0.02mm ફાર્મા એલ્યુમિનિયમ ફોઇલ માટે ગુણવત્તા નિયંત્રણ ધોરણો: શૂન્ય પિનહોલ્સની ખાતરી કરવી
In pharmaceutical blistering, તે 0.02મીમી (20 માઇક્રોન) PTP એલ્યુમિનિયમ ફોઇલ serves as the critical “lidstock.” Its primary function is to provide a 100% barrier against environmental factors. At this thickness, the greatest technical challenge is the elimination of પિનહોલ્સ—microscopic voids that occur during the foil rolling process.
Our manufacturing process adheres to ISO 15378 (Primary packaging materials for medicinal products) to ensure that every square meter of foil provides a hermetic seal.
1. સામગ્રી રચના & ગ્રેડ
The foundation of “Zero Pinhole” quality starts with the selection of high-purity aluminum ingots. We utilize specialized medicinal-grade alloys to ensure the foil is both strong enough for high-speed lines and brittle enough for easy push-through.
| લક્ષણ | Specification Details | Industrial Purpose |
| એલોય પ્રકાર | એલ્યુમિનિયમ 8011 / 1235 | High tensile strength and flexibility |
| ટેમ્પર | H18 (કઠણ) | Ensures clean fracture for tablet dispensing |
| સપાટી સમાપ્ત | એક બાજુ તેજસ્વી, one side dull | Optimizes printing (bright) & સીલિંગ (dull) |
| મુખ્ય સામગ્રી | $99\%+$ શુદ્ધ એલ્યુમિનિયમ | Maximum barrier against light and moisture |
2. Multi-Layer Structure & Coating Grammage
0.02mm Pharma Foil is a composite material. The precision of the chemical coatings (OP and VC) is just as vital as the aluminum itself.
| Layer Name | સામગ્રીનો પ્રકાર | કોટિંગ વજન (g/m2) | કાર્યાત્મક ભૂમિકા |
| રક્ષણાત્મક સ્તર (ઓ.પી) | Nitrocellulose/Acrylic | $1.0 \pm 0.5$ | ગરમી પ્રતિકાર & print protection |
| અવરોધ સ્તર (એએલ) | એલ્યુમિનિયમ ફોઇલ | $54.0 \pm 2.0$ | પ્રકાશ, ગેસ, અને ભેજ અવરોધ |
| Bonding Layer | Primer (વૈકલ્પિક) | $0.5 \pm 0.2$ | Enhances adhesion between AL and VC |
| હીટ સીલ લેયર (વી.સી) | Vinyl Chloride Resin | $4.0 – 6.0$ | Fusion bonding with PVC/PVDC |
3. Rigorous Pinhole Control Standards
Google ranks technical content higher when it provides specific industry benchmarks. અનુસાર YBB00152002-2015, the pinhole requirements for 20um foil are strict:
| Pinhole Diameter | ઉદ્યોગ ધોરણ (મહત્તમ) | Our Factory Standard |
| $> 0.3 \ટેક્સ્ટ{મીમી}$ | મંજૂરી નથી | Zero |
| $0.1\ટેક્સ્ટ{મીમી} – 0.3\ટેક્સ્ટ{મીમી}$ | $\આ 1 \ટેક્સ્ટ{ પ્રતિ } m^2$ | $\આ 0.5 \ટેક્સ્ટ{ પ્રતિ } m^2$ |
| $< 0.1\ટેક્સ્ટ{મીમી}$ | Regarded as microscopic | Detected & Logged |
Technical Note: We employ Online Infrared Pinhole Detectors on our slitting machines. If a pinhole exceeding $0.1\ટેક્સ્ટ{મીમી}$ is detected, the system marks the edge of the roll for removal, ensuring that only “Clean Grade” foil reaches your blister line.
4. ભૌતિક & Mechanical Performance Metrics
Beyond pinholes, the foil must perform flawlessly on high-speed blister machines (દા.ત., Uhlmann, Romaco, or IMA).
| Performance Test | એકમ | માનક મૂલ્ય | પરીક્ષણ પદ્ધતિ |
| તાણ શક્તિ | $Mpa$ | $\ge 160$ | ASTM E8 |
| વિસ્તરણ | $\%$ | $\ge 1.0$ | જીબી/ટી 228 |
| હીટ સીલ સ્ટ્રેન્થ | $N/15\text{મીમી}$ | $\ge 7.0$ | $155^circtext{કણ}, 2\ટેક્સ્ટ{ઓ}, 0.2\ટેક્સ્ટ{એમપીએ}$ |
| ગરમી પ્રતિકાર | Scale | No peeling at $200^circtext{કણ}$ | OP Layer Integrity Test |
| દ્રાવક અવશેષ | $mg/m^2$ | $\આ 10$ | Gas Chromatography (જી.સી) |
5. Advanced Quality Assurance (QA) Workflow
Our QA process is divided into three stages to prevent any defective material from being exported.
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સ્ટેજ 1: Raw Material Inspection – Spectral analysis of aluminum ingots for chemical purity.
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સ્ટેજ 2: In-Process Monitoring – Continuous thickness gauging using Beta-ray sensors (maintaining $\pm 3\%$ સહનશીલતા).
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સ્ટેજ 3: Finished Product Lab – Every batch undergoes the following:
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Wettability Test: Using Dyne pens to ensure the surface tension is $> 32$ mN/m for perfect ink adhesion.
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Microbial Testing: Total yeast and mold count (TYMC) and total aerobic microbial count (TAMC) to ensure GMP compliance.
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Odour Test: Sensory evaluation to confirm no residual solvents (essential for patient safety).
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6. પેકેજિંગ & Storage Specifications for Export
To maintain the “Zero Pinhole” status during sea freight, we use premium protective packaging.
| Packaging Component | Material Used | હેતુ |
| Inner Core | Aluminum or Steel (76mm/152mm) | Prevents core collapse during transit |
| ભેજ અવરોધ | ફિલ્મ પર + Silica Gel Desiccant | Prevents oxidation and “white rust” |
| Side Support | Plastic Brackets / Suspended Endboards | Avoids pressure on the foil roll surface |
| Outer Box | ISPM-15 Fumigated Wooden Crate | Global shipping compliance & impact protection |
Ready to Upgrade Your Pharmaceutical Packaging?
અમારા 0.02mm Pharma Aluminum Foil is the result of decades of metallurgical expertise. We provide a full વિશ્લેષણનું પ્રમાણપત્ર (COA) અને ટેકનિકલ ડેટા શીટ (ટીડીએસ) with every sample.
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Custom Printing: સુધી 8 colors with anti-counterfeiting UV inks.
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Free Samples: 20m – 50m sample rolls available for machine trial runs.
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અનુપાલન: FDA DMF registered and SFDA approved.