This standard specifies the product classification, specifications, dimensions, technical requirements, test methods, inspection rules and marking, packaging, transportation and storage of molded antibiotic glass bottles. This standard applies to molded antibiotic glass bottles for containing antibiotic powder drugs. GB 2640-1990 Molded antibiotic glass bottles GB2640-1990 Standard download decompression password: www.bzxz.net

UDC666.176
National Standard of the People's Republic of China
GB 2640—90
Molded antibiotic glass vials
Injection vials for antibiotics1990-07-17Promulgated
1991-02-01Implementation
State Administration of Technical Supervision
National Standard of the People's Republic of China
Molded antibiotic glass vials
Injection vials for antibiotics1Subject content and scope of application
GB2640—90
Replaces GB2640--81
This standard specifies the product classification, specifications and dimensions, technical requirements, test methods, inspection rules and markings, packaging, transportation and storage of molded antibiotic glass vials.
This standard applies to molded antibiotic glass vials for containing antibiotic powder drugs. Reference standards
GB2828
GB4546
GB4547
Count sampling procedures and sampling tables for batch inspection (applicable to inspection of continuous batches) Test method for internal pressure of glass bottles and jars
Test method for thermal shock resistance of glass bottles and jars
GB8452 Glass container Test method for vertical axis deviation of glass bottles GB12415 Internal stress inspection method of medicinal glass containers Test method and classification of water resistance of medicinal glass containers GB12416.1
3 Product classification and classification
3.1 According to the shape, it is divided into type A and type B.
3.2 According to the quality grade, it is divided into three grades: superior product, first-class product and qualified product. Specifications and dimensions
4.1 Specifications and dimensions of type A and type B shall comply with the provisions of Table 1 and Figures 1 and 2. Approved by the State Bureau of Technical Supervision on July 17, 1990, and implemented on February 1, 1991
GB2640--90
080k
曾孕一
98：0k
090k
990k
990k
090k
曾靠一
080k
000k
00°98
09°92
060k
020k
090k|| tt||090k
GB2640-90
00°68~
00\9k
00°6~
00°28
020k
曾孕—
020k
08*℃
Annon Hall
5 Technical requirements
5.1 Physical and chemical properties
5.1.1 Water resistance of the inner surface
GB2640-90
Should meet the requirements of any level of HC1, HC2, HC3 in GB12416.1. 5.1.2 Thermal shock resistance
The glass bottle shall not break after the thermal shock test of 42℃ temperature difference. 5.1.3 Resistance to internal pressure
The glass bottle can withstand an internal pressure of 600kPa without breaking. 5.1.4 Internal stress
The internal stress per millimeter of glass thickness should be less than 40nm. 5.2 Appearance quality
5.2.1 Color
Colorless and transparent, slightly green or slightly yellow is allowed. 5.2.2 Appearance
Should be flat and smooth.
5.2.3 Stones
Stones are not allowed at the mouth of the bottle.
No more than 2 stones less than or equal to 1.0mm and without cracks around. Stones larger than 1.0mm are not allowed.
Thin-skinned bubbles are not allowed.
Bubble diameters greater than 3.0mm are not allowed.
No more than 3 bubbles with a diameter of 1.0~3.0mm. Type B
The number of bubbles that can be visually observed with a diameter of less than 1.0mm shall not exceed 6 per square centimeter. A
GB2640—90
e. Bubbles larger than 1.5mm are not allowed at the mouth. 5.2.5 Seam
No cracks thicker than 0.3mm are allowed.
5.2.6 Cracks
No cracks are allowed (except for surface scratches).
6 Test methods
6.1 Water resistance of the inner surface of the bottle
Measured in accordance with the test provisions of GB12416.1. 6.2 Thermal shock resistance
Measured in accordance with the provisions of the qualification test in GB4547. 6.3 Internal pressure resistance
Measured in accordance with the provisions of the qualification test in GB4546. 6.4 Internal stress
Measured in accordance with the provisions of GB12415.
6.5Vertical axis deviation
Measured in accordance with the provisions of GB8452.
