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1、BRITISH STANDARD BS 1679-6: 1994 Containers for pharmaceutical dispensing Part 6: Specification for glass medicine bottles UDC 615.014.8:621.798.147-033.5 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 24 03:29:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 1679-6:1994 This British Standard,
2、having been prepared under the direction of the Packaging and Freight Containers Standards Policy Committee, was published under the authority of the Standards Board and comes into effect on 15 May 1994 BSI 07-1999 First published October 1967 Second edition February 1984 Third edition May 1994 The
3、following BSI references relate to the work on this standard: Committee reference PKM/27 Draft for comment 93/305994 DC ISBN 0 580 22859 2 Committees responsible for this British Standard The preparation of this British Standard was entrusted by the Packaging and Freight Containers Standards Policy
4、Committee (PKM/-) to Technical Committee PKM/27, upon which the following bodies were represented: Association of British Health-care Industries Association of Clinical Pathologists British Glass Manufacturers Confederation Department of Health Guild of Hospital Pharmacists Metal Packaging Manufactu
5、rers Association National Pharmaceutical Association Pharmaceutical Services Negotiating Committee Public Health Laboratory Service Pira International Royal College of Ophthalmologists Royal Pharmaceutical Society of Great Britain Amendments issued since publication Amd. No.DateComments Licensed Cop
6、y: sheffieldun sheffieldun, na, Fri Nov 24 03:29:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 1679-6:1994 BSI 07-1999i Contents Page Committees responsibleInside front cover Forewordii 1Scope1 2References1 3Nominal capacity and reference number1 4Materials1 5Design and construction1 6Marking4 7P
7、erformance4 8Closures4 Annex A (normative) Method of test for light transmission5 Figure 1 Style and dimensions of medicine bottles2 Table 1 Nominal capacity and reference number1 Table 2 Brimfull capacity and dimensions of medicine bottles3 List of referencesInside back cover Licensed Copy: sheffie
8、ldun sheffieldun, na, Fri Nov 24 03:29:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 1679-6:1994 ii BSI 07-1999 Foreword This Part of BS 1679 has been prepared under the direction of the Packaging and Freight Containers Standards Policy Committee, at the request of the Royal Pharmaceutical Societ
9、y of Great Britain. It supersedes BS 1679-6:1984, which is withdrawn. This Part is one of a series, originally prepared at the request of the then Ministry of Health, specifying containers suitable for use by pharmacists in National Health Service dispensing. It has now been revised to change the ne
10、ck finish described in earlier editions to the standard R3 neck finish, in order to permit the use of a wider range of closures, including those which, in combination with the bottles specified, may enable the container (the combination of bottle plus closure) to conform to BS EN 28317 Child-resista
11、nt packaging. Requirements and testing procedures for reclosable packages. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer
12、 immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, pages 1 to 6, an inside back cover and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated i
13、n the amendment table on the inside front cover. Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 24 03:29:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 1679-6:1994 BSI 07-19991 1 Scope This Part of BS 1679 specifies requirements for materials, design and construction for a range of glass bott
14、les for dispensing liquid medicines for oral use. 2 References 2.1 Normative references This Part of BS 1679 incorporates, by dated or undated reference, provisions from other publications. These normative references are made at the appropriate places in the text and the cited publications are liste
15、d on the inside back cover. For dated references, only the edition cited applies; any subsequent amendments to, or revisions of, the cited publication apply to this Part of BS 1679 only when incorporated in the reference by amendment or revision. For undated references, the latest edition of the cit
16、ed publication applies, together with any amendments. 2.2 Informative references This Part of BS 1679 refers to other publications that provide information or guidance. Editions of these publications current at the time of issue of this standard are listed on the inside back cover, but reference sho
17、uld be made to the latest editions. 3 Nominal capacity and reference number The nominal capacities and corresponding reference numbers for the range shall be as given in Table 1. Table 1 Nominal capacity and reference number 4 Materials The bottles shall be made from amber or white flint soda-lime-s
18、ilica glass. 5 Design and construction 5.1 The brimfull capacity, nominal mass and principal dimensions of the bottles shall be as given in Table 2. 5.2 The shape of the bottles shall be as shown in Figure 1, as defined by the dimensions given in Table 2. 5.3 The dimensions and profile of the neck f
19、inish of the bottles shall be as specified in BS 1918-1:1978 for the R3/22 and R3/28 neck finishes. NOTEUnits for all dimensions (including finishes), capacities, mass and tolerances are expressed as specified in BS 4602. Nominal capacity ml Reference number 50N50 100N 100 150N 150 200N 200 300N 300
20、 500N 500 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 24 03:29:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 1679-6:1994 2 BSI 07-1999 NOTEAll bottles in this series have profiles similar to that illustrated, consistent with the dimensions given. Figure 1 Style and dimensions of medicine
21、bottles Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 24 03:29:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 1679-6:1994 BSI 07-19993 Table 2 Brimfull capacity and dimensions of medicine bottles Reference number CapacityNominal massPrincipal dimensions (See Figure 1) Design dimensionsa (See
22、 Figure 1)Neck finishb BrimfullToleranceABCDEF GRHR (nominal capacity in ml)mlmlg max. mm min. mm max. mm max. mmmmmmmmmmmmR3 size N5057.1 3.05399.997.946.428.012.748.621.137.0110.022 N 100108.6 4.592120.2118.257.634.915.958.221.145.0135.022 N 150160.6 5.5129134.6132.465.139.417.465.121.151.0155.022
23、 N 200213 6.0171148.1145.971.343.119.071.425.556.0170.028 N 300318 7.5236168.6166.281.249.122.281.725.564.0195.028 N 500519.5 9.5360196.3193.995.457.925.496.425.575.0225.028 a These dimensions are for mould-making purposes only. b For neck finish, see BS 1918-1:1978. Licensed Copy: sheffieldun sheff
24、ieldun, na, Fri Nov 24 03:29:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 1679-6:1994 4 BSI 07-1999 6 Marking The base of each bottle shall be embossed with: a) the reference number (see Table 1); b) the manufacturers name or trade mark; c) the mould number. 7 Performance 7.1 Transmission of lig
25、ht When tested by the method described in Annex A, bottles made from amber glass shall transmit no more than 10 % of the incident radiation at any wavelength between 290 nm and 450 nm. 7.2 Hydrolytic resistance Bottles shall be of at least hydrolytic resistance class HC 3 when tested in accordance w
26、ith BS 3473-4.1:1989. 8 Closures Internal dimensions of screw closures shall be suitable for the appropriate neck finish given in Table 2. Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 24 03:29:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 1679-6:1994 BSI 07-19995 Annex A (normative) Method
27、 of test for light transmission A.1 Principle A spectrophotometer or similar instrument is used to measure the transmission of light, at the specified wavelengths, of a specimen cut from the side-wall of the bottle. The light transmission may be measured in air or in liquid. A.2 Apparatus A.2.1 Spec
28、trophotometer or other instrument(s) capable of producing light at wavelengths between 290 nm and 450 nm and of measuring the light transmitted through a test specimen of glass in relation to the intensity of the incident light. The measurement may be recorded as percentage transmission or as transm
29、ission density. A.3 Preparation of test specimen A.3.1 From the side-wall of the bottle cut test specimens with parallel sides, of a size suitable for the measuring instrument in use. A.3.2 Measure the average wall thickness of the bottle in millimetres and select the test specimen whose thickness c
30、orresponds most closely to the average wall thickness