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YBB 00172002-2015 PDF English

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YBB 00172002-2015: Laminated film and pouches (PET/Al/PE) for pharmaceutical packaging
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Standard IDContents [version]USDSTEP2[PDF] deliveryName of Chinese StandardStatus
YBB 00172002-2015English125 Add to Cart 0-9 seconds. Auto-delivery Laminated film and pouches (PET/Al/PE) for pharmaceutical packaging Valid

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YBB 00162003   YBB 00162004   YBB 00172004   

YBB 00172002-2015: Laminated film and pouches (PET/Al/PE) for pharmaceutical packaging

---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YBB00172002-2015
PHARMACEUTICAL INDUSTRY STANDARD 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 ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.


      

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