TitleProduct

10ml Clear Glass Ampoule

  • Price:

    Negotiable

  • minimum:

  • Total supply:

  • Delivery term:

    The date of payment from buyers deliver within days

  • seat:

    Henan

  • Validity to:

    Long-term effective

  • Last update:

    2021-07-14 01:25

  • Browse the number:

    66

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Company Profile

Zhengzhou Frontier Pharmaceutical Co., Ltd

By certification [File Integrity]

Contact:fengan(Mr.)  

Email:

Telephone:

Phone:

Area:Henan

Address:Henan

Website:http://www.fapharmaceutical.com/ http://fengan.china-gdl.com/

PRODUCT DETAILS

Series Of Ampoule Bottle


The biggest advantage of ampoule bottle is string anti-interference,and the druge is only in contact with glass.

According to the ISO (TypeB, TypeC, TypeD) and YBB specification, or custom to design.

Form:1~40ml

Color: Clear amber

Break System: Point nick broken(OPC)

Easy To fold the ring broken(CBR)

Heavy metal - free color ring printing



Key

Key

Key

1 constriction

1 funnel

1 dome

2 sealing point

/ /

3 stem

/ /

4 bulb

/ /

5 shoulder

/ /

6 base or bottom

/ /


Note

For dimensions of parameters, see Table 1.

Figure 1 - Form B Stem, cut ampoule with constriction
Figure 2 - Form C Stem, open-funnel ampoule with constriction
Figure 3 -Form D Stem, sealed ampoule with constriction


Table 1 — Dimensions Of Ampoules

Dimensions In Millimetres


Dimension

Nominal volume

ml

1

2

3

5

10

20 25 30

External diameter

Body

a

d1

/

10,75

10,75

12,75

14,75

17,75

22,5

22,5

22,5

tol.

±0,15

±0,15

±0,15

±0,15

±0,20

±0,25

±0,25 ±0,25

Constriction

b

d2

/

6,5

6,5

6,5

7

7,5

8,5

8,5

8,5

tol.

±0,5

±0,5

±0,5

±0,5

±0,5

±0,5

±0,5 ±0,5

Bulb

d3

/

8,5

8,5

8,5

9

9,5

12

12

12

tol.

±0,5

±0,5

±0,5

±0,5

±0,5

±1

±1 ±1

Stem

d4

/

6

6

6

7

7,1

7,8

7,8

7,8

tol.

±0,35

±0,35

±0,35

±0,35

±0,35

±0,5

±0,5 ±0,5

Funnel

c

d5

/

9

9

10,7

12,2

13

14

14

14

tol.

±0,8

±0,8

±0,8

±1

±1

±1

±1 ±1

Dome

c

d6

/

10

10

10,5

12

13,5

13,5

13,5

13,5

tol.

±1

±1

±1

±1

±1

±1

±1 ±1

Flared end

d7

/

8

8

8

9

9,5

11

11

11

tol.

±1

±1

±1

±1

±1

±1

±1 ±1

Overall height

Form B

h1

/

60

72

75

83

102

113

128

143

tol.

±1

±1

±1

±1

±1

±1

±1 ±1

Form C

h2

/

67

79

82

90

109

120

135

150

tol.

±1

±1

±1

±1

±1

±1,5

±1,5 ±1,5

Form D

h3

/

70

83

89

95

112

126

141

156

tol.

±1

±1

±1

±1

±1

±1

±1 ±1

Height

Height to constriction

h4

/

25,5

37,5

39,5

46,5

62

76

91

106

tol.

±0,5

±0,5

±0,5

±0,5

±1

±1,3

±1,3 ±1,3

Height to gauging point

h5

/

47

57

62

68

87

100

115

130

tol.

±2

±2

±2

±2

±2

±2

±2 ±2

Body height

h6


min.

21

33

35

41

55

65

80 95


Height measured from centre

of constriction to bulb

h7


max.

4,5

4,5

5

5,5

6

6,5

6,5 6,5

Base

Radius

r

/

1

1

1,5

1,5

1,5

2,0

2,0

2,0

tol.

±0,5

±0,5

±0,5

±0,5

±0,5

±0,5

±0,5 ±0,5

Depth of the base

e

/

1

1

1

1

1,25

1,5

1,5

1,5

tol.

±0,5

±0,5

±0,5

±0,5

±0,75

±1

±1 ±1


Table 1 (Continued) Dimensions In Millimetres


Dimension

Nominal volume

ml

1

2

3

5

10

20 25 30

Wall thickness

Glass thickness of body

w1

/

0,5

0,5

0,5

0,55

0,6

0,7

0,7

0,7

tol.

