BS 1679-7-1968 Specification for containers for pharmaceutical dispensing - Ribbed oval glass bottles《药剂容器规范 第7部分 扁圆形玻璃瓶》.pdf

1、BRITISH STANDARD BS1679-7: 1968 Incorporating Amendment No.1 Specification for Containers for pharmaceutical dispensing Part7: Ribbed oval glass bottlesBS1679-7:1968 This British Standard, having been approved by the Packaging Standards Committee, was published under the authority ofthe Executive Bo

2、ard on 29 November1968 BSI09-1999 The following BSI references relate to the work on this standard: Committee references P/188, P/188/2 Draft for comment68/14764 ISBN 580 00394 9 Co-operating organizations The Packaging Standards Committee, under whose supervision this British Standard was prepared,

3、 consists of representatives from the following Government departments and scientific and industrial organizations: Association of Steel Drum Manufacturers Fibreboard Packing Case Manufacturers Board of Trade Association British Carton Association* Food Manufacturers Federation British Jute Trade Fe

4、deral Council Incorporated British Paper Bag Federation Glass Manufacturers Federation* British Paper & Board Makers Association Institute of Packaging (Incorporated) Institute of Weights and Measures British Paper Box Federation* Administration British Plastics Federation* Institution of Production

5、 Engineers British Tin Box Manufacturers Federation* Ministry of Technology Chemical Industries Association Ministry of Transport Collapsible Tube Manufacturers Packaging Films Manufacturers Association Association* Paintmakers Association of Great Britain Crown Agents for Oversea Governments and So

6、ap & Detergent Industry Association Administrations Society of Motor Manufacturers and Traders Envelope Makers & Manufacturing Ltd. Stationers Association Timber Container Confederation The industrial organizations marked with an asterisk in the above list, together with the following, were directly

7、 represented on the committees entrusted with the preparation of this British Standard: Aluminium Federation Institute of Purchasing and Supply Association of British Pharmaceutical Ministry of Health Industry National Pharmaceutical Union British Closure Manufacturers Association Pharmaceutical Soc

8、iety of Great Britain British Pharmacopoeia Commission The Research Association for the Paper and British Rubber Manufacturers Association Board, Printing and Packaging Industries Guild of Public Pharmacists (PIRA) Amendments issued since publication Amd. No. Date of issue Comments 7203 August1992 I

9、ndicated by a sideline in the marginBS1679-7:1968 BSI 09-1999 i Contents Page Co-operating organizations Inside front cover Foreword ii 1 Scope 1 2 Materials 1 3 Design 1 4 Capacities and designation 1 5 Marking 1 6 Closures 3 Figure 1 Style and dimensions of ribbed oval bottles 2 Table 1 Capacities

10、 and dimensions of ribbed oval bottles 4BS1679-7:1968 ii BSI 09-1999 Foreword This standard makes reference to the following British Standards: BS1918, Glass container finishes Part1: (a) Shallow continuous thread finish (b) Tall continuous thread finish. BS3473, Methods for testing the chemical res

11、istance of glass used in the production of laboratory glassware. This British Standard is one of a series which has been prepared under the authority of the Packaging Standards Committee, following a request from the Ministry of Health for British Standards for containers suitable for pharmacists to

12、 use for National Health Service dispensing. This standard, in common with others, contains both capacity and constructional requirements. The sizes specified range from50ml to500ml and are intended to meet the need, except when very small quantities are to be dispensed, for containers for all prepa

13、rations for which ribbed bottles are necessary or desirable. When ribbed bottles are required for preparations for quantities less than50ml the10ml and20ml bottles specified in Part5, “Eye dropper bottles” of BS1679 are suitable. A British Standard does not purport to include all the necessary provi

14、sions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pagesi andii, pages1 to4 and a b

15、ack cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover.BS1679-7:1968 BSI 09-1999 1 1 Scope This Part of this British Standard specifies materials, design, capacities and marking

16、of ribbed bottles for dispensing liquid medicines for external use. Requirements for closures are also laid down. 2 Materials 2.1 Material. The bottles shall be made from soda-lime glass and, when tested in accordance with clause7 of BS3473-3:1987 1) , shall be deemed to be satisfactory if the mean

17、value does not exceed1.5ml of0.02mol/l hydrochloric acid per gram of glass. (This is equivalent to9304g of Na 2 O per gram of glass.) 2.2 Colour. The bottles shall be made from either clear or amber glass. 2.3 Light resistance. If the bottles are required to be light resistant they shall be made of

18、material which does not transmit more than10% of the incident radiation at any wavelength between300nm and400nm. 3 Design 3.1 Dimensions. Bottles shall conform to the dimensions given in Table 1. 3.2 Wall thickness. The wall thickness of the bottles shall be reasonably uniform so as to ensure that t

19、he container is not likely to fracture in normal use. 3.3 Style. Bottles shall be made in the shape shown in Figure 1. 3.4 Sealing surface. The sealing surface of the bottles shall be such that a linerless thermoplastic closure can be used. 3.5 Neck finish. The neck finish shall be in accordance wit

20、h theR3 series specified in BS1918-1 2) , the appropriate size for each bottle being as given in Table 1. 4 Capacities and designation The capacities of the bottles shall be as given in Table 1, and the bottles shall be designated by the appropriate BS reference number given in the table. 5 Marking

