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Korea GMP Certified 8021-O Aluminum Foil for Cold Forming Blister Packaging

2025-07-14 10:02:04

Under Korea’s strict pharmaceutical regulations, 8021-O temper foil is the preferred material for high-barrier cold forming blister lids due to ultra-ductility and purity. Mingtai Aluminum, a top 3 Chinese pharmaceutical foil producer with ISO 15378 certification, delivers KFDA-compliant solutions.

Core Advantages of Mingtai 8021 Foil

Superior Deep Drawing (O Temper)

Elongation: ≥3% (0.025mm foil: 3.2-3.8%)

Erichsen value: ≥1.8mm (ASTM E643)

15% deeper draw depth vs 8079 alloy

Pharmaceutical-Grade Cleanliness

Class 100,000 cleanroom (ISO 14644 Class 8)

Residual oil: ≤2mg/m² total (DIN EN 14287)

Microbial limits: ≤50 CFU/m² (USP <1111>)

Optimized Lamination

Surface tension: ≥72 dyn/cm

Compatible with PVC/PVDC/COP heat sealing

Pinholes: ≤5/m² (0.025mm foil)

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Korea-Specific Services

✓ Cert Support: KP documentation (KOLAS reports, heavy metal migration tests)

✓ Precision Slitting: Width 200-1600mm, burr ≤0.003mm

✓ Sterile Packaging: Double anti-static film + nitrogen flush + γ-ray sterilization

✓ Logistics:

– FOB Shanghai/Qingdao → Incheon/Busan (7 days)

– China-Korea FTA COO (Form B, 0% duty)

Request KFDA Compliance Package!

▸ Email: sales@mingtai-al.com

▸ WhatsApp/WeChat: +86-17760728273

▸ Website: www.mingtaialuminum.com

▸ Factory: No.162 Jinbai Road, Hi-Tech Zone, Zhengzhou, China

FAQ: Critical Concerns for Blister Foil

Q1: Difference between 8021 vs 8079 for deep drawing?

A1: 8021 delivers:

+0.5-1.0% higher elongation

+0.3-0.5mm max draw depth

Better for cavity depth/diameter ratio >1:1

Q2: Compliance with Korea Pharmaceutical Affairs Act Article 42?

A2: We provide:

Heavy metal migration reports (Pb/Cd/CrVI <0.1ppm)

Non-volatile residue test (SGS ISO 6486)

Traceable cleanroom production logs

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Q3: MOQ & lead time?

A3:

Master coil MOQ: 800kg (width ≥1000mm)

Slit coils MOQ: 5 ton

Delivery: Stock 15 days, custom 25 days (incl. shipping)

Q4: Do you support KP (Korea Product) certification?

A4: Mingtai has assisted 12 Korean pharma clients with KP certification. We supply:

GMP facility certificates (ISO 15378)

Bilingual MSDS

Third-party KOLAS test reports

*End-product KP must be applied by Korean importers

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