Control injection bottle specification standard reference
2019-08-08 04:02:34
China Pharmaceutical Packaging Association
CPPA/T×××—200×
Foreword
This standard revision refers to ISO 8362-1:2003 controlled glass injection bottles and GB2641-90 controlled antibiotic glass bottles.
This standard is used as a trade supply contract.
Compared with YBB standard and GB2641-90, this standard has the following features:
- Integrate YBB with GB2641-90 content.
—Adjusted specifications and limit deviations.
- Added appearance quality test items.
- Improves the quality level AQL
This standard is under the jurisdiction of Beijing Glass Ceramic Quality Supervision and Inspection Center.
This standard is drafted by: North China Pharmaceutical Co., Ltd. Glass Branch
The main drafters of this standard: Bu Xiaoyong Zhang Xijun
CPPA/T×××—200×
1 Scope
This standard specifies the form, specification, dimensions, technical requirements, sampling, inspection rules and test methods for glass-controlled injection bottles.
This standard applies to soda lime glass control injection bottle, low borosilicate glass control injection bottle, neutral borosilicate glass control injection bottle, and high borosilicate glass control injection bottle. The container is used for the packaging and storage of single-use injections.
2 Normative references
The clauses in the following documents have been adopted as references to this standard. All subsequent amendments (not including errata content) or revisions do not apply to this standard. Encourage parties that agree on the standard to study whether the latest versions of these documents can be used. For undated references, the latest version is applicable to this standard.
YBB00332003 Soda-lime Glass Control Injection Bottle
YBB00302002 Low Borosilicate Glass Control Injection Bottle
YBB00292005-1 High Borosilicate Glass Control Injection Bottle
YBB00292005-2 Neutral Borosilicate Glass Control Injection Bottle
GB 191-90 packaging, storage and transportation logo
GB 2828-2003 Batch inspection sampling procedure
GB 6543-86 Corrugated paper
YBB00272003 Low Borosilicate Glass Medical Tube
YBB00282003 Soda-lime glass medicinal
YBB00012005-1 Medicinal borosilicate glass tube
YBB00012005-2 Medicinal Neutral Borosilicate Glass Tube
3 Product Categories
3.1 The product is classified into soda-lime glass control injection bottles, low-borosilicate glass injection injection bottles, neutral borosilicate glass injection injection bottles, and borosilicate glass injection injection bottles.
3.2 The products are divided into two types, A and B, according to their size.
4 Specifications
The size of the glass-controlled injection bottle should meet the requirements of Type A Table 1, Type B Table 2, Reference Size Table 3 and Figure 1.
Figure 1 Glass Control Injection Bottle
CPPA/T×××—200×
Type A Table 1 Main Specification Size of Glass Control Injection Bottle Unit: mm
Specification mL
Body diameter d1
Outer diameter d2
Bottle inner diameter d4
Bottle height h1
Bottle thickness h4
Bottom 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
±0.3
13.0
+0.2
-0.3
7.0
±0.2
31.0
±0.5
3.6
±0.3
0.50
1.0
3
35.0
4
7.6
37.6
2.8
0.45
5
18.4
±.0.35
39.7
7
22.0
19.6
±0.35
12.6
+0.2
-0.3
39.7
3.2
3.6
1.2
8
45.0
10
49.7
12
24.0
52.0
15
26.0
0.50
20
28.0
±0.4
55.0
±0.7
1.5
25
28.0
65.0
30
32.0
±0.5
66.0
Note: The basic dimensions in the table can be changed according to the user's needs.
CPPA/T×××—200×
Type B Table 2 Main Specification Size of Glass Control Injection Bottle Unit: mm
Specification mL
Body diameter d1
Outer diameter d2
Bottle inner diameter d4
Bottle height h1
Bottle thickness h4
Bottom 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
±0.2
31.0
±0.4
3.6
±0.2
0.50
1.0
3
35.0
4
7.6
37.6
2.8
0.45
5
18.4
±.0.3
39.7
7
22.0
19.6
±0.25
12.6
+0.2
-0.3
39.7
3.2
3.6
±0.3
1.2
8
45.0
10
49.7
12
24.0
52.0
15
26.0
0.50
20
28.0
±0.35
55.0
±0.5
1.5
25
28.0
65.0
30
32.0
66.0
Note: The basic dimensions in the table can be changed according to the user's needs.
