Awọn Ilana Iṣakoso Didara fun 0.02mm Pharma Aluminium Foil: Aridaju Zero Pinholes
Ni elegbogi roro, awọn 0.02mm (20 mimin) PTP Aluminiomu bankanje Sin bi awọn lominu ni “ideri.” Išẹ akọkọ rẹ ni lati pese a 100% idena lodi si ayika ifosiwewe. Ni sisanra yii, ipenija imọ-ẹrọ ti o tobi julọ ni imukuro pi pinholes— awọn ofo airi ti o waye lakoko ilana yiyi bankanje.
Ilana iṣelọpọ wa ni ibamu si ISO 15378 (Awọn ohun elo iṣakojọpọ akọkọ fun awọn ọja oogun) lati rii daju wipe gbogbo square mita ti bankanje pese a hermetic asiwaju.
1. Ohun elo ohun elo & Ipo
Ipilẹ ti “Odo Pinhole” didara bẹrẹ pẹlu yiyan ti ga-mimọ aluminiomu ingots. A lo awọn ohun elo amọja ti oogun lati rii daju pe bankanje mejeeji lagbara to fun awọn laini iyara giga ati brittle to fun titari-rọrun.
| Ẹya | Awọn alaye sipesifikesonu | Idi Iṣẹ |
| Alloy Iru | Aluminiomu 8011 / 1235 | Agbara fifẹ giga ati irọrun |
| Ibinu | H18 (Lile) | Ṣe idaniloju fifọ fifọ fun fifun tabulẹti |
| Dada Ipari | Imọlẹ ẹgbẹ kan, ọkan ẹgbẹ ṣigọgọ | Ṣe iṣapeye titẹ sita (imọlẹ) & lilẹ (ṣigọgọ) |
| Ohun elo mojuto | $99\%+$ Funfun aluminium | O pọju idena lodi si ina ati ọrinrin |
2. Olona-Layer Be & Giramu ti a bo
0.02mm Pharma Foil jẹ ohun elo akojọpọ. Awọn konge ti awọn kemikali ti a bo (OP ati VC) jẹ bii pataki bi aluminiomu funrararẹ.
| Orukọ Layer | Iru iru ohun elo | Aso Iwuwo (G / m2) | Iṣẹ ṣiṣe |
| Layer Idaabobo (OP) | Nitrocellulose/Akiriliki | $1.0 \pm 0.5$ | Ooru resistance & titẹ sita Idaabobo |
| Iridani Layer (Al) | Aluminiomu bankanje | $54.0 \pm 2.0$ | Imọlẹ, gaasi, ati ọrinrin idankan |
| Imora Layer | Alakoko (iyan) | $0.5 \pm 0.2$ | Ṣe ilọsiwaju ifaramọ laarin AL ati VC |
| Ooru Igbẹhin Layer (VC) | Fainali kiloraidi Resini | $4.0 – 6.0$ | Isopọpọ idapọ pẹlu PVC / PVDC |
3. Awọn ajohunše Iṣakoso Pinhole lile
Google ṣe ipo akoonu imọ-ẹrọ ti o ga julọ nigbati o pese awọn ipilẹ ile-iṣẹ kan pato. Gẹgẹ bi YBB00152002-2015, awọn ibeere pinhole fun bankanje 20um jẹ ti o muna:
| Pinhole Opin | Ibi aabo ile-iṣẹ (O pọju) | Standard Factory wa |
| $> 0.3 \ọrọ{mm}$ | Ko gba laaye | Odo |
| $0.1\ọrọ{mm} – 0.3\ọrọ{mm}$ | $\awọn 1 \ọrọ{ fun } m^2$ | $\awọn 0.5 \ọrọ{ fun } m^2$ |
| $< 0.1\ọrọ{mm}$ | Ti ṣe akiyesi bi ohun airi | Ti ṣawari & Wọle |
Imọ Akọsilẹ: A gbaṣẹ Online Infurarẹẹdi Pinhole oluwari lori awọn ẹrọ slitting wa. Ti pinhole ba pọ ju $0.1\ọrọ{mm}$ ti wa ni ri, eto aami eti eerun fun yiyọ, ni idaniloju pe nikan “Mọ Ite” bankanje de laini roro rẹ.
