Daki mai tsafta wuri ne na musamman wanda ake sarrafawa wanda abubuwa kamar adadin barbashi a cikin iska, zafi, zafin jiki da kuma tsayayyen wutar lantarki za'a iya sarrafa su don cimma takamaiman ƙa'idodin tsaftacewa. Ana amfani da ɗakuna masu tsafta a cikin manyan masana'antun fasaha kamar semiconductor, kayan lantarki, magunguna, jirgin sama, sararin samaniya da biomedicine.
A cikin ƙayyadaddun gudanarwa na sarrafa magunguna, ɗakin tsabta ya kasu kashi 4: A, B, C da D.
Class A: Wuraren aiki masu haɗari, kamar wuraren cikawa, wuraren da ganga mai tsayawa roba da buɗaɗɗen kwantena suna cikin hulɗa kai tsaye tare da shirye-shiryen bakararre, da wuraren da ake gudanar da taron aseptic ko ayyukan haɗin gwiwa, ya kamata a sanye su da tebur mai gudana na unidirectional. don kula da yanayin muhalli na yankin. Dole ne tsarin yawo na unidirectional ya ba da iska daidai gwargwado a wurin aiki tare da saurin iska na 0.36-0.54m/s. Ya kamata a sami bayanai don tabbatar da matsayin kwararar unidirectional kuma a tabbatar da su. A cikin rufaffiyar, keɓe mai aiki ko akwatin safar hannu, ana iya amfani da ƙananan saurin iska.
Class B: yana nufin yankin baya inda aji A tsaftataccen yanki yake don ayyuka masu haɗari kamar shirye-shiryen aseptic da cikawa.
Class C da D: koma zuwa wurare masu tsabta tare da ƙananan matakai masu mahimmanci a cikin samar da samfurori marasa lafiya.
Dangane da ka'idodin GMP, masana'antar harhada magunguna ta ƙasata ta raba wurare masu tsabta zuwa matakan ABCD 4 kamar yadda suke sama bisa ga alamu kamar tsabtace iska, matsin iska, ƙarar iska, zafin jiki da zafi, hayaniya da abun ciki.
An rarraba matakan wurare masu tsabta bisa ga ƙaddamar da ƙwayoyin da aka dakatar a cikin iska. Gabaɗaya magana, ƙarami ƙimar, haɓaka matakin tsabta.
1. Tsaftar iska tana nufin girma da adadin barbashi (ciki har da ƙwayoyin cuta) da ke cikin iska a kowace juzu'in sararin samaniya, wanda shine ma'auni don bambance matakin tsaftar sarari.
Static yana nufin jihar bayan an shigar da na'urar sanyaya iska mai tsafta kuma tana aiki cikakke, kuma ma'aikatan dakin tsabta sun kwashe wurin kuma sun tsarkake kansu na mintuna 20.
Dynamic yana nufin cewa ɗaki mai tsabta yana cikin yanayin aiki na yau da kullun, kayan aikin suna aiki akai-akai, kuma ma'aikatan da aka keɓe suna aiki bisa ƙayyadaddun bayanai.
2. Ma'auni na ABCD ya fito ne daga GMP wanda Hukumar Lafiya ta Duniya (WHO) ta sanar, wanda shine ƙayyadaddun kulawa da ingancin samar da magunguna na kowa a cikin masana'antar harhada magunguna. A halin yanzu ana amfani da shi a yawancin yankuna na duniya, ciki har da Tarayyar Turai da China.
Tsohuwar sigar GMP ta kasar Sin ta bi ka'idojin tantance maki na Amurka (aji na 100, aji 10,000, aji 100,000) har zuwa lokacin da aka fara aiwatar da sabon tsarin GMP a shekarar 2011. Masana'antar harhada magunguna ta kasar Sin ta fara amfani da ka'idojin tantance WHO tare da amfani da ABCD don bambance bambance-bambancen. matakan wurare masu tsabta.
Sauran ƙa'idodin rarraba ɗaki mai tsabta
Daki mai tsabta yana da ma'auni daban-daban a cikin yankuna da masana'antu daban-daban. An gabatar da matakan GMP a baya, kuma a nan mun fi gabatar da ƙa'idodin Amurka da ka'idojin ISO.
(1). American Standard
Tunanin samar da tsaftataccen ɗaki Amurka ce ta fara gabatar da shi. A cikin 1963, an ƙaddamar da ƙa'idar tarayya ta farko don sashin soja na ɗaki mai tsabta: FS-209. Ma'auni na 100 da aka sani, aji 10000 da ma'auni na 100000 duk an samo su daga wannan ma'auni. A cikin 2001, Amurka ta daina amfani da ma'aunin FS-209E kuma ta fara amfani da ma'aunin ISO.
(2). Matsayin ISO
Ƙungiya ta Duniya don Daidaitawa ISO ta gabatar da ƙa'idodin ISO kuma ya rufe masana'antu da yawa, ba kawai masana'antar magunguna ba. Akwai matakai tara daga aji 1 zuwa aji na 9. A cikinsu, aji na 5 daidai yake da ajin B, aji na 7 daidai yake da ajin C, aji na 8 daidai yake da ajin D.
