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YBB 00242002-2015: PA/AL/PVC cold-formed foil for solid preparation
YBB 00242002-2015
YY / YBB
PETROCHEMICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
PA/AL/PVC cold-formed foil for solid preparation
ISSUED ON. AUGUST 11, 2015
IMPLEMENTED ON. DECEMBER 01, 2015
Issued by. China Food and Drug Administration of PRC
PA/AL/PVC cold-formed foil for solid preparation
This standard applies to the composite film using the polyvinyl chloride (PVC),
aluminum foil (Al), and polyamide (PA) by the adhesive through compositing
operation. It is applicable to the cold stamping molding blister packaging for
solid pharmaceutical (tablets, capsules, etc.).
[Appearance] TAKE appropriate amount of this product; CONDUCT visual
inspection against it in bright natural light. It shall be free from perforations,
foreign body, odor, adhesion, composite layer separation and significant
damage, bubbles, wrinkles, dirt or other defects.
[Identification] Infrared spectrum. TAKE appropriate amount of this product;
FOLLOW the method 4 of the packaging material infrared spectrum
determination method (YBB00262004-2015) to determine it; AND the PA layer
and the PVC layer shall be basically in consistent with the control map.
[Physical performance] Water vapor permeation amount. TAKE
appropriate amount of this product. FOLLOW the method 1 test condition B
OR the method 2 test condition B OR the method 4 test condition 2 of the
water vapor permeation determination method (YBB00092003-2015) to
determine it. During the test, LET the PVC face to the low humidity side, which
shall not exceed 0.5 g/(m2 • 24h).
Oxygen permeation amount. TAKE appropriate amount of this product.
FOLLOW the method 1 OR the method 2 of the air permeation determination
method (YBB00082003-2015) to determine it. During the test, LET the PVC
face to the oxygen low pressure side, which shall not exceed 0.5 cm3/(m2 • 24h
• 0.1 MPa).
Peel strength. TAKE appropriate amount of this product; MAKE determination
in accordance with the peel strength determination method
(YBB001020003-2015). The peel strength between the PA layer and the Al
layer shall be not less than 8.0 N/15 mm; AND the peel strength between the
Al layer and the PVC layer shall be not less than 7.0 N/15 mm. (If the
composite layer cannot be peeled off OR otherwise if the composite layer
breaks, the peel strength is qualified).
Heat sealing strength. TAKE appropriate amount of this product; CUT 2 small
pieces of 100 mm x 100 mm; OVERLAP the PVC side with the same size
aluminum foil for medical use (YBB00152002-2015); MAKE it subjected to
heat sealing on the heat sealing instrument, at the heat sealing temperature of
155 °C ± 5 °C and the pressure of 0.2 MPa, for 1 second. CUT a 15 mm width
sample from the heat sealing part; TAKE the middle 3 strips for test. FOLLOW
the heat sealing strength determination method (YBB00122003-2015) to
determine it, AND the mean value of the heat sealing strength of the 6 samples
shall be not less than 6.0 N/15 mm.