Ingancin kayan pharmaceutical kayayyaki ne, kuma marufi yana taka muhimmiyar rawa wajen kiyaye amincin su, daidaituwa, kuma shiryayye rayuwa.

Daga cikin kayan marufi daban-daban, Pharmaceutical aluminum tsare ya fito fili don banda kayan sharri.

Duk da haka, Ba kawai kowane koll kase bane zai isa; mai tsauri Pharmaceutical aluminum fannoni Gwada tsarin sa, kaddarorin, da kuma aikin don biyan bukatun masana'antar kiwon lafiya.

Wannan labarin yana ba da bincike mai zurfi na waɗannan bayanan, tabbatar da cikakkiyar fahimta ga masana'anta, ingancin tabbatar da inganci, da injiniyoyi masu rufi.

1. Shigowa da: Mahimmancin rawar da ke cikin kayan kwalliya a cikin kunshin magunguna

Aluminu na aluminum wani katako ne a cikin kunshin magunguna saboda hade na musamman na halaye.

Yana aiki a matsayin shinge na m, Kare tsarin magunguna masu mahimmanci daga lalata lalacewa ta hanyar abubuwan da suka haifar.

Me yasa aluminum na kan magunguna don magunguna?

Products samfuran galibi galibi suna da saukin kamuwa da danshi, oxygen, haske, microorganishms, da sauran manyan abubuwan.

Pharmaceutical aluminum tsare yadda ya dace rage wadannan hadarin. Fa'idodinta na farko sun hada da:

• Cikakken shinge: Yana ba da cikakken katanga ga gas, danshi, da haske, Ko da a cikin manyan rantsuwa.
• Hygienic da marasa guba: Aluminium ba mai guba bane kuma baya tashar jiragen ruwa ko inganta ci gaban kwayan cuta, Yin ba shi da aminci don saduwa da kai tsaye da kai tsaye tare da samfuran miyagun ƙwayoyi.
• Tsari da masu kashe-guntu properties: Ana iya samun sauƙin ƙirƙira cikin siffofi da yawa (kamar fakitoci) kuma rike da siffar shi da kyau (ninki), muhimmiyar don aminci.
• Siye: A farfajiya ya yarda da bugu sosai don bera, Bayanin Samfurin, da kuma abubuwan da suka dace.

A sakamakon haka, Gwaji da Adahon ga madaidaici Pharmaceutical aluminum fannoni ba sasantawa bane.

Bayyanin “FARKON CIKIN SAUKI”

“FARKON CIKIN SAUKI” ya nuna cewa aluminium na aluminium ya hadu da takamaiman inganci, m, da kuma matakan aiwatar da dace da kai tsaye ko kai tsaye tare da samfuran harhada magunguna.

An cimma wannan ƙirar ta hanyar bin sasantawa daban-tsalle, Ka'idodin gudanarwa, da kuma ayyukan masana'antu mafi kyau.

Wadannan ka'idojin suna tabbatar da cewa tsare kanta baya gurbata kayan miyagun ƙwayoyi ko jayayya da kwanciyar hankali.

2. Core abubuwan da aka haɗa da fannonin aluminum na aluminum coil na aluminum

Cikakken Pharmaceutical aluminum foil ya mamaye sigogi da yawa.

Waɗannan sigogi suna tabbatar da katako ya dace da manufar ta kuma tazara tare da tsammanin ci gaba.

Abubuwan da ke ciki da Alloy

Kayan tushe ne mai matukar muhimmanci.

• Alloy zaba:
  Don yawancin aikace-aikacen magunguna, manyan-fina-finai aluminum aluminium daga Jerin AA8xxx (misali, AA8011, AA8079) ko Jerin AA1xxx (misali, Aa1235) ana amfani da shi sosai.
  Wadannan alloys an zabi su ne don ingantaccen daidaituwar su, ƙarfi, da katangar katako.
  Misali, AA8011 sau da yawa ya ƙunshi baƙin ƙarfe (Fe) a da 0.6-1.0% da silicon (Da) a da 0.5-0.9% Don haɓaka kayan aikinta na injiniya.
• M:
  Aluminum da ake amfani da shi dole ne ya zama tsarkakakku don rage kasancewar abubuwan da aka gano wanda zai iya yin tsalle cikin samfurin magani.
  Yawanci, abun ciki na aluminum shine >99.0%.

