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YBB 00082004-2015 (YBB00082004-2015)

Chinese standards (related to): 'YBB 00082004-2015'
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YBB 00082004-2015English130 Add to Cart 0-9 seconds. Auto delivery. Bromobutyl rubber plungers for prefilled syringes YBB 00082004-2015 Valid YBB 00082004-2015


   
BASIC DATA
Standard ID YBB 00082004-2015 (YBB00082004-2015)
Description (Translated English) Bromobutyl rubber plungers for prefilled syringes
Sector / Industry Medical & Pharmaceutical Packaging Industry Standard
Classification of Chinese Standard C08
Word Count Estimation 3,357
Date of Issue 2015-08-11
Date of Implementation 2015-12-01
Older Standard (superseded by this standard) YBB 0008-2004
Regulation (derived from) China Food & Drug Administration Announcement 2015 No.164


YBB 00082004-2015: PDF in English
YBB 00082004-2015
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
Bromobutyl rubber plungers for prefilled syringes
Bromobutyl rubber plungers for prefilled syringes
This standard applies to brominated butyl rubber plungers for prefilled syringes.
Plunger types are either snap-fit type (PSL) or threaded type (PT).
[Appearance] Take a few of this product. In a bright place with natural light,
visually check it from front side. The surface color shall be uniform. There shall
be no stains, impurities, bubbles, cracks, lack of glue, roughness, rubber hair,
glue chipping, sponge, burrs. There shall be no defects or jaggedness caused
by edge removal. There shall be no obvious molding mark. If there is pouring
mouth, it shall not project from the surface of the plunger.
[Identification] * (1) Weigh 2.0 g of this product. Cut it into small particles.
Place it in a crucible. Add 2.0 g of sodium bicarbonate to cover the specimen
evenly. Place it on an electric furnace. Slowly heat to carbonize it. Let it cool.
Place it in a muffle furnace at 300 °C to burn it until completely ash it. After
taking out, cool it to room temperature. Add 10 ml of water to dissolve it. Filter
it. Take 1.5 ml of the filtrate. Place it in a test tube. Add nitric acid. Add 1 drop
of silver nitrate test solution. It shall produce light yellow precipitate.
(2) Take an appropriate amount of this product. Follow the 4th method of the
“Determination method for packaging materials by infrared spectrometry” (YBB
00262004-2015). It shall be basically consistent with the control spectrum.
[Matching of plunger and push rod] [Plunger lubricity] [Plunger sliding
performance] [Plunger tightness] Check it according to the method under the
“Assembly of pre-filled syringe (with injection needle)” (YB 00112004-2015). It
shall comply with requirements.
[Ash content] Take 1.0 g of this product. Follow the “Determination method of
ash content” (YBB 00262005-2015) to make determination. The residual
residue shall not exceed 50%.
[Volatile sulfide] * Take this product and determine it according to the
“Determination method of volatile sulfide” (YBB 00302004-2015), which shall
meet the requirements.
[Insoluble particles] Take 10 of this product. Add 50 ml of water for particle
inspection. Follow the medicinal rubber stopper item under the “Determination
method of insoluble particle of packaging materials” (YBB 00272004-2015).
There shall be no more than 60 particles that are larger than 10 µm particles
per 1 ml. There shall be no more than 6 particles that are larger than 25 µm
particles per 1 ml.
[Chemical properties] Preparation of test solution: Take a number of complete
shall not exceed one millionth.
Ammonium ion: Precisely take 10 ml of the test solution. Add 2 ml of alkaline
potassium mercury iodide test solution. Let it stand for 15 min. It shall not have
color development. If color is developed, when compared with the control
solution which is prepared by 2.0 mL of ammonium chloride solution (add an
appropriate amount of ammonia-free water into 31.5 mg of ammonium chloride
to dissolve and dilute it to 1000.0 ml), 8 ml of blank extraction solution, 2 ml of
alkaline potassium mercury iodide test solution, it shall not be deeper (0.0002%)
Zinc ion: Take the test solution. Use a 0.45 um filter membrane to filter it.
Precisely take 10 ml of the 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 it, which shall be prepared before use) to mix it. It shall not
be turbid. If it is turbid, it shall be compared with the control solution which is
prepared by 3.0 ml of the standard zinc solution (weigh 44.0 mg of zinc sulfate
heptahydrate; use the freshly boiled and cooled water to dissolve and dilute it
to 1000.0 ml; this product shall be prepared before use), 7 ml of blank control
solution, 1 ml of 2 mol/L hydrochloric acid, 3 drops of ferrocyanide potassium
chloride test solution; the color shall not be deeper (0.0003%).
Conductivity: Within 5 hours of the preparation of the test solution, use a
conductivity meter to measure it. Use water to rinse the measuring electrode
(bright platinum electrode or platinum black electrode) for several times. Take
the blank solution to rinse the electrode at least 2 times. The measured
conductivity of the blank solution shall not to exceed 3.0 µS/cm (20 °C ± 1 °C).
Then use the test solution to rinse the electrode for at least 2 times. Measure
the conductivity of the test solution, which shall not exceed 40.0 µS/cm. If the
measurement is not performed at 20 °C ± 1 °C, it shall correct the temperature.
[Biological test] Pyrogen * Take this product. Add sodium chloride injection
according to the irregular shape ratio. Place it in a high-pressure steam sterilizer
at 115 °C ± 2 °C for 30 minutes. Make determination according to the “Pyrogen
inspection method” (YBB 00022003-2015). The results shall meet the
requirements.
Acute systemic toxicity test ** Take this product. Add sodium chloride
injection according to the irregular shape ratio. Place it in a high-pressure steam
sterilizer at 115 °C ± 2 °C for 30 minutes. Make determination according to the
“Acute systemic toxicity test method” (YBB 00042003-2015). The results shall
meet the requirements.
Hemolysis ** Take this product and make determination according to the
“Hemolysis test method” (YBB 00032003-2015). The hemolysis rate shall meet
the requirements.
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