{"id":2839,"date":"2015-04-15T10:48:04","date_gmt":"2015-04-15T17:48:04","guid":{"rendered":"https:\/\/americancleanrooms.jzlsq0-liquidwebsites.com\/?page_id=2839"},"modified":"2026-05-26T12:32:32","modified_gmt":"2026-05-26T19:32:32","slug":"cleanroom-testing-and-certification","status":"publish","type":"page","link":"https:\/\/www.americancleanrooms.com\/es\/cleanroom-testing-and-certification\/","title":{"rendered":"Cleanroom Testing and Certification"},"content":{"rendered":"

Cleanrooms are designed to control airborne particulate and environmental conditions. Certification testing is to show they meet the US FED STD 209E or ISO 14644-1 cleanroom standards<\/p>\r\n\r\n\r\n\r\n

\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n
Clase<\/td>\r\nUS FED STD 209E
Maximum\u00a0 Particles\/ft\u00b3<\/td>\r\n		ISO Equivalente<\/td>\r\n<\/tr>\r\n
><\/span>0.1 um<\/td>\r\n><\/span>0.2 um<\/td>\r\n><\/span>0.3 um<\/td>\r\n><\/span>0.5 um<\/td>\r\n><\/span>5 um<\/td>\r\n<\/tr>\r\n
\u00a01<\/td>\r\n35<\/td>\r\n7<\/td>\r\n3<\/td>\r\n1<\/td>\r\n\u00a0<\/td>\r\nISO3<\/td>\r\n<\/tr>\r\n
\u00a010<\/td>\r\n350<\/td>\r\n75<\/td>\r\n30<\/td>\r\n10<\/td>\r\n\u00a0<\/td>\r\nISO4<\/td>\r\n<\/tr>\r\n
100<\/td>\r\n\u00a0<\/td>\r\n\u00a0<\/td>\r\n\u00a0<\/td>\r\n100<\/td>\r\n\u00a0<\/td>\r\nISO5<\/td>\r\n<\/tr>\r\n
1000<\/td>\r\n\u00a0<\/td>\r\n\u00a0<\/td>\r\n\u00a0<\/td>\r\n1000<\/td>\r\n7<\/td>\r\nISO6<\/td>\r\n<\/tr>\r\n
10,000<\/a><\/td>\r\n\u00a0<\/td>\r\n\u00a0<\/td>\r\n\u00a0<\/td>\r\n10,000<\/td>\r\n70<\/td>\r\nISO7<\/td>\r\n<\/tr>\r\n
100,000<\/td>\r\n\u00a0<\/td>\r\n\u00a0<\/td>\r\n\u00a0<\/td>\r\n100,000<\/td>\r\n700<\/td>\r\nISO8<\/td>\r\n<\/tr>\r\n<\/tbody>\r\n<\/table>\r\n<\/figure>\r\n\r\n\r\n\r\n

