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YBB 00092004-2015 PDF in English


YBB 00092004-2015 (YBB00092004-2015) PDF English
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YBB 00092004-2015: PDF in English

YBB 00092004-2015
MEDICAL PACKAGING STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Stainless steel needles for prefilled syringes
Stainless steel needles for prefilled syringes
This standard is applicable to stainless steel needles which are assembled to
the prefilled syringes for the use of human intradermal, subcutaneous,
intramuscular, intravenous injections, and so on.
[Appearance] Take the appropriate amount of this product. In bright natural
light, make visual inspection. The needle tube shall be clean and free of
impurities. The need tube shall be straight. The tip must be free of defects such
as burrs and hooks. When the surface of the needle tube uses lubricant, the
surface of the needle tube shall be free of droplets. The connection between
the syringe and the needle holder shall be straight; there shall be no obvious
skew.
[Rigidity] Take appropriate amount of this product which has been separated
from the glass needle tube. Put it on a rigid test instrument [it may apply a force
of at most 60 N (accuracy of ±0.1 N) through the push rod; the force is
perpendicularly action onto the needle tube. The lower end of the push rod
consists of a wedge with an angle of 60° and a cylindrical surface which has a
radius of curvature of 1 mm. The width of the push rod is at least 5 mm. The
measurement accuracy of the displacement of instrument is 0.01 mm (Figure
1)]. Follow the requirements below to adjust the need tube and the rigid test
instrument: 1. Make the span be the value as corresponding to the
specifications of tested needle tube in Table 1; 2. Make the surface of the end
of the push rod be located at the center of the span; 3. Make the needle tube
be perpendicular to the two syringe holders and the push rod; meanwhile make
the centerline of the needle tube coincide to the centerline of the syringe holder.
Use the span and load conditions as specified in Table 1 to carry out test: Based
on the force corresponding to the syringe specifications in this Table, use the
rate of 1 mm/min to apply a downward bending force to the needle tube through
the push rod. Measure and record the deflection of the needle tube at the point
of force application, accurate to 0.01 mm. The syringe shall have good rigidity.
The maximum deflection shall meet the requirements of Table 1.
skin. The needle tip points to the center of the circular puncture region. At a
speed of 100 mm/min ± 10 mm/min, perpendicularly puncture the simulated
skin to carry out the puncture test. Meanwhile record the maximum peak force
(note: it shall not use the film the circular puncture region of which had been
subjected to puncture). The maximum puncture force of the tip shall meet the
requirements of Table 5.
Table 5 -- Puncture force
[Connection force between needle and syringe holder] [Pull-out force of
needle cap] Use the method of “Prefilled syringe assembly (with injection
needle) (YBB 00112004-2015) to carry out inspection. It shall meet
requirements.
[Chemical properties] Preparation of test solution: Immerse 25 pieces of the
product from which the cap and glass needle tube have been removed into 250
ml of water. At the temperature of 37 ~ 40 °C, immerse it for 1 hour. Take out
the injection needle. Use the same method to prepare blank solution to carry
out the following tests.
pH: Take 20 mL of the test solution. Add 1 mL of potassium chloride solution
(1→1000). Make determination according to the four volumes of general
provisions 0631 of “Chinese Pharmacopoeia” 2015 version. The difference from
the blank solution must not exceed 1.0.
Cadmium ions: Take an appropriate amount of test solution. If necessary, it
may be concentrated. According to the atomic absorption spectrophotometry in
the four volumes of general provisions 0406 of “Chinese Pharmacopoeia” 2015
version, make determination at the wavelength of 228.8 nm, which shall be not
more than 1 part per 10 million.
Heavy metal: Precisely take 20 mL of test solution. Add 2 mL of acetate buffer
(pH 3.5). Use the method-1 of the four volumes of general provisions 0821 of
“Chinese Pharmacopoeia” 2015 version, to carry out inspection. The content of
heavy metal does not exceed 5 parts per million.
[Biological test] ** Preparation of test solution: Immerse 25 pieces of the
product from which the cap and glass needle tube have been removed into 250
mL of sodium chloride injection. At the temperature of 37 ~ 40 °C, immerse it
for 1 hour. Take out the injection needle (The test solution shall not be stored
for more than 2 hours).
Specifications (mm) Puncture force (N)
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.