border-box;text-align:center}.mw-parser-output .tmulti .tsingle .thumbcaption{text-align:left}.mw-parser-output .tmulti .trow>.thumbcaption{text-align:center}}@media screen{html.skin-theme-clientpref-night .mw-parser-output .tmulti .multiimageinner img{background-color:white}}@media screen and (prefers-color-scheme:dark){html.skin-theme-clientpref-os .mw-parser-output .tmulti .multiimageinner img{background-color:white}}</style><div class="thumb tmulti tnone center"><div class="thumbinner multiimageinner" style="width:408px;max-width:408px"><div class="trow"><div class="tsingle" style="width:202px;max-width:202px"><div class="thumbimage"><span typeof="mw:File"><a href="/wiki/File:Turbulenter_Reinraum.png" class="mw-file-description"><img alt="" src="//upload.wikimedia.org/wikipedia/commons/thumb/a/a6/Turbulenter_Reinraum.png/200px-Turbulenter_Reinraum.png" decoding="async" width="200" height="214" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/a/a6/Turbulenter_Reinraum.png/300px-Turbulenter_Reinraum.png 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/a/a6/Turbulenter_Reinraum.png/400px-Turbulenter_Reinraum.png 2x" data-file-width="487" data-file-height="520" /></a></span></div><div class="thumbcaption">Airflow pattern for "Turbulent Cleanroom"</div></div><div class="tsingle" style="width:202px;max-width:202px"><div class="thumbimage"><span typeof="mw:File"><a href="/wiki/File:Laminar_Flow_Reinraum.png" class="mw-file-description"><img alt="" src="//upload.wikimedia.org/wikipedia/commons/thumb/b/b2/Laminar_Flow_Reinraum.png/200px-Laminar_Flow_Reinraum.png" decoding="async" width="200" height="213" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/b/b2/Laminar_Flow_Reinraum.png/300px-Laminar_Flow_Reinraum.png 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/b/b2/Laminar_Flow_Reinraum.png/400px-Laminar_Flow_Reinraum.png 2x" data-file-width="478" data-file-height="510" /></a></span></div><div class="thumbcaption">Airflow pattern for "<a href="/wiki/Laminar_Flow" class="mw-redirect" title="Laminar Flow">Laminar Flow</a> Cleanroom"</div></div></div></div></div> <p>Cleanrooms maintain particulate-free air through the use of either <a href="/wiki/HEPA" title="HEPA">HEPA</a> or <a href="/wiki/ULPA" class="mw-redirect" title="ULPA">ULPA</a> filters employing laminar or turbulent airflow principles. Laminar, or unidirectional, airflow systems direct filtered air downward or in horizontal direction in a constant stream towards filters located on walls near the cleanroom floor or through raised perforated floor panels to be recirculated. Laminar airflow systems are typically employed across 80% of a cleanroom ceiling to maintain constant air processing. Stainless steel or other <a href="/w/index.php?title=Non_shedding_materials&action=edit&redlink=1" class="new" title="Non shedding materials (page does not exist)">non shedding materials</a> are used to construct laminar airflow filters and hoods to prevent excess particles entering the air. Turbulent, or non-unidirectional, airflow uses both laminar airflow hoods and nonspecific velocity filters to keep air in a cleanroom in constant motion, although not all in the same direction. The rough air seeks to trap particles that may be in the air and drive them towards the floor, where they enter filters and leave the cleanroom environment. US FDA and EU have laid down stringent guidelines and limits to ensure freedom from microbial contamination in pharmaceutical products.<sup id="cite_ref-13" class="reference"><a href="#cite_note-13"><span class="cite-bracket">[</span>13<span class="cite-bracket">]</span></a></sup> <a href="/wiki/Plenum_chamber" title="Plenum chamber">Plenums</a> between <a href="/wiki/Air_handler" title="Air handler">air handlers</a> and <a href="/wiki/Fan_filter_unit" title="Fan filter unit">fan filter units</a>, along with <a href="/wiki/Sticky_mat" title="Sticky mat">sticky mats</a>, may also be used. </p><p>In addition to air filters, cleanrooms can also use <a href="/wiki/Ultraviolet" title="Ultraviolet">ultraviolet light</a> to <a href="/wiki/Disinfect" class="mw-redirect" title="Disinfect">disinfect</a> the air.<sup id="cite_ref-14" class="reference"><a href="#cite_note-14"><span class="cite-bracket">[</span>14<span class="cite-bracket">]</span></a></sup> UV devices can be fitted into ceiling light fixtures and irradiate air, killing potentially <a href="/w/index.php?title=Infectious_particulates&action=edit&redlink=1" class="new" title="Infectious particulates (page does not exist)">infectious particulates</a>, including 99.99 percent of airborne microbial and fungal contaminants.