YBB 00112012 PDF English
Search result: YBB 00112012_English: PDF (YBB00112012)
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Name of Chinese Standard | Status |
| YBB00112012 | English | 195 |
Add to Cart
|
0-9 seconds. Auto-delivery.
|
Injection Vials Made of Neutral Borosilicate Glass Tubing
| |
BUY with any currencies (Euro, JPY, GBP, KRW etc.): YBB 00112012 Related standards: YBB 00112012
PDF Preview: YBB 00112012
YBB 00112012: PDF in English YBB 00112012
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
Injection Vials Made of Neutral Borosilicate Glass Tubing
中性硼硅玻璃管制注射剂瓶
Injection Vials Made of Neutral Borosilicate Glass Tubing
This Standard applies to the injection vials made of neutral borosilicate glass tubing that contain
directly sub-packaged injection, sterile powder for injection and concentrated solution for
injection.
[Appearance] Take an appropriate amount of this product and look directly at it in a bright
natural light place. It shall be colorless and transparent or brown and transparent; the surface
shall be smooth and flat, and there shall be no obvious glass defects; there shall be no cracks in
any part.
[Identification] * (1) Linear thermal expansion coefficient: Take an appropriate amount of this
product; and measure it according to the average linear thermal expansion coefficient
measurement method (YBB60412012) or the linear thermal expansion coefficient
measurement method (YBB60422012), which shall be (4~5)×10-6K-1 ( 20~300℃).
(2) The content of diboron trioxide: Take an appropriate amount of this product and measure it
according to the diboron trioxide measurement method (YBB60432012). The content of B2O3
shall be 8% ~ 12%.
[Water resistance by particle method at 121°C] Take an appropriate amount of this product
and measure it according to the water resistance measurement method of glass particles at
121°C (YBB60452012), which shall meet Class-1.
[Water resistance by particle method at 98°C] Take an appropriate amount of this product
and measure it according to the water resistance measurement method of glass particles at 98°C
(YBB60112012), which shall meet the Class-HGB1.
[Water resistance on the inner surface] Take an appropriate amount of this product and
measure it according to the water resistance determination method of the inner surface at 121°C
(YBB60442012), which shall meet the Class-HC1.
[Acid resistance] * Take an appropriate amount of this product, and measure it according to
the first method of the corrosion resistance of glass in boiling hydrochloric acid measurement
method (YBB60092012), which shall meet the Class-1; or measure it according to the second
method of the corrosion resistance of glass in boiling hydrochloric acid measurement method
(YBB60092012); the leaching amount of alkaline oxide shall not exceed 100μg/dm2.
[Alkali resistance] * Take an appropriate amount of this product and measure it according to
the corrosion resistance of glass in boiling mixed alkali aqueous solution measurement method
(YBB60102012), which shall be no lower than Class-2.
[Internal stress] Take an appropriate amount of this product and measure it according to the
internal stress determination method (YBB60372012). The optical path difference caused by
the maximum permanent stress after annealing shall not exceed 40nm/mm.
[Heat resistance] Take an appropriate amount of this product; put it in an oven; within 30
minutes, heat it to a constant temperature of 180°C for 2 hours; and take it out immediately, it
shall not be broken.
[Freezing resistance] Take an appropriate amount of this product; pour 1/2 of the nominal
capacity of water into the freezer; and control the temperature at -41℃±2℃. Take it out after
24 hours; put it in water at 40℃±1℃ immediately; take it out after 1 minute, it shall not be
broken.
[Leaching amount of arsenic, antimony, lead, and cadmium] * Take an appropriate amount
of this product and measure it according to the method for the determination of leaching amount
of arsenic, antimony, lead and cadmium (YBB60122012). The amount of arsenic, antimony,
lead, and cadmium in each 1L of leaching solution shall not exceed 0.2 mg, 0.7 mg and 1.0mg,
and 0.25mg, respectively.
[Vertical axis deviation] Take an appropriate amount of this product and measure it according
to the vertical axis deviation measurement method (YBB60402012), which shall meet the
requirements in Table 1.
Attachment-I: Inspection Rules
1. Product inspection is divided into full inspection and partial inspection.
2. In one of the following situations, the full inspection shall be carried out according to the
requirements of the standard.
(1) Product registration.
(2) The product is re-manufactured after a major quality accident occurs.
(3) Supervise random testing.
(4) Resumption of production after the product has been discontinued.
3. After the product is approved to register, the pharmaceutical packaging material production
and use enterprises can conduct inspections for items other than "*" in accordance with the
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
|