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1、BRITISH STANDARD BS ISO 11418-3:2005 Containers and accessories for pharmaceutical preparations Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms ICS 11.040.20; 11.120.99 ? Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:54:28 GMT+00:00 2006, Uncontrolled Copy, (c)
2、 BSI BS ISO 11418-3:2005 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2006 BSI 2006 ISBN 0 580 49454 3 National foreword This British Standard was published by BSI. It is the UK implementation of ISO 11418-3:2005. The UK partici
3、pation in its preparation was entrusted to Technical Committee CH/212, IVDs. A list of organizations represented on CH/212 can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct appli
4、cation. Compliance with a British Standard cannot confer immunity from legal obligations. Amendments issued since publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:54:28 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 11418-3:2005(E) INTERNAT
5、IONAL STANDARD ISO 11418-3 Second edition 2005-02-01 Containers and accessories for pharmaceutical preparations Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms Rcipients et accessoires pour prparations pharmaceutiques Partie 3: Flacons en verre bouchon vis (veral) pour for
6、mes sches et liquides BS ISO 11418-3:2005 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:54:28 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:54:28 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iii Foreword ISO (the International Organ
7、ization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been establish
8、ed has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
9、 International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Pu
10、blication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such paten
11、t rights. ISO 114183 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use. This second edition cancels and replaces the first edition (ISO 11418-3:1996), which has been technically revised. ISO 11418 consists of the following
12、 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 Part 5: Dropper assemb
13、lies Part 7: Screw-neck vials made of glass tubing for liquid dosage forms BS ISO 11418-3:2005 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:54:28 GMT+00:00 2006, Uncontrolled Copy, (c) BSI blank Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:54:28 GMT+00:00 2006, Uncontrolled
14、 Copy, (c) BSI 1 Containers and accessories for pharmaceutical preparations Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms 1 Scope This part of ISO 11418 specifies the design, dimensions, material and requirements of screw-neck glass bottles (veral) for pharmaceutical pre
15、parations in solid and liquid dosage forms. Screw-neck glass bottles are applicable to primary packs used in direct contact with a drug. This part of ISO 11418 is applicable to screw-neck glass bottles (veral) used in pharmacy. Together with the corresponding closure systems, they serve for packagin
16、g of pharmaceutical preparations in solid and liquid dosage forms 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 affected by the nature and performance of the primary pack. 2 Normative references
17、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. ISO 719:1985, Glass Hydrolytic resistance of glas
18、s grains at 98 C Method of test and classification ISO 720:1985, Glass Hydrolytic resistance of glass grains at 121 C Method of test and classification ISO 1101:2004, Geometrical Product Specifications (GPS) Geometrical tolerancing Tolerances of form, orientation, location and run-out ISO 4802-1:198
19、8, Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 1: Determination by titration method and classification ISO 4802-2:1988, Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 2: Determination by flame spectrometry and classification IS
20、O 7459:2004, Glass containers Thermal shock resistance and thermal shock endurance Test methods ISO 8113:2004, Glass containers Resistance to vertical load Test method BS ISO 11418-3:2005 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:54:28 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 2 3 D
21、imensions and designation 3.1 Dimensions The dimensions of screw-neck glass bottles veral1) for pharmaceutical preparations in solid and liquid dosage forms 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 part of ISO
22、 11418 shall be in accordance with ISO 1101. 3.2 Designation Screw-neck glass bottles (veral) for pharmaceutical preparations in solid and liquid dosage forms shall be designated by a reference to this part of ISO 11418, followed by the nominal volume and the colour of the glass. EXAMPLE A screw-nec
23、k glass bottle (veral) with a 28 mm pilferproof finish of nominal volume 100 ml, made of amber glass (br) of hydrolytic resistance container class ISO 4802 HC 3, in accordance with this part of ISO 11418 is designated as follows: Screw-neck glass bottle ISO 114183 100 br 4 Requirements 4.1 Material
24、The 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 resistance grain class ISO 719 HGB 3 or ISO 720 HGA 2. 4.2 Performance 4.2.1 Vertical load resistance The resistance to vertica
25、l load shall be in accordance with ISO 8113. 4.2.2 Hydrolytic resistance When tested in accordance with ISO 4802-1 or ISO 4802-2, the hydrolytic resistance of the internal surface of the screw-neck glass bottle shall comply with the requirements of the hydrolytic resistance container class ISO 4802
26、HC 3. 4.2.3 Thermal shock resistance Screw-neck glass bottles (veral) shall withstand the thermal shock of a temperature difference of 42 C when tested in accordance with the thermal shock resistance test specified in ISO 7459. 5 Marking The screw-neck glass bottle (veral) shall be marked with the i
27、nformation specified in Figure 1 (view Y). 1) From the French term “verre allg” “lightweight glass”. BS ISO 11418-3:2005 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:54:28 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 3 Dimensions in millimetres Key 1 ISO letters (optional) 2 manufacturers
28、 trademark 3 nominal volume (optional) 4 bottom surface may be granular, flat or riffled 5 manufacturers code/designation of the mould a The number of the mould may be placed on the curve r3, on the bottom or on the shoulder of the bottle. b On approximately 1 mm depth from the top of the neck. Figu
29、re 1 Typical screw-neck glass bottle (veral) with a 28 mm pilferproof neck finish, showing marking locations BS ISO 11418-3:2005 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:54:28 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Table 1 Nominal volume, overflow capacity and dimensions of scre
30、w-neck glass bottles (veral) for solid and liquid dosage forms Dimensions in millimetres Mass Nominal volume Minimum overflow (brimful) capacity a d1 h1 h2 h3 h4 r1 r2 r3 r4 g mI ml nom. tol. nom. tol. 50 60,5 1,1 40,8 0,8 83 0,7 12 64,6 50,6 6 8 25 2,5 59 75 85,8 1,2 47,4 0,8 91,4 0,8 13 73 56,5 6
31、9 28 2,8 86 100 115,3 1,3 51,6 0,8 98 0,8 14 79,6 60,6 6 9,5 30 3 95 125 144,8 1,3 57 0,9 98 0,8 15 79,6 58,6 6 10 35 3,2 103 150 169,4 1,4 57 0,9 110,4 0,8 15 92 71 6 10 35 3,2 110 200 221,6 1,6 64 1 116 0,9 17 97,6 71,6 6 14 38 3,5 140 250 277,8 1,7 64 1 137,5 0,9 17 119,1 93,1 6 14 38 3,5 168 500
32、 546,9 2,1 82,6 1,3 161,8 1 22 143,4 105 8 18 40 4 270 1 000 1 079 2,7 100,6 1,6 206,2 1,2 24 187,5 140 10 21 45 5 485 4 BS ISO 11418-3:2005 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:54:28 GMT+00:00 2006, Uncontrolled Copy, (c) BSI blank Licensed Copy: sheffieldun sheffieldun, na, Su
33、n Nov 26 02:54:28 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 11418-3:2005 BSI 389 Chiswick High Road London W4 4AL BSI British Standards Institution BSI is the independent national body responsible for preparing British Standards. It presents the UK view on standards in Europe and at the inte
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