DIN ISO 11418-5-2017 Containers and accessories for pharmaceutical preparations - Part 5 Dropper assemblies (ISO 11418-5 2015)《药品配制用容器及附件 第5部分 滴管组件(ISO 11418-5-2015)》.pdf

1、February 2017 English price group 9No 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!%_z“2608796www

2、.din.deDIN ISO 11418-5Containers and accessories for pharmaceutical preparations Part 5: Dropper assemblies (ISO 114185:2015),English translation of DIN ISO 11418-5:2017-02Behltnisse und Zubehr fr Arzneimittel Teil 5: Pipettenmonturen (ISO 114185:2015),Englische bersetzung von DIN ISO 11418-5:2017-0

3、2Rcipients et accessoires pour prparations pharmaceutiques Partie 5: Comptegouttes (ISO 114185:2015),Traduction anglaise de DIN ISO 11418-5:2017-02SupersedesDIN ISO 114185:199809www.beuth.deDocument comprises 13 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original s

4、hall be considered authoritative.01.17 A comma is used as the decimal marker. 1 Scope . 52 Normative references 53 Dimensions and designation . 53.1 Dimensions . 53.1.1 Dropper bulb with small suction volume (DBS) . 73.1.2 Dropper bulb with medium suction volume (DBM) . 83.1.3 Screw cap 93.1.4 Pipet

5、te 103.2 Designation . 113.2.1 Screw cap. 113.2.2 Dropper bulb with small suction volume (DBS) 113.2.3 Dropper bulb with medium suction volume (DBM) 113.2.4 Pipette 114 Material . 114.1 Dropper bulb . 114.2 Pipette 124.3 Screw cap 125 Requirements . 125.1 Dropper bulb . 125.2 Pipette 12Bibliography

6、. 13Contents PageNational Annex NA (informative) Bibliography 4National foreword .3DIN ISO 11418-5:2017-02 2 National foreword This document (ISO 11418-5:2015) has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection, and blood processing equipment for medical and phar

7、maceutical 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 063-02-15 AA Elastomere Pharmapackmittel und zugehrige Komponenten. Attention is drawn to t

8、he 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 consists of the following parts, under the general title Containers and accessories for pharmaceuti

9、cal 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 Part 5: Dropper assemblies Part 7: Screw-neck vials made of glass tubing for liquid dosage forms

10、 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 4802 (all parts) DIN ISO 4802 ISO 8362-2 DIN EN ISO 8362-2 ISO 8871 (all parts) DIN EN ISO 8871 (all parts) ISO 11418-1 DIN ISO 11418-1 Amendments

11、This standard differs from DIN ISO 11418-5:1998-09 as follows: a) normative references have been updated; b) the standard has been editorially revised. Previous editions DIN 58378-5: 1986-08 DIN EN ISO 11418-5: 1998-09 DIN ISO 11418-5:2017-02 3 National Annex NA (informative) Bibliography DIN EN ISO

12、 8362-2, Injection containers and accessories Part 2: Closures for injection vials DIN ISO 4802 (all parts), Glassware Hydrolytic resistance of the interior surfaces of glass containers DIN EN ISO 8871 (all parts), Elastomeric parts for parenterals and for devices for pharmaceutical use DIN ISO 719,

13、 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 11418-1, Containers and accessories for pharmaceutical preparations Part 1: Drop-dispensing glass bottles

14、 DIN ISO 11418-5:2017-02 4 Containers and accessories for pharmaceutical preparations Part 5: Dropper assemblies1 ScopeThis part of ISO 11418 specifies the design, dimensions, material, and requirements of dropper assemblies consisting of a screw cap, dropper bulbs, and pipettes for the application

15、and dosage of liquid pharmaceutical preparations.This part of ISO 11418 is applicable to dropper assemblies used in the medical field in order to deliver pharmaceutical preparations contained in screw neck bottles according to ISO 11418-1.Dropper assemblies are applicable to primary packs used in di

16、rect contact with the drug.NOTE The potency, purity, stability, and safety of a drug during its manufacture and storage can be strongly affected by the nature and performance of the primary pack.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this do

17、cument and are indispensable for its application. For dated references, only the edition cited applies. For undated references, 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 cla

18、ssificationISO 720, Glass Hydrolytic resistance of glass grains at 121 degrees C Method of test and classificationISO 8362-2, Injection containers and accessories Part 2: Closures for injection vialsISO 11418-1, Containers and accessories for pharmaceutical preparations Part 1: Drop-dispensing glass