<sup id="cite_ref-15" class="reference"><a href="#cite_note-15"><span class="cite-bracket">[</span>15<span class="cite-bracket">]</span></a></sup> UV light has previously been used to clean surface contaminants in sterile environments such as hospital operating rooms. Their use in other cleanrooms may increase as equipment becomes more affordable. Potential advantages of <a href="/w/index.php?title=UV-based_decontamination&action=edit&redlink=1" class="new" title="UV-based decontamination (page does not exist)">UV-based decontamination</a> includes a reduced reliance on <a href="/w/index.php?title=Chemical_disinfectants&action=edit&redlink=1" class="new" title="Chemical disinfectants (page does not exist)">chemical disinfectants</a> and the extension of HVAC filter life. </p> <div class="mw-heading mw-heading3"><h3 id="Cleanrooms_of_different_kinds">Cleanrooms of different kinds</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Cleanroom&action=edit&section=5" title="Edit section: Cleanrooms of different kinds"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Some cleanrooms are kept at a <a href="/wiki/Positive_pressure" title="Positive pressure">positive pressure</a> so if any leaks occur, air leaks out of the chamber instead of unfiltered air coming in. This is most typically the case in semiconductor manufacturing, where even minute amounts of particulates leaking in could contaminate the whole process, while anything leaking out <span class="citation-needed-content" style="padding-left:0.1em; padding-right:0.1em; color:var(--color-subtle, #54595d); border:1px solid var(--border-color-subtle, #c8ccd1);">would not be harmful to the surrounding community</span><sup class="noprint Inline-Template Template-Fact" style="margin-left:0.1em; white-space:nowrap;">[<i><a href="/wiki/Wikipedia:Citation_needed" title="Wikipedia:Citation needed"><span title="This claim needs references to reliable sources. (November 2023)">citation needed</span></a></i>]</sup>. The opposite is done, e.g., in the case of high-level bio-laboratories that handle dangerous bacteria or viruses; those are always held at <a href="/wiki/Negative_room_pressure" title="Negative room pressure">negative pressure</a>, with the exhaust being passed through high-efficiency filters, and further sterilizing procedures. Both are still cleanrooms because the particulate level inside is maintained within very low limits. </p><p>Some cleanroom <a href="/wiki/HVAC" class="mw-redirect" title="HVAC">HVAC</a> systems control the <a href="/wiki/Humidity" title="Humidity">humidity</a> to such low levels that extra equipment like <a href="/wiki/Air_ioniser" title="Air ioniser">air ionizers</a> are required to prevent <a href="/wiki/Electrostatic_discharge" title="Electrostatic discharge">electrostatic discharge</a> problems. This is a particular concern within the semiconductor business, because static discharge can easily damage modern circuit designs. On the other hand, active ions in the air can harm exposed components as well. Because of this, most workers in high electronics and semiconductor facilities have to wear <a href="/w/index.php?title=Conductive_boots&action=edit&redlink=1" class="new" title="Conductive boots (page does not exist)">conductive boots</a> while working. Low-level cleanrooms may only require special shoes, with completely smooth soles that do not track in dust or dirt. However, for safety reasons, shoe soles must not create slipping hazards. Access to a cleanroom is usually restricted to those wearing a <a href="/wiki/Cleanroom_suit" title="Cleanroom suit">cleanroom suit</a>, including the necessary machinery. </p><p>In cleanrooms in which the standards of air contamination are less rigorous, the entrance to the cleanroom may not have an air shower. An <a href="/wiki/Anteroom" class="mw-redirect" title="Anteroom">anteroom</a> (known as a "gray room") is used to put on cleanroom clothing. This practice is common in many nuclear power plants, which operate as low-grade inverse pressure cleanrooms, as a whole. </p><p><b>Recirculating vs. one pass cleanrooms</b> </p><p><a href="/w/index.php?title=Recirculating_cleanroom&action=edit&redlink=1" class="new" title="Recirculating cleanroom (page does not exist)">Recirculating cleanrooms</a> return air to the negative pressure plenum via low wall air returns. The air then is pulled by HEPA fan filter units back into the cleanroom. The air is constantly recirculating and by continuously passing through HEPA filtration removing particles from the air each time. Another advantage of this design is that air conditioning can be incorporated. </p><p><a href="/w/index.php?title=One_pass_cleanroom&action=edit&redlink=1" class="new" title="One pass cleanroom (page does not exist)">One pass cleanrooms</a> draw air from outside and pass it through HEPA fan filter units into the cleanroom. The air then leaves through exhaust grills. The advantage of this approach is the lower cost. The disadvantages are comparatively shorter HEPA fan filter life, worse particle counts than a recirculating cleanroom, and that it cannot accommodate air conditioning. </p> <div class="mw-heading mw-heading2"><h2 id="Operating_procedure">Operating procedure</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Cleanroom&action=edit&section=6" title="Edit section: Operating procedure"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>In order to minimize the carrying of particulate by a person moving into the cleanroom, staff enter and leave through <a href="/wiki/Airlock" title="Airlock">airlocks</a> (sometimes including an <a href="/wiki/Air_shower_(room)" title="Air shower (room)">air shower</a> stage) and wear protective clothing such as <a href="/wiki/Hood_(headgear)" title="Hood (headgear)">hoods</a>, face masks, gloves, boots, and <a href="/wiki/Coveralls" class="mw-redirect" title="Coveralls">coveralls</a>. </p><p>Common materials such as <a href="/wiki/Paper" title="Paper">paper</a>, <a href="/wiki/Pencil" title="Pencil">pencils</a>, and <a href="/wiki/Textile" title="Textile">fabrics</a> made from <a href="/wiki/Natural_fibers" class="mw-redirect" title="Natural fibers">natural fibers</a> are often excluded because they shed particulates in use. </p><p>Particle levels are usually tested using a <a href="/wiki/Particle_counter" title="Particle counter">particle counter</a> and microorganisms detected and counted through <span class="clarify-content" style="padding-left:0.1em; padding-right:0.1em; color:var(--color-subtle, #54595d); border:1px solid var(--border-color-subtle, #c8ccd1);">environmental monitoring methods</span><sup class="noprint Inline-Template Template-Clarify" style="margin-left:0.1em; white-space:nowrap;">[<i><a href="/wiki/Wikipedia:Please_clarify" title="Wikipedia:Please clarify"><span title="This passage needs to be better explained. (November 2023)">clarify</span></a></i>]</sup>.