China National Standard for Injection Vials Made of Neutral Borosilicate Glass Tubing (YBB00292005-2-2015)
This standard applies to Injection Vials Made of Neutral Borosilicate Glass Tubing intended for directly filled injections, sterile powders for injection, and concentrated solutions for injection.
Appearance
Take an appropriate quantity of the product and visually inspect it under bright natural light from a frontal view. The vials shall be colorless and transparent or translucent amber. The surface shall be smooth and even, free from obvious glass defects. Cracks are not permitted in any part of the vial.
Identification*
(1) Coefficient of Linear Thermal Expansion
Take an appropriate quantity of the product and determine according to the Average Coefficient of Linear Thermal Expansion Method (YBB00202003-2015) or the Linear Thermal Expansion Coefficient Method (YBB00212003-2015). The result should be (3.5–6.1) × 10⁻⁶ K⁻¹ (20 °C–300 °C).
(2) Boron Trioxide Content
Take an appropriate quantity of the product and determine according to the Boron Trioxide Content Determination Method (YBB00232003-2015). The content of boron trioxide shall not be less than 8%.
121 °C Hydrolytic Resistance of Glass Grains
Take an appropriate quantity of the product and determine according to the Determination and Classification Method for Hydrolytic Resistance of Glass Grains at 121 °C (YBB00252003-2015). It shall comply with Class 1.
98 °C Hydrolytic Resistance of Glass Grains
Take an appropriate quantity of the product and determine according to the Determination and Classification Method for Hydrolytic Resistance of Glass Grains at 98 °C (YBB00362004-2015). It shall comply with Class HGB1.
Hydrolytic Resistance of the Inner Surface
Take an appropriate quantity of the product and determine according to the Determination and Classification Method for Hydrolytic Resistance of the Inner Surface at 121 °C (YBB00242003-2015). It shall comply with Class HC1.
Acid Resistance*
Take an appropriate quantity of the product and determine according to Method I of the Determination Method for Resistance of Glass to Boiling Hydrochloric Acid (YBB00342004-2015). It shall comply with Class 1; or determine according to Method II of the same standard, in which case the leached amount of alkaline oxides shall not exceed 100 µg/dm².
Alkali Resistance*
Take an appropriate quantity of the product and determine according to the Determination Method for Resistance of Glass to Boiling Mixed Alkali Aqueous Solution (YBB00352004-2015). It shall not be lower than Class 2.
Internal Stress
Take an appropriate quantity of the product and determine according to the Internal Stress Determination Method (YBB00162003-2015). After annealing, the optical path difference caused by the maximum permanent stress shall not exceed 40 nm/mm.
Thermal Resistance
Take an appropriate quantity of the product, place it in an oven, heat to 180 °C within 30 minutes, maintain at constant temperature for 2 hours, then remove immediately. It shall not crack.
Freeze Resistance
Take an appropriate quantity of the product, fill it with water to 1/2 of the nominal capacity, and place it in a freezer at −41 °C ± 2 °C. After 24 hours, remove it and immediately place it in water at 40 °C ± 1 °C. After 1 minute, remove it. It shall not crack.
Leachable Amounts of Arsenic, Antimony, Lead, and Cadmium*
Take an appropriate quantity of the product and determine according to the Determination Method for Leachable Amounts of Arsenic, Antimony, Lead, and Cadmium (YBB00372004-2015). In each 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 an appropriate quantity of the product and determine according to the Vertical Axis Deviation Determination Method (YBB00192003-2015). It shall comply with the requirements specified in Table 1.
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Table 1 Maximum Allowable Vertical Axis Deviation |
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Specification（ml） |
2 |
3 |
4 |
5 |
6 |
8 |
10 |
15 |
20 |
25 |
30 |
50 |
|
Maximum vertical axis deviation amax (mm) — Flat-shoulder vials |
1.00 |
- |
1.00 |
- |
1.20 |
1.50 |
- |
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Maximum vertical axis deviation amax (mm) — Sloping-shoulder vials |
1.00 |
1.20 |
- |
1.30 |
- |
- |
1.40 |
- |
1.50 |
1.80 |
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Annex I – Inspection Rules
1.Product inspection shall be divided into full inspection and partial inspection.
2.Full inspection shall be conducted in accordance with the requirements of this standard under any of the following circumstances:
(1) Product registration;
(2) Resumption of production after a major quality incident;
(3) Regulatory or supervisory sampling inspection;
(4) Resumption of production after a production suspension.
