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GB/Z 12414-2021 English PDF (GBZ12414-2021)

GB/Z 12414-2021 English PDF (GBZ12414-2021)

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GB/Z 12414-2021: Pharmaceutical glass tube
GB/Z 12414-2021
GB
NATIONAL STANDARDIZATION GUIDING TECHNICAL
DOCUMENT OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 81.040.01
CCS N 64
Replacing GB/T 12414-1995
Pharmaceutical glass tube
ISSUED ON: NOVEMBER 26, 2021
IMPLEMENTED ON: JUNE 01, 2022
Issued by: General Administration of Quality Supervision, Inspection and
Quarantine;
Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword ... 3 
1 Scope ... 5 
2 Normative references ... 5 
3 Terms and definitions ... 5 
4 Classification ... 6 
5 Specifications and dimensions ... 6 
6 Technical requirements ... 9 
7 Test methods ... 12 
8 Inspection rules ... 13 
9 Marking, packaging, transportation and storage ... 14 
Appendix A (Normative) Method for determination of light transmittance of colored
glass ... 16 
Appendix B (Normative) Methods for determination of arsenic and antimony release
of pharmaceutical glass tubes ... 18 
Pharmaceutical glass tube
1 Scope
This document specifies the classification, specifications and dimensions, technical
requirements, test methods, inspection rules and marking, packaging, transportation and
storage of pharmaceutical glass tubes.
This document applies to the manufacture of glass tubes for pharmaceutical packaging
containers such as ampoules, injection bottles, oral liquid bottles, medicine bottles,
prefilled syringes and snap-on bottles.
2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
GB/T 191 Packaging - Pictorial marking for handling of goods
GB/T 2828.1 Sampling procedures for inspection by attributes - Part 1: Sampling
schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection
GB/T 12416.2 Glass - Hydrolytic resistance of glass grains at 121 °C - Test method
and classification
GB/T 21170 Glass hollowware - Test method for lead and cadmium release
GB/T 35595 Glass containers - Testing methods for arsenic and antimony release
GB/T 35599 Laboratory glass and glassware outward defect terms
YBB 00392004 Test for straightness
3 Terms and definitions
For the purpose of this document, the following terms and definitions apply.
3.1
limit deviation
The difference between the actual measured value and the basic dimension of the glass
tube.
7 Test methods
7.1 Specifications and dimensions
7.1.1 Outer diameter
USE a caliper with an accuracy of 0.01 mm or a measuring device with an equivalent
accuracy to measure twice (rotate 90°) on the same measuring surface at a distance of
250 mm from both ends of the glass tube.
7.1.2 Inner diameter
USE a caliper with an accuracy of 0.01 mm or a measuring device with an equivalent
accuracy to measure twice (rotate 90°) on the same measuring surface at an inner
diameter of 250 mm from both ends of the glass tube.
7.1.3 Wall thickness
USE a thickness gauge with an accuracy of 0.01 mm or a measuring device with an
equivalent accuracy to measure rotationally on the same measuring surface.
7.1.4 Length
MEASURE with a tape measure or ruler with an accuracy of 1 mm.
7.1.5 Straightness
It is determined according to the method specified in YBB 00392004.
7.2 Appearance
It is carried out according to the provisions of GB/T 35599, supplemented by a 10-fold
reading magnifying glass or a caliper with an accuracy of 0.01 mm if necessary.
7.3 Hydrolytic resistance of glass grains at 121 ℃
It is determined according to the method specified in GB/T 12416.2.
7.4 Light transmittance
It is determined according to the method specified in Appendix A.
7.5 Arsenic, antimony, lead and cadmium release
Lead and cadmium release is determined according to the method specified in GB/T
21170.
Appendix A
(Normative)
Method for determination of light transmittance of colored glass
A.1 Definition
The light transmittance of colored glass refers to the percentage (T) of the intensity I of
the light passing through TO the incident light intensity I0, when the light beam emitted
by the light source passes through the monochromator and becomes parallel light beams
of different wavelengths, and is vertically irradiated on the sample to be tested. It is
calculated according to formula (A.1).
where:
T - the light transmittance of colored glass, %;
I - the intensity of the light passing through colored glass;
I0 - the intensity of incident light.
A.2 Instruments and equipment
A.2.1 UV-vis spectrophotometer
An instrument equipped with a photodiode detector or photomultiplier tube that can be
coupled with an integrating sphere to detect light transmittance in the wavelength range
of 250 nm ~ 800 nm.
A.2.2 Glass cutting machine
Equipment for cutting glass with a carbon-based or emery-based ring blade or saw blade
of other materials.
A.3 Test procedure
A.3.1 Select glass pieces that can represent the wall thickness, and trim them to fit into
the spectrophotometer. After cutting, wash and dry each sample, taking care to avoid
scratching the surface. If the sample is too small to completely cover the opening in the
sample holder, cover the uncovered portion of the opening with opaque paper or tape,
provided the sample is longer than the narrow seam length.
Appendix B
(Normative)
Methods for determination of arsenic and
antimony release of pharmaceutical glass tubes
B.1 Determination of arsenic and antimony release of pharmaceutical glass tubes
by atomic fluorescence spectrometry
B.1.1 Principle
Atomic fluorescence spectrometry is to use an excitation light source to irradiate the
atomic vapor containing a certain concentration of the element to be tested, so that the
atoms of ground state transition to the excited state; and then they are de-excited back
to a lower energy state or ground state, and emit atomic fluorescence. Determine the
intensity of atomic fluorescence so that the content of this element in the sample to be
tested can be obtained. Arsenic (or antimony) in the leaching solution, under acidic
conditions, in which pentavalent arsenic (or antimony) is reduced to trivalent arsenic
(or antimony) by adding thiourea and ascorbic acid. Trivalent arsenic (or antimony) and
reducing agent (usually potassium borohydride or sodium) reacts in the hydride
generation system to generate gaseous hydride, which is brought into the atomizer by
the carrier gas (argon) for atomization. Under the irradiation of the excitation light
source (usually a hollow cathode lamp) of the element to be tested, the atoms of ground
state are excited to a high energy state. When they are de-excited back to the ground
state, they emit fluorescence with a characteristic wavelength. The fluorescence
intensity is proportional to the content of the element to be tested, and is quantitatively
compared with the standard series.
B.1.2 Reagents
Glacial acetic acid; high-grade pure hydrochloric acid; analytically pure ascorbic acid;
analytically pure thiourea; analytically pure sodium hydroxide; analytically pure
sodium borohydride; arsenic element standard solution; antimony element standard
solution.
B.1.3 Test procedure
B.1.3.1 TAKE a glass tube with a total surface area (including inner and outer surfaces)
of about 500 cm2; finely GRIND the cross-sections at bo...
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