1. Standard lembaran PVC yang digunakan dalam pembungkusan ubat adalah: YBB00212005 PVC Lembaran keras pepejal pepejal. Standard Pembungkusan Farmaseutikal Kebangsaan (Bahan) Standard. Piawaian ini digunakan untuk tablet keras yang diperbuat daripada resin polyvinyl chloride (PVC) sebagai bahan mentah utama untuk pembungkusan ubat pepejal (tablet, kapsul, dll.).
2. Piawaian yang berkaitan:
GB/T 2918-1998 Persekitaran standard untuk pelarasan keadaan dan ujian sampel plastik
GB/T1037-1988 Kaedah Ujian dan Ujian Jerebu Filem Plastik
GB/T 2410-1980 Transmisi Lampu Plastik Telus dan Kaedah Ujian Jerebu
GB/T 6672-2001 Filem plastik dan ketebalan lembaran penentuan kaedah pengukuran mekanikal
GB/T 6673-2001 Penentuan Panjang dan Lebar Filem dan Lembaran Plastik
GB/T 4615-1984 Penentuan kandungan monomer vinil klorida sisa dalam resin polyvinyl chloride
GB/T 15047-1994 Kaedah Ujian Ketegangan 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 & ketelusan yang sangat baik
√ Kawalan ketebalan yang sangat baik
√ formabiliti yang sangat baik (pakej normal & dalam-draw)
√ Pengedap unggul
√ Kekuatan kesan yang sangat baik