CPPA/T×××—200×
Table 3 Reference Size of Control Injection Bottles 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
1.0
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
25.0
0.8
5.0
7.5
7
16.0
25.0
7.5
1.0
1.1
3.5
2.0
8.2
10.5
8
27.0
8.5
11.5
10
37.0
9.7
13.5
12
42.0
10.5
14.5
15
30.0
8.5
12.1
18.0
20
35.0
1.2
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
5 appearance quality
5.1 Material
5.1.1 The controlled injection bottle is made of a colorless or amber transparent medicinal glass tube.
5.1.2 Pharmaceutical glass tubes used for the control of injection vials shall meet any of the requirements of YBB00282003, YBB00272003, YBB00012005-1, and YBB00012005-2.
5.2 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.
5.3 Bubble Line
There should be no bubble line with a width greater than 0.1mm.
5.4 bottle bottom bubble
There should be no bubbles larger than 0.3mm at the bottom of the bottle.
5.5 Cracks
No cracks are allowed on any part (the surface is not cracked).
5.6 Break
No breakage is allowed along the inner edge of the bottle mouth, and no obvious breakage is allowed along the outer edge of the bottle mouth.
5.7 Scratching of the bottle (due to scratches on the outer surface due to friction between glass tubes or bottles)
There should be no scratch greater than 0.2mm in width
6 Sampling
6.1 Batch
The production plant takes the daily output, class output, or the daily output of the Taiwanese machine, the output of the Taiwanese machine class as a batch, or the batch quantity of the customers receiving goods at once as a batch.
6.2 Sampling plan
CPPA/T×××—200×
6.2.1 Sampling according to the provisions of GB 2828.
6.2.2 The test items, inspection levels and the level of qualified quality are to comply with the requirements of Table 4.
Table 4 Test items, inspection levels and quality standards
Test group number
Test item number
Pilot projects
This standard clause
Inspection level
IL
Qualified quality level
AQL
one
2
crack
5.5
I
1.0
two
3
4
Body diameter
Outer diameter of bottle
4
I
2.5
three
5
6
7
Bottle full height
Bottle mouth thick
Bottle inner diameter
4
4
I
2.5
four
8
Vertical axis deviation
4
S-3
2.5
Fives
9
Bottom thickness
4
S-2
4.0
six
10
11
12
13
14
15
16
stone
Nodule
Bubble line
Bottle bottom bubble
Break
Bottle scratch
5.2
5.2
5.3
5.4
5.6
5.7
5.8
I
I
4.0
6.3 Decision Rules
6.3.1 The factory shall pass the 6.2 requirements when all the items are qualified before they leave the factory.
6.3.2 When the receiving party accepts and accepts that any of the technical specifications fails to meet the requirements of 6.2, the receiving party and the manufacturer shall carry out a conjoint inspection of the unqualified items, and determine the batch of products by the results of the joint inspection.
7 Experimental methods
7.1 Specifications
7.1.1 Inner diameter, outer diameter, height, wall thickness
Measured with vernier caliper with an accuracy of 0.02mm.
7.1.2 Thickness
Measured with a bottom thickness gauge with an accuracy of 0.01mm.
7.1.3 Vertical axis deviation
Measured with a vertical axis deviation meter with an accuracy of 0.01 mm.
CPPA/T×××—200×
7.1.4 Quality
Measured with an instrument with an accuracy of 0.1g.
7.1.5 Capacity
The titration method was used to determine its full capacity.
7.2 Appearance quality
The main focus is inspection, supplemented with a tenfold reading magnifying glass when necessary.
8 Signs and packaging
8.1 Logo
8.1.1 The packaging mark shall comply with the relevant provisions in GB191.
8.1.2 Each product should be accompanied by a certificate or label, and indicate the following:
—Product name, license number, product implementation standard number
— Production plant name, site, trademark
—Product specifications, quantity, identification
- Production date, name of the inspector or code name
8.2.1 Medicinal glass controlled injection bottles should be packed in plastic film shrink packaging or carton packaging.
8.2.2 The carton shall be a five-layer double corrugated carton, which shall comply with the relevant provisions in GB 6543.
8.2.3 Transportation
Packages must be protected from violent vibration during transportation and should be handled with care.
8.2.4 Storage
Packages should be stored in a clean, dry, ventilated, non-polluting room.
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