Chinese National Standard for Soda-Lime Glass Moulded Pharmaceutical Bottles (YBB00272002-2015)

This standard applies to molded soda-lime glass pharmaceutical bottles intended for containing oral or topical (external-use) medicinal products.

Appearance
Take an appropriate quantity of the product and examine visually under bright natural light from a frontal view. The bottles shall be colorless and transparent or translucent amber. The surface shall be smooth and even, free from obvious glass defects; no cracks are permitted in any part of the bottle.

Identification * Coefficient of Linear Thermal Expansion
Take an appropriate quantity of the product and determine according to the Method for Determination of Mean Linear Thermal Expansion Coefficient (YBB00202003-2015) or the Method for Determination of Linear Thermal Expansion Coefficient (YBB00212003-2015). The coefficient shall be (7.6–9.0) × 10⁻⁶ K⁻¹ (20–300 °C).

Seam Line
Take an appropriate quantity of the product and measure using a vernier caliper.
The protrusion of the seam line at the bottle mouth shall be not more than 0.3 mm, and at other positions shall be not more than 0.5 mm.

Hydrolytic Resistance of Glass Grains at 121 °C
Take an appropriate quantity of the product and determine according to the Method and Classification for Hydrolytic Resistance of Glass Grains at 121 °C (YBB00252003-2015). The result shall comply with Class 2.

Hydrolytic Resistance of the Inner Surface
Take an appropriate quantity of the product and determine according to the Method and Classification for Hydrolytic Resistance of the Inner Surface at 121 °C (YBB00242003-2015). The result shall comply with Class HC3.

Thermal Shock Resistance
Take an appropriate quantity of the product and determine according to the Methods for Thermal Shock and Thermal Shock Strength (YBB00182003-2015), Method I. After withstanding a temperature difference of 42 °C, the bottle shall not crack or break.

Internal Stress
Take an appropriate quantity of the product and determine according to the Method for Determination of Internal Stress (YBB00162003-2015).
After annealing, the optical path difference caused by the maximum residual stress shall be not more than 40 nm/mm.

Extractable Amounts of Arsenic, Antimony, Lead, and Cadmium *
Take an appropriate quantity of the product and determine according to the Method for Determination of Extractable Arsenic, Antimony, Lead, and Cadmium (YBB00372004-2015).
In each liter of extract solution:

Arsenic (As): ≤ 0.2 mg

Antimony (Sb): ≤ 0.7 mg

Lead (Pb): ≤ 1.0 mg

Cadmium (Cd): ≤ 0.25 mg

Vertical Axis Deviation
Take an appropriate quantity of the product and determine according to the Method for Determination of Vertical Axis Deviation (YBB00192003-2015). The result shall comply with the requirements specified in Table 1.

Table 1 Maximum Allowable Vertical Axis Deviation
Size (ml)	≤100	120-350	400-950	1000
Vertical Axis Deviation αmax (mm)	1.5	2	2.5	3.2

 

Brimful Capacity
Take an appropriate quantity of the container. Weigh the empty bottle using a balance with an accuracy of 1 g, then fill it with water at room temperature up to the brim and weigh again. The difference between the two weights is the brimful capacity (1 g of water at room temperature can be approximately regarded as 1 ml).

The capacity of wide-mouth pharmaceutical bottles shall comply with the requirements of Table 2, and that of narrow-mouth pharmaceutical bottles shall comply with the requirements of Table 3.

Table 2 Capacity Tolerance of Wide-Mouth Pharmaceutical Bottles                                                                                                                                                                               Unit: ml
Size	Brimful Capacity	Tolerance	Size	Brimful Capacity	Tolerance
10	13	±3	250	285	±11
20	23		300	335
30	35	±4	350	385
40	45		400	435	±12
50	55	±5	450	485
60	65		500	535
80	90	±7	550	600	±13
100	110		600	650
120	130		650	700
140	160	±9	750	800	±15
170	190		850	900
200	220		950	1000

 

Table 3 Capacity Tolerance of Narrow-Mouth Pharmaceutical Bottles                                                                                                                                                                            Unit: ml
Size	Brimful Capacity	Tolerance	Size	Brimful Capacity	Tolerance
25	30	±3	200	240	±11
50	60	±5	500	600	±13
100	120	±7	1000	1200	±15

 

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 (supervisory) 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, in accordance with the requirements of this standard, perform inspections excluding the items marked with “*”.

