China National Standard for Injecion Vials Made of Moulded Soda Lime Glass (YBB00312002-2015)
This standard applies to molded soda lime glass vials for sterile powder injections.
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* Linear Thermal Expansion Coefficient
Take an appropriate amount of the product and determine according to the Determination of Average Linear Thermal Expansion Coefficient (YBB00202003-2015) or Determination of Linear Thermal Expansion Coefficient (YBB00212003-2015). The coefficient should be (7.6–9.0) × 10⁻⁶ K⁻¹ (20–300℃).
Seam Line
Take an appropriate amount of the product and measure with a vernier caliper. The seam line at the vial mouth, measured by projection, shall not exceed 0.1 mm; seam lines at other parts shall not exceed 0.2 mm.
121℃ Granular Water Resistance
Take an appropriate amount of the product and test according to the Determination and Classification of Glass Granule Water Resistance at 121℃ (YBB00252003-2015). It shall meet Level 2 requirements.
Inner Surface Water Resistance
Take an appropriate amount of the product and test according to the Determination and Classification of Inner Surface Water Resistance at 121℃ (YBB00242003-2015). It shall meet HC3 level; if the inner surface has been neutralized, it shall meet HC2 level.
Thermal Shock Resistance
Take an appropriate amount of the product and determine according to the Method for Thermal Shock and Thermal Shock Strength (YBB00182003-2015, Method 1). After a thermal shock test with a temperature difference of 42℃, the vial shall not fracture.
Internal Pressure Resistance
Take an appropriate amount of the product and determine according to the Method for Internal Pressure Resistance (YBB00172003-2015, Method 1). After an internal pressure test of 0.6 MPa, the vial shall not fracture.
Internal Stress
Take an appropriate amount of the product and determine according to the Method for Internal Stress Determination (YBB00162003-2015). The optical path difference caused by the maximum residual stress after annealing shall not exceed 40 nm/mm.
Leachables of Arsenic, Antimony, Lead, and Cadmium
Take an appropriate amount of the product and determine according to the Determination of Leachables of Arsenic, Antimony, Lead, and Cadmium (YBB00372004-2015). The leachables shall not exceed 0.2 mg/L for arsenic, 0.7 mg/L for antimony, 1.0 mg/L for lead, and 0.25 mg/L for cadmium.
Vertical Axis Deviation
Take an appropriate amount of the product and determine according to the Method for Measuring Vertical Axis Deviation (YBB00192003-2015). The results 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) |
5 |
7 |
8 |
10 |
12 |
15 |
20 |
25 |
30 |
50 |
100 |
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Bottle Type |
A |
B |
A |
B |
A |
B |
A |
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Vertical Axis Deviation amax(mm) |
1.1 |
1.2 |
1.4 |
1.5 |
1.6 |
1.9 |
2.4 |
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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 Item |
Inspection Level |
Acceptable Quality Limit (AQL) |
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Appearance |
Cracks |
1 |
0.65 |
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Others |
4.0 |
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Seam Line |
S-4 |
4.0 |
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Thermal Shock Resistance |
S-3 |
1.0 |
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Internal Pressure Resistance |
S-3 |
1.5 |
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Internal Stress |
S-2 |
1.0 |
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Vertical Axis Deviation |
S-2 |
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 Main Specification Dimensions Unit：mm |
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Specification（ml） |
Vertical Axis Deviation amax |
Overall Bottle Height h1 |
Bottle Body Outer Diameter d1 |
Bottle Neck Outer Diameter d2 |
Bottle Neck Inner Diameter d3 |
Neck Wall Thickness S1 |
Bottom Thickness S2 |
Neck Outer Diameter d4 |
Neck Inner Diameter d5 |
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Dimension |
Tolerance |
Dimension |
Tolerance |
Dimension |
Tolerance |
Dimension |
Tolerance |
Dimension |
Tolerance |
Dimension |
Tolerance |
max |
min |
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5.0 |
Type A |
1.1 |
41.3 |
土0.5 |
20.8 |
土0.4 |
20.0 |
+0.2 |
12.6 |
土0.2 |
3.8 |
土0.3 |
3.0 |
土1.2 |
17.0 |
11.5 |
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Type B |
38.7 |
22.0 |
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7.0 |
Type A |
40.8 |
22.1 |
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Type B |
38.7 |
24.5 |
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8.0 |
Type A |
1.2 |
46.8 |
土0.6 |
23.0 |
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10.0 |
1.4 |
53.5 |
25.4 |
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12.0 |
Type B |
1.5 |
56.8 |
27.0 |
-0.3 |
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15.0 |
Type A |
58.8 |
26.5 |
土0.5 |
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20.0 |
58.0 |
32.0 |
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25.0 |
36.0 |
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30.0 |
1.6 |
62.8 |
土0.7 |
36.0 |
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50.0 |
1.9 |
73.0 |
土0.8 |
42.5 |
土0.8 |
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100.0 |
2.4 |
94.5 |
土0.9 |
51.6 |
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Table 4 Additional Specification Dimensions unit：mm |
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Specification |
Full Capacity (ml) |
Weight (g) |
Concave Bottom Thickness t |
h2 |
h3 |
r1 |
r2 |
r3 |
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|
≈ |
≈ |
≈ |
min |
min |
≈ |
≈ |
≈ |
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|
5.0 |
Type A |
7.0 |
14.0 |
1.0 |
26.2 |
5.5 |
8.4 |
1.5 |
10.0 |
|
Type B |
7.3 |
14.5 |
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7.0 |
Type A |
9.0 |
13.0 |
26.7 |
6.0 |
5.0 |
2.0 |
4.4 |
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Type B |
14.5 |
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8.0 |
Type A |
10.0 |
16.0 |
29.5 |
6.0 |
9.5 |
1.5 |
7.0 |
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|
10.0 |
15.0 |
21.0 |
35.3 |
5.7 |
10.0 |
2.0 |
5.1 |
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12.0 |
Type B |
16.0 |
25.0 |
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15.0 |
Type A |
17.0 |
24.0 |
36.5 |
5.8 |
15.0 |
2.5 |
9.5 |
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|
20.0 |
26.0 |
29.0 |
36.1 |
5.5 |
12.0 |
3.0 |
6.1 |
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25.0 |
32.0 |
30.0 |
1.5 |
34.0 |
6.5 |
5.0 |
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30.0 |
38.0 |
35.0 |
40.8 |
5.5 |
4.3 |
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50.0 |
60.0 |
50.0 |
46.0 |
6.0 |
12.5 |
8.5 |
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100.0 |
119.0 |
89.0 |
2.0 |
58.0 |
5.8 |
25.6 |
4.0 |
7.0 |
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