<sup id="cite_ref-16" class="reference"><a href="#cite_note-16"><span class="cite-bracket">[</span>16<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-Sandle,_T_392–403_17-0" class="reference"><a href="#cite_note-Sandle,_T_392–403-17"><span class="cite-bracket">[</span>17<span class="cite-bracket">]</span></a></sup> <a href="/wiki/Polymer" title="Polymer">Polymer</a> tools used in cleanrooms must be carefully determined to be <a href="/wiki/Chemical_compatibility" class="mw-redirect" title="Chemical compatibility">chemically compatible</a> with cleanroom processing fluids <sup id="cite_ref-18" class="reference"><a href="#cite_note-18"><span class="cite-bracket">[</span>18<span class="cite-bracket">]</span></a></sup> as well as ensured to generate a low level of particle generation.<sup id="cite_ref-19" class="reference"><a href="#cite_note-19"><span class="cite-bracket">[</span>19<span class="cite-bracket">]</span></a></sup> </p><p>When cleaning, only special <a href="/wiki/Mop" title="Mop">mops</a> and <a href="/wiki/Bucket" title="Bucket">buckets</a> are used. Cleaning chemicals used tend to involve sticky elements to trap dust, and may need a second step with <a href="/w/index.php?title=Light_molecular_weight_solvents&action=edit&redlink=1" class="new" title="Light molecular weight solvents (page does not exist)">light molecular weight solvents</a> to clear. Cleanroom furniture is designed to produce a minimum of particles and is easy to clean. </p><p>A cleanroom is as much a process and a meticulous culture to maintain, as it is a space as such. </p> <div class="mw-heading mw-heading3"><h3 id="Personnel_contamination_of_cleanrooms">Personnel contamination of cleanrooms</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Cleanroom&action=edit&section=7" title="Edit section: Personnel contamination of cleanrooms"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <table class="centered"> </table> <p>The greatest threat to cleanroom contamination comes from the users themselves.<sup id="cite_ref-20" class="reference"><a href="#cite_note-20"><span class="cite-bracket">[</span>20<span class="cite-bracket">]</span></a></sup> In the healthcare and pharmaceutical sectors, control of microorganisms is important, especially microorganisms likely to be deposited into the air stream from <a href="/w/index.php?title=Skin_shedding&action=edit&redlink=1" class="new" title="Skin shedding (page does not exist)">skin shedding</a>. Studying cleanroom <a href="/wiki/Microflora" class="mw-redirect" title="Microflora">microflora</a> is of importance for microbiologists and quality control personnel to assess changes in trends. Shifts in the types of microflora may indicate deviations from the "norm" such as <a href="/w/index.php?title=Resistant_strains&action=edit&redlink=1" class="new" title="Resistant strains (page does not exist)">resistant strains</a> or problems with cleaning practices. </p><p>In assessing cleanroom microorganisms, the typical flora are primarily those associated with human skin (<a href="/wiki/Gram-positive_cocci" class="mw-redirect" title="Gram-positive cocci">Gram-positive cocci</a>), although microorganisms from other sources such as the environment (<a href="/wiki/Gram-positive_rods" class="mw-redirect" title="Gram-positive rods">Gram-positive rods</a>) and water (<a href="/w/index.php?title=Gram-negative_rods&action=edit&redlink=1" class="new" title="Gram-negative rods (page does not exist)">Gram-negative rods</a>) are also detected, although in lower number. Common bacterial genera include <i><a href="/wiki/Micrococcus" title="Micrococcus">Micrococcus</a></i>, <i><a href="/wiki/Staphylococcus" title="Staphylococcus">Staphylococcus</a></i>, <i><a href="/wiki/Corynebacterium" title="Corynebacterium">Corynebacterium</a></i>, and <i><a href="/wiki/Bacillus" title="Bacillus">Bacillus</a></i>, and fungal genera include <i><a href="/wiki/Aspergillus" title="Aspergillus">Aspergillus</a></i> and <i><a href="/wiki/Penicillium" title="Penicillium">Penicillium</a></i>.<sup id="cite_ref-Sandle,_T_392–403_17-1" class="reference"><a href="#cite_note-Sandle,_T_392–403-17"><span class="cite-bracket">[</span>17<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="Cleanroom_classification_and_standardization">Cleanroom classification and standardization</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Cleanroom&action=edit&section=8" title="Edit section: Cleanroom classification and standardization"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <figure typeof="mw:File/Thumb"><a href="/wiki/File:ISS_space_station_modules_in_the_SSPF.jpg" class="mw-file-description"><img src="//upload.wikimedia.org/wikipedia/commons/thumb/9/92/ISS_space_station_modules_in_the_SSPF.jpg/300px-ISS_space_station_modules_in_the_SSPF.jpg" decoding="async" width="300" height="200" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/9/92/ISS_space_station_modules_in_the_SSPF.jpg/450px-ISS_space_station_modules_in_the_SSPF.jpg 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/9/92/ISS_space_station_modules_in_the_SSPF.jpg/600px-ISS_space_station_modules_in_the_SSPF.jpg 2x" data-file-width="3000" data-file-height="1995" /></a><figcaption>The cleanroom processing bay of the <a href="/wiki/Kennedy_Space_Center" title="Kennedy Space Center">KSC</a> <a href="/wiki/Space_Station_Processing_Facility" class="mw-redirect" title="Space Station Processing Facility">Space Station Processing Facility</a>. NASA maintains a standard of 100,000 class in the SSPF.