Tulaga Fa'atonu mo le 0.02mm Pharma Aluminum Foil: Faamautinoaina Zero Pinholes
I pharmaceutical blistering, o le 0.02mm (20 micron) PTP Aluminium Foil e avea o se tagata faitio “lidstock.” O lana galuega autu o le saunia o se 100% pa puipui i mea tau le siosiomaga. I lenei mafiafia, o le lu'itau fa'atekinisi sili o le fa'aumatiaina o lima piopio-o gaogao mata'utia e tutupu i le faagasologa o le ta'avale pepa.
O la matou gaosiga fa'agasologa o lo'o tausisia ISO 15378 (Mea fa'apipi'i muamua mo vaila'au) ia mautinoa o sikuea sikuea uma o pepa pepa e maua ai se faʻamaufaʻailoga.
1. Meafaatinoina Mea & Vasega
O le faavae o “Zero Pinhole” uiga lelei e amata i le filifilia o ingots alumini maualuga-mama. Matou te faʻaogaina mea faʻapitoa faʻapitoa mo vailaʻau e faʻamautinoa ai e lava le malosi o le pepa pepa mo laina televave ma lava maʻaleʻale mo le faigofie ona tulei..
| Foliga | Fa'amatalaga Fa'amatalaga | Faamoemoega Alamanuia |
| Ituaiga Alloy | Alumini 8011 / 1235 | Malosi maualuga tensile ma fetuutuunai |
| Ita | H18 (Faigata) | Faʻamautinoa mama gau mo le tuʻuina atu o laupepa |
| Fa'ai'uga | Malamalama le tasi itu, le tasi itu e lemu | Fa'asilisiliina lomitusi (susulu) & faamaufaailogaina (fa'ase'e) |
| Mea Autu | $99\%+$ Mama o le almuninum | Pa puipui aupito maualuga e faasaga i le malamalama ma le susu |
2. Fa'afuafuaga Fa'aopoopo & Fa'afuifu kalama
0.02mm Pharma Foil ose mea tu'ufa'atasi. Le sa'o o le pa'u kemisi (OP ma VC) e tutusa lava le taua e pei o le alumini lava ia.
| Igoa Laega | Mea ituaiga | Ufiufi mamafa (g / m2) | Galuega Faatino |
| Laega Puipui (OP) | Nitrocellulose/Acrylic | $1.0 \pm 0.5$ | Vevela tetee & puipuiga lolomi |
| Paraer Filemu (Al) | Pepa alumini | $54.0 \pm 2.0$ | Malamalama, kesi, ma pupuni o le susu |
| Fa'amauga | Palemia (Filifili) | $0.5 \pm 0.2$ | Faʻaleleia le pipii i le va o AL ma VC |
| Fa'amaufa'ailoga vevela (VC) | Vinyl Chloride Resin | $4.0 – 6.0$ | Fa'atasiga fa'atasi ma le PVC/PVDC |
3. Fa'atonuga Pulea Pinhole
Google fa'atulagaina mea fa'apitoa fa'apitoa pe a tu'uina atu fa'ailoga fa'apitoa tau alamanuia. Ae faimai foi YBB00152002-2015, o manaoga pine mo 20um foil e saʻo:
| Pu'u-a'i | Alamanuia Fuafuaga (Max) | Ole matou Falegaosimea |
| $> 0.3 \tusitusiga{mm}$ | E le faatagaina | O |
| $0.1\tusitusiga{mm} – 0.3\tusitusiga{mm}$ | $\le 1 \tusitusiga{ i le } m^2$ | $\le 0.5 \tusitusiga{ i le } m^2$ |
| $< 0.1\tusitusiga{mm}$ | Fa'atatauina o se microscopic | Ua maua & Fa'amauina |
Fa'amatalaga Fa'atekinisi: Matou te faafaigaluegaina Initoneti Infrared Pinhole Detectors i luga oa tatou masini slitting. Afai e sili atu le pu $0.1\tusitusiga{mm}$ ua iloa, o le faiga e faailoga ai le pito o le lola mo le aveeseina, fa'amautinoa na'o “Vasega Mama” e o'o atu foi le pepa i lou laina ma'i.
