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State Food and Drug Administration

State Drug Packing Container (Material) Standard

(Pilot Edition)

                                                                                       YBB00272003 

Dipengguiboli Yaoyongguan Pharmaceutical tube made of low borosilicate glass

 This standard applies to low borosilicate glass tubing used to manufacture low borosilicate glass ampoule, injection vial, oral liquid bottle, etc.

 [Appearance] Perform direct visual inspection on a proper dose of this product in bright natural light. It shall be colourless or brown, smooth in surface and free of obvious glass defect.

 Crack. No crack shall exit at any part of this product.

 HAIRLINE By measurement via 0.02mm precision vernier caliper, ampoule tubing shall be free of any hairline wider than 0.10mm. This limit is 0.20mm for either injection vial or oral liquid bottle.

Concretion. By measurement via 0.02mm precision vernier caliper, ampoule tubing shall be free of any hairline with dia. greater than 0.50mm. The limits are 1.00mm and 2.00mm for injection vial and oral liquid bottle separately.

Knot. By measurement via 0.02mm precision vernier caliper, ampoule tubing shall be free of any hairline wider than 1.00mm. This limit is 2.00mm for either injection vial or oral liquid bottle.

Tube End Finishing and Flaring. Glass tube shall be finished and flared at both ends, or finished and flared at one end and closed at the other, free of bur or opening.

[Determination]* (1) Linear Thermal Expansion Coefficient: The coefficient shall be 6.2-7.5 ×10-6K-1 (20°C～300°C) by determining a proper dose of glass material as per Coefficient of mean linear thermal expansion (YBB00202003).

(2) Diboron Trioxide Content: B2O3 content shall be in the range: 5.0% ≦ content ＜8.0% (g/g) by determining a proper dose of this product as per Diboron trioxide determination (YBB00232003).

[Dimension Deviation] This below items shall be determined by measuring a proper dose of this product.

Outer Dia. Deviation. The deviation shall comply with Table 2, 3 or 4 by measuring the same section twice 250mm away from both tube ends via 0.02mm precision vernier caliper.

Wall Thickness Deviation and Skewness. Rotational measured shall be done at the same section via 0.01mm precision thickness. Wall thickness points to difference between max. and min thickness on the same section. By measurement, both wall thickness deviation and skewness shall comply with Table 2, 3 or 4.

Straightness. Max. nonstraightness of testing glass tube shall be not more than 2.5‰ by using the straightness tester with precision 0.10mm.

[121°C Glass Granule Water Resistance Determination Method] The result shall comply with class 1 requirement by measuring a proper dose of this product as per 121 degrees centigrade hydrolytic resistance of glass granule and classification (YBB00252003).

[Arsenic, Antimony and Lead Leaching Content]* The 3 element contents shall be: As≤0.07mg/dm2;Sb≤0.7mg/dm2;Pb≤0.8mg/dm2 by measuring a proper dose of this product as per Tests for release of arsenic antimony and lead (YBB00222003).

Appendix

Determination Rule Perform determination of crack, hairline, concretion, knot, tube end finishing & flaring, outer dia. deviation, wall thickness deviation & skewness and straightness as per Sampling procedures for inspection by attributes-Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection (GB/T2828-87) Inspection item, inspection level and acceptable quality level shall comply with Table 1.

Table 1 Inspection Item, Inspection Level and Acceptable Quality Level

Inspection Item		Inspection Level (IL)	Acceptable Quality Level (AQL)
Appearance	Crack	S-4	0.65
	Hairline		6.5
	Concretion
	Knot
	Tube  End Finishing & Flaring
Dimension Deviation	Outer Dia. Deviation		2.5
	Wall Thickness Deviation		2.5
	Wall Thickness Skewness
	Straightness	S-2	4.0

Note: Those items with * shall be performed at least once half a year. Besides, it shall be inspected promptly once main raw material source changes or production process changes greatly.

Appendix II Specification & Dimension

Specification & dimension of glass tube shall comply with Table 1 and Table 2, 3 or 4.