<sup id="cite_ref-21" class="reference"><a href="#cite_note-21"><span class="cite-bracket">[</span>21<span class="cite-bracket">]</span></a></sup></figcaption></figure> <p>Cleanrooms are classified according to the number and size of particles permitted per volume of air. Large numbers like "class 100" or "class 1000" refer to <a href="/wiki/FED-STD-209E" title="FED-STD-209E">FED-STD-209E</a>, and denote the number of particles of size 0.5 μm or larger permitted per cubic foot of air. The standard also allows interpolation; for example <a href="/wiki/SNOLAB" title="SNOLAB">SNOLAB</a> is maintained as a class 2000 cleanroom. </p><p>A discrete, light-scattering airborne particle counter is used to determine the concentration of airborne particles, equal to and larger than the specified sizes, at designated sampling locations. </p><p>Small numbers refer to <a href="/wiki/ISO_14644" title="ISO 14644">ISO 14644-1</a> standards, which specify the decimal <a href="/wiki/Logarithm" title="Logarithm">logarithm</a> of the number of particles 0.1 μm or larger permitted per m<sup>3</sup> of air. So, for example, an ISO class 5 cleanroom has at most 10<sup>5</sup> particles/m<sup>3</sup>. </p><p>Both FS 209E and ISO 14644-1 assume log-log relationships between particle size and particle concentration. For that reason, zero particle concentration does not exist. Some classes do not require testing some particle sizes, because the concentration is too low or too high to be practical to test for, but such blanks should not be read as zero. </p><p>Because 1 m<sup>3</sup> is about 35 ft<sup>3</sup>, the two standards are mostly equivalent when measuring 0.5 μm particles, although the testing standards differ. Ordinary room air is around class 1,000,000 or ISO 9.<sup id="cite_ref-22" class="reference"><a href="#cite_note-22"><span class="cite-bracket">[</span>22<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="ISO_14644-1_and_ISO_14698">ISO 14644-1 and ISO 14698</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Cleanroom&action=edit&section=9" title="Edit section: ISO 14644-1 and ISO 14698"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p><a href="/wiki/ISO_14644" title="ISO 14644">ISO 14644-1</a> and <a href="/wiki/ISO_14698" title="ISO 14698">ISO 14698</a> are <a href="/wiki/Non-governmental_organization" title="Non-governmental organization">non-governmental</a> standards developed by the <a href="/wiki/International_Organization_for_Standardization" title="International Organization for Standardization">International Organization for Standardization</a> (ISO).<sup id="cite_ref-23" class="reference"><a href="#cite_note-23"><span class="cite-bracket">[</span>23<span class="cite-bracket">]</span></a></sup> The former applies to cleanrooms in general (see table below), the latter to cleanrooms where <a href="/wiki/Contamination" title="Contamination">biocontamination</a> may be an issue. Since the strictest standards have been achieved only for space applications, it is sometimes difficult to know whether they were achieved in vacuum or standard conditions. </p><p><a href="/wiki/ISO_14644" title="ISO 14644">ISO 14644-1</a> defines the maximum concentration of particles per class and per particle size with the following formula<sup id="cite_ref-Whyte2001_24-0" class="reference"><a href="#cite_note-Whyte2001-24"><span class="cite-bracket">[</span>24<span class="cite-bracket">]</span></a></sup> </p><p><span class="mwe-math-element"><span class="mwe-math-mathml-inline mwe-math-mathml-a11y" style="display: none;"><math xmlns="http://www.w3.org/1998/Math/MathML" alttext="{\displaystyle {\text{C}}_{\text{N}}=10^{\text{N}}\left({\frac {0.1}{\text{D}}}\right)^{2.08}}"> <semantics> <mrow class="MJX-TeXAtom-ORD"> <mstyle displaystyle="true" scriptlevel="0"> <msub> <mrow class="MJX-TeXAtom-ORD"> <mtext>C</mtext> </mrow> <mrow class="MJX-TeXAtom-ORD"> <mtext>N</mtext> </mrow> </msub> <mo>=</mo> <msup> <mn>10</mn> <mrow class="MJX-TeXAtom-ORD"> <mtext>N</mtext> </mrow> </msup> <msup> <mrow> <mo>(</mo> <mrow class="MJX-TeXAtom-ORD"> <mfrac> <mn>0.1</mn> <mtext>D</mtext> </mfrac> </mrow> <mo>)</mo> </mrow> <mrow class="MJX-TeXAtom-ORD"> <mn>2.08</mn> </mrow> </msup> </mstyle> </mrow> <annotation encoding="application/x-tex">{\displaystyle {\text{C}}_{\text{N}}=10^{\text{N}}\left({\frac {0.1}{\text{D}}}\right)^{2.08}}</annotation> </semantics> </math></span><img src="https://wikimedia.org/api/rest_v1/media/math/render/svg/86ee70101171b7a24ca1d1db5cc85b85fa105784" class="mwe-math-fallback-image-inline mw-invert skin-invert" aria-hidden="true" style="vertical-align: -2.505ex; width:20.416ex; height:6.509ex;" alt="{\displaystyle {\text{C}}_{\text{N}}=10^{\text{N}}\left({\frac {0.1}{\text{D}}}\right)^{2.08}}"></span> </p><p>Where <span class="mwe-math-element"><span class="mwe-math-mathml-inline mwe-math-mathml-a11y" style="display: none;"><math xmlns="http://www.w3.org/1998/Math/MathML" alttext="{\displaystyle {\text{C}}_{\text{N}}}"> <semantics> <mrow class="MJX-TeXAtom-ORD"> <mstyle displaystyle="true" scriptlevel="0"> <msub> <mrow class="MJX-TeXAtom-ORD"> <mtext>C</mtext> </mrow> <mrow class="MJX-TeXAtom-ORD"> <mtext>N</mtext> </mrow> </msub> </mstyle> </mrow> <annotation encoding="application/x-tex">{\displaystyle {\text{C}}_{\text{N}}}</annotation> </semantics> </math></span><img src="https://wikimedia.org/api/rest_v1/media/math/render/svg/fa9b80782d230d1870ca8ddcc16ffb29f29a3690" class="mwe-math-fallback-image-inline mw-invert skin-invert" aria-hidden="true" style="vertical-align: -0.671ex; width:3.143ex; height:2.509ex;" alt="{\displaystyle {\text{C}}_{\text{N}}}"></span> is the maximum concentration of particles in a volume of 1m<span class="mwe-math-element"><span class="mwe-math-mathml-inline mwe-math-mathml-a11y" style="display: none;"><math xmlns="http://www.w3.org/1998/Math/MathML" alttext="{\displaystyle ^{3}}"> <semantics> <mrow class="MJX-TeXAtom-ORD"> <mstyle displaystyle="true" scriptlevel="0"> <msup> <mi></mi> <mrow class="MJX-TeXAtom-ORD"> <mn>3</mn> </mrow> </msup> </mstyle> </mrow> <annotation encoding="application/x-tex">{\displaystyle ^{3}}</annotation> </semantics> </math></span><img src="https://wikimedia.org/api/rest_v1/media/math/render/svg/73c05e3410279c99fc3d8b9fcdaa15b71a98772a" class="mwe-math-fallback-image-inline mw-invert skin-invert" aria-hidden="true" style="vertical-align: -0.171ex; width:1.054ex; height:2.509ex;" alt="{\displaystyle ^{3}}"></span> of airborne particles that are equal to, or larger, than the considered particle size which is rounded to the nearest whole number, using no more than three significant figures, <span class="mwe-math-element"><span class="mwe-math-mathml-inline mwe-math-mathml-a11y" style="display: none;"><math xmlns="http://www.w3.org/1998/Math/MathML" alttext="{\displaystyle {\text{N}}}"> <semantics> <mrow class="MJX-TeXAtom-ORD"> <mstyle displaystyle="true" scriptlevel="0"> <mrow class="MJX-TeXAtom-ORD"> <mtext>N</mtext> </mrow> </mstyle> </mrow> <annotation encoding="application/x-tex">{\displaystyle {\text{N}}}</annotation> </semantics> </math></span><img src="https://wikimedia.org/api/rest_v1/media/math/render/svg/ecb64aa46d7a3fd6c0a087e157506d8ec218d202" class="mwe-math-fallback-image-inline mw-invert skin-invert" aria-hidden="true" style="vertical-align: -0.338ex; width:1.743ex; height:2.176ex;" alt="{\displaystyle {\text{N}}}"></span> is the ISO class number, <span class="mwe-math-element"><span class="mwe-math-mathml-inline mwe-math-mathml-a11y" style="display: none;"><math xmlns="http://www.w3.org/1998/Math/MathML" alttext="{\displaystyle {\text{D}}}"> <semantics> <mrow class="MJX-TeXAtom-ORD"> <mstyle displaystyle="true" scriptlevel="0"> <mrow class="MJX-TeXAtom-ORD"> <mtext>D</mtext> </mrow> </mstyle> </mrow> <annotation encoding="application/x-tex">{\displaystyle {\text{D}}}</annotation> </semantics> </math></span><img src="https://wikimedia.org/api/rest_v1/media/math/render/svg/4aed11739b57eeb07a4dd1a7e1925369dcd9df99" class="mwe-math-fallback-image-inline mw-invert skin-invert" aria-hidden="true" style="vertical-align: -0.338ex; width:1.776ex; height:2.176ex;" alt="{\displaystyle {\text{D}}}"></span> is the size of the particle in <span class="mwe-math-element"><span class="mwe-math-mathml-inline mwe-math-mathml-a11y" style="display: none;"><math xmlns="http://www.w3.org/1998/Math/MathML" alttext="{\displaystyle \mu }"> <semantics> <mrow class="MJX-TeXAtom-ORD"> <mstyle displaystyle="true" scriptlevel="0"> <mi>μ</mi> </mstyle> </mrow> <annotation encoding="application/x-tex">{\displaystyle \mu }</annotation> </semantics> </math></span><img src="https://wikimedia.org/api/rest_v1/media/math/render/svg/9fd47b2a39f7a7856952afec1f1db72c67af6161" class="mwe-math-fallback-image-inline mw-invert skin-invert" aria-hidden="true" style="vertical-align: -0.838ex; width:1.402ex; height:2.176ex;" alt="{\displaystyle \mu }"></span>m and 0.1 is a constant expressed in <span class="mwe-math-element"><span class="mwe-math-mathml-inline mwe-math-mathml-a11y" style="display: none;"><math xmlns="http://www.w3.org/1998/Math/MathML" alttext="{\displaystyle \mu }"> <semantics> <mrow class="MJX-TeXAtom-ORD"> <mstyle displaystyle="true" scriptlevel="0"> <mi>μ</mi> </mstyle> </mrow> <annotation encoding="application/x-tex">{\displaystyle \mu }</annotation> </semantics> </math></span><img src="https://wikimedia.org/api/rest_v1/media/math/render/svg/9fd47b2a39f7a7856952afec1f1db72c67af6161" class="mwe-math-fallback-image-inline mw-invert skin-invert" aria-hidden="true" style="vertical-align: -0.838ex; width:1.402ex; height:2.176ex;" alt="{\displaystyle \mu }"></span>m. The result for standard particle sizes is expressed in the following table. </p> <table class="wikitable"> <tbody><tr> <th rowspan="2">Class </th> <th colspan="6" align="center">Maximum particles/m<sup>3 a</sup> </th> <th rowspan="2">FED STD 209E equivalent </th></tr> <tr> <th>≥0.1 μm </th> <th>≥0.2 μm </th> <th>≥0.3 μm </th> <th>≥0.5 μm </th> <th>≥1 μm </th> <th>≥5 μm </th></tr> <tr> <th>ISO 1 </th> <td align="right">10<sup>b</sup> </td> <td align="right"><sup>d</sup> </td> <td