Fushi

Fushin fuska na tsare yana nuna kaddarorinta, kamar wuya da wahala.

• Fushi mai laushi (Anane – 'O’ Fushi):
  Wannan shine mafi yawan zafin zuciya ga magungunan magunguna (misali, berister fakitin).
  Annealing yana sa coil sosai ductile, m, kuma yana tabbatar da kyawawan halaye masu kyau.
  Karfinta na zamani na iya kasancewa a kusa 50-95 MPA.
• Wuya fushi ('H18’ ko 'H19’ Fushi):
  M tiry rayuwa ba shi da tsari amma yana da ƙarfi mai yawa (misali, >130 MPa don H18).
  Yawanci ana amfani dashi azaman kayan haɗin ko don aikace-aikacen takamaiman aikace-aikacen da ke buƙatar mafi girma da kuma turawa-juriya.

Kauri (Ma'auni)

Kauri mai mahimmanci ne mai mahimmanci kai tsaye tasiri shingen mallaka da ƙarfin injin.

• Hankulan hali:
  • Borster lidding tsare tsare (Tura-ta): Na kowa 20µm (0.020mm) zuwa 30μm (0.030mm). A 25μM na ci na yau da kullun ne.
  • Colm na sanyi (Tafi-gol): Layer na aluminum a cikin cold laminates shine kauri, yawanci 45μM zuwa 60μm.
  • Akwatin fakitoci: Na iya kasancewa daga 25μM zuwa 4μm.
• Haƙuri: Mummunar haƙuri mai kauri (misali, ± 5% ko ± 8%) suna da mahimmanci don aiwatarwa a yayin aikin tattarawa da kuma tabbatar da matsalolin shinge.

Halaye na farfajiya

Yanayin farfajiya na tsare yana da mahimmanci don ingancin samfurin ƙarshe.

• Gama:
  • Matt / mai haske: Mafi yawan foils suna da gefe ɗaya (gefen lamba) kuma daya gefen (gefen lamba a lokacin biya na ƙarshe).
    Bayani dalla-dalla sau da yawa ana nufin wane gefen ne aka yi nufin bugawa ko hatimi.
  • Duka bangarorin biyu (BSB): Cimma nasarar wasu aikace-aikacen.
• M: Dole ne a sami free daga cikin mai, ramesin, ƙura, ko duk wani gurbata wanda zai iya shafar tasirin lacquers / cox ko ingantaccen tsarin.
  Iyakar abin da ake kayyade na mai (misali, <0.3 MG / M²).
• Rashin iyawa (Mataki na Dyne): Mahimmanci don adesion na inks, siyarwa, da kuma rufe-tafiya.
  Mafi karancin matakin (misali, >36 Dynes / cm) yawanci ana tantancewa, musamman ga gefen da za a buga ko mai rufi.

3. Suttura da lamaring: Ingantawa Aiki

Ba a yi amfani da tsare na aluminum ba tare da wuya ba. Ana amfani da mayafin.

Tsarin farko

Ana amfani da Firayim na Aluminum na aluminium na aluminium don inganta adhesion na yadudduka kamar buga inkoki ko kuma zaɓar da ke cikin Lucquers.

• Manufar: Tabbatar da haɗin gwiwa, hana yin birgima ko tawada Fling.
• Iri: Sau da yawa vinyl-tushen ko wasu tsarin polymer dacewa da duka aluminium da na gaba Layer.
• Nauyin aikace-aikace: Kayyade a g / m² (misali, 0.5 – 1.5 g / m²).

