YBB 00202004-2015 English PDF (YBB00202004-2015)

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YBB 00202004-2015: Laminated Film and Pouches (PT/Al/PE) for Pharmaceutical Packaging
YBB 00202004-2015
YBB
National Drug Packing Container (Material) Standard
Laminated Film and Pouches
(PT/Al/PE) for Pharmaceutical Packaging
ISSUED ON. AUGUST 11, 2015
IMPLEMENTED ON. DECEMBER 1, 2015
Issued by. China Food and Drug Administration
3. No action is required - Full-copy of this standard will be automatically and
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Laminated Film and Pouches
(PT/Al/PE) for Pharmaceutical Packaging
Glass paper is a type of cellophane paper which is produced with regenerated fibre,
English name plane transparent cellophane, abbr. PT, also called cellophane.
The film of this product refers to the film formed by compounding glass paper (PT),
aluminium (Al) and polyethylene (PE). The pouches of this product refer to the pouches
which are made by thermal welding the film above mentioned.
This Standard applies to the laminated film and pouches for solid pharmaceuticals.
[Appearance] Take an appropriate amount of this product; conduct inspection in
accordance with the method under the item of appearance of General Rules for
Laminated Film and Pouches for Pharmaceutical Packaging (YBB00132002-2015). It
shall be as specified.
[Identification] Infrared Spectrum * Take an appropriate amount of this product;
conduct measurement in accordance with the fourth method of Test for Infrared
Spectrum of Packaging Materials (YBB00262004-2015). The PT and PE layers shall
be basically consistent with the reference spectrums.
[Barrier Property] Water Vapour Transmission Take an appropriate amount of this
product; conduct measurement in accordance with the test condition B of the second
method and the test condition 2 of the fourth method of Test for Water Transmission
(YBB00092003-2015). During test, the PE layer faces to the lower-humidity side, not
exceeding 0.5 g/(m2·24 h).
Oxygen Transmission Take an appropriate amount of this product; conduct
measurement in accordance with the first method or the second method of Test for
Gas Transmission (YBB00082003-2015). During test, the PE layer faces to the lower
oxygen pressure side, not exceeding 0.5 cm3/(m2·24 h·0.1 MPa).
[Mechanical Property] Peel Strength between Al Layer and PE Layer Take an
appropriate amount of this product; conduct measurement in accordance with Test for
Peel Strength (YBB00102003-2015). The mean values of peel strength, longitudinally
and laterally, shall not be lower than 2.5 N/15 mm.
[Thermal Welding Strength] (Film) Cut 4 test pieces of 100 mm × 100 mm; fold the
PE faces of any two test pieces together; conduct thermal welding on a thermal seal
tester. thermal welding temperature 120 ~ 160°C, pressure 0.2 ~ 0.3 MPa, duration 1
s. Conduct measurement in accordance with Test for Welding Strength
(YBB00122003-2015). The mean value shall not be lower than 12 N/15mm.