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YBB 00242002-2015

Search Result of Chinese Standard: 'YBB 00242002-2015'
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Detail Information of YBB 00242002-2015; YBB00242002-2015
Description (Translated English): (Polyamide/aluminum/PVC cold forming solid medicinal compound rigid sheet)
Sector / Industry: Medical & Pharmaceutical Packaging Industry Standard
Classification of Chinese Standard: C08
Word Count Estimation: 2,227
Date of Issue: 2015-08-11
Date of Implementation: 2015-12-01
Older Standard (superseded by this standard): YBB 0024-2002
Regulation (derived from): China Food & Drug Administration Announcement 2015 No.164

YB B00242002-2015
(Polyamide/aluminum/PVC cold forming solid medicinal compound sheet)
Polyurethane/aluminum/polyvinyl chloride cold stamping solid composite hard film
Juxianan/Lü/Julüyixi Lengchongγachengxing Guti Yaoyong Fuhe Yingpian
PA/AI/PVC Cold-formed Foil for Solid Preparation
This standard applies to the combination of polyvinyl chloride (PVC), aluminum foil (Al), polyamide (PA) through the adhesive, the composite
sheet. Applicable to solid drugs (tablets, capsules, etc.) with cold stamping molding blister packaging.
[Appearance] take this product amount, in the natural light bright place, facing visual inspection. No perforation, foreign body, odor, adhesion,
Composite layer separation and obvious damage, bubbles, wrinkles, dirt and other defects.
【Identification】 infrared spectrum to take this product amount, according to packaging materials, infrared spectroscopy (YB B00262004-2015) fourth
Method, PA and PVC layer should be consistent with the control map.
【Physical properties】 The amount of water vapor through this amount, according to the water vapor permeability measurement method (YB B00092003-2015)
The first method test condition B or the second method test condition B or the fourth method test condition 2 determination, the test when the PVC for low humidity
Side, not over 0.5 g/(m2 • 24 h).
Oxygen through the amount of the amount of this product, according to the gas permeability measurement method (YB B00082003-2015) first or second method
It is not allowed to pass 0.5cm3/(m2 • 24h • 0.1MPa) for PVC low side.
Peel strength to take this product amount, according to peel strength determination (YB B00102003-2015) determination. PA and Al interlayer peeling
Strength shall not be less than 8.0 N/15 mm; Al and PVC layer peel strength shall not be less than 7.0 N/15 mm. (If the composite layer can not
Peel or composite layer fracture, the peel strength is qualified).
Heat sealing strength to take this product amount, cut 100 mm × 100mm small pieces of 2, the PVC surface with the same size of the drug
(YB B00152002-2015), heat sealing, heat sealing temperature of 155 ℃ ± 5 ℃, pressure 0.2MPa,
Time 1 second. From the heat of the site cut 15mm wide sample, take the middle of the three test. Determination of heat intensity
(YB B00122003-2015), the average heat sealing strength of 6 specimens shall not be less than 6.0 N/15 mm.
【Vinyl chloride monomer】 take this product amount, according to the determination of vinyl chloride monomer (YB B00142003-2015) determination, not over one hundred
One ten thousandth.
[Dissolution test] Preparation of the test solution. take this product amount, respectively, take the inner surface area of 300 cm2 (divided into 3 cm long,
(70 ° C ± 2 ° C), 65% ethanol (70 ° C ± 2 ° C), n-hexane (58 ° C)
± 2 ℃).200 ml each soak for 2 hours after the removal, let cool to room temperature, with the same batch of test solvent added to the original volume as a supply
Test solution, with the same batch of water, 65% ethanol, positive kang as blank liquid, the following test.
Easy to extract the amount of water for the test solution 20 ml, potassium permanganate titration solution (0.002 mol/L) 20 ml and dilute sulfuric acid 1 ml,
Boil for 3
Related standard:   YBB 00242003-2015  YBB 00242004-2015
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