4.Inspections of appearance, seam line, thermal shock resistance, internal stress, vertical axis deviation, and brimful capacity 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 4.

Table 4 Inspection Items, Inspection Levels and Acceptance Quality Limits (AQL)
Inspection Items		Inspection Level	Acceptance Quality Limit (AQL)
Appearance	Cracks	I	1.5
	Others		4.0
Seam line	I	4.0	4.0
Thermal shock resistance	S-2	1.0	1.0
Internal stress	S-2	0.65	0.65
Vertical axis deviation	S-3	2.5	2.5
Brimful capacity	S-3	1.5	1.5

 

Appendix II Dimensional Specifications (Reference Dimensions)

The dimensional specifications may refer to Figures 1 and 2 and Table 5, as well as Figures 3 and 4 and Tables 6, 7 and 8.

 

 

Table 5 Main Dimensional Specifications of Wide-Mouth Glass Pharmaceutical Bottles                                                                                                                                                                                                                                                                                                                               Unit: mm
Nominal Size (ml)	Body Outside Diameter D		Overall Bottle Height H		Thread Outside Diameter d1		Finish Outside Diameter d2		Finish Inside Diameter d3		Neck Outside Diameter d4	Base Diameter d5	Shoulder Radius r1	Bottom Radius r2	Finish (Head) Height h1	Bottom Arc Depth h2	Thread Width b	Thread Pitch t
	Dimension	Tolerance	Dimension	Tolerance	Dimension	Tolerance	Dimension	Tolerance	Dimension	Tolerance	Dimension	Dimension	Dimension	Dimension	Dimension	Dimension	Dimension	Dimension
10	32	±1.0	43	±1.0	25	+0.0 -0.6	22.6	0.0 -0.6	16	+0.0 -1.0	19.6	22	4	5	12.0	1.5	2.0	3.5
20			62
30	38		64		32		29.2		22		26	24	6	7			2.5	4.0
40			76
50	43		73									29	8		14.0	2.0
60			83
80	51	±1.2	75	±1.2	40	+0.0 -0.8	37.2	+0.0 -0.8	30		34	37
100			88
120			100
140	59		88		50		47.2		40		44	41	7	9
170			101
200			111
250	70	±1.2	107	±1.2	63	+0.0 -1.0	60.2	+0.0 -1.0	53	+0.0 -1.0	57	48	6	11
300			122
350			137
400	76	±1.5	130	±1.5								54	9
450			143
500			156
550	84		141		70		67.2		60		64	58		13
600			151
650			161
750	94		155
850			171
950			187

 

Table 6 Main Dimensional Specifications of Narrow-Mouth Glass Pharmaceutical Bottles        Unit: mm
Nominal Size (ml)	Body Outside Diameter D		Overall Bottle Height H		Thread Outside Diameter d1		Finish Outside Diameter d2		Finish Inside Diameter d3		Neck Outside Diameter d4	Base Diameter d5	Shoulder Radius r1	Bottom Radius r2	Finish (Head) Height h1	Bottom Arc Depth h2	Thread Width b	Thread Pitch t
	Dimension	Tolerance	Dimension	Tolerance	Dimension	Tolerance	Dimension	Tolerance	Dimension	Tolerance	Dimension	Dimension	Dimension	Dimension	Dimension	Dimension	Dimension	Dimension
25	34	±1.0	71	±1.0	22	+0.0 -0.6	19.6	+0.0 -0.6	13	+0.0 -1.0	16.6	24	3	5	12	1.5	2.0	3.5
50	42		89									30	4	6
100	50	±1.2	107	±1.2	25		22.6		16		19.6	36		7		2.0
200	61		128									44		10
500	83	±1.5	168	±1.5	32		29.2		22		26.0	59		12	14	2.5	2.5	4.0
1000	103		210									75		14

 

Table 7 Weight of Wide-Mouth Pharmaceutical Bottles
Size (ml)	Weight (g)	Size (ml)	Weight (g)	Size (ml)	Weight (g)
10	23	120	116	450	266
20	38	140	125	500	280
30	50	170	140	550	294
40	58	200	155	600	310
50	70	250	180	650	326
60	77	300	198	750	358
80	90	350	216	850	390
100	103	400	252	950	422

 

Table 8 Weight of Narrow-Mouth Pharmaceutical Bottles
Size (ml)	Weight (g)	Size (ml)	Weight (g)	Size (ml)	Weight (g)
25	47	100	105	500	312
50	78	200	180	1000	500