DIN ISO 11418-1-2017 Containers and accessories for pharmaceutical preparations - Part 1 Drop-dispensing glass bottles (ISO 11418-1 2016)《药剂制备容器及附件 第1部分 玻璃点滴瓶(ISO 11418-1-2016)》.pdf

1、April 2017 English price group 6No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.120.99; 55.100!%cO$“2644401www.d

2、in.deDIN ISO 11418-1Containers and accessories for pharmaceutical preparations Part 1: Dropdispensing glass bottles (ISO 114181:2016),English translation of DIN ISO 11418-1:2017-04Behltnisse und Zubehr fr Arzneimittel Teil 1: Tropfflaschen aus Glas (ISO 114181:2016),Englische bersetzung von DIN ISO

3、11418-1:2017-04Rcipients et accessoires pour prparations pharmaceutiques Partie 1: Flacons comptegouttes en verre (ISO 114181:2016),Traduction anglaise de DIN ISO 11418-1:2017-04SupersedesDIN ISO 114181:200508www.beuth.deDocument comprises 8 pagesDTranslation by DIN-Sprachendienst.In case of doubt,

4、the German-language original shall be considered authoritative.04.17 A comma is used as the decimal marker. Contents Nationalforeword.31 Scope . 52 Normative references 53 Terms and definitions . 54 Dimensions and designation . 64.1 Dimensions . 64.2 Designation 65 Requirements 65.1 Material . 65.2

5、Performance 65.2.1 Vertical load resistance 65.2.2 Hydrolytic resistance . 65.2.3 Thermal shock resistance 66 Marking 6PageNationalAnnexNA(informative)Bibliography.4DIN ISO 11418-1:2017-04 2 National foreword This document (ISO 11418-1:2016) has been prepared by Technical Committee ISO/TC 76 “Transf

6、usion, infusion and injection, and blood processing equipment for medical and pharmaceutical use”, with the active participation of German experts. The responsible German body involved in its preparation was DIN-Normenausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 063-02-

7、03 AA “Packaging systems for loading and application of medical devices”. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. DIN shall not be held responsible for identifying any or all such patent rights. The DIN ISO 11418 series co

8、nsists of the following parts, under the general title Containers and accessories for pharmaceutical preparations: Part 1: Drop-dispensing glass bottles Part 2: Screw-neck glass bottles for syrups Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms Part 4: Tablet glass bottles

9、 Part 5: Dropper assemblies Part 7: Screw-neck vials made of glass tubing for liquid dosage forms The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 719 DIN ISO 719 ISO 720 DIN ISO 720 ISO 1101 DIN EN ISO 1101 ISO 4802-1 DIN ISO 4802-1 ISO

10、 4802-2 DIN ISO 4802-2 ISO 7459 DIN EN ISO 7459 ISO 8113 DIN EN ISO 8113 Amendments This standard differs from DIN ISO 11418-1:2005-08 as follows: a) Figure 1 displaying drop-dispensing glass bottles and Table 1 concerning nominal volume, brimful capacity and dimensions of drop-dispensing glass bott

11、les have been updated; b) the quantities 25 ml and 75 ml have been deleted from Table 1; c) the text of the standard has been editorially revised. Previous editions DIN 58378-2: 1979-12, 1983-08, 1987-04 DIN EN ISO 11418-1: 1996-08, 2005-08 DIN ISO 11418-1:2017-04 3 National Annex NA (informative) B

12、ibliography DIN EN ISO 1101, Geometrical Product Specifications (GPS) Geometrical tolerancing Tolerances of form, orientation, location and run-out DIN EN ISO 7459, Glass containers Thermal shock resistance and thermal shock endurance Test methods DIN EN ISO 8113, Glass containers Resistance to vert

13、ical load Test method DIN ISO 719, Glass Hydrolytic resistance of glass grains at 98 C Method of test and classification DIN ISO 720, Glass Hydrolytic resistance of glass grains at 121 C Method of test and classification DIN ISO 4802-1, Glassware Hydrolytic resistance of the interior surfaces of gla

14、ss containers Part 1: Determination by titration method and classification DIN ISO 4802-2, Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 2: Determination by flame spectrometry and classification DIN ISO 11418-1:2017-04 4 Containers and accessories for pharmaceutic

15、al preparations Part 1: Drop-dispensing glass bottles1 ScopeThis document specifies the design, dimensions, material and requirements of drop-dispensing glass bottles. Drop-dispensing glass bottles are applicable to primary packs used in direct contact with a drug.This document is applicable to drop

16、-dispensing glass bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations which are not intended for parenteral use.NOTE The potency, purity, stability and safety of a drug during its manufacture and storage can be strongly a

17、ffected by the nature and performance of the primary pack.2 Normative referencesThe following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references,

