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YBB 00212005-2015: PVC Sheet for Solid Preparation
YBB 00212005-2015
YBB
National Drugs Packing Containers (Materials) Standards
PVC Sheet for Solid Preparation
ISSUED ON. AUGUST 11, 2015
IMPLEMENTED ON. DECEMBER 01, 2015
Issued by. China Food and Drug Administration of PRC
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PVC Sheet for Solid Preparation
This Standard applies to solid preparation that takes polyvinyl chloride (PVC) resin as main raw
material, used for blister packaging of solid pharmaceuticals (tablets, capsules, etc.).
[Appearance] Take an appropriate amount of this product. Place at a bright place under natural
light. Visually inspect it. It shall be in uniform color, without bumps, oil stains, foreign material,
perforation, impurities. In per 100 cm2, the crystal points of 1.3 mm and less than 1.3 mm must
not exceed 3. There must be no crystal points over 1.3 mm.
[Identification] (1) IR* Take an appropriate amount of this product; determine according to the
Fourth Method of Packaging materials - Infrared spectroscopy (YBB 00262004-2015) and it shall
be consistent with the control map.
(2) Density Take about 2 g of this product. Determine according to Density measurement
method (YBB 00132003-2015) and it shall be 1.35 ~ 1.45 g/cm3.
[Physical performance] Water vapor permeation Take an appropriate amount of this product.
Determine according to the First Method test conditions of Water vapor transmission
measurement method (YBB 00092003-2015) or the Second Method (test temperature of 23°C ±
0.5°C, relative humidity of 90% ± 2%) or the Fourth Method (test temperature of 23°C ± 0.5°C,
relative humidity of 90% ± 2%). It must not exceed 2.5 g/(m2 • 24h).
Oxygen permeation Take an appropriate amount of this product. Determine according to the
First Method of Gas permeation measurement method (YBB 00082003-2015). It must not exceed
30 cm3 / (m2 • 24 h • 0.1 MPa).
Tensile strength Take an appropriate amount of this product. Determine according to Tensile
performance measurement method (YBB 00112003-2015). Test speed (without load) is 100
mm/min ± 10 mm/min. Sample is Type I. The average of longitudinal, transverse tensile strength
must not be less than 44 MPa.
Impact resistance Take an appropriate amount of this product. Extract 150mm x 50mm test
piece, 5 pieces in total vertically and horizontally. Place the sample at a temperature of 23°C ±
2°C and relative humidity of 50% ± 5% for over 4 hours. Carry out the test under the above
conditions. Fix the sample on the falling ball impact testing machine of which the span is 100 mm.
Select the steel ball and drop height according to Table 1 to make the ball free fall in the central
part of the span. It is not allowed to have more than two pieces of damage at the vertical and
horizontal directions.
Table 1 -- Selection of steel ball and drop height
mm
Sample thickness Drop height Steel ball diameter
0.20 ~ 0.30 600 25 (60 g ± 6 g)
0.31 ~ 0.40 600 28.6 (100 g ± 10 g)