YBB 00162004-2015 PDF in English
YBB 00162004-2015 (YBB00162004-2015) PDF English
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Name of Chinese Standard | Status |
| YBB 00162004-2015 | English | 110 |
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Bromobutyl rubber plungers and liners for pen-injectors
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Standards related to (historical): YBB 00162004-2015
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YBB 00162004-2015: PDF in English YBB 00162004-2015
YY / YBB
National Drug Packing Container (Material) Standard
Bromobutyl rubber plungers
and liners for pen-injectors
ISSUED ON. AUGUST 11, 2015
IMPLEMENTED ON. DECEMBER 01, 2015
Issued by. China Food and Drug Administration of PRC
3. No action is required - Full-copy of this standard will be automatically &
immediately delivered to your EMAIL address in 0~60 minutes.
Bromobutyl rubber plungers
and liners for pen-injectors
This standard applies to bromobutyl rubber plungers and liners for pen-injectors sleeves.
[Appearance] TAKE several products; MAKE visual inspection from frontside in the bright
natural light. The surface color shall be uniform; it shall be free from stains, impurities,
bubbles, cracks, lack of plastic, roughness, rubber thread, rubber fragment, sponge-like, or
burr; it shall be free from incompleteness or jagging due to trimming operation; AND it shall
be free from obvious mark due to die.
[Identification] * (1) TAKE appropriate amount of this product; CUT it into small particles;
WEIGH 2.0 g; PLACE it into crucible; ADD 2.0 g of sodium bicarbonate to uniformly cover
the sample; PLACE it on the electric furnace; slowly HEAT it until it is carbonized; LET it cool
naturally; PLACE it in the high temperature furnace at 300 °C to heat it until it is totally ashed;
TAKE it out; LET it cool naturally; ADD 10 mL of water to dissolve it; FILTER it; TAKE 1.5 mL
of filtrate; PLACE it into the test tube; ADD nitric acid to acidize it; ADD 1 drop of silver nitrate
test solution; AND it shall produce yellow precipitate.
(2) TAKE appropriate amount of this product; MAKE determination in accordance with the
method 4 of the packaging material infrared spectroscopy (YBB00262004-2015), AND the
results shall be consistent with the control map.
[Puncture chip] (Liner) liner pretreatment. TAKE a few liners; ADD water (ml) the volume of
which is twice the total surface area (cm2) of the liner; MAKE it boil for 5 min; USE water to
flush it for 5 times; PLACE the liner into the conical flask; ADD water the volume of which is
twice the total surface area (cm2) of the liner to cover the liner; USE aluminum foil or silicon
borate beaker to cover the conical flask mouth; PLACE it into the high pressure steam
sterilizer for heating; INCREASE the temperature to 121 °C ± 2 °C; MAINTAIN this
temperature for 30 minutes; COOL it to room temperature; TAKE it out; BAKE it at 60 °C for
60 minutes; STORE it in a sealed glass vessel to prepare for use.
FILL water into the 50 pen-injector sleeves fitted with a plunger to half of its volume; USE the
liner under test and aluminum cap (with hole at middle) to seal it; USE 50 pen-injector sleeves
equipped with the liner having known number of puncture chip numbers to repeat this
procedure. Alternatively PUNCTURE the rubber liner in the sequence of the liner under test
AND then the liner having known number of puncture chip. During puncturing, PLACE the
pen-injector sleeve perpendicularly on a stable base; MAKE the liner end upwards; FILL
water into the injector sleeve and REMOVE the water from the injection needle (outer
diameter 0.4 mm subcutaneous injection needle, as shown in Figure 1 and Table 1); HOLD
the injector sleeve vertically to puncture the liner; INJECT 1 ml of water into the flask; before
each puncturing, USE acetone or methyl-isobutyl ketone to wipe the injection needle;
REPLACE the injection needle after 20 times of puncturing, until all the liners are punctured
for one time; TAKE off the liner under test; USE fast filter paper to filter all the water in the
flask; ENSURE that there is no chip remaining in the flask; under normal conditions, KEEP
the distance from the eyes and the filter paper at 25 cm; USE naked eyes to fast observe the
number of chips on the fast filter paper; MAKE record; MAKE same operation for the liners
Nonvolatile matter. precisely MEASURE 100 ml of test solution and blank solution,
respectively; PLACE them respectively into the evaporation dish which had been dried to
constant weight; EVAPORATE it dry in water bath; DRY it at 105 °C to constant weight; AND
the difference between the two must not be more than 4.0 mg.
Heavy metal. precisely MEASURE 10 ml of test solution; ADD 2 ml of acetate buffer (pH
3.5); MAKE reference to the (four general rules 0821 of “Chinese Pharmacopoeia” 2015
version); AND the heavy metal content shall not be more than one millionth.
Ammonium ion. precisely MEASURE 10 ml of test solution; ADD 2 ml of alkaline potassium
mercuric iodide test solution; PLACE it for 15 min; AND it shall not have color; if it has color,
COMPARE it with the control solution which is prepared by adding 8 ml of blank solution and
2 ml of alkaline potassium mercuric iodide test solution into the ammonium chloride solution
(TAKE 31.5 mg of ammonium chloride; ADD appropriate amount of ammonia free water to
dissolve and dilute it to 1000.0 ml), AND its color shall not be deeper (0.0002%).
Zinc ion. TAKE the test solution; USE the filter membrane having a pore size of 0.45 μm to
filter it; precisely MEASURE 10 ml of filtrate; ADD 1 ml of 2 mol/L hydrochloric acid and 3
drops of potassium ferrocyanide test solution (WEIGH 4.2 g of potassium ferrocyanide
trihydrate; USE water to dissolve it and dilute it to 100 ml; SHAKE it uniformly to obtain this
test solution, which shall be prepared before use); MIX it; AND it shall be free from turbidity;
however, if there is turbidity, COMPARE it with the control solution which is prepared by
adding 7 ml of blank control solution, 1 ml of 2 mol/L hydrochloric acid and 3 drops of
potassium ferrocyanide test solution into 3.0 ml of standard zinc solution (WEIGH 44.0 mg
of zinc sulfate heptahydrate; USE newly boiled and cooled water to dissolve and dilute it to
1000.0 ml; AND this product shall be prepared before use); AND it shall not be deeper
(0.0003%).
Conductivity. Within 5 hours of preparation of the test solution; USE the conductivity meter
to make determination, AND the conductivity of the blank solution shall not exceed 3.0 μS/cm
(20 °C ± 1 °C); AND the conductivity of the solution under test shall not exceed 40.0 μS/cm.
However, if the determination is not made at 20 °C ± 1 °C, the temperature shall be corrected.
[Biological test] pyrogen*. TAKE this product; ADD sodium chloride injection in accordance
with the proportion of irregular shape; PLACE it into the high pressure steam sterilizer at
115 °C ± 2 °C; MAINTAIN for 30 minutes; MAKE determination in accordance with the
pyrogen inspection method (YBB00022003-2015); AND it shall comply with requirements.
Acute systemic toxicity test**. TAKE this product; ADD sodium chloride injection in
accordance with the proportion of irregular shape; PLACE it into the high pressure steam
sterilizer at 115 °C ± 2 °C; MAINTAIN for 30 minutes; MAKE determination in accordance
with the acute systemic toxicity inspection method (YBB00042003-2015); AND it shall comply
with requirements.
Hemolysis**. TAKE this product; MAKE determination in accordance with the hemolysis
inspection method (YBB00032003-2015); AND the hemolysis rate shall comply with
requirements.
Appendix I inspection rules
1. Product inspection is divided into full item inspection and partial item inspection.
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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