DIN ISO 11418-7-2017 Containers and accessories for pharmaceutical preparations - Part 7 Screw-neck vials made of glass tubing for liquid dosage forms (ISO 11418-7 2016)《药品配制用容器及附件.pdf

1、February 2017 English price group 7No 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 11.040.20; 11.120.99!%_z“2608799

2、www.din.deDIN ISO 11418-7Containers and accessories for pharmaceutical preparations Part 7: Screwneck vials made of glass tubing for liquid dosage forms (ISO 114187:2016),English translation of DIN ISO 11418-7:2017-02Behltnisse und Zubehr fr Arzneimittel Teil 7: Gewindeflaschen aus Rhrenglas fr flss

3、ige Arzneimittel (ISO 114187:2016),Englische bersetzung von DIN ISO 11418-7:2017-02Rcipients et accessoires pour prparations pharmaceutiques Partie 7: Flacons avec bague vis en verre tir pour diagnostics forme liquide (ISO 114187:2016),Traduction anglaise de DIN ISO 11418-7:2017-02SupersedesDIN ISO

4、114187:199901www.beuth.deDocument comprises 9 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.01.17 A comma is used as the decimal marker. National Annex NA (informative) Bibliography 4Introduction . 51 Scope . 62 Normative ref

5、erences 63 Dimensions and designation . 63.1 Dimensions . 63.2 Designation 64 Material 75 Characteristics 86 Requirements 86.1 Hydrolytic resistance . 86.2 Annealing quality 86.3 Light resistance 87 Marking 88 Packaging . 8Contents PageDIN ISO 11418-7:2017-02 2National foreword .3National foreword T

6、his document (ISO 11418-7:2016) has been prepared by Technical Committee ISO/TC 76 “Transfusion, 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

7、-Normenausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 063-02-03 AA Verpackungssysteme fr die Befllung und Applikation von medizinischen Produkten. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. DIN sha

8、ll not be held responsible for identifying any or all such patent rights. The DIN ISO 11418 series consists 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 Pa

9、rt 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms Part 4: Tablet glass bottles 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 fo

10、llows: ISO 719 DIN ISO 719 ISO 720 DIN ISO 720 ISO 4802-1 DIN ISO 4802-1 ISO 4802-2 DIN ISO 4802-2 Amendments This standard differs from DIN ISO 11418-7:1999-01 as follows: a) in Table 1, the mass of screw-neck vials has been updated; b) the text of the standard has been editorially revised. Previou

11、s editions DIN 58378-1: 1983-08 DIN ISO 11418-7: 1999-01 DIN ISO 11418-7:2017-02 3 National Annex NA (informative) Bibliography 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

12、of test and classification DIN ISO 4802-1, Glassware Hydrolytic resistance of the interior surfaces of glass 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 f

13、lame spectrometry and classification DIN ISO 11418-7:2017-02 4 IntroductionThe purpose of this part of ISO 11418 is to specify the dimensions, capacities, form and requirements of screw-neck vials made from tubular glass intended for medical use. Vials made from glass tubing are considered to be sui

14、table for the packaging and storage of pharmaceutical preparations until they are administered for medicinal purposes. Such vials may be made of different types of glass which can affect chemical resistance properties. For example, those made from borosilicate glass will have a very high level of ch

15、emical resistance where others made from soda-lime-silica glass will have a lower but adequate chemical resistance for the purposes for which they are intended.Because vials may be made from different types of glass and because it is the chemical behaviour of the internal surface which is important

16、when they are filled with pharmaceutical preparations, it is essential to specify the test procedures by which the performance can be measured.DIN ISO 11418-7:2017-02 5 Containers and accessories for pharmaceutical preparations Part 7: Screw-neck vials made of glass tubing for liquid dosage forms1 S

17、copeThis part of ISO 11418 specifies the design, dimensions, material and requirements of screw-neck vials for pharmaceutical preparations. Screw-neck vials are applicable to primary packs used in direct contact with a drug.This part of ISO 11418 applies to colourless or amber glass vials made from

18、borosilicate or soda-lime-silica glass, made from glass tubing and intended to be used in the packaging, storage or transportation of pharmaceutical products.NOTE The potency, purity, stability and safety of a drug during its manufacture and storage can be strongly affected by the nature and perform

19、ance of the primary pack.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced docum

20、ent (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 4802-1, Glassware Hydrolytic resistance of the inter

21、ior surfaces of glass containers Part 1: Determination by titration method and classificationISO 4802-2, Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 2: Determination by flame spectrometry and classification3 Dimensions and designation3.1 DimensionsThe dimensions

22、 of screw-neck vials shall be as shown in Figure 1 and as given in Table 1.3.2 DesignationScrew-neck vials for pharmaceutical preparations in liquid form made of glass tubing shall be designated by a reference to this part of ISO 11418, followed by the letters Glt, for glass tubing, together with th

23、e nominal tubing size, followed by the colour of the glass, followed by the hydrolytic resistance class.DIN ISO 11418-7:2017-02 6 EXAMPLE A screw-neck vial for pharmaceutical preparations in liquid form, made of amber glass (br), glass tubing of nominal size 10, of hydrolytic resistance container cl

24、ass ISO 4802 HC 1, in accordance with this part of ISO 11418 is designated as follows:Vial ISO 11418-7 - Glt 10 - br - 1Dimensions in millimetresk5= p4()+23kb = p dd 1 3Keyd5diameter of the flankb width of the thread profilec depth of the thread profilek 0,675 (constant for construction of the threa