Lucquers na Lafiya (Hsl)

An yi amfani da HSL zuwa gefen tsare wanda za'a rufe shi zuwa ga borter tushe (misali, PVC, Farashin PVDC, PP, PET).

• Manufar: Yana kunna hatimi na heretic lokacin zafi da matsin lamba ana amfani da shi yayin aikin tattarawa.
• Iri: Vinyl-acrylic copolymers, Polyes hot, ko wasu polymers sun dace da tsarin gidan yanar gizo da aka yi niyya.
  Zabi ya dogara da yawan zafin jiki, Bukatun ƙarfi na hatimi, da kuma dacewa da samfuri.
• Nauyin aikace-aikace: Kayyade a g / m² (misali, 3 – 8 g / m²). Da nauyi tasiri da karfi karfin da amincin.
• Allon: Bayani dalla-dalla zai hada da karfin da aka yi niyya (misali, >7.5 N / 15mm fadin zuwa PVC a takamaiman zafin jiki na dillali kuma zauna lokaci) da rufin zafin jiki.

Buga inkis

Don allo, Shafin samfurin, da bayanan gudanarwa.

• Iri: Abubuwan da ke tattare da abin da aka fi dacewa da su.
• Kaddarorin: Dole ne ya zama mai guba, low ƙaura, Kyakkyawan m, Rub da tsayayya, da walƙiya.
• Yarda: Inks dole ne ya bi ka'idodin tsarin abinci ko takamaiman jagororin magunguna (misali, Jagororin Epia).

Lacquers (Fiye da vurnish – Opv)

Amfani da bugu don kare shi daga abrasion, danshi, ko harin sunadarai.

• Manufar: Inganta karkatar da bugu kuma yana iya canza matakan masu sheki.
• Iri: Irin sunadarai iri ɗaya ko hsls, Amma an tsara don kariya ta ƙasa.

Lamation (Don sanyi na sanyi)

A cikin tsari mai sanyi (Duk-lokaci) tsare, Layerum Layer ya lalace tsakanin waje opa opa (Ollyamide / Neylon) Layer da PVC na ciki (ko wasu polymer) shimfiɗa.

• Opa Layer: Samar da juriya na tattarawa da ƙarfin injin (yawanci 25μm).
• Aluminum tsare: Core katangar Core (yawanci 45-60μm).
• PVC / Polymer Layer: Samfurin Samfurin da Layer (yawanci 60μm).
• Adheresives: Babban aiki mai girma a kan wannan yadudduka, da ƙarfin haɗinsu shine ƙayyadadden ra'ayi.

4. Mabuɗin kayan aikin injin da na jiki a cikin bayanai

Bayan abun da aka gyara da cox, takamaiman awo na aiki yana da mahimmanci.

Tenerile ƙarfi da elongation

• Da tenerile: Matsakaicin damuwa da tsare zai iya tsayayya da shi ko aka ja kafin a wuya.
  Mai mahimmanci don kulawa ta yanar gizo yayin bugawa, shafi, kuma marufi. 25μm 'o’ Halicci tsare, Wannan na iya kasancewa a kusa 60-90 N / mm² (MPA).
• Elongation: Gwargwadon abin da yake iya shimfiɗa kafin ya watse. Mafi girma elongation yana da kyawawa don tsari. Na 'o’ fushi, Elongation na iya zama >5%.

Fashe ƙarfi (don lidding freils)

Wannan yana auna matsin da ake buƙata don lalata kayan rufe, yana nuna amincin hatimin da karfi da ake buƙata don aiwatar da ayyuka.

Magana ce mai mahimmanci ga ƙirar yara masu tsayayya da ƙirar yara masu ɗorawa.

Lissafin Pinhole

Pinholes minti na minti daya a cikin tsare wanda zai iya sasanta kaddarorinsa.