6.6Capacity
Use a burette to inject water into the sample bottle and check its value. 6.7Specifications and dimensions
Measured with a vernier caliper with an accuracy of 0.02mm. 6.8Bottle bottom thickness
Measured with a glass bottle bottom thickness gauge with an accuracy of 0.02mm. 6.9Bottle mouth edge thickness
Measured with a bottle mouth edge thickness measuring instrument with an accuracy of 0.02mm. 6.10Bottle mouth inner diameter
Measured with a vernier caliper with an accuracy of 0.02mm at a distance of 2mm from the mouth plane. 6.11Appearance and color
Visual inspection, if necessary, can be supplemented by a 10x scale magnifying glass. 7 Inspection rules
7.1 Factory inspection
7.1.1 Batch
The manufacturer takes the daily output, shift output or machine output as a batch, and the consignee takes the one-time delivery as a batch. 7.1.2 Sampling plan and qualified quality level
Sampling shall be carried out in accordance with the GB2828 plan.
The inspection items, inspection level and qualified quality level shall comply with the provisions of Table 2. b.
The classification of specifications, dimensions and appearance quality is shown in Table 3 and Table 4. Test group
Outer diameter of bottle mouth
Test item
Item number
Vertical axis deviation of bottle mouth
Crack>2mm
Thin skin bubble
7.1.3 Water resistance test
GB2640-90
Item name
Internal stress
Resistance to internal pressure
Resistance to thermal shock
Class A failure
Class B failure
Class C failure
Class A failure
Class B failure
Class C failure
This standard
Table 3 Specification and size classification
Total height of bottle
Inner diameter of bottle mouth
Outer diameter of bottle body
Crack≤ 2mm
Stones at the mouth of the bottle
Appearance quality classification
Inspection level
Qualified quality level
Thickness of the edge of the bottle
Thickness of the bottom of the bottle
Full mouth capacity
Outer diameter of the bottleneck
Inner diameter of the bottleneck
Stones larger than 1.0mm
Stones with no cracks around ≤1.0mmMore than 2 bubbles with a diameter larger than 3.0mm
More than 3 bubbles with a diameter of 1.0~3.0mm
Bubbles at the mouth of the bottle>1.5mm
More than 6 bubbles below 1.0mm that can be visually observed/cm2Seam thickness greater than 0.3mm
The number of samples specified in GB12416.1 shall be drawn from each batch for inspection and must meet the technical requirements. 7.2 Judgment rules
When the consignee accepts the product, if any technical indicator fails to meet the requirements, the consignee and the manufacturer shall conduct a joint inspection on the unqualified item. GB2640-90
The joint inspection results shall be used to determine whether the grade of the batch of products is qualified or unqualified. 8 Marking, packaging, transportation, storage
8.1 Each packaged product shall be accompanied by a certificate or label, indicating the production unit, product name, specification, quantity, marking type, grade, manufacturing date, shift, name or code of the inspector and packager, and shall indicate words such as "glass container" and "handle with care". 8.2 Packaging
Antibiotic bottles are packaged in cartons, and the packaging materials should be kept clean and dry. 8.3·Transportation
Severe vibration must be prevented during transportation, and the product should be handled with care during loading and unloading. 8.4 Storage
The storage place should be clean and dry.
Additional remarks:
This standard is proposed by the State Drug Administration. This standard is under the jurisdiction of the National Glass and Porcelain Product Quality Supervision, Inspection and Testing Center. This standard was drafted by Shanghai Glass Factory. The main drafter of this standard was Zhou Rongzhao.
People's Republic of China
National Standard
Molded Antibiotic Glass Bottle
GB2640-90
Published by China Standards Press
(Beijing Fuwai Sanlihe)bZxz.net
Printed by Beijing Printing House of China Standards Press Distributed by Beijing Distribution Office of Xinhua Bookstore Sold by Xinhua Bookstores in various places Copyright is exclusive and may not be reproduced
Format 880×12301/16 Printing Sheet 3/4 Number of Words 12000 First Edition in October 1990
First Printing in October 1990
Print Quantity 1-3000
Book Number: 155066·1-7849
Price 0.75 yuan
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