Dakin mai tsabta shine yanayin da ake sarrafawa musamman wanda abubuwa kamar yawan barbashi a cikin iska, zafi, zazzabi, zazzabi da wutar lantarki za'a iya sarrafawa don cimma takamaiman ka'idodin tsabtatawa. Ana amfani da ɗakuna masu tsabta a cikin masana'antu masu fasaha kamar semiconductors masu semicmonductors masu semicmontuctors, masu lantarki, Aerospace da biomediciine.
A cikin maganganun sarrafa tsarin samar da magunguna, dakin mai tsabta ya kasu kashi 4: A, B, C da D.
Class A: Yankin Gudanar da Hadarin, kamar masu cika wurare, da kuma wuraren da aka yi amfani da babban taro ko ayyukan haɗin kai tsaye, ya kamata a sanye da kayan haɗin kai tsaye, ya kamata a sanye shi da tebur mai gudana don kula da matsayin muhalli na yankin. Tsarin kwararar da ba a tsare ba zai wadatar da iska a ko'ina cikin yankin aiki tare da saurin iska na 0.36-0.54m / s. Ya kamata a sami bayanai don tabbatar da matsayin kwararar da ba ta dace ba kuma a tabbatar da shi. A cikin rufaffiyar, ana iya amfani da akwatin saiti ko safar hannu, ana iya amfani da ƙananan iska.
Class B: Yana nufin yankin bango inda aji mai tsabta yanki yake don manyan haɗari kamar shiri na babban hadari kamar shi.
Class C da D: Duba zuwa yankuna masu tsabta tare da ƙasa da mahimman matakai a cikin samar da propale props.
Dangane da ka'idojin GMP, masana'antar magunguna na ƙasata sun rarraba yankuna 4 na abcd kamar yadda ke kan alamu, karar iska, amo da mmobial.
An rarraba matakan yankuna masu tsabta bisa ga taro na haramtattun barbashi a cikin iska. Gabaɗaya magana, ƙaramin ƙimar, mafi girman matakin tsabta.
1. Tsabta na iska yana nufin girman da adadin barbashi (gami da ƙananan ƙwayoyin cuta) waɗanda ke cikin iska kowane ɗayan juzu'i na sarari na sarari.
Static yana nufin jihar bayan tsabtace tsarin dakin dakin da aka tsaftace matattarar gida, da kuma kyawawan ma'aikatan da suka tsallake sun tsarkaka shafin kuma sun tsarkaka na tsawon mintina 20.
Hanyoyin yana nufin cewa ɗakin tsabta yana cikin yanayin aiki na yau da kullun, kayan aikin suna aiki daidai, kuma ma'aikatan da aka tsara suna aiki bisa bayanan bayanai.
2. The ABCD grading standard comes from the GMP promulgated by the World Health Organization (WHO), which is a common pharmaceutical production quality management specification in the pharmaceutical industry. A halin yanzu ana amfani dashi a yawancin yankuna a duniya, ciki har da Tarayyar Turai da China.
Tsohon tsohuwar kasar Sin ta bi ka'idojin grading na Amurka (Class 100, aji 10,000, aji 100,000) har zuwa aiwatar da sabon sigar Pharmacetal da kuma amfani da AbCD don rarrabe da matakan tsabta wurare.
Wasu ka'idojin ma'auni na daki mai tsabta
Room mai tsabta suna da matsayin grading daban-daban a yankuna daban daban da masana'antu. An gabatar da ka'idojin GMM a baya, kuma a nan muna gabatar da ka'idodin Amurka da ka'idojin ISO.
(1). Ka'idojin Amurka
Manufar gringation mai tsabta daki ne da Amurka ta gabatar. A cikin 1963, ma'aunin tarayya na farko don ɓangaren soja na tsabtace dakin an ƙaddamar: fs-209. Tsarin da ya saba 100, Class 10000 da kuma matakan 100000 duk an samo su ne daga wannan matsayin. A shekara ta 2001, Amurka ta daina amfani da matsayin FS-209e kuma ya fara amfani da Reot Storation.
(2). Matsayi na ISO
Kungiyar ISO ta gabatar da ka'idoji na yau da kullun don daidaitawa ISO kuma suna rufe masana'antu da yawa, ba kawai masana'antar magunguna ba ce. Akwai matakan tara daga aji1 zuwa 9. Daga cikin su, aji 5 yayi daidai da aji B, aji 7 yayi daidai da aji D.
