YBB 2027-2012 English PDF (YBB2027-2012)

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YBB 2027-2012: PA/Al/PVC Cold-formed Foil for Solid Pharmaceutical Packaging
YBB2027-2012
State Food and Drug Administration
of the People’s Republic of China
Direct contact with drug’s
packaging materials and containers standard
National Institutes for Food and Drug Control
Packaging Materials and Pharmaceutical Excipients Inspection Institute
December 2012
PA/Al/PVC Cold-formed Foil for
Solid Pharmaceutical Packaging
This standard applies to the foil that is compositely made of medicinal polyvinyl chloride (PVC),
aluminum (Al), and polyamide (PA) through an adhesives. It applies to solid medicines (tablets,
capsules, suppositories, etc.) that is packaged with blister packs by cold-form.
[Appearance] Take appropriate amount of the sample. Under natural light, visually inspect it
directly. There must not have defects such as perforation, foreign bodies, smell, adhesion,
composite layer’s separation and significant damage, bubbles, wrinkles, and dirt.
[Identification] Infrared spectrum*: Take appropriate amount of the sample. Determine it
according to the Fourth Method of The Test Method for Infrared Spectrum in Packaging material
(YBB60012012). PA and PVC shall be consistent with the contrast spectrums respectively.
[Physical Properties] Water Transmission: Take appropriate amount of the sample. It shall be
determined according to Test Methods for Water Transmission’s (YBB60302012) The Second
Test Method’s test conditions to select Option B or The Fourth Method’s test conditions to select
Option 2. When testing, the side of the PVC that faces to low humidity must not exceed 0.5g /
(M2 • 24h).
Gas Transmission: Take appropriate amount of the sample. It shall be determined according to
Test Methods for Gas Transmission’s (YBB60292012) First Method (When testing, PVC shall
be faced to the low-pressure side). It must not exceed 0.5cm3 / (m2 • 24h • 0.1MPa).
Peel strength: Take appropriate amount of the sample. It shall be determined according to Tests
for Peel Strength (YBB60312012). The peel strength between PA / Al layer must not be less than
8.0N / 15mm. The peel strength between Al / PVC layer must not be less than 7.0N / 15mm. (If
the composite layer can not be peeled off or the composite layer is fractured, then the peel
strength is deemed as qualified).
Welding strength: Cut 2 slices of the sample in 100mm × 100mm. The PVC surface of the
composite foil is superimposed to the same-size pharmaceutical packaging aluminum foil
(YBB10012012). Perform the welding on heat-seal instrument. The welding temperature is
155 °C ± 5 °C. The pressure is 0.2Mpa. The time is 1 second. Cut 15mm-wide samples from the
welding area. Take the middle 3 strips to perform the test. It shall be determined according to the
Tests for Welding Strength (YBB60332012). The average value of welding strengths of 6 samples
must not be less than 6.0N / 15mm.
[Translator: This paragraph is not part of December-2012 version] [Solvent residue] Take
appropriate amount of the sample. Cut out 0.2m2 of the inner surface area. It shall be determined
according to the Test Method for Residue of Solvent in Packaging Material (YBB60062012). The
total amount of solvent residues must not exceed 5.0mg / m2; in which, the residue of benzene-
type solvents must not be detected. The detection limit of single benzene-type solvent is 0.01mg
/ m2. [Translator: This paragraph is not included in December-2012 version]
[Vinyl chloride monomer] Take appropriate amount of the sample. It shall be determined
according to Tests for Determination of vinyl chloride monomer (YBB60352012). It must not
exceed one in a million.