±0,03

±0,03

±0,03

±0,03

±0,04

±0,04

±0,04 ±0,04

Glass thickness of stem at gauging

w2

/

0,37

0,37

0,37

0,40

0,47

0,50

0,50

0,50

tol.

±0,05

±0,05

±0,05

±0,05

±0,05

±0,05

±0,05 ±0,05

Glass thickness at base

w3


min.

0,3

0,3

0,3

0,4

0,4

0,5

0,5 0,5

Glass thickness at constriction

w4

/

0,7

0,7

0,7

0,7

0,8

1

1

1

tol.

±0,1

±0,1

±0,1

±0,15

±0,15

±0,2

±0,2 ±0,2

Glass thickness of dome

w5


/

0,1 to 0,25 0,1 to 0,30

Circular run-out tolerance

td


/

0,6

0,6

0,8

1

1

1,2

1,2 1,2

Volume to centre of constriction ml »

V


/

1,5

2,3

3,5

5,5

11,5

23,5

28,5 33,5

a. The deviation from the perpendicularity between bottom and length axis at the body outside diameter shall not exceed an angle of 2°.

b. If there is a need to reduce the constriction diameter, e.g. due to a reduction of particles, it shall be agreed between the manufacturer and purchaser.

c. No point of the funnel and the dome shall be outside the body diameter.

d. The run-out tolerance shall be measured at the sealing point (according to ISO 1101).


Table 2 — Breaking Force


Nominal volume

ml

Length

l (= l1 + l2) mm

Breaking force

Fmin.

N

Fmax.

N

1

36 (= 18 + 18)

30

80

2

3

5

10

60 (= 22 + 38)

90

20

100

25

30


1. Test For Breaking Force

1.1 Principle


The test is suitable for determining the force required to separate the ampoule stem from the body and for assessing whether a clean break is obtained.


1.2 Tensile Testing Machine


The tensile testing machine shall be in accordance with ISO 7500-1 and have the following characteristics:

↓ A test speed, v, of 10 mm/min;

↓ A measuring range for force of 200 N.


Note

Other test procedures, e.g. with a power increase of 20 N/s, are admissible if equivalent results can be obtained.

An example of the test set-up is illustrated in Figure 4.


1.3 Sampling

1.3.1 Number Of Samples


Random sampling in accordance with ISO 2859-1 (inspection level S-4) is recommended.


1.3.2 Conditioning Of Samples

The temperature of the samples shall be 20 °C ± 5 °C.


1.4 Procedure


Set the distance between the metal bars, as shown in Figure 4 so that the force is imparted on the middle of the bars at an angle of 90° to the axis of the ampoule.

Apply the force using the tensile testing machine to rupture. Record the breaking force.


Dimensions In Millimetres



Key


1 metal bars

2 ampoule

3 punch of the tensile testing machine


Note

For dimensions of parameters, see Table 2.

Figure 4 — Example of test set-up for determining the force for breaking ampoules


1.5 Expression Of Results


In order for the ampoule to comply with this part of ISO 9187, all single test results shall comply with the relevant values specified in Table 2.


1.6 Test Report


The following information shall be specified in the test report:

a) A description of the test set-up, including the tensile testing machine;

b) A description of the sample;

c) The number of samples;

d) The test results, including the arithmetic mean, x , and the standard deviation, s, of the sample;

e) The place and date of the tests;

f) The name and signature of the person who carried out the tests.


2. Delivery


2.1 Ampoules shall be sorted according to their design and nominal volumes, and shall be delivered in packaging units (see Clause 8).

2.2 If desired, secondary sorting of ampoules according to stem diameter, d4, in the measuring axis shall be subject to agreement between the manufacturer and user.


3. Packaging


3.1 The packaging unit shall have the following dimensions:

↓ Length (internal): 384 mm;

↓ Width (internal): 143 mm;

↓ Height of the appropriate type of ampoule +2 mm.

Packaging units whose dimensions differ from those stated above are subject to agreement between the manufacturer and user.


3.2 As far as possible, all packaging immediately surrounding the ampoules shall be made from materials that do not shed particles.


4. Marking


The following information shall be marked on the packaging:

↓ The manufacturer's name and address;

↓ The designation in accordance with 3.2.

Further marking shall be subject to agreement between the manufacturer and the user.


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