(3). Don tabbatar da matakin aji wani yanki mai tsabta, samfurin girma na kowane samfurin aya ba zai zama ƙasa da mita 1 na cubic ba. Matsayin barbashi na iska a cikin aji mai tsabta furen ne ISO 5, tare da barbashi dakatar da su. Matsayin barbashi na iska a Class na Class B (static) shine Iso 5, kuma ya hada da dakatar da dakatar da barbashi biyu a cikin tebur. Don Classan C Tsabtace wurare (tsayayye da ƙarfi), matakan barbashi na iska sune iso 7 da ISO 8 bi da bi. Don Class Dable Dreabaru (static) matakin barbashi Airborne barbashi ne iso 8.
(4). A lokacin da ke tabbatar da matakin, wani ƙura ƙura ƙirar counter tare da ɗan gajeren ƙwayar bututu don hana ≥5.0μmm da aka dakatar da ƙananan bututu na tsarin nesa. A cikin tsarin kwarara na gudana, ya kamata a yi amfani da shugabannin Athetinetic.
(5) Ana iya yin gwajin ƙarfi yayin ayyukan yau da kullun da tsarin al'adun al'adu sun cimma nasarar aiwatar da gwaji na buƙatar gwajin mai tsauri a ƙarƙashin "mafi munin yanayin".
Aji daki mai tsabta
Class dakin mai tsabta, wanda kuma aka sani da dakin aji 100 mai tsabta ko ɗakin ɗorawa mai tsabta, shine ɗayan ɗakuna masu tsabta tare da mafi girman tsabta. Zai iya sarrafa adadin barbashi a cikin ƙafa mai cubic a cikin iska zuwa ƙasa da 35.5, da yawa daga cikin mita mitir ba zai iya wuce 3,520 (tsayayye da ƙarfi). Class dakin da mai tsabta yana da matukar tsayayyen buƙatu kuma suna buƙatar amfani da HEPA masu tacewa, keɓaɓɓiyar matsin lamba na iska don cimma babban abubuwan da suke da zafi. Ainihin ɗakuna masu tsabta ana amfani da su a cikin sarrafa microectronics, bipharmawan kayan aiki, masana'antu kayan aiki, Aerospace da sauran filayen.
Class B mai tsabta daki
Hakanan ana kiran Class Class Class aji 1000 masu tsabta. Matsakaicin tsabtarsu ba lallai ba ne, ba da izinin yawan barbashi mafi girma fiye da ko daidai da 0.5um a kowace mita na ruwa don kai har zuwa 352000 (wuyar). Class na Classan ɗakuna na fure yawanci yana amfani da matakan matakai masu yawa da kuma shaye shaye don sarrafa gumi, zazzabi da bambancin yanayin yanayin cikin gida. Ana amfani da Class Classan ɗakuna galibi a cikin biomediciine, magunguna na magunguna, kayan masarufi da kayan aikin kayan aiki da sauran filayen.
Class C mai tsabta daki
Ana kuma kiran Class ɗakuna 10,000 ɗakuna 10,000. Matsakaicin tsabtarsu ba lallai ba ne, ba da izinin yawan barbashi mafi girma fiye da ko daidai da mita na 352,000 (statra) da 352,0000 (wuyar). Class c Shorts yawanci suna amfani da matattarar HEPA, Ikon iska mai kyau, kewaya iska, zazzabi da kuma sauran fasahar don cimma takamaiman ka'idodin tsabtarsu. Ana amfani da Class Class a yawancin ɗakuna a cikin magunguna, masana'antar na'urori na na'urar masana'antu, kayan masarufi da kuma masana'antar lantarki da sauran filayen.
Class D mai tsabta daki
Hakanan ana kiran aji dubun ɗakuna 100,000 masu tsabta. Matsakaicin tsabtarsu ba lallai ba ne, ba da izinin adadin barbashi mafi girma fiye da ko daidai yake da mita 3,520,000 (a tsaye). Class dilsan ɗakuna masu tsabta galibi suna amfani da matattarar HEPA da sarrafawar yau da kullun da ke tattarawa don sarrafa yanayin cikin gida. Ana amfani da Class Dildsan ɗakuna galibi a cikin masana'antar masana'antu, sarrafa abinci da kuma kwantena, bugu, warenhousing da sauran filayen.
Matakai daban-daban na ɗakuna masu tsabta suna da nasu iyakokin aikace-aikacen, wanda ya kamata a zaɓa gwargwadon ainihin bukatun. A cikin aikace-aikacen aikace-aikace, ikon kula da ɗakunan yanayi shine muhimmin aiki, wanda ya shafi cikakkiyar abubuwan da yawa. Tsarin kimiyya da na yau da kullun da aiki na iya tabbatar da ingancin da kwanciyar hankali na yanayin tsabtace yanayin.
Lokaci: Mar-07-2024