Babban Layin Jikin Nau'in granulation

Takaitaccen Bayani:

Ya dace da samar da magunguna masu guba sosai, masu aiki sosai, kuma masu ƙarfi masu ƙarfi, kuma dole ne su kai ga OEB4 & OEB5 don rage haɗarin masu aiki yayin aikin samarwa da tasirin muhalli.

Kayan aikin sun bi ka'idodin GMP na 2010 na China, GMP na Turai, da dokokin FDA, kuma sun cika buƙatun hana iska na OEB, ta yadda za a rage lalacewar samfurin ga lambobin kayan aiki;

Madaidaitan Jagororin EHS don Masana'antar Magunguna ta Sin (2020);Iyakar Bayyanar Sana'a don Abubuwa masu haɗari a Wurin Aiki


Cikakken Bayani

Tags samfurin

tuta5

Siffofin

1.Adopt iska jakar hatimi, aminci interlock iko;
2.Adopt PE jakar ko ab bawul don saukewa da saukewa;
3.Adopt tsarin BIBO don shayewar iska, tare da matattarar F9 / H13;
4.WIP tsaftacewa / CIP tsaftacewa / tsaftacewa ta atomatik.

Ma'anar ƙullawar OEB

APIs tare da cytotoxicity da babban aiki sune nau'in sinadaran magunguna tare da manyan ayyukan harhada magunguna, tare da ƙananan adadin magunguna da ƙarancin sakamako masu illa, kuma sun jawo hankali sosai daga kasuwa a cikin 'yan shekarun nan.Ko da yake kasuwar magungunan da ke aiki sosai tana da faɗi, suna kuma fuskantar ƙalubale masu girma.Baya ga kashe ƙwayoyin cutar kansa, magungunan rigakafin ƙari na iya kashe ƙwayoyin al'ada.Hankalin su na iya haifar da rashin lafiyar mutane, kuma suna da illa sosai ga lafiyar mutane masu lafiya.Sabili da haka, babban haɗarin da aka yi la'akari da shi a cikin tsarin samar da cytotoxic da APIs masu aiki sosai shine bayyanar ƙura.Mafi kyawun bayani shine amfani da fasahar keɓewar iska don sarrafa adadin ƙurar ƙura a cikin aikin samarwa.Dangane da wannan sifa, wannan aikin ya fi yin nazarin ƙimar OEL mai dacewa (Iyakar Exposure Limit) a ƙarƙashin matakan haɗarin haɗari na kayan aiki daban-daban, kazalika da kayan aikin da suka dace na OEB matakin iska da dabarun iska.Dangane da halaye na cytotoxic da kayan albarkatu masu aiki sosai, dangane da fasahar rufe labyrinth data kasance, fasahar rufewa mara kyau da fasahar keɓewar iska, an yi nazarin nau'ikan haɗaɗɗun hatimin da suka dace da irin waɗannan kayan.Fasahar hatimin ƙaramar leakage na iya toshewa ko toshe tare da babban cytotoxicity.Tashoshin leka na APIs masu aiki don sarrafa ƙimar zubewar

Bukatun kayan aikin OEB

1.OEB 1 ~ 2 ana buƙatar saita kayan aikin da aka haifar da gida, kamar ingantaccen iskar gida a wuraren da aka fallasa.

2.OEB 3 Lokacin da ake hulɗa da sana'a, ya kamata a yi amfani da kayan aiki da kayan aiki kamar yadda zai yiwu, kuma a yi amfani da matakan sarrafawa irin su samun iska, laminar flow hood, ɗakin aiki mai zaman kanta tare da na'urar samun iska ta gida, murfin hayaki, da dai sauransu. sassan da aka fallasa na ƙurar ƙwayoyi.

3. OEB 4-5 matakin ya kamata a ba da fifiko ga yin amfani da cikakken tsari na rufe kayan aiki da kayan aiki, da kuma tsara hanyoyin samar da fasaha da ke kewaye.Ya kamata layin samfurin ya ɗauki duk kayan aiki da wurare da ke kewaye.Haɗin hulɗar sana'a, matakan sarrafawa kamar keɓewa, aikin rufe akwatin safar hannu, bawul α-β, jaka a ciki da fitar da jaka, da sauransu yakamata a yi amfani da su.Ya kamata kayan aikin samarwa su yi amfani da nasu ƙarfin iska, kamar na'urar bushewa uku-cikin ɗaya.

Production - ci-gaba aiki kayan aiki

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Production - ci-gaba aiki kayan aiki

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Ƙirƙira - Gudanar da Lean (Shafin Taro)

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Production- Quality management

Manufar inganci:
abokin ciniki na farko, inganci na farko, ci gaba da haɓakawa da ƙwarewa.

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Babban kayan aiki + kayan aikin gwaji daidai + kwararar tsari + ingantaccen binciken samfur + FAT abokin ciniki
= Lalacewar samfuran masana'anta

Gudanar da ingancin samarwa (kayan aikin gwaji daidai)

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shiryawa & jigilar kaya

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  • Na baya:
  • Na gaba:

  • Ku rubuta sakonku anan ku aiko mana

    Rukunin samfuran