4. Fa'aletino & Fuafuaga Fa'atino Fa'ainisinia
I tua atu o pine, e tatau ona fa'atino lelei le pepa iila i luga o masini pa'u saosaoa (E.g., Uhlmann, Romaco, po o le IMA).
| Su'ega Fa'atinoga | Iunite | Tulaga Taua | Metotia Su'ega |
| Malosi Tetele | $Mpa$ | $\ge 160$ | ASTM E8 |
| Faasolosolo | $\%$ | $\ge 1.0$ | Gb / t 228 |
| Malosi fa'amaufa'ailoga vevela | $N/15\text{mm}$ | $\ge 7.0$ | $155^ liʻo Tusitusiga{I}, 2\tusitusiga{s}, 0.2\tusitusiga{Mpa}$ |
| Vevela tetee | Fua | Leai se pa'u i $200^ liʻo Tusitusiga{I}$ | OP Layer Su'ega Fa'amaoni |
| Toega Solvent | $mg/m^2$ | $\le 10$ | Kesi Chromatography (GC) |
5. Fa'amautinoaga Tulaga Maualuga (QA) Fa'asologa o galuega
O la matou faiga QA ua vaevaeina i ni vaega se tolu e puipuia ai soʻo se mea leaga mai le faʻatau atu i fafo.
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Tulaga 1: Su'ega o Mea Mata - Su'esu'ega fa'apitoa o alumini ingots mo vaila'au mama.
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Tulaga 2: Mata'ituina i le Fa'agasologa – Fa'aauau le fuaina o le mafiafia e fa'aaoga ai masini fa'a-Beta (tausia $\pm 3\%$ faapalepale).
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Tulaga 3: Falesu'e Oloa Maua - O vaega uma e feagai ma mea nei:
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Su'ega Susū: Fa'aaogā peni Dyne e fa'amautinoa ai o lo'o fa'ateteina le i luga $> 32$ mN/m mo le pipii atoatoa vaitusi.
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Su'ega Microbial: Aofa'i le fefete ma le fa'afefete (TYMC) ma le faitau aofa'i ole microbial aerobic (FOI) ia mautinoa le tausisia o le GMP.
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Su'ega manogi: Su'esu'ega fa'apitoa e fa'amaonia ai e leai se vaifofo totoe (taua mo le saogalemu o ma'i).
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6. afifiina & Fa'amatalaga Teuina mo le Fa'atau Atu
Ina ia faatumauina le “Zero Pinhole” tulaga i le taimi o uta i le sami, matou te fa'aogaina le afifiina o le puipuiga malu.
| Vaega Fa'apipi'i | Mea Fa'aaogā | Faamoemoega |
| Autu Totonu | Alumini po'o Uamea (76mm/152mm) | Puipuia le pa'u autu a'o felauaiga |
| Mosture papupuni | I luga o ata tifaga + Silica Gel Desiccant | Puipuia fa'ama'i ma “ele paepae” |
| Lagolago Itu | Fa'amau Fa'ailoga / Fa'agata Endboards | Aloese mai omiga i luga o le pepa ta'ai pepa |
| Pusa i fafo | ISPM-15 Pu'u La'au Fa'asa | O le tausisia o felauaiga i le lalolagi & puipuiga o aafiaga |
Sauni e Fa'aleleia Lau Fa'aputuga Fa'afoma'i?
Tatou 0.02mm Pharma Alumini pepa o le taunuuga o le tele o tausaga o tomai faʻameamea. Matou te tuʻuina atu atoa Tusi Faamaonia o Iloiloga (COA) ma Pepa Fa'amatalaga Fa'atekinisi (TDS) ma fa'ata'ita'iga uma.
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Lomiga Fa'apitoa: I luga 8 lanu fa'atasi ai ma vaitusi UV fa'asese.
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Fa'ata'ita'iga Sa'oloto: 20m – 50m fa'ata'ita'iga lola avanoa mo su'ega masini.
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Tausisia: FDA DMF resitala ma SFDA faamaonia.