YBB 00172002-2015 English PDF (YBB00172002-2015)

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YBB 00172002-2015: Laminated film and pouches (PET/Al/PE) for pharmaceutical packaging
YBB 00172002-2015
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Laminated film and pouches (PET/Al/PE) for
pharmaceutical packaging
Laminated film and pouches (PET/Al/PE) for
pharmaceutical packaging
This product refers to the films as composited of polyester (PET), aluminum (Al)
and polyethylene (PE) by a binder, as well as the pouches made by heat-sealing
the above films.
This standard applies to composite films and pouches for packaging of solid
pharmaceutical.
[Appearance] Take appropriate amount of this product. Use the method under
the appearance item of the General rules for composite films and pouches (YBB
00132002-2015). It shall comply with the requirements.
[Identification] Take appropriate amount of this product. Use the method 4 of
the Determination of packaging materials by infrared spectroscopy (YBB
00262004-2015) to make determination. The PET and PE layers shall be
basically consistent with the control map, respectively.
[Barrier performance] The amount of permeated water vapor: Take
appropriate amount of this product. Use the method 1, 2, or 4 of the
Determination of permeated water vapor (YBB 00092003-2015) to make
determination. During the test, allow the PE layer to face the lower-humidity
side. The test temperature is 38 °C ± 2 °C. The relative humidity is 90% ± 5%.
It shall not exceed 0.5 g / (m2 • 24 h).
The amount of permeated oxygen: Take the appropriate amount of this
product. Use the method 1 or 2 of the Determination of the amount of
permeated gas (YBB 00082003-2015) to make determination. During the test,
allow the PE layer to face the low-pressure side of oxygen. It shall not exceed
0.5 cm3 / (m2 • 24 h • 0.1 MPa).
[Mechanical properties] Peel strength of PE layer and Al layer: Use the
method under the peel strength item of inner layer and sub-inner layer of the
General rules for medicinal composite films and pouches (YBB 00132002-2015)
to make determination. The average values of longitudinal and transverse peel
strength shall not be lower than 2.5 N/15 mm.
[Heat bonding strength] (film) Cut 4 test pieces of 100 mm × 100 mm. Stack
the PE sides of any two test pieces. Put it on the heat sealer to heat-bond it.
The heat-sealing temperature is 150 ~ 170 °C. The pressure is 0.2 ~ 0.3 MPa.
The time is 1 second. Use the method of the Determination of heat bonding