Borosilicate glass regulatory injection bottle revision draft

14   Specifications and product identification

14.1   Standard sizes        

     The size of the glass-controlled injection bottle should meet the requirements of Table 7 , Table 8, and Figure 1 .

Table 7 Specification of Borosilicate Glass Regulatory Injection Bottles

Unit: mm

Specification mL

Body diameter d1

Outer diameter d2

Bottle inner diameter d4

Bottle height h1

Bottle thickness h4

Thickness s2

≥

Vertical axis deviation a

basic size

limit deviation

basic size

limit

deviation

basic size

limit

deviation

Basic

size

limit

deviation

Basic

size

limit

deviation

2

16.0

± 0.2

13.0

+0.2

-0.3

7.0

± 0.20

31.00

± .030

3.6

± 0.20

0.60

1.0

3

35.00

4

7.6

37.60

0.50

5

18.4

± 0.2

39.7

± 0.40

7

21.8

19.6

± 0.25

12.6

+0.2

-0.3

39.7

1.2

8

42.7

10

49.7

12

24.5

44.5

15

25.9

26.5

51.7

52.0

0.60

20

28.0

± 0.3

55.0

± 0.50

1.5

25

28.0

65.0

30

32

66.0

  Note: The basic size in the table is non-mandatory.

Table 8 Borosilicate Glass Regulatory Injection Bottle Reference Size

Unit: mm

specification

Ml

bottleneck

Outside diameter

D3max

Bottle height

H2

≈

bottleneck

H3

≈

Wall thickness

S1

≈

R1

≈

R2

≈

t

Max

quality

≈

g

Full of mouth

capacity

Ml

2

10.5

18.0

8.0

0.8

2.5

1.5

0.7

4.2

3.5

3

20.0

4.6

4.2

4

23.0

6.8

4.8

4.8

5

25

7.5

7.5

7.5

7

16.0

25

1.0

3.5

2.0

8.2

10.5

8

27

8.5

11.5

10

37

9.7

13.5

12

42

10.5

14.5

15

30

9.8

1.15

12.1

18.0

20

35.0

7.5

1.20

5.5

2.5

1.0

15.0

23.5

25

45.0

16.2

28.5

30

45.0

10.0

20.3

35

  Note: This table is non-mandatory.

14.2 Product Identification

Example: YBB00292002 meet the requirements, specifications for 10ml (10R), the water level GB12416.1 - HC1 (1) as a colorless glass (Cl) control injection bottles identified as follows: Bottle YBB00292002    10R — cl — 1

15   skills requirement

15.1   Materials

15.1.1   Borosilicate glass employed as a colorless injection bottles (Cl) or amber (br) pharmaceutically acceptable transparent borosilicate glass tubing.

15.1.2   Borosilicate glass tubes for borosilicate glass controlled injection bottles should meet the requirements of YBB00262003 .

15.2   Water resistance

     Water resistance of inner surface of borosilicate glass control injection bottle should conform to GB12416.1   HC1 water resistance rating.

15.3   Internal stress

     The internal stress of the bottle should be less than 15 nm/mm glass thickness.

15.4   Appearance Quality

15.4.1   Stones and nodules

        a. There should be no stones greater than 0.5mm in diameter .

        b. There should be no nodules larger than 1.0 mm in diameter .

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