21、The base of each bottle shall be moulded with: 1) A number, placed centrally, indicating the nominal capacity (in millilitres). 2) The manufacturers name or trademark. 3) The mould number. The inclusion of the number of this standard, BS1679, on the bottle is optional. 1) BS3473, Chemical resistance

22、 of glass used in the production of laboratory glassware, Part3:1987 Method for determination of hydrolytic resistance of glass grains at121 C. 2) BS1918, Glass container finishes, Part1:1978 Specification for continuous thread finish.BS1679-7:1968 2 BSI 09-1999 NOTEThe mark BS1679 on or in relation

23、 to the product is a claim by the manufacturer that it complies with the requirements of the standard. The British Standards Institution is the owner of a registered certification trade mark. This is shown below, enclosed in the words “Approved to British Standard”. This mark can be used only by man

24、ufacturers licensed under the certification mark scheme operated by BSI. The presence of this mark on or in relation to a product is an assurance that the goods have been produced to comply with the requirements of the British Standard under a system of supervision, control and testing operated duri

25、ng manufacture and including periodical inspection at the manufacturers works in accordance with the certification mark scheme of BSI. Further particulars of the terms of licence may be obtained from the Director General, British Standards Institution,2 Park Street, London,W.1. NOTE 1All bottles in

26、this series have profiles similar to that illustrated consistent with the dimensions given. NOTE 2The filling point dimension is measured centrally inside from the top of the bottle. NOTE 3The inch equivalent to the2.4mm dimension in this drawing is0.093in. Figure 1 Style and dimensions of ribbed ov

27、al bottlesBS1679-7:1968 BSI 09-1999 3 6 Closures Caps shall be made either of metal or of plastics manufactured from either a thermosetting or a thermoplastic material. Caps and liners, if, used, shall have no deleterious effect on the contents of the bottles. They shall be sufficiently stout to res

28、ist distortion or fracture on repeated tightening to make an adequate seal, without damaging the closure or liner. They shall be suitable for the R3 finish specified in BS1918-1 3)(seeTable 1 for relevant details). 3) BS1918, Glass container finishes, Part1:1978 Specification for continuous thread f

29、inish.BS 1679-7:1968 4 BSI 09-1999 Table 1 Capacities and dimensions of ribbed oval bottles BS reference number (Nominal capacity inml) Capacity Approx. weight Dimensions (mm) Neck finish size no.(R3 a ) A B B 1 C D E F G Filling point Tolerance max. min. max. min. O50 ml 53.5 ml 3 g 60 109.1 107.1

30、44.7 27.3 15.9 61.7 21.1 16.7 33.3 22 O100 105 4.5 105 131.4 129.3 55.3 34.0 19.0 75.3 21.1 19.0 40.5 22 O200 207 6 185 161.5 159.2 69.0 42.5 23.8 93.9 23.1 21.8 50.8 24 O300 309 7.5 255 183.2 180.8 78.8 48.7 27.0 107.6 25.5 23.8 57.2 28 O500 511 9.5 380 212.4 209.8 92.3 56.9 31.8 124.7 25.5 25.4 68

31、.3 28 a BS1918, Glass container finishes, Part1:1978 Specification for continuous thread finish.blankBS1679-7: 1968 BSI 389 Chiswick High Road London W4 4AL BSIBritishStandardsInstitution BSI is the independent national body responsible for preparing BritishStandards. It presents the UK view on stan

32、dards in Europe and at the international level. It is incorporated by Royal Charter. Revisions BritishStandards are updated by amendment or revision. Users of BritishStandards should make sure that they possess the latest amendments or editions. It is the constant aim of BSI to improve the quality o

33、f our products and services. We would be grateful if anyone finding an inaccuracy or ambiguity while using this BritishStandard would inform the Secretary of the technical committee responsible, the identity of which can be found on the inside front cover. Tel:02089969000. Fax:02089967400. BSI offer

34、s members an individual updating service called PLUS which ensures that subscribers automatically receive the latest editions of standards. Buying standards Orders for all BSI, international and foreign standards publications should be addressed to Customer Services. Tel:02089969001. Fax:02089967001

35、. In response to orders for international standards, it is BSI policy to supply the BSI implementation of those that have been published as BritishStandards, unless otherwise requested. Information on standards BSI provides a wide range of information on national, European and international standard

36、s through its Library and its Technical Help to Exporters Service. Various BSI electronic information services are also available which give details on all its products and services. Contact the Information Centre. Tel:02089967111. Fax:02089967048. Subscribing members of BSI are kept up to date with

37、 standards developments and receive substantial discounts on the purchase price of standards. For details of these and other benefits contact Membership Administration. Tel:02089967002. Fax:02089967001. Copyright Copyright subsists in all BSI publications. BSI also holds the copyright, in the UK, of

38、 the publications of the international standardization bodies. Except as permitted under the Copyright, Designs and Patents Act 1988 no extract may be reproduced, stored in a retrieval system or transmitted in any form or by any means electronic, photocopying, recording or otherwise without prior wr

39、itten permission from BSI. This does not preclude the free use, in the course of implementing the standard, of necessary details such as symbols, and size, type or grade designations. If these details are to be used for any other purpose than implementation then the prior written permission of BSI must be obtained. If permission is granted, the terms may include royalty payments or a licensing agreement. Details and advice can be obtained from the Copyright Manager. Tel:02089967070.