3.After the product has been approved for registration, where there are no changes in raw material origin, additives, production processes, or other relevant factors, pharmaceutical packaging material manufacturers and users may perform inspections excluding the items marked with “*”, in accordance with the requirements of this standard.
4.Inspections for appearance, seam line, thermal shock resistance, internal pressure resistance, internal stress, and vertical axis deviation shall be carried out in accordance with Sampling Procedures for Inspection by Attributes — Part 1: Sampling Schemes Indexed by Acceptance Quality Limit (AQL) for Lot-by-Lot Inspection (GB/T 2828.1-2012).
The inspection items, inspection levels, and acceptance quality limits are specified in Table 2.
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Table 2 Inspection Items, Inspection Levels, and Acceptable Quality Limits (AQL) |
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Inspection Items |
Inspection Levels |
Acceptable Quality Limits (AQL) |
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Appearance |
Cracks |
I |
0.65 |
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Others |
4.0 |
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Internal stress |
S-1 |
1.5 |
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Thermal resistance |
S-3 |
0.65 |
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Freeze resistance |
S-3 |
0.65 |
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Vertical axis deviation |
S-3 |
2.5 |
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Appendix II Specification Dimensions (Reference Dimensions)
The specification dimensions can be referred to in Figure 1, Table 3, and Table 4.
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Table 3 Dimensional Specifications of Flat-Shoulder Type Vials |
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Specification（ml） |
2 |
4 |
6 |
8 |
10 |
15 |
20 |
25 |
30 |
|
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Maximum vertical axis deviation amax |
1 |
1.2 |
1.5 |
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Outer diameter of the bottle d1 |
Dimension |
16 |
22 |
24 |
30 |
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Tolerance |
±0.2 |
±0.2 |
±0.3 |
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Outer diameter of the vial mouth d2 |
Dimension |
13 |
20 |
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Tolerance |
+0.2 -0.3 |
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Outer diameter of the neck finish d3max |
10.5 |
16 |
16.5 |
17.5 |
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Inner diameter of the vial mouth d4 |
Dimension |
7 |
12.5 |
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Tolerance |
±0.2 |
±0.2 |
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Bottom thickness S2 |
≥0.7 |
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Overall vial height h1 |
Dimension |
35 |
45 |
40 |
45 |
60 |
55 |
65 |
75 |
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Tolerance |
±0.5 |
±0.7 |
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Body length h2 |
23 |
33 |
27 |
32 |
31 |
46 |
35 |
45 |
55 |
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Neck length h3 |
Dimension |
8 |
8.5 |
9 |
10 |
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Tolerance |
±0.5 |
±0.75 |
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Rim thickness h4 |
Dimension |
3.6 |
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Tolerance |
±0.2 |
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Wall thickness S1 |
Dimension |
1 |
1.2 |
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Tolerance |
±0.04 |
±0.05 |
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Table 4 Dimensional Specifications of Sloping-Shoulder Type Vials |
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Specification （ml） |
2 |
3 |
5 |
10 |
15 |
20 |
30 |
50 |
|
|
Vertical axis deviation amax |
1.00 |
1.20 |
1.30 |
1.40 |
1.50 |
1.80 |
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Outer diameter of the bottle d1 |
Dimension |
16.00 |
16.40 |
22.00 |
24.00 |
28.00 |
40.00 |
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Tolerance |
±0.3 |
±0.35 |
±0.4 |
1.00 |
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Outer diameter of the vial neck d1 |
Dimension |
13.00 |
19.60 |
28.80 |
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Tolerance |
+0.2 -0.3 |
±0.3 |
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Outer diameter of the vial neck d3max |
10.50 |
16.00 |
16.50 |
17.50 |
23.30 |
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Inner diameter of the vial mouth d4 |
Dimension |
7.00 |
12.50 |
18.80 |
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Tolerance |
±0.2 |
±0.3 |
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Bottom thickness S2 |
≥0.4 |
≥0.7 |
≥1 |
≥1.2 |
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Overall vial height h1 |
Dimension |
35.00 |
37.00 |
39.00 |
48.00 |
58.00 |
60.00 |
80.00 |
80.00 |
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Tolerance |
±0.5 |
±0.7 |
±1 |
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Neck length h3 |
Dimension |
8.00 |
8.50 |
12.00 |
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Tolerance |
±0.5 |
±0.8 |
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Rim thickness h4 |
Dimension |
3.60 |
4.50 |
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Tolerance |
±0.2 |
±0.3 |
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Wall thickness S1 |
Dimension |
1.00 |
1.10 |
1.30 |
1.50 |
1.80 |
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Tolerance |
±0.06 |
±0.08 |
±0.1 |
±0.05 |
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