19、 bottles3 Dimensions and designation3.1 DimensionsThe design of the dropper assembly (see Figure 1) may vary, however the dimensions shall be as shown in Figures 2, 3, 4 and 5 and as given in Tables 1, 2, 3 and 4.Application shall be directed to the location indicated from the diagnostic or therapeu

20、tic point of view and shall enable dosage in drops.DIN ISO 11418-5:2017-02 5 Key1 dropper bulb2 screw cap3 pipette4 screw neck bottleFigure 1 Typical dropper assemblyDIN ISO 11418-5:2017-02 6 3.1.1 Dropper bulb with small suction volume (DBS)Dimensions in millimetresFigure 2 Dropper bulb with small

21、suction volumeDIN ISO 11418-5:2017-02 7 3.1.2 Dropper bulb with medium suction volume (DBM)Dimensions in millimetresFigure 3 Dropper bulb with medium suction volumeTable 1 Volume and dimensions of dropper bulbDimensions in millimetresTypeVolume mld10,15d20,2d30,2d40,2d50,2h10,5h20,2DBS 0,15 15,0 8,5

22、 7,5 6,0 9,6 24,0 4,3DBM 0,6 15,6 11,8 8,5 6,7 13,3 23,5 4,3DIN ISO 11418-5:2017-02 8 3.1.3 Screw capDimensions in millimetresFigure 4 Screw capTable 2 Diameter D in relationship to dropper bulb suction volumeDimensions in millimetresDropper bulb suction volumeD 0,2Small (DBS) 8,5Medium (DBM) 12DIN

23、ISO 11418-5:2017-02 9 3.1.4 PipetteDimensions in millimetresFigure 5 PipetteTable 3 Diameter of the pipetteDimensions in millimetresTyped10,15d20,25x max.DBS 6,35 7,75 6,6DBM 7,25 8,25 7,5DIN ISO 11418-5:2017-02 10 Table 4 Length of pipetteDimensions in millimetresNominal volume of screw neck bottle

24、 in accordance with ISO 11418-1 mlLength/l1 0,5DBS DBM5 41,5 4510 47,5 5115 59 62,520 59 62,525 59 6130 66 69,550 83 86,575 87,5 91100 90,5 943.2 Designation3.2.1 Screw capDesignation of a screw cap, type (DBS) complying with the requirements in this part of ISO 11418:Screw cap ISO 11418-5 DBS3.2.2

25、Dropper bulb with small suction volume (DBS)Designation of a dropper bulb with small suction volume (DBS) complying with the requirements in this part of ISO 11418:Dropper bulb ISO 11418-5 DBS3.2.3 Dropper bulb with medium suction volume (DBM)Designation of a dropper bulb with medium suction volume

26、(DBM) complying with the requirements in this part of ISO 11418:Dropper bulb ISO 11418-5 DBM3.2.4 PipetteDesignation of a pipette for screw neck bottles in accordance with ISO 11418-1 with a nominal volume (25 ml) and type (DBS) complying with the requirements in this part of ISO 11418:Pipette ISO 1

27、1418-5 25-DBS4 Material4.1 Dropper bulbThe dropper bulb shall be of an elastomeric material.The material itself and its hardness shall be agreed between manufacturer and customer.DIN ISO 11418-5:2017-02 11 4.2 Pipette4.2.1 The pipette shall be of colourless borosilicate glass1)or soda lime-silica gl

28、ass1)(but see also 4.2.2) of one of the following hydrolytic resistance grain classes:a) ISO 719 HGB 1b) ISO 719 HGB 3 or ISO 720 HGA 2.4.2.2 The use of thermoplastics instead of glass is permitted provided it is agreed upon between manufacturer and user.4.3 Screw capThe screw cap shall be of a plas

29、tics material which is agreed between manufacturer and user.5 Requirements5.1 Dropper bulbThe dropper bulb shall be in accordance with the chemical and biological requirements given in ISO 8362-2.5.2 PipetteThe design of the pipette tip shall be agreed between manufacturer and customer.1) Definition

30、s are given in ISO 4802-1 and ISO 4802-2.DIN ISO 11418-5:2017-02 12 Bibliography1 ISO 4802 (all parts), Glassware Hydrolytic resistance of the interior surfaces of glass containers2 ISO 8871 (all parts), Elastomeric parts for parenterals and for devices for pharmaceutical useDIN ISO 11418-5:2017-02 13