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YBB 00132002-2015: General requirement for laminated films and products for pharmaceutical packaging
YBB 00132002-2015
YY / YBB
PETROCHEMICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
General requirement for laminated films
and products for pharmaceutical packaging
ISSUED ON. AUGUST 11, 2015
IMPLEMENTED ON. DECEMBER 01, 2015
Issued by. China Food and Drug Administration of PRC
General requirement for laminated films
and products for pharmaceutical packaging
Composite film refers to the film formed by a variety of plastic and paper, metal
or other plastic through adhesives, with the thickness of generally not greater
than 0.25mm.
Composite bag refers to the bag made by heat sealing method of the
composite film, which can be divided into three-sided sealed bag, middle
sealed bag, organ bag, self-reliance bag, zipper bag, and so on.
This standard applies to the pharmaceutical composite film and bag for other
uses than injection.
Pharmaceutical composite film is classified in accordance with the material
combinations, as shown in Table 1.
Table 1 -- Composite film classification
Type Material Typical example
I Paper, plastic Paper or PT / adhesive layer / PE or EVA, CPP
II Plastic BOPET or BOPP, BOPA / adhesive layer / PE or EVA, CPP
III Plastic, aluminized film
BOPET or BOPP / adhesive / aluminized CPP
BOPET or BOPP / adhesive layer / aluminized BOPET / adhesive
layer / PE or EVA, CPP, EMA, EAA, ionic polymer
IV Paper, aluminium film, plastic
Paper or PT / adhesive layer / aluminium foil / adhesive layer / PE
or EVA, CPP, EMA, EAA, ionic polymer
Coating / aluminium foil / adhesive layer / PE or CPP, EVA, EMA,
EAA, ionic polymer
V Plastic (non-single layer), aluminium film
BOPET or BOPP, BOPA / adhesive layer / aluminium foil /
adhesive layer / PE or CPP, EVA, EMA, EAA, ionic polymer
Note 1. The glass paper is shortly referred to as PT, the biaxially-oriented
polypropylene is shortly referred to as BOPP, the biaxially-oriented
polypropylene terephthalate is shortly referred to as BOPET, the
biaxially-oriented polyamide nylon is shortly referred to as BOPA, The
polyethylene is shortly referred to as PE, the casting polypropylene is shortly
referred to as CPP, the copolymer of ethylene and ethylene vinyl acetate is
shortly referred to as EVA, the copolymer of ethylene and acrylic acid is shortly
referred to as EAA, AND the copolymer of ethylene and methacrylic acid is
shortly referred to as EMA.
Note 2. The composite may be of dry composite method or solvent-free
composite method, AND at this time the adhesive layer is general adhesive. It
may also use extrusion composite method, AND at this time the adhesive layer
is PE or EVA, EMA, EAA, and other resins.
1 mL of diluted sulfuric acid; MAKE it boil for 3 min; COOL it down quickly; ADD
0.1 g of potassium iodide; PLACE it in the dark for 5 min; USE the sodium
thiosulfate titration solution (0.01 mol/L) to titrate it, until it approaches to the
end point; ADD 5 drops of starch indicator solution; CONTINUE titration until it
is colorless; TAKE water blank solution and REPEAT the operation; AND the
difference of the sodium thiosulfate titration solution (0.01 mol/L) consumed
between them shall be not more than 1.5 mL.
Non-volatile substance. respectively and precisely MEASURE 100 mL of
water, 65% ethanol, n-hexane test solution, and blank solution into a
evaporation dish which had been reached to constant weight; EVAPORATE it
dry in water bath; DRY it at 105 °C for 2 hours; after cooling it down, WEIGH it
precisely; AND the difference between the water non-volatile substance
residues and the blank solution shall be not more than 30.0 mg; the difference
between the 65% ethanol non-volatile substance residues and the blank
solution residues shall be not more than 30.0 mg; AND the difference between
the n-hexane non-volatile substance residues and the blank solution residues
shall be not more than 30.0 mg.
Heavy metal. precisely MEASURE 20 mL of water test solution; ADD 2 mL of
acetate buffer (pH 3.5); CHECK the method 1 of the four general rules 0821 of
Chinese Pharmacopoeia 2015 version), AND the heavy metal content shall not
exceed one millionth.
[Microbial limit]. TAKE this product; USE the sterilized metal template having
an opening area of 20 cm2 to press it onto the inner layer; USE sodium
chloride injection to slightly wet the sterile cotton swab; WIPE within the plate
hole range for 5 times; CHANGE another swab to wipe it for another 5 times,
with each position wiped by 2 swabs for 10 times in total, AND totally 5
positions (100 cm2) are wiped. Each swab is cut (or burnt) off immediately after
wiping operation, AND placed into a conical flask (or large tube) containing 30
mL of sodium chloride injection. After all swabs are placed into the flask,
quickly SHAKE the flask for 1 min; LET it stand for 10 min, to obtain the test
solution. MAKE the test solution be filtered by the film; CHECK the four general
rules 1105 and 1106 of the Chinese Pharmacopoeia 2015 version; AND the
results shall comply with the requirements of Table 6.
Table 6 -- Microbial limits
Item Ordinary composite film and bag
Composite film and bag
for drugs of external use
Composite film and
bag for suppository
Number of bacteria (cfu
/ 100 cm2) ≤ 1000 ≤ 100 ≤ 100
Number of mold and
yeast (cfu / 100 cm2) ≤ 100 ≤ 100 ≤ 10
Escherichia coli Not detected - -
Staphylococcus aureus - Not detected Not detected
Pseudomonas
aeruginosa - Not detected Not detected
Note. “-” means that not detected for every 100 cm2.