align="right"><sup>d</sup> </td> <td align="right"><sup>d</sup> </td> <td align="right"><sup>d</sup> </td> <td align="right"><sup>e</sup> </td> <td> </td></tr> <tr> <th>ISO 2 </th> <td align="right">100 </td> <td align="right">24<sup>b</sup> </td> <td align="right">10<sup>b</sup> </td> <td align="right"><sup>d</sup> </td> <td align="right"><sup>d</sup> </td> <td align="right"><sup>e</sup> </td> <td> </td></tr> <tr> <th>ISO 3 </th> <td align="right">1,000 </td> <td align="right">237 </td> <td align="right">102 </td> <td align="right">35<sup>b</sup> </td> <td align="right"><sup>d</sup> </td> <td align="right"><sup>e</sup> </td> <td align="center">Class 1 </td></tr> <tr> <th>ISO 4 </th> <td align="right">10,000 </td> <td align="right">2,370 </td> <td align="right">1,020 </td> <td align="right">352 </td> <td align="right">83<sup>b</sup> </td> <td align="right"><sup>e</sup> </td> <td align="center">Class 10 </td></tr> <tr> <th>ISO 5 </th> <td align="right">100,000 </td> <td align="right">23,700 </td> <td align="right">10,200 </td> <td align="right">3,520 </td> <td align="right">832 </td> <td align="right"><sup>d,e,f</sup> </td> <td align="center">Class 100 </td></tr> <tr> <th>ISO 6 </th> <td align="right">1,000,000 </td> <td align="right">237,000 </td> <td align="right">102,000 </td> <td align="right">35,200 </td> <td align="right">8,320 </td> <td align="right">293 </td> <td align="center">Class 1,000 </td></tr> <tr> <th>ISO 7 </th> <td align="right"><sup>c</sup> </td> <td align="right"><sup>c</sup> </td> <td align="right"><sup>c</sup> </td> <td align="right">352,000 </td> <td align="right">83,200 </td> <td align="right">2,930 </td> <td align="center">Class 10,000 </td></tr> <tr> <th>ISO 8 </th> <td align="right"><sup>c</sup> </td> <td align="right"><sup>c</sup> </td> <td align="right"><sup>c</sup> </td> <td align="right">3,520,000 </td> <td align="right">832,000 </td> <td align="right">29,300 </td> <td align="center">Class 100,000 </td></tr> <tr> <th>ISO 9 </th> <td align="right"><sup>c</sup> </td> <td align="right"><sup>c</sup> </td> <td align="right"><sup>c</sup> </td> <td align="right">35,200,000 </td> <td align="right">8,320,000 </td> <td align="right">293,000 </td> <td align="center">Room air </td></tr> <tr> <td colspan="8"><div style="font-size:85%;"><sup>a</sup> All concentrations in the table are cumulative, e.g. for ISO Class 5, the 10 200 particles shown at 0,3 μm include all particles equal to and greater than this size.<br /> <p><sup>b</sup> These concentrations will lead to large air sample volumes for classification. Sequential sampling procedure may be applied; see Annex D.<br /> <sup>c</sup> Concentration limits are not applicable in this region of the table due to very high particle concentration.<br /> <sup>d</sup> Sampling and statistical limitations for particles in low concentrations make classification inappropriate.<br /> <sup>e</sup> Sample collection limitations for both particles in low concentrations and sizes greater than 1 μm make classification at this particle size inappropriate due to potential particle losses in the sampling system.<br /> </p> <sup>f</sup> In order to specify this particle size in association with ISO Class 5, the macroparticle descriptor M may be adapted and used in conjunction with at least one other particle size. (See C.7.)</div> </td></tr></tbody></table> <div class="mw-heading mw-heading3"><h3 id="US_FED_STD_209E">US FED STD 209E</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Cleanroom&action=edit&section=10" title="Edit section: US FED STD 209E"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>US <a href="/wiki/FED-STD-209E" title="FED-STD-209E">FED-STD-209E</a> was a <a href="/wiki/United_States" title="United States">United States</a> <a href="/wiki/Federal_government_of_the_United_States" title="Federal government of the United States">federal</a> standard. It was officially cancelled by the <a href="/wiki/General_Services_Administration" title="General Services Administration">General Services Administration</a> on November 29, 2001,<sup id="cite_ref-25" class="reference"><a href="#cite_note-25"><span class="cite-bracket">[</span>25<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-26" class="reference"><a href="#cite_note-26"><span class="cite-bracket">[</span>26<span class="cite-bracket">]</span></a></sup> but is still widely used.<sup id="cite_ref-27" class="reference"><a href="#cite_note-27"><span class="cite-bracket">[</span>27<span class="cite-bracket">]</span></a></sup> </p> <table class="wikitable"> <tbody><tr> <th rowspan="2">Class </th> <th colspan="5" align="center">Maximum particles/ft<sup>3</sup> </th> <th rowspan="2">ISO<br />equivalent </th></tr> <tr> <th>≥0.1 μm </th> <th>≥0.2 μm </th> <th>≥0.3 μm </th> <th>≥0.5 μm </th> <th>≥5 μm </th></tr> <tr> <th>1 </th> <td align="right">35 </td> <td align="right">7.5 </td> <td align="right">3 </td> <td align="right">1 </td> <td align="right">0.007 </td> <td align="center">ISO 3 </td></tr> <tr> <th>10 </th> <td align="right">350 </td> <td align="right">75 </td> <td align="right">30 </td> <td align="right">10 </td> <td align="right">0.07 </td> <td align="center">ISO 4 </td></tr> <tr> <th>100 </th> <td align="right">3,500 </td> <td align="right">750 </td> <td align="right">300 </td> <td align="right">100 </td> <td align="right">0.7 </td> <td align="center">ISO 5 </td></tr> <tr> <th>1,000 </th> <td align="right">35,000 </td> <td align="right">7,500 </td> <td align="right">3000 </td> <td align="right">1,000 </td> <td align="right">7 </td> <td align="center">ISO 6 </td></tr> <tr> <th>10,000 </th> <td align="right">350,000 </td> <td align="right">75,000 </td> <td align="right">30,000 </td> <td align="right">10,000 </td> <td align="right">70 </td> <td align="center">ISO 7 </td></tr> <tr> <th>100,000 </th> <td align="right"><span class="nowrap"><span data-sort-value="7006350000000000000♠"></span>3.5<span style="margin-left:0.25em;margin-right:0.15em;">×</span>10<sup>6</sup></span> </td> <td align="right">750,000 </td> <td align="right">300,000 </td> <td align="right">100,000 </td> <td align="right">830 </td> <td align="center">ISO 8 </td></tr></tbody></table> <p>Current regulating bodies include ISO, USP 800, US FED STD 209E (previous standard, still used). </p> <ul><li>Drug Quality and Security Act (DQSA) created in Nov. 2013 in response to drug compounding deaths and serious adverse events.</li> <li>The Federal Food, Drug, and Cosmetic Act (FD&C Act) created specific guidelines and policies for human compounding. <ul><li>503A addresses compounding by state or federally licensed facility by licensed personnel (pharmacist/ physicians)</li> <li>503B pertaining to outsourcing facilities need direct supervision from a licensed pharmacist and do not need to be a licensed pharmacy. Facility is licensed through the Food and Drug Administration (FDA) <sup id="cite_ref-28" class="reference"><a href="#cite_note-28"><span class="cite-bracket">[</span>28<span class="cite-bracket">]</span></a></sup></li></ul></li></ul> <div class="mw-heading mw-heading3"><h3 id="EU_GMP_classification">EU GMP classification</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Cleanroom&action=edit&section=11" title="Edit section: EU GMP classification"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>EU GMP guidelines are more stringent than others, requiring cleanrooms to meet particle counts at operation (during manufacturing process) and at rest (when manufacturing process is not carried out, but room <a href="/wiki/Air_handler" title="Air handler">AHU</a> is on). </p> <table class="wikitable"> <tbody><tr> <th rowspan="3">Class </th> <th colspan="4" align="center">Maximum particles/m<sup>3</sup><sup id="cite_ref-29" class="reference"><a href="#cite_note-29"><span class="cite-bracket">[</span>29<span class="cite-bracket">]</span></a></sup> </th></tr> <tr> <th colspan="2">At Rest </th> <th colspan="2">In Operation </th></tr> <tr> <th>0.5 μm </th> <th>5.0 μm </th> <th>0.5 μm </th> <th>5.0 μm </th></tr> <tr> <th>Grade A </th> <td>3,520 </td> <td>20 </td> <td>3,520 </td> <td>20 </td></tr> <tr> <th>Grade B </th> <td>3,520 </td> <td>29 </td> <td>352,000 </td> <td>2,900 </td></tr> <tr> <th>Grade C </th> <td>352,000 </td> <td>2,900 </td> <td>3,520,000 </td> <td>29,000 </td></tr> <tr> <th>Grade D </th> <td>3,520,000 </td> <td>29,000 </td> <td>Not defined </td> <td>Not defined </td></tr></tbody></table> <div class="mw-heading mw-heading3"><h3 id="BS_5295">BS 5295</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Cleanroom&action=edit&section=12" title="Edit section: BS 5295"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>BS 5295 is a <a href="/wiki/British_Standard" class="mw-redirect" title="British Standard">British Standard</a>. </p> <table class="wikitable"> <tbody><tr> <th rowspan="2">Class </th> <th colspan="6" align="center">Maximum particles/m<sup>3</sup> </th></tr> <tr> <th>≥0.5 μm </th> <th>≥1 μm </th> <th>≥5 μm </th> <th>≥10 μm </th> <th>≥25 μm </th></tr> <tr> <th>Class 1 </th> <td align="right">3,000 </td> <td align="right">  </td> <td align="right">0 </td> <td align="right">0 </td> <td align="right">0 </td></tr> <tr> <th>Class 2 </th> <td align="right">300,000 </td> <td align="right">  </td> <td align="right">2,000 </td> <td align="right">30 </td> <td align="right">  </td></tr> <tr> <th>Class 3 </th> <td align="right">  </td> <td align="right">1,000,000 </td> <td align="right">20,000 </td> <td align="right">4,000 </td> <td align="right">300 </td></tr> <tr> <th>Class 4 </th> <td align="right">  </td> <td align="right">  </td> <td align="right">200,000 </td> <td align="right">40,000 </td> <td align="right">4,000 </td></tr> </tbody></table> <p>BS 5295 Class 1 also requires that the greatest particle present in any sample can not exceed 5 μm.<sup id="cite_ref-30" class="reference"><a href="#cite_note-30"><span class="cite-bracket">[</span>30<span class="cite-bracket">]</span></a></sup> BS 5295 has been superseded, withdrawn since the year 2007 and replaced with "BS EN ISO 14644-6:2007".<sup id="cite_ref-31" class="reference"><a href="#cite_note-31"><span class="cite-bracket">[</span>31<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="USP_<800>_standards"><span id="USP_.3C800.3E_standards"></span>USP <800> standards</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Cleanroom&action=edit&section=13" title="Edit section: USP <800> standards"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>USP 800 is a United States standard developed by the United States Pharmacopeial Convention (USP) with an effective date of December 1, 2019.