1 Scope
This document specifies the classification of pharmaceutical glass tubes. Specifications, dimensions, technical requirements, test methods, inspection rules and signs, packaging, transportation and storage.
This document applies to the manufacture of glass tubes for pharmaceutical packaging containers such as ampoules, injection bottles, oral solution bottles, medicine bottles, pre-filled syringes and cassette bottles.
2 normative reference documents
The contents of the following documents constitute the essential provisions of this document through the normative references in the text. Among them, note the date of the reference document, only the date of the corresponding version applies to this document; do not note the date of the reference document, its latest version (including all the revision of the list) applies to this document.
GB/T 191 Packaging Storage and transportation iconic signs
GB/T 2828.1 Counting sampling inspection procedures Part 1: Lot-by-lot inspection sampling plan by acceptance quality limit (AQL) retrieval
GB/T 12416.2 Test method and classification of water resistance of glass particles at 121 C
GB/T 21170 glass containers of lead, cadmium dissolved in the determination method
GB/T 35595 glass containers arsenic, antimony dissolved in the determination of the amount of
GB/T 35599 Terminology for defects in the appearance of glass and its products for apparatus:
YBB 00392004 Straightness Determination Method
3 terms and definitions
The following terms and definitions are applicable to this document.
3.1
Limit deviation limit dev iation
The difference between the actual measured value of the glass tube and the basic size.
3.2
Wall thickness skevwness of wall thickness
The difference between the thickest and thinnest of the same measurement surface of the glass tube.
3.3
Ellipticity ovality
Glass tube with the same measurement surface outside diameter measurement of the maximum value and the minimum difference.
4 Classification
Pharmaceutical glass tubes are mainly divided into glass tubes for ampoules according to the use of function. Glass tubes for injection bottles, glass tubes for oral medicine bottles. Glass tubes for oral liquid bottles. Glass tubes for pre-sealed syringes and cassette bottles.
5 Specifications and dimensions.
5.1
Pharmaceutical glass tube specifications and symbols marked in Figure 1.
6 Technical requirements
6.1 Appearance
6.1.1 Crack
There should be no cracks in any part.
6.1.2 Bubble line
There should be no broken skin or thin skin bubble line, other bubble line requirements see Table 7.
6.2
121 C glass particles method of water resistance
121 C glass particles method of water resistance should be in line with the provisions of Table 11.
Table 11
121 C glass particle method water resistance requirements
6.3 Light transmission
Wall thickness of less than 1.0 mm colored glass tube in the wavelength range of 290 nm ~ 450 nm light transmission should not be greater than 50%.
6.4 Arsenic, antimony, lead. Cadmium dissolved amount
Arsenic (As) dissolved amount of not more than 0.07 mg/dm2 . Antimony (Sb) dissolved not more than 0.7 mg/dm2, lead (Pb) dissolved not more than 0.8 mg/dm2, cadmium (Cd) dissolved not more than 0.07 mg/dm?
7 test method
7.1 Specification size
7.1.1 Outside diameter
With an accuracy of 0.01mm caliper or equivalent precision measuring equipment. Measure twice on the same measuring surface at 250mm from both ends of the glass tube (rotate 90*).
7.1.2 Inner diameter
Using 0.01mm caliper or equivalent measuring equipment, measure twice on the same measuring surface at 250mm from both ends of the glass tube (rotate 90").
7.1.3 Wall thickness
With an accuracy of 0.01mm thickness gauge or equivalent precision measuring equipment measurement in the same -. Measuring surface rotation measurement.
7.1.4 Length
Measured with a tape measure or straightedge with an accuracy of 1 mm.
7.1.5 Straightness
Measured according to the method specified in YBB 00392004.
7.2 Appearance
According to the provisions of GB/T 35599 ● Supplemented by a 10x reading magnifier or caliper with an accuracy of 0.01 mm, if necessary.
7.3121C glass particle method of water resistance
Determination by the method specified in GB/T 12416.2.
7.4 Light transmission rate
Determination by the method specified in Appendix A.
7.5 arsenic. Antimony, lead, cadmium dissolved amount
Lead. Cadmium dissolved in accordance with the provisions of GB/T 21170 method of determination.
Arsenic. Antimony dissolved in accordance with GB/T35595 or Appendix B of the method of determination.
8 test rules
8.1 batch
Production plant with the size of the same size glass tube daily production. Class production or machine output for - - batch. Users to a delivery volume for a batch.
8.2 Sampling program
8.2.1 Sampling according to the program specified in GB/T 2828.1.
8.2.2 Inspection items See Table 12.
Table 12 factory inspection and type inspection items and requirements
9 Marking. Packaging. Transportation and storage.
9.1 Logo
Packaging markings should comply with the provisions of GB/T 191.
9.2 Packaging
9.2.1 Slope glass tube should be heat-shrinkable packaging or wrap-around film packaging at both ends. Or use other packaging better than these two forms.
9.2.2 glass tube packaging should be accompanied by a certificate of conformity or label, and indicate the following:
-Product name:
Manufacturer's name, registered trademark, factory address, telephone:
Size, quantity or weight:
Production date. Producer and inspector code:
-Product lot number.
9.3 Transportation
Any means of transportation can be used for transportation, transportation should be dustproof, rain and snowproof measures, loading and unloading should not be thrown.
9.4 Storage
After packing, it should be stored in clean. Ventilation, dry. No pollution indoor storage. Should not be in contact with strong acid, strong alkali, fluoride and other corrosive materials.