Table1

Table 2 Specification & dimension of Ampoule Glass Tube                             mm

Specification mL	Outer Dia. of Glass Tube d		Wall Thickness of Glass Tube S			Length of Glass Tube L		Nonstraightness t
	Basic Dimension	Extreme Deviation	Basic Dimension	Extreme Deviation	Wall Thickness Deviation	Basic Dimension	Extreme Deviation	Measured Distance	t ≤
1	10.00	±0.26	0.50	±0.04	≤0.04	700～2000	±6	1000	2.50‰
2	11.50
5	16.00	±0.30	0.55	±0.05	≤0.05
10	18.40	±0.35	0.60
20	22.00		0.70

Table 3 Specification & dimension of Injection Vial Glass Tube        mm

Specification mL	Outer Dia. of Glass Tube d		Wall Thickness of Glass Tube S			Length of Glass Tube L		Nonstraightness t
	Basic Dimension	Extreme Deviation	Basic Dimension	Extreme Deviation	Wall Thickness Deviation	Basic Dimension	Extreme Deviation	Measured Distance	t ≤
5	18.4	±0.30	0.80 0.90 1.00 1.20	±0.07	≤0.06	1000～2000	±6	1000	2.50‰
7 10	22.00	±0.35			≤0.07
25	28.00				≤0.08

Table 4 Specification & dimension of Oral Liquid Bottle Glass Tube      mm

Specification mL	Outer Dia. of Glass Tube d		Wall Thickness of Glass Tube S			Length of Glass Tube L		Nonstraightness t
	Basic Dimension	Extreme Deviation	Basic Dimension	Extreme Deviation	Wall Thickness Deviation	Basic Dimension	Extreme Deviation	Measured Distance	t ≤
10	18.00 18.40	±0.35	0.90	±0.06	≤0.06	1000～ 2000	±6	1000	2.50‰
20 25	22.00 28.00		1.10	±0.07	≤0.07

 

State Food and Drug Administration

State Drug Packing Container (Material) Standard

(Pilot Edition)

                                                               Instead  of  YBB00322005-2  

ZhongXingboli Anbu Ampoules made of neutral borosilicate glass tubing

This standard applies to colour circle and stipple mark easy-to-break neutral glass tube.

【[Appearance] Perform direct visual inspection on a proper dose of this product in bright natural light. It shall be colourless transparent or brown transparent, smooth in surface and free of obvious glass defect. No crack is allowed at any part. Coloured point of stipple mark easy-to-break ampoule shall be marked in the center of stipple with deviation not more than ±1.0mm from centerline.

[Determination]*

(1) Linear Thermal Expansion Coefficient. The coefficient shall be not more than 5×10-6k-1 (20°C-300°C) by determining a proper dose of this product as per Coefficient of linear thermal expansion (YBB00212003).

(2) Diboron Trioxide Content: B2O3 content shall be not less than 8% (g/g) by determining a proper dose of this product as per Diboron trioxide determination method (YBB00232003).

[121°C Water Resistance Granule Determination Method] The result shall comply with class 1 requirement by measuring a proper dose of this product as per 121 degrees centigrade hydrolytic resistance of glass granule and classification (YBB00252003).

[98°C Water Resistance Granule Determination Method] The result shall comply with class HGB1 requirement by measuring a proper dose of this product as per 98 degrees centigrade hydrolytic resistance of glass granule (YBB00362004).

[Internal Surface Water Resistance] This resistance shall comply with class HC1 requirement by measuring a proper dose of this product as per 121 degrees centigrade hydrolytic resistance of inside surface and classification (YBB00242003).

[Acid Resistance]* This resistance shall comply with class 1 requirement as per Method 1 in Glass--Resistance to attack by a boiling hydrochloric acid--gravimetric method of test and classification (YBB00342004); alternatively, basic content leaching content shall be less than or equal to 100μg/dm2 by measuring a proper dose as per Method 2 in Glass--Resistance to attack by a boiling hydrochloric acid--gravimetric method of test and classification (YBB00342004).

[Basic Resistance]* This resistance shall comply with class 2 requirement by measuring a proper dose of this product as per Glass - resistance to attack by boiling aqueous solution of mixed alkali - method of test and classification (YBB00352004).

[Internal Stress] Optical path difference resulted from max. permanent stress after annealing shall not exceed 40nm/mm by measuring a proper dose of this product as per Internal stress determination (YBB00162003).

[Circle Run-out] This shall comply with Table 1 by measuring a proper dose of this product as per Vertical axis deviation determination (YBB00192003).

Table 1 Max. Allowable Circle Run-out

Specification，ml	2	2	5	10	20
Circle Run-out t , mm	≤1.0		≤1.7		≤2.4

Note: Circle run-out is max. variation in outer dia. of stem of ampoule rotating around axis.

[Breaking Strength] This strength shall comply with value specified in Tables 2, 3 by measuring a proper dose of this product as per method in Appendix II. When ampoule is broken, the break section shall be smooth.

