1. Standar lembar PVC yang digunakan dalam pengemasan obat adalah: YBB00212005 PVC Solid Sheet Obat. Standar Wadah Kemasan Farmasi Nasional (Material). Standar ini berlaku untuk tablet keras yang terbuat dari resin polyvinyl chloride (PVC) sebagai bahan baku utama untuk pengemasan blister obat -obatan padat (tablet, kapsul, dll.).
2. Standar Terkait:
GB/T 2918-1998 Lingkungan Standar untuk Penyesuaian Kondisi dan Pengujian Sampel Plastik
GB/T1037-1988 Metode Transmisi Film Plastik dan Tes Haze
GB/T 2410-1980 Transmisi lampu plastik transparan dan metode uji kabut
GB/T 6672-2001 Film plastik dan Metode Pengukuran Mekanik Ketebalan Lembar
GB/T 6673-2001 Penentuan panjang dan lebar film dan lembaran plastik
GB/T 4615-1984 Penentuan kandungan monomer vinil klorida residual dalam resin polivinil klorida
GB/T 15047-1994 Metode Uji Kekakuan Torsional Plastik
TEST ITEM AND CONCLUSION
|
Item
|
Specification
|
Test Result
|
Conclusion
|
Appearance
|
Accord to standard
|
Yes
|
Qualified
|
Thickness
|
±0.02mm
|
0.30mm
|
Qualified
|
Density
|
1.35~1.45g/m³
|
1.36
|
Qualified
|
Water Vapor Transmission
|
≤20.0g/(㎡•24h•0.1mm)
|
5.9
|
Qualified
|
Oxygen Transmission
|
≤30cm³(㎡•24h•0.1Mpa)
|
16.49
|
Qualified
|
Tensile Strength
|
TD:≥44Mpa
|
52.1
|
Qualified
|
MD:≥44Mpa
|
54.6
|
Qualified
|
falling Ball Impact Brittle Rate
|
TD:≤40%
|
0
|
Qualified
|
TD:≤40&
|
0
|
Qualified
|
Heating Shrinking rate
|
≤±10%
|
TD:-3% MD:4%
|
Qualified
|
Heating Sealing Strength
|
≥7.0N/15mm
|
8.9
|
Qualified
|
Vinyl Chloride Monomer
|
≤1mg/kg
|
<0.1
|
Qualified
|
Test
|
|
Drgree of Clear
|
|
clear
|
clear
|
Qualified
|
|
Test of Oxidation
|
|
Difference of Titer≤1.5ml
|
0.98
|
Qualified
|
|
Heavy Metal
|
|
≤0.0001%
|
≤0.0001%
|
Qualified
|
Non-Volatile
|
Water
|
≤30mg/100ml
|
6.4
|
Qualified
|
65%Ethanol
|
≤30mg/100ml
|
7.6
|
Qualified
|
n-Hexane
|
≤30mg/100ml
|
8.6
|
Qualified
|
Barium
|
Ought to clear
|
YES
|
Qualified
|
Micro-organism
|
Bacterium
|
≤1000/100m³
|
39
|
Qualified
|
Mildewµzyme
|
≤1000/100m³
|
<10
|
Qualified
|
Coliform
|
Non-permit
|
Not be discovered
|
Qualified
|
Storage Insturction
|
Store for 180 days at normal temperature and keep dry
|
√ Kejelasan & transparansi yang sangat baik
√ Kontrol ketebalan yang sangat baik
√ Formabilitas yang sangat baik (Paket normal & dalam-dalam)
√ Sealing superior
√ Kekuatan dampak yang sangat baik