18、 the latest edition of the referenced document (including any amendments) applies.ISO 719, Glass Hydrolytic resistance of glass grains at 98 degrees C Method of test and classificationISO 720, Glass Hydrolytic resistance of glass grains at 121 degrees C Method of test and classificationISO 1101, Geo

19、metrical product specifications (GPS) Geometrical tolerancing Tolerances of form, orientation, location and run-outISO 4802-1, Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 1: Determination by titration method and classificationISO 4802-2, Glassware Hydrolytic res

20、istance of the interior surfaces of glass containers Part 2: Determination by flame spectrometry and classificationISO 7459, Glass containers Thermal shock resistance and thermal shock endurance Test methodsISO 8113, Glass containers Resistance to vertical load Test method3 Terms and definitionsNo t

21、erms and definitions are listed in this document.ISO and IEC maintain terminological databases for use in standardization at the following addresses: IEC Electropedia: available at http:/www.electropedia.org/ ISO Online browsing platform: available at http:/www.iso.org/obpDIN ISO 11418-1:2017-04 5 4

22、 Dimensions and designation4.1 DimensionsThe dimensions of drop-dispensing glass bottles shall be as shown in Figure 1 and as given in Table 1.Tolerancing of form, orientation, location and run-out not specified in this document shall be in accordance with ISO 1101.4.2 DesignationDrop-dispensing gla

23、ss bottles for pharmaceutical use shall be designated by a reference to this document, followed by the nominal volume and the colour of the glass.EXAMPLE A drop-dispensing glass bottle of nominal volume 100 ml, made of colourless glass (cl) of hydrolytic resistance container class ISO 4802-HC 3, in

24、accordance with this document is designated as follows:Drop-dispensing glass bottle ISO 11418-1 100 cl5 Requirements5.1 MaterialThe material shall be colourless (cl) or amber (br) borosilicate glass (see ISO 4802-1 or ISO 4802-2) or soda-lime-silica glass (see ISO 4802-1 or ISO 4802-2) of hydrolytic

25、 resistance grain class ISO 719-HGB 3 or ISO 720-HGA 2.5.2 Performance5.2.1 Vertical load resistanceThe resistance to vertical load shall be in accordance with ISO 8113.5.2.2 Hydrolytic resistanceWhen tested in accordance with ISO 4802-1 and ISO 4802-2, the hydrolytic resistance of the internal surf

26、ace of the drop-dispensing glass bottle shall comply with the requirements of the hydrolytic resistance container class ISO 4802-HC 3.5.2.3 Thermal shock resistanceDrop-dispensing glass bottles shall withstand the thermal shock of a temperature difference of 42 C when tested in accordance with the t

27、hermal shock resistance test specified in ISO 7459.6 MarkingThe drop-dispensing glass bottle shall be marked with the information specified in Figure 1.DIN ISO 11418-1:2017-04 6 Key1 ISO letters (optional)2 manufacturers trademark3 nominal volume (optional)4 bottom surface may be granular, flat or r

28、iffled5 manufacturers code/designation of the mould6 blow back within the range 2 mm to 5 mm 0 mm to entry bore diameter for seating a plastic lineraThe number of the mould may be placed on the curve r3, on the bottom or on the shoulder of the bottle but not on the cylindrical part to avoid any conf

29、lict of contact.bEntry bore.cThe approximate values are at the manufacturers discretion.Figure 1 Typical drop-dispensing glass bottle, showing marking locationsDIN ISO 11418-1:2017-04 7 Table 1 Nominal volume, brimful capacity and dimensions of drop-dispensing glass bottlesDimensions in millimetresN

30、ominal volumeMinimum brimful capacityad1h1h2h3h4r1r2r4tMassgnom. tol. nom. tol.ml ml 5 7 0,80 22,5 0,5 53,2 0,6 37, 8 34,1 45,5 1,5 2,5 1,5 1,5 2710 14 0,85 25,0 0,5 60,7 0,8 45,2 37, 5 54,0 3,0 7,1 2,0 1,5 2815 20 1,00 28,5 0,5 65,2 0,9 49,5 39,5 58,5 3,0 8,0 2,0 2,0 3320 25 1,00 29,5 0,6 72,2 0,9 56,5 46,0 65,5 4,0 8,0 2,0 1,5 3830 36 1,05 33,0 0,5 80,2 1,0 64,5 52,5 72,0 4,0 9,0 2,5 2,0 4550 58 1,20 38,0 0,6 91,7 1,0 76,0 60,0 84,0 5,0 12,0 2,5 2,0 65100 110 1,50 47,0 0,6 110,7 1,1 95,0 75,0 103,4 5,0 14,0 3,0 2,0 108DIN ISO 11418-1:2017-04 8