GB/Z 12414-2021Pharmaceutical glass tube (English PDF)

1 Scope

This document specifies the classification, the specifications and dimensions, the technical requirements, the test methods, the inspection rules and the provisions on marking, packaging, transport and storage for pharmaceutical glass tubing. This document applies to glass tubing used in the manufacture of pharmaceutical packaging containers such as ampoules, injection vials, oral liquid bottles, oral medicine bottles, prefilled syringes and cartridges.

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.

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.