squatsaluminium foil

2021年1月20日发(作者：丫鬟怎么写)
Chinese State Food and Drug Administration Standard for Container
(material) of Pharmaceuticals

Aluminum Foil for Medicine


YBB00152002-2015

This standard specifies the specification of aluminium foil which adhered to PVC, PVDC
and
used for solid
medicine (tablet, capsule) packaging. The
aluminium foil consists of
protective layer and adhesive layer.
Appearance

Visual examination. It should be clear, smooth, evenly. The literature and
draft should be correct, clear and steady.
Pin hole


T
ake 10 samples of 400mmx250mm, check the pin-hole on a inspecting stand
(or wooden box , 800mmx600mmx300mm, 30W light, a glass plate on the box, a black
paper under the glass with the area of 400mmx250mm empty for checking) individually in
the dark. No close, continuous and periodic hole existed: In every 1 square meter no hole
which
diameter
is
above
0.3mm
existed;
and
not
more
than
1
hole
which
diameter
is
between 0.1-0.3mm.

Block
property



Water
vapor
transmission


Perform
the
test
according
to
test
condition B of method I or test condition B of method II or test condition 2 of method IV of
Test for Water Transmission (YBB00092003-2015),the side of heat-seal is towards to low
humidity side . Not more than 0.5g/(m
2
.24h).


Heat sealing strength of adhesive layer
Unless other specified
,
cut 2 samples with the
size
of
100mmx100mm,
sealed
by
heat
with
the
same
size
of
PVC
sheet
(YBB00212005-2015)or
PVC/PDVC
compound
sheet(YBB00222005-2015)
under
following conditions: 155
±
5
℃
,0.2MPa, 1 s. Cool and cut 3 strips (width: 15mm) from the
centre
of
each
sealed
sample,
perform
the
Tests
for
Welding
Strength
(YBB00122003-2015), test speed: 200mm/min
±
20mm/ the tension tester peel
the
piece
of
PVC(PVDC)
and
aluminium
foil
at
the
direction
of
180
°
,
Not
more
than
7.0N/15mm for PVC, 6.0N/15mm for PVDC.



Banding property of protective layer

Take a sample with the length of 90mm (no
crumple) and put it on a glass plate, protective layer up. Adhere the protective layer with
polyester type (peeling strength is not less than 2.94N/20mm) averagely. Peel rapidly at
the direction of 160-180
°
.(See figure 1). No obvious falling emerged on protective layer.

Figure 1: Banding property of protective layer

Heat
resistant
property
of
protective
layer


Take
3
samples
with
the
size
of
100mx100mm, superimpose the protective layer with aluminium foil raw material, sealed
by
heat
(200
℃
,0.2MPa,
1
s).
Cool
and
separate
the
sample
from
aluminium
foil
raw
material.
Observe
change
of
the
protective
layer.
There
is
no
obvious
falling
on
the
surface of protective layer.

Weight variation of adhesive

Take 5 samples with the size of 100mmx100mm, weigh
each
sample
accurately
(m
1
).
Remove
adhesive
by
ethyl
acetate
or
other
solvent
and
weigh
again
(m
2
).
The
difference
of
m
1

and
m
2

is
the
amount
of
adhesive
applied.
Calculate the average value of the 5 samples. The derivation between the weight of each


and the average should be within
±
10%.

The property of opening and rolling


Take 4 samples with the size of 100mmx100mm,
superimpose the protective layer and the adhesive layer. Put it on a flat plate, add another
flat plate of 20mmx20mm and a balance weight of 1.0kg (figure 2) and keep for 2 hours at
40
℃
in
an
oven.
The
protective
layer
and
the
adhesive
layer
should
not
be
adhered
together.


Figure 2: The property of opening and rolling.

Breaking strength


Not less than 98KPa, Take 3 samples with the size of 40mmx40mm
and test by breaking tester.

Fluorescent matter

No flake-formed fluorescence emerged on the protective layer or
the
adhesive
layer.
Take
2
samples
with
the
size
of
100mmx100mm,
observe
under
UV254nm and 365nm.


Volatile matter

Take 2 samples with the size of 100mmx100mm, weigh accurately (m
a
).
Dry at 130
℃
for 20 minutes and store at desiccator for 30 minutes, weigh again (m
b
). The
difference of (m
a
-m
b
) should be not more than 4mg.

Tests on soluble matters

Take 1 sample with the inner surface area of 300cm
2
(cut into
the pieces with
the size of 3cmx0.3cm), wash
by water and
dry. Put the
sample into a