Table 2 Breaking Strength of Colour Ring and Stipple Mark Easy-To-Break Ampoule

Specification ml	Inter-Support Distance l =( l1 + l2 ) mm	Breaking Strength，N
		Min.	Max.
1	36 =（18+18）	30	80
2
3
5
10	60 =（22+38）		90
20			100
25

【[Arsenic, Antimony, , Lead , and Cadmium Leaching Content]* The 4 ele, ment contents shall be: As≤0.2mg/L, ; Sb≤0.07mg/L; Pb≤1.0, mg/L; Cd≤0.25mg/L by measuring a proper dose of this product, as per Tes, ts for Release of Arsenic Antimony Lead and Cadmium (YBB00372004).

Appendix I

Inspection Rule

1. Product inspection falls into full inspection and partial-item inspection.

2. If any below case occurs, please perform full inspection as per the standard.

（1）    Product registration.

（2）    Reproduction after severe quality accident of product.

（3）    Supervision of sample inspection.

（4）    Production restoration after stop of product.

3. Upon approval of product registration, inspection excluding items with “*” can be performed with no change of raw material origin, additive, production process, etc. by enterprises producing and employing medicine packing materials.

4. Appearance, internal stress, circle run-out, breaking strength shall be performed as per sampling procedures for inspection by attributes-Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection (GB/T2828.1-2003). Inspection item, inspection level and acceptable quality level shall comply with Table 3.

Table 3 Inspection Item, Inspection Level and Acceptable Quality Level.

Inspection Item	Inspection Level	Acceptable Quality Level
Appearance	I	4.0
Internal Stress	S—3	2.5
Circle Run-out	S—3	4.0
Breaking Strength	S—3	4.0

Appendix II

Breaking Strength Determination Method

Principle: Breaking strength is an applied force to separate ampoule bottle neck and body.

Meter: 0.1N precision ampoule breaking strength testing apparatus shall have the following characteristics:

--Determination Speed v: 10mm/min

--Breaking Measuring Range: 0-200N

See Fig. 1 for the testing apparatus.

Fig. 1 Easy-to-Break Ampoule Breaking Strength Test Apparatus

Test Steps: Retain a distance between 2 metal supports (shown as Fig. 1, specified by Table 2), so as to apply force between the 2 supports perpendicular to the tested ampoule central axis.

Force is applied via breaking strength testing apparatus until ampoule break; keep record of breaking strength value.

Note: When testing stipple mark easy-to-break ampoule breaking strength, force-applying parts of the apparatus shall be positioned at the center of stipple (stipple downward); otherwise, breaking strength will increase.

Appendix Ⅲ

Ampoule Specification & Dimension (Reference Dimension)

Fig. 2 Colour Ring Easy-to-Break Ampoule

Fig. 3 Stipple Mark Easy-to-Break Ampoule

Table 4 Specification & Dimension

Specification	Outer Dia.									Height
	Outer Dia.  of Body d1		Outer Dia. of Neck d2		Outer Dia. of Bulb d3		Outer Dia. of Stem d4		Coloured Point Dia. d7	Overall Height h1		Bottom-to-Neck Height h4		Bottom-to-Measuring Point Height h5
	Basic Dimension	Extreme Deviation	Basic Dimension	Extreme Deviation	Basic Dimension	Extreme Deviation	Basic Dimension	Extreme Deviation		Basic Dimension	Extreme Deviation	Basic Dimension	Extreme Deviation	Basic Dimension
1	10.00	±0.26	6.3	±0.8	7.8	±1.0	5.0	±0.6	2.0±0.5	60.0	±1.0	25.0	±1.0	57.0
2	11.50	±0.26	7.0	±0.8	8.5	±1.0	5.5	±0.6		70.0	±1.0	36.5	±1.0	67.0
3	13.30	±0.30	8.0	±0.8	9.2	±1.0	5.8	±0.6		70.0	±1.0	36.5	±1.0	67.0
5	16.00	±0.30	8.2	±1.0	10.0	±1.0	6.0	±0.6		87.0	±1.0	43.0	±1.0	84.0
10	18.40	±0.35	8.8	±1.2	11.0	±1.0	6.8	±0.8		102.0	±1.0	58.5	±1.2	99.0
20	22.00	±0.35	10.5	±1.2	13.0	±1.2	7.3	±1.0		126.0	±1.3	76.5	±1.5	123.0
25	22.00	±0.35	10.5	±1.2	13.0	±1.2	7.3	±1.0		144.0	±1.3	94.5	±1.5	141.0
Note: For the same ampoule: d1>d3>d2>d4