<sup id="cite_ref-32" class="reference"><a href="#cite_note-32"><span class="cite-bracket">[</span>32<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="Ramifications_and_further_applications">Ramifications and further applications</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Cleanroom&action=edit&section=14" title="Edit section: Ramifications and further applications"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>In <a href="/wiki/Hospital" title="Hospital">hospitals</a>, <a href="/wiki/Operating_theater" title="Operating theater">theatres</a> are similar to cleanrooms for surgical patients' operations with <a href="/wiki/Surgical_incision" title="Surgical incision">incisions</a> to prevent any infections for the patient. </p><p>In another case, severely <a href="/wiki/Immunocompromised" class="mw-redirect" title="Immunocompromised">immunocompromised</a> patients sometimes have to be held in prolonged isolation from their surroundings, for fear of infection. At the extreme, this necessitates a cleanroom environment. The same is the case for patients carrying airborne infectious diseases, only they are handled at negative, not positive pressure. </p><p>In <a href="/wiki/Exobiology" class="mw-redirect" title="Exobiology">exobiology</a> when we seek out contact with other planets, there is a biological hazard both ways: we must not contaminate any sample return missions from other stellar bodies with terrestrial microbes, and we must not contaminate possible other ecosystems existing in other planets. Thus, even by international law, any probes we send to <a href="/wiki/Outer_space" title="Outer space">outer space</a> must be sterile, and so to be handled in cleanroom conditions.<sup class="noprint Inline-Template Template-Fact" style="white-space:nowrap;">[<i><a href="/wiki/Wikipedia:Citation_needed" title="Wikipedia:Citation needed"><span title="This claim needs references to reliable sources. (August 2023)">citation needed</span></a></i>]</sup> </p><p>Since larger cleanrooms are very sensitive controlled environments upon which multibillion-dollar industries depend, sometimes they are even fitted with numerous <a href="/wiki/Seismic_base_isolation" title="Seismic base isolation">seismic base isolation</a> systems to prevent costly equipment malfunction.<sup id="cite_ref-33" class="reference"><a href="#cite_note-33"><span class="cite-bracket">[</span>33<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="See_also">See also</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Cleanroom&action=edit&section=15" title="Edit section: See also"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <style data-mw-deduplicate="TemplateStyles:r1259569809">.mw-parser-output .portalbox{padding:0;margin:0.5em 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class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Cleanroom&action=edit&section=16" title="Edit section: References"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <style data-mw-deduplicate="TemplateStyles:r1239543626">.mw-parser-output .reflist{margin-bottom:0.5em;list-style-type:decimal}@media screen{.mw-parser-output .reflist{font-size:90%}}.mw-parser-output .reflist .references{font-size:100%;margin-bottom:0;list-style-type:inherit}.mw-parser-output .reflist-columns-2{column-width:30em}.mw-parser-output .reflist-columns-3{column-width:25em}.mw-parser-output .reflist-columns{margin-top:0.3em}.mw-parser-output .reflist-columns ol{margin-top:0}.mw-parser-output .reflist-columns li{page-break-inside:avoid;break-inside:avoid-column}.mw-parser-output .reflist-upper-alpha{list-style-type:upper-alpha}.mw-parser-output .reflist-upper-roman{list-style-type:upper-roman}.mw-parser-output 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.id-lock-limited.id-lock-limited a,.mw-parser-output .id-lock-registration.id-lock-registration a{background:url("//upload.wikimedia.org/wikipedia/commons/d/d6/Lock-gray-alt-2.svg")right 0.1em center/9px no-repeat}.mw-parser-output .id-lock-subscription.id-lock-subscription a{background:url("//upload.wikimedia.org/wikipedia/commons/a/aa/Lock-red-alt-2.svg")right 0.1em center/9px no-repeat}.mw-parser-output .cs1-ws-icon a{background:url("//upload.wikimedia.org/wikipedia/commons/4/4c/Wikisource-logo.svg")right 0.1em center/12px no-repeat}body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-free a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-limited a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-registration a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-subscription a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .cs1-ws-icon a{background-size:contain;padding:0 1em 0 0}.mw-parser-output .cs1-code{color:inherit;background:inherit;border:none;padding:inherit}.mw-parser-output .cs1-hidden-error{display:none;color:var(--color-error,#d33)}.mw-parser-output .cs1-visible-error{color:var(--color-error,#d33)}.mw-parser-output .cs1-maint{display:none;color:#085;margin-left:0.3em}.mw-parser-output .cs1-kern-left{padding-left:0.2em}.mw-parser-output .cs1-kern-right{padding-right:0.2em}.mw-parser-output .citation .mw-selflink{font-weight:inherit}@media screen{.mw-parser-output .cs1-format{font-size:95%}html.skin-theme-clientpref-night .mw-parser-output .cs1-maint{color:#18911f}}@media screen and (prefers-color-scheme:dark){html.skin-theme-clientpref-os .mw-parser-output .cs1-maint{color:#18911f}}</style><cite id="CITEREFYardley2012" class="citation news cs1">Yardley, William (2012-12-04). <a rel="nofollow" class="external text" href="https://www.nytimes.com/2012/12/05/business/willis-whitfield-clean-room-inventor-dies-at-92.html">"Willis Whitfield, Clean Room 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