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1、BRITISH STANDARD BS ISO 11418-1:2005 Containers and accessories for pharmaceutical preparations Part 1: Drop-dispensing glass bottles ICS 11.040.20; 11.120.99 ? Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:54:30 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 11418-1:2005 This British
2、 Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2006 BSI 2006 ISBN 0 580 49456 X National foreword This British Standard was published by BSI. It is the UK implementation of ISO 11418-1:2005. The UK participation in its preparation was entrust
3、ed 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 application. Compliance with a British Sta
4、ndard cannot confer immunity from legal obligations. Amendments issued since publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:54:30 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 11418-1:2005(E) INTERNATIONAL STANDARD ISO 11418-1 Second edi
5、tion 2005-02-01 Containers and accessories for pharmaceutical preparations Part 1: Drop-dispensing glass bottles Rcipients et accessoires pour prparations pharmaceutiques Partie 1: Flacons compte-gouttes en verre BS ISO 11418-1:2005 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:54:30 GMT
6、+00:00 2006, Uncontrolled Copy, (c) BSI ii Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:54:30 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iii Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The
7、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 established has the right to be represented on that committee. International organizations, governmental and non-gover
8、nmental, 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. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. Th
9、e 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. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote
10、. 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 patent rights. ISO 11418-1 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equi
11、pment for medical and pharmaceutical use. This second edition cancels and replaces the first edition (ISO 11418-1:1996), which has been technically revised. ISO 11418 consists of the following parts, under the general title Containers and accessories for pharmaceutical preparations: Part 1: Drop-dis
12、pensing 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 BS ISO 11418-1:2005 Licensed Copy
13、: sheffieldun sheffieldun, na, Sun Nov 26 02:54:30 GMT+00:00 2006, Uncontrolled Copy, (c) BSI blank Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:54:30 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 1 Containers and accessories for pharmaceutical preparations Part 1: Drop-dispensing glass bo
14、ttles 1 Scope This part of ISO 11418 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 part of ISO 11418 is applicable to drop-dispensing glass bottles u
15、sed 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 affected by the nature and
16、performance of the primary pack. 2 Normative references 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) ap
17、plies. ISO 719:1985, Glass Hydrolytic resistance of glass 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 o
18、f form, orientation, location and run-out ISO 4802-1:1988, 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: D
19、etermination by flame spectrometry and classification ISO 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 11418-1:2005 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 0
20、2:54:30 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 2 3 Dimensions and designation 3.1 Dimensions The 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 part of ISO 11418 shall
21、 be in accordance with ISO 1101. 3.2 Designation Drop-dispensing glass bottles for pharmaceutical use 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 drop-dispensing glass bottle of nominal volume 100 ml, made of col
22、ourless glass (cl) of hydrolytic resistance container class ISO 4802 HC 3, in accordance with this part of ISO 11418 is designated as follows: Drop-dispensing glass bottle ISO 11418-1 100 cl 4 Requirements 4.1 Material The material shall be colourless (cl) or amber (br) borosilicate glass (see ISO 4
23、802-1 or ISO 4802-2) or soda-lime-silica glass (see ISO 4802-1 or ISO 4802-2) of hydrolytic resistance grain class ISO 719HGB 3 or ISO 720HGA 2. 4.2 Performance 4.2.1 Vertical load resistance The resistance to vertical load shall be in accordance with ISO 8113. 4.2.2 Hydrolytic resistance When teste
24、d in accordance with ISO 4802-1 or ISO 4802-2, the hydrolytic resistance of the internal surface of the drop-dispensing glass bottle shall comply with the requirements of the hydrolytic resistance container class ISO 4802 HC 3. 4.2.3 Thermal shock resistance Drop-dispensing glass bottles shall withs
25、tand 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 drop-dispensing glass bottle shall be marked with the information specified in Figure 1 (view Y). BS ISO 11418-1:2005 Licensed Copy: sheffi
26、eldun sheffieldun, na, Sun Nov 26 02:54:30 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 3 Dimensions in millimetres Key 1 ISO letters (optional) 2 manufacturers trademark 3 nominal volume (optional) 4 bottom surface may be granular, flat or riffled 5 manufacturers code/designation of the mould a The n
27、umber 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. Figure 1 Typical drop-dispensing glass bottle, showing marking locations BS ISO 11418-1:2005 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 2
28、6 02:54:30 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Table 1 Nominal volume, overflow capacity and dimensions of drop-dispensing glass bottles Dimensions in millimetres Mass Nominal volume Minimum overflow (brimful) capacity a d1 h1 h2 h3 h4 h5 r1 r2 r3 r4 t g mI ml nom. tol. nom. tol. 5 8,4 0,8 22
29、,5 0,6 50,7 0,6 6 33,5 26 42,2 7,5 3,5 22 1,8 1,0 17 10 14,2 0,85 28 0,6 56,7 0,6 6,5 39,5 28,5 48,2 7,5 4 24 2 1,0 25 15 18,8 1,0 28 0,6 68,2 0,7 7,5 51 38 59,7 7,5 4 24 2 1,0 28 20 23,9 1,0 32 0,7 68,5 0,7 8 51,3 38 60,0 7,5 4 25 2,5 1,0 35 25 29,2 1,0 35 0,7 67,9 0,7 8,5 50,7 38,5 59,4 7,5 5 25 2
30、,5 1,5 38 30 35 1,05 35 0,7 76,6 0,7 10 59,4 46 67,1 7,5 5 25 2,5 1,5 43 50 56,2 1,2 38,6 0,7 93,3 0,8 11 76,1 60 83,8 7,5 5 30 3 1,5 58 75 83,5 1,3 46,1 0,8 98 0,8 12 80,8 62 88,5 7,5 5,5 35 3 2,0 87 100 110 1,5 51,6 0,8 101 0,8 12,5 83,8 60,5 91,5 7,5 6 37 3,5 2,0 90 4 BS ISO 11418-1:2005 Licensed
31、 Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:54:30 GMT+00:00 2006, Uncontrolled Copy, (c) BSI blank Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:54:30 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 11418-1:2005 BSI 389 Chiswick High Road London W4 4AL BSI British Standards Insti
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