(3). Don tabbatar da matakin tsaftataccen yanki na Class A, ƙimar samfurin kowane wuri na samfur ba zai zama ƙasa da mita cubic 1 ba. Matsayin barbashi na iska a cikin aji A tsaftataccen yanki shine ISO 5, tare da dakatarwar barbashi ≥5.0μm azaman ma'aunin iyaka. Matsayin barbashi na iska a cikin aji mai tsabta ajin B (tsaye) shine ISO 5, kuma ya haɗa da rataye barbashi masu girma biyu a tebur. Don wurare masu tsabta na aji C (tsaye da tsauri), matakan barbashi na iska sune ISO 7 da ISO 8 bi da bi. Don wurare masu tsabta na aji D (a tsaye) matakin barbashi na iska shine ISO 8.
(4). Lokacin da tabbatar da matakin, a šaukuwa kura barbashi counter tare da guntu samfurin tube ya kamata a yi amfani da su hana ≥5.0μm dakatar barbashi daga daidaitawa a cikin dogon samfurin tube na m samfurin tsarin. A cikin tsarin kwarara unidirectional, yakamata a yi amfani da kawunan samfurin isokinetic.
(5) Za'a iya yin gwaji mai ƙarfi yayin ayyukan yau da kullun da al'adun simulators da aka kwaikwayi tsarin cikawa don tabbatar da cewa an cimma matakin tsafta mai ƙarfi, amma gwajin cike da matsakaicin matsakaicin al'ada yana buƙatar gwaji mai ƙarfi a ƙarƙashin "mafi munin yanayi".
Class A tsaftataccen ɗaki
Aji mai tsabta, wanda kuma aka sani da ɗaki mai tsabta na aji 100 ko ɗaki mai tsafta, yana ɗaya daga cikin ɗakuna mafi tsafta tare da mafi girman tsafta. Yana iya sarrafa adadin barbashi a kowace ƙafar kubik a cikin iska zuwa ƙasa da 35.5, wato adadin barbashi mafi girma ko kuma daidai da 0.5um a cikin kowace mita cubic na iska ba zai iya wuce 3,520 (tsaye da ƙarfi). Ajin Tsabtataccen ɗaki yana da ƙaƙƙarfan buƙatu kuma yana buƙatar amfani da matatun hepa, sarrafa matsi daban-daban, tsarin kewayawa iska da tsarin kula da zafin jiki akai-akai don cimma babban buƙatun tsafta. Ana amfani da ɗakuna masu tsabta na Class A a cikin sarrafa microelectronics, biopharmaceuticals, ƙirar kayan aiki daidai, sararin samaniya da sauran filayen.
Ajin B mai tsabta
Ajin B masu tsafta kuma ana kiran su dakuna masu tsabta ajin 1000. Matsayin tsaftar su yana da ƙasa kaɗan, yana barin adadin barbashi mafi girma ko daidai da 0.5um a kowace mita cubic na iska don isa 3520 (a tsaye) da 352000 (tsauri). Dakuna masu tsabta na Class B yawanci suna amfani da matattara mai inganci da tsarin shaye-shaye don sarrafa zafi, zafin jiki da bambancin matsa lamba na mahalli na cikin gida. An fi amfani da ɗakuna masu tsabta na Class B a cikin biomedicine, masana'antar harhada magunguna, injuna daidai da kera kayan aiki da sauran fannoni.
Ajin C mai tsabta
Hakanan ana kiran ɗakuna masu tsabta ajin C mai tsabta ajin 10,000. Matsayin tsaftarsu yana da ƙasa kaɗan, yana ba da damar adadin barbashi mafi girma ko daidai da 0.5um a kowace mita cubic na iska don isa 352,000 (a tsaye) da 352,0000 (tsauri). Dakuna masu tsabta na Class C yawanci suna amfani da matatun hepa, ingantacciyar sarrafa matsi, kewayawar iska, zazzabi da kula da zafi da sauran fasahohi don cimma takamaiman ƙa'idodin tsabtarsu. Ana amfani da ɗakuna masu tsabta na Class C a cikin magunguna, masana'antar na'urorin likitanci, injuna daidai da kera kayan lantarki da sauran fannoni.
Ajin D mai tsafta
Ajin D mai tsafta kuma ana kiran dakuna masu tsabta aji 100,000. Matsayin tsaftarsu yana da ƙasa kaɗan, yana ba da damar adadin barbashi mafi girma ko daidai da 0.5um a kowace mita cubic na iska don isa 3,520,000 (a tsaye). Dakuna masu tsabta na Class D yawanci suna amfani da matatun hepa na yau da kullun da ingantaccen tsarin kula da matsa lamba da tsarin kewaya iska don sarrafa mahalli na cikin gida. An fi amfani da ɗakuna masu tsabta na Class D a cikin samar da masana'antu gabaɗaya, sarrafa abinci da marufi, bugu, ɗakunan ajiya da sauran filayen.
Matakan dakuna masu tsabta daban-daban suna da nasu ikon yin amfani da su, wanda ya kamata a zaba bisa ga ainihin bukatun. A cikin aikace-aikace masu amfani, kula da muhalli na ɗakuna mai tsabta abu ne mai mahimmanci mai mahimmanci, wanda ya haɗa da cikakken la'akari da abubuwa masu yawa. Ƙirar kimiyya kawai da ma'ana da aiki za su iya tabbatar da inganci da kwanciyar hankali na yanayin ɗaki mai tsabta.
Lokacin aikawa: Maris-07-2024