25、d profile)p pitchaThe neck finish shall be cylindrical and shall have the diameter d2until the depth h3. A form of a truncated cone is permitted if at the same time the following conditions are fulfilled: the truncated cone has the height h3; the admissible tolerances of d2are retained; the larger d

26、iameter is located at the bottle opening; the larger diameter is maximum of 0,3 mm longer than the smaller one.Figure 1 Typical example of a screw-neck vial with a round thread (knuckle thread) with two complete threads4 MaterialThe material shall be colourless (cl) or amber (br) borosilicate glass

27、(see ISO 4802-1 or ISO 4802-2) or soda-lime-silica glass (see ISO 4802-1 or ISO 4802-2) of one of the following hydrolytic resistance grain classes.DIN ISO 11418-7:2017-02 7 ISO 719 HGB 3 or ISO 720 HGA 2.5 Characteristics5.1 Screw-neck vials shall not contain seed or bubbles to an extent which inte

28、rfere with the visual examination of the contents.5.2 Screw-neck vials shall have a sealing surface which shall not affect the sealing performance of the closure.6 Requirements6.1 Hydrolytic resistanceWhen tested in accordance with ISO 4802-1 or ISO 4802-2, the hydrolytic resistance of the internal

29、surface of the screw-neck vials shall comply with the requirements specified for one of the following hydrolytical resistance container classes: ISO 4802 HC 1 ISO 4802 HC 2 ISO 4802 HC 36.2 Annealing qualityThe screw-neck vials shall be annealed so that the maximum residual stress does not produce a

30、n optical retardation exceeding 40 nm per millimetre of glass thickness when the vials are inspected in a strain viewer.6.3 Light resistanceLight-resistance requirements met by using amber coloured glass are not specified in this part of ISO 11418; light-resistance test methods are, however, specifi

31、ed in relevant pharmacopoeias, e.g. Ph. Eur.1)or USP2).7 MarkingThe number of pieces and the designation, together with the name or symbol of the manufacturer, shall be shown on the package. Further information may appear, subject to agreement.8 PackagingThe recommended packaging size for a paper ca

32、rton, a plastic carton or a shrink-pack in foil can be agreed upon between manufacturer and customer.1) See https:/www.edqm.eu2) See http:/www.usp.org/ ISO 720 HGA 1 orDIN ISO 11418-7:2017-02 8 Table 1 Dimensions, overflow capacity, thread designation and mass of screw neck vialsDimensions in millim

33、etresNominal sizeOverflow capacity (brimful)mlANomi nal threaddPitchpd1d2cd3R1R2d4h1h2h3r1r2aS1S2bt Mass d, egtol. tol. min. 0,5 0,05 +0,3-0,2tol.5 6,5 1,0 14 2,5 18 0,20 8,6 0,20 12,3 0,4 0,62 0,25 14,0 -0,4 45 0,5 29 10,5 3,0 1 1,5 0,5 1,2 0,8 0,5 0,3 7,17, 5 9,0 1,2 18 3,0 22 0,20 11,5 0,20 16,0

34、0,5 0,74 0,3 18,0 -0,5 40 0,5 23 11,0 3,5 1 2,0 0,5 1,2 0,8 0,5 0,3 8,810 12,5 1,2 18 3,0 24 0,20 11,5 0,20 16,0 0,5 0,74 0,3 18,0 -0,5 45 0,5 28 11,0 3,5 1 2,0 0,5 1,2 0,8 0,5 0,3 10,515 17, 5 1,2 18 3,0 24 0,20 11,5 0,20 16,0 0,5 0,74 0,3 18,0 -0,5 60 0,5 43 11,0 3,5 1 2,0 0,5 1,2 0,8 0,5 0,3 13,7

35、20 25,5 1,5 22 30 30 0,30 15,2 0,25 20,0 0,5 0,74 0,3 22,0 -0,5 55 0,7 36 11,0 5,5 1,5 2,5 1 1,2 0,8 0,6 0,4 16,525 31,5 1,5 22 3,0 30 0,30 15,2 0,25 20,0 0,5 0,74 0,3 22,0 -0,5 65 0,7 46 11,0 5,5 1,5 2,5 1 1,2 0,8 0,6 0,4 18,630 37, 5 1,5 22 3,0 30 0,30 15,2 0,25 20,0 0,5 0,74 0,3 22,0 -0,5 75 0,7

36、56 11,0 5,5 1,5 2,5 1 1,2 0,8 0,6 0,4 21,2aIn case of using screw-neck vials for freeze-drying, radius r2may be possibly bigger than the value specified in Table 1. This value and the concavity of the bottom shall be agreed upon between manufacturer and customer.bThe pip in the middle of the bottom

37、internal surface should be not more than 0,5 mm high.cIn the case of special closure types, the bore, d2, could differ from the specified value. The difference shall be agreed upon between manufacturer and customer.dMean values that can deviate about 10 %.eThe mass specifications apply to screw-neck

38、 vials made of colourless borosilicate glass having a linear expansion coefficient of approximately 5,1 106K1, density 2,34 g/cm2The mass of vials made of other glass types (e.g. amber glass or borosilicate glass 3.3) need to be calculated using the density of the particular glass.N1)N a t i o n a l f o o t n o t e : T h e d e n s i t y i s s t a t e d i n c o r r e c t l y i n t h e E n g l i s h r e f e r e n c e v e r s i o n I S O 1 1 4 1 8 - 7 . I t s h o u l d r e a d 2 , 3 4 g / c m3. N1).D I N I S O 1 1 4 1 8 - 7 : 2 0 1 7 - 0 2 9