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YBB 00292005-2-2015 English PDF (YBB00292005-2-2015)

YBB 00292005-2-2015 English PDF (YBB00292005-2-2015)

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YBB 00292005-2-2015: Injection Vials Made of Middle Borosilicate Glass Tubing

The Standard is applicable to injection vials made of middle borosilicate glass tubing containing directly-dispensed injections, sterile powders for injection and concentrated solutions for injection.
YBB00292005-2-2015
YBB
Injection Vials Made of Middle Borosilicate Glass Tubing
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The Standard is applicable to injection vials made of middle borosilicate glass tubing containing directly-dispensed injections, sterile powders for injection and concentrated solutions for injection.
[Appearance] TAKE appropriate amount of this product; in the light of natural light, visually INSPECT from front. It shall be colorless and transparent or brown and transparent; the surface shall be clean and smooth, and there shall be no obvious glass defects; no cracks are allowed on any part.
[Identification]* (1) Coefficient of linear thermal expansion. TAKE
appropriate amount of this product, DETERMINE according to Tests for
Coefficient of Mean Linear Thermal Expansion (YBB00202003-2015) or Tests for Coefficient of Linear Thermal Expansion (YBB00212003-2015). It shall be (3.5 ~ 6.1) ?? 10-6 K-1 (20 ~ 300 ??C).
(2) Content of boron oxide. TAKE appropriate amount of this product,
DETERMINE according to Determination of Boron Oxide (YBB00232003-2015). The content of boron oxide shall not be less than 8 %.
[Hydrolytic resistance of glass grains at 121 ??C] TAKE appropriate amount of this product, DETERMINE according to Test and Classification for Hydrolytic Resistance of Glass Grains at 121 ??C (YBB00252003-2015). It shall comply with Grade 1.
[Hydrolytic resistance of glass grains at 98 ??C] TAKE appropriate amount of this product, DETERMINE according to Test and Classification for Hydrolytic Resistance of Glass Grains at 98 ??C (YBB00362004-2015). It shall comply with Grade HGB1.
[Hydrolytic resistance of interior surfaces] TAKE appropriate amount of this product, DETERMINE according to Test and Classification for Hydrolytic
Resistance of Interior Surfaces at 121??C (YBB00242003-2015). It shall comply with Grade HC1.
[Acid resistance]* TAKE appropriate amount of this product, DETERMINE
according to the first method of Tests for Resistance to Attack of Glass by Boiling Hydrochloric Acid (YBB00342004-2015), it shall comply with Grade 1; or DETERMINE according to the second method of Tests for Resistance to
Attack of Glass by Boiling Hydrochloric Acid (YBB00342004-2015), the amount of alkaline oxide leaching shall not exceed 100 ??g/dm2.
[Alkali resistance]* TAKE appropriate amount of this product, DETERMINE according to Tests for Resistance to Attack of Glass by Mixed Alkali Aqueous Solution (YBB00352004-2015), it shall not be lower than Grade 2.
[Internal stress] TAKE appropriate amount of this product, DETERMINE
according to Test for Stress (YBB00162003-2015). The optical path difference caused by the maximum permanent stress after annealing shall not exceed 40 nm/mm.
[Heat resistance] TAKE appropriate amount of this product, PLACE it in an oven, HEAT to 180 ??C in 30 minutes and KEEP at constant temperature for 2 hours, REMOVE it immediately, it shall not be broken.
[Freezing resistance] TAKE appropriate amount of this product, INJECT 1/2 of the nominal capacity of water into the freezer. The temperature is controlled at -41 ??C ?? 2 ??C. REMOVE after 24 hours, immediately PLACE it in the water at 40 ??C ?? 1 ??C; REMOVE after 1 minute, it shall not be broken.
[Leaching amount of arsenic, antimony, lead, cadmium]* TAKE appropriate amount of this product, DETERMINE according to Tests for Leaching Amount of Arsenic, Antimony, Lead and Cadmium (YBB00372004-2015). In per liter of leachate, arsenic shall not exceed 0.2 mg, antimony shall not exceed 0.7 mg, lead shall not exceed 1.0 mg, and cadmium shall not exceed 0.25 mg.
[Vertical axis deviation] TAKE appropriate amount of this product,
DETERMINE according to Test for Vertical Axis Deviation of Bottles
(YBB00192003-2015). It shall comply with the specifications of Table 1.

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