ISO 14644-1 Est\u00e1ndares para Cuartos Limpios<\/h2>\r\n\r\n\r\n\r\n
\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n
Clase<\/td>\r\nMaximum\u00a0 Particles\/m\u00b3<\/td>\r\nISO Equivalente<\/td>\r\n<\/tr>\r\n
><\/span>0.1 um<\/td>\r\n><\/span>0.2 um<\/td>\r\n><\/span>0.3 um<\/td>\r\n><\/span>0.5 um<\/td>\r\n><\/span>1 um<\/td>\r\n><\/span>5 um<\/td>\r\n<\/tr>\r\n
ISO 1<\/td>\r\n10<\/td>\r\n2<\/td>\r\n\u00a0<\/td>\r\n\u00a0<\/td>\r\n\u00a0<\/td>\r\n\u00a0<\/td>\r\n\u00a0<\/td>\r\n<\/tr>\r\n
ISO 2<\/td>\r\n100<\/td>\r\n24<\/td>\r\n10<\/td>\r\n4<\/td>\r\n\u00a0<\/td>\r\n\u00a0<\/td>\r\n\u00a0<\/td>\r\n<\/tr>\r\n
ISO 3<\/td>\r\n1,000<\/td>\r\n237<\/td>\r\n102<\/td>\r\n35<\/td>\r\n8<\/td>\r\n\u00a0<\/td>\r\nClass1<\/td>\r\n<\/tr>\r\n
ISO 4<\/td>\r\n10,000<\/a><\/td>\r\n2,370<\/td>\r\n1,020<\/td>\r\n352<\/td>\r\n83<\/td>\r\n\u00a0<\/td>\r\nClass10<\/td>\r\n<\/tr>\r\n
ISO 5<\/td>\r\n100,000<\/td>\r\n23,7000<\/td>\r\n102,000<\/td>\r\n3,5200<\/td>\r\n8,320<\/td>\r\n\u00a0293<\/td>\r\nClass 100<\/td>\r\n<\/tr>\r\n
ISO 6<\/td>\r\n1,000,000<\/td>\r\n237,000<\/td>\r\n102,000<\/td>\r\n35,200<\/td>\r\n8,320<\/td>\r\n2,930<\/td>\r\nClass1,000<\/td>\r\n<\/tr>\r\n
ISO 7<\/td>\r\n\u00a0<\/td>\r\n\u00a0<\/td>\r\n\u00a0<\/td>\r\n352,000<\/td>\r\n83,200<\/td>\r\n2,930<\/td>\r\nClass 10,000<\/td>\r\n<\/tr>\r\n
ISO 8<\/td>\r\n\u00a0<\/td>\r\n\u00a0<\/td>\r\n\u00a0<\/td>\r\n3,520,000<\/td>\r\n832,000<\/td>\r\n29,300<\/td>\r\nClass 100,000<\/td>\r\n<\/tr>\r\n
ISO 9<\/td>\r\n\u00a0<\/td>\r\n\u00a0<\/td>\r\n\u00a0<\/td>\r\n35,200,000<\/td>\r\n8,320,000<\/td>\r\n293,000<\/td>\r\nRoom Air<\/td>\r\n<\/tr>\r\n<\/tbody>\r\n<\/table>\r\n<\/figure>\r\n\r\n\r\n\r\n
\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n
Criterio<\/td>\r\nClase 10 ISO4<\/td>\r\nClase 100 ISO5<\/td>\r\nClase 1000 ISO6<\/td>\r\nClase 10,000 ISO7<\/a><\/td>\r\nClase 100,000 ISO8<\/td>\r\n<\/tr>\r\n
Cambios de Aire por HR \/ Min<\/td>\r\n500-600 \/ 8 to 10<\/td>\r\n300 to 480 \/ 5 to 8<\/td>\r\n180 \/ 3<\/td>\r\n60 \/1<\/td>\r\n30 \/ 0.5<\/td>\r\n<\/tr>\r\n
% de Cobertura por Filtros<\/td>\r\n90 \u2013 100<\/td>\r\n60 \u2013 70<\/td>\r\n20 \u2013 30<\/td>\r\n7 \u2013 15<\/td>\r\n4\u00a0 \u2013 5<\/td>\r\n<\/tr>\r\n
CFM por pie Cuadrado<\/td>\r\n85 \u2013 90<\/td>\r\n36 \u2013 65<\/td>\r\n18 \u2013 32<\/td>\r\n9 \u2013 16<\/td>\r\n4 \u2013 8<\/td>\r\n<\/tr>\r\n
Eficiencia de Filtro<\/td>\r\n99.9997% ULPAs<\/td>\r\n99.997% HEPAs<\/td>\r\n99.997% HEPAs<\/td>\r\n99.997% HEPAs<\/td>\r\n99.97% HEPAs<\/td>\r\n<\/tr>\r\n
Tipo de Techo<\/td>\r\nCielo Raso Barra T Perfil de Aluminio<\/td>\r\nCielo Raso Barra T Perfil de Aluminio<\/td>\r\nCielo Raso Barra T Perfil de Aluminio<\/td>\r\nCielo Raso Barra T Convencional<\/td>\r\nCielo Raso Barra T Convencional<\/td>\r\n<\/tr>\r\n
Tipo de Accesorio de Iluminaci\u00f3n<\/td>\r\nPara Techos Suspendidos o Empotrados<\/td>\r\nPara Techos Suspendidos o Accesorio para Cuarto Limpio de 2\u2019x4\u2032<\/td>\r\nAccesorio para Cuarto Limpio de 2\u2019x4\u2032<\/td>\r\nAccesorio para Cuarto Limpio de 2\u2019x4\u2032<\/td>\r\n2\u2019x4\u2019 standard fixture<\/td>\r\n<\/tr>\r\n
Panel de Techo<\/td>\r\nFRP, Vinilo o Mylar<\/td>\r\nFRP, Vinilo o Mylar<\/td>\r\nVinilo o Mylar<\/td>\r\nVinilo o Mylar<\/td>\r\nVinilo o Mylar<\/td>\r\n<\/tr>\r\n
Sistema de Pared<\/td>\r\nModular o Construido Est\u00e1ndar<\/td>\r\nModular o Construido Est\u00e1ndar<\/td>\r\nModular o Construido Est\u00e1ndar<\/td>\r\nModular o Drywall<\/td>\r\nModular o Drywall<\/td>\r\n<\/tr>\r\n
Cubierta de Suelo<\/td>\r\nVinilo Laminado Soldado o Epoxi<\/td>\r\nVinilo Laminado Soldado o Epoxi<\/td>\r\nVinilo Laminado Soldado o Epoxi<\/td>\r\nHoja de Vinilo o VCT<\/td>\r\nHoja de Vinilo o VCT<\/td>\r\n<\/tr>\r\n
Base de Suelo<\/td>\r\nCabinas de 2\u201d to 6\u201d<\/td>\r\nC\u00f3ncavas o Canal con Base de Aluminio<\/td>\r\nC\u00f3ncavas o Canal con Base de Aluminio<\/td>\r\nC\u00f3ncavas o Canal con Base de Aluminio<\/td>\r\nC\u00f3ncavas o Canal con Base de Aluminio<\/td>\r\n<\/tr>\r\n
Retorno de Flujo de Aire<\/td>\r\nPiso Elevado o Centro de Retorno de Aire<\/td>\r\nPared Baja en Eje Largo<\/td>\r\nPared Baja en el Per\u00edmetro<\/td>\r\nPared Baja<\/td>\r\nPared o Techo Bajo<\/td>\r\n<\/tr>\r\n<\/tbody>\r\n<\/table>\r\n<\/figure>\r\n\r\n\r\n\r\n

Cleanrooms can be positive or negative pressure environments that use HEPA filtered air to eliminate particulates.<\/p>\r\n\r\n\r\n\r\n

Typical testing is annual certification. Some pharmaceutical operations are required to do it every 6 months.<\/h3>\r\n\r\n\r\n\r\n