4. Ti ara & Mechanical Performance Metiriki
Ni ikọja pinholes, bankanje gbọdọ ṣe flawlessly lori ga-iyara roro ero (f.eks., Uhlmann, Romaco, tabi IMA).
| Idanwo Iṣe | Ẹyọkan | Iye owo | Ọna Idanwo |
| Agbara fifẹ | $Mpa$ | $\ge 160$ | ASTM E8 |
| Ilọsiwaju | $\%$ | $\ge 1.0$ | GB / t 228 |
| Ooru Igbẹhin Agbara | $N/15\text{mm}$ | $\ge 7.0$ | $155^ ọrọ{C}, 2\ọrọ{s}, 0.2\ọrọ{Mppa}$ |
| Resistance ooru | Iwọn | Ko si peeling ni $200^ ọrọ{C}$ | OP Layer iyege igbeyewo |
| Aloku Solusan | $mg/m^2$ | $\awọn 10$ | Gaasi Chromatography (GC) |
5. To ti ni ilọsiwaju Didara idaniloju (QA) Ṣiṣan iṣẹ
Ilana QA wa ti pin si awọn ipele mẹta lati ṣe idiwọ eyikeyi ohun elo ti ko ni abawọn lati okeere.
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Ipele 1: Aise Ohun elo Ayewo – Spectral onínọmbà ti aluminiomu ingots fun kemikali ti nw.
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Ipele 2: Ni-ilana Abojuto + Iwọn sisanra ti o tẹsiwaju ni lilo awọn sensọ Beta-ray (mimu $\pm 3\%$ ifarada).
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Ipele 3: Ti pari ọja Lab – Gbogbo ipele faragba awọn wọnyi:
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Igbeyewo Wettability: Lilo awọn aaye Dyne lati rii daju pe ẹdọfu dada jẹ $> 32$ mN/m fun adhesion inki pipe.
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Idanwo makirobia: Lapapọ iwukara ati kika m (TYMC) ati lapapọ aerobic makirobia ka (PELU) lati rii daju ibamu GMP.
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Idanwo wònyí: Igbelewọn ifarako lati jẹrisi ko si awọn olomi to ku (pataki fun ailewu alaisan).
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6. Iṣakojọpọ & Awọn pato Ibi ipamọ fun okeere
Lati ṣetọju awọn “Odo Pinhole” ipo nigba ẹru okun, a lo awọn apoti aabo Ere.
| Ohun elo apoti | Ohun elo Lo | Idi |
| Inu mojuto | Aluminiomu tabi Irin (76mm / 152mm) | Ṣe idilọwọ iṣubu mojuto lakoko gbigbe |
| Ọrinrin | LORI fiimu + Yanrin jeli Desiccant | Idilọwọ ifoyina ati “ipata funfun” |
| Atilẹyin ẹgbẹ | Ṣiṣu Biraketi / Idaduro Endboards | Yago fun titẹ lori bankanje eerun dada |
| Lode Apoti | ISPM-15 Fumigated Onigi Crate | Agbaye sowo ibamu & ikolu Idaabobo |
Ṣetan lati Ṣe imudojuiwọn Iṣakojọpọ elegbogi rẹ?
Tiwa 0.02mm Pharma Aluminiomu bankanje jẹ abajade ti awọn ewadun ti imọ-ẹrọ irin. A pese kikun Iwe-ẹri ti itupalẹ (COA) ati Imọ Data Dì (TDS) pẹlu gbogbo ayẹwo.
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Aṣa Titẹ sita: To 8 awọn awọ pẹlu egboogi-counterfeiting UV inki.
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Awọn apẹẹrẹ ọfẹ: 20m – 50m ayẹwo yipo wa fun ẹrọ iwadii gbalaye.
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Ifarada: FDA DMF forukọsilẹ ati SFDA fọwọsi.