• Gwadawa: Yawanci ƙayyadaddun adadin adadin pinholes kowane yanki naúrar (misali, da m²) kuma sau da yawa matsakaicin halayyarsu.
  Don foil na magunguna, Mafi kyawun shine “Pinhole-free,” Musamman ga Gaugan Auges.
  Ka'idoji kamar Astm B479 suna ba da jagora. Na 20-30μm tsare, manufa ta gari ita ce <1 Pinhole / M².
• Gwadawa: Binciken gani akan akwatin haske ko masu binciken zane mai sarrafa kansa.

Hawaye juriya

Da ikon tsare don tsayayya da ji, mai mahimmanci don kulawa da kuma tabbatar da ingantawa.

Murfi da ƙarfi

Kamar yadda aka ambata a ƙarƙashin HLS, Wannan karfin da ake buƙata don rarrabe hatimi.

Dole ne ya kasance da ƙarfi isa ya kula da hatimin hermetic amma yana ba da izinin buɗewar da aka yi niyya (misali, tura-ta). An auna wannan a cikin N / 15mm ko N / 25mm.

5. Daidaitaccen ka'idoji da daidaitattun ka'idodi

Bin ka'idodi mai tsauri da ƙimar ƙimar gaskiya ne ga Pharmaceutical aluminum fannoni.

Pharpopopopopoeia

Mahimmancin magunguna (misali, USP, 2., Jp) na iya samun takamaiman monographs ko janar baburi dangane da kayan aikin, gami da tsare gwalum, Rufe fannoni kamar tsarkakakke, m, kuma bazaka.

Gudanar da abinci da magani (FDA) Ka'idojin

A cikin U.S., Kayan aiki don sadarwar ƙwayoyi dole ne su bi ka'idodin FDA, kamar wadanda aka samu a ciki 21 Cfr.

Masu wadata galibi suna kiyaye fayilolin Master (Dmfs) Tare da FDA, Bayar da cikakken bayani game da tsare da kayan sa.

Tarayyar Turai (EU) Ka'idojin

Irin waɗannan ka'idodi sun wanzu a cikin EU, An gudanar da Hukumar Magungunan Turai (Ema) da takamaiman umarnin / ƙa'idodi game da kayan aiki tare da samfuran magani (misali, Ƙa'ida (EC) A'a 1935/2004 Don Kayan Kayan Gidan abinci, wanda yawanci aka ambata).

Matsayi na ISO

• Iso 9001: Game da tsarin ingancin inganci.
• Iso 15378: Musamman don kayan aikin firam na kayan magani, hada masana'antu mai kyau (Hula) ƙa'idodi.
  Bin wannan misalin ana tsammanin.

Kyawawan masana'antu (Hula)

Masu ba da kaya na Pharmaceutical aluminum tsare Dole ne ya yi aiki a ƙarƙashin yanayin Gmp don tabbatar da ingancin inganci, rashin ladabi, da rigakafin gurbata.

Wannan ya hada da iko akan kayan masarufi, masana'antu, halin zaman jama'a, ma'aikata, da kuma takardun.

6. Misali magunguna aluminum na aluminum coil tebur (A sauƙaƙe)

Don dalilai na nuna alama, Daidaitaccen bayani na mai sauƙaƙewa don murkushewa na gama gari zai iya haɗawa:

Wannan tebur yana da ma'ana; Bayanai na gaske sun zama cikakkun bayanai da kuma wanda aka daidaita don takamaiman samfuran samfuri da mahimman mahimman ƙananan.

7. Muhimmancin cancantar kaya da masu duba

Zabi mai kaya Pharmaceutical aluminum tsare shawara ce mai mahimmanci.

• Karfin fasaha: Tabbatar da mai ba da tallafi a koyaushe yana haɗuwa da ƙayyadaddun bayanai.
• Tsarin ingancin: Tabbatar da tsarin ingancin ingancin sarrafawa (misali, Iso 9001, Iso 15378 ba da takardar shaida).
• Yarjejeniyar Tsara: Tabbatar da fahimtar su da biyayya ga ka'idojin magunguna masu dacewa.
• Rashin ladabi: Cikakken irin kayan albarkatun kasa da kuma batuttuka na samarwa yana da mahimmanci.
• Dubawa: Ana duba masu siyar da kaya na yau da kullun sun zama dole don tabbatar da bin doka da inganci.

8. Kammalawa: Matsakaicin daidaitaccen abu don kariya ta magunguna

The Pharmaceutical aluminum foil ba kawai takarda bane; Yana da dabarun kulawa mai mahimmanci don tabbatar da cewa maɓuɓɓuffukan aminci yana kare samfuran magunguna a duk rayuwarsu.

Daga madaidaici Daidaici da ciki da fushi zuwa daidai kauri, Dawowar nauyi, da kuma shingen aiki, Kowane daki-daki al'amura.

Bin waɗannan cikakkun bayanai, Gudanar da tsarin ingantaccen tsarin ingancin mai ƙarfi da kuma haɗin mai amfani da kaya, kiyaye lafiyar haƙuri ta hanyar rike ingancin da aka yi niyya, aminci, da ingancin maganin magada.

Kamar yadda kayayyakin magunguna suka zama hadaddun da hankali, Matsayin mai inganci, daidai ƙayyadadden kayan aluminium zai ci gaba da girma cikin mahimmanci.

Faqs

Q1: Mene ne mafi yawan abin da aka fi so na Allioy na amfani da FALDMACETICAL?

A: AA8011 Sallar abu ne mai ban mamaki ga magungunan FARMARCETICET DOIL saboda kyakkyawan tsari da ƙarfinsa bayan anan. Ana kuma amfani da AA1235.

Q2: Me yasa fushinsa na aluminium na ke da mahimmanci a aikace-aikacen magunguna?

A: Mai fushi ya bayyana kaddarorin kayan aikin na tsare.

Fushi mai laushi ('O') yana da mahimmanci ga girki mai kyau kamar yadda yake ba da damar yin amfani da ƙwanƙwasa ƙuƙwalwar da ya zama dole “tura-ta” na hali.

Wuya fushi ('H18') yana ba da ƙarfi mafi girma kuma ana iya amfani dashi don fasali mai tsayayya da yara ko mafi girman tsari.

Q3: Me ake yi “Pinhole-free” ma'ana a cikin magunguna aluminum coil dalla-dalla?

A: Da kyau, “Pinhole-free” yana nufin babu lalata.

A aikace, bayani dalla-dalla galibi suna ayyana iyaka mai yarda, kamar ƙasa da 1 Pinhole na wani matsakaicin matsakaicin diamita (misali, <50µm) A kowace murabba'in murabba'i, musamman ma na bakin ciki ma'aunin da aka yi amfani da su a cikin lidding.

Don aikace-aikace masu haɗari kamar sanyi na sanyi, Abincin yana da inganci Pinholes.

Q4: Ta yaya za a sami karfin alkalami na tsare?

A: Kusan murfi na hatimi ana gwada shi bisa ga ka'idoji kamar Astm F88 (“Hanyar gwaji na Standard don ƙarfin ƙarfin kayan masarufi”).

Tsiri na kayan da aka rufe an ja shi baya a cikin tsari mai sarrafawa, kuma karfi da ake buƙata don rarrabe hatimi an auna.

4 Q5: Mene ne fayil ɗin Master (Dmf) Don magunguna aluminum na aluminum?

A: Fayil na Master (Dmf) wani amintaccen ƙaddamarwa ne ga hukumomin gudanarwa (Kamar FDA) ta hanyar masana'anta.

Ya ƙunshi cikakken bayani game da sunadarai, masana'antu, iko mai inganci, da kwanciyar hankali na kayan marufi.

Pharmaceutican kamfanoni za su iya ganin wannan DMF a aikace-aikacen samfuran su, Ba da damar hukumar tsari don nazarin bayanan kayan kundin ba tare da mai samar da tsarewar ba tare da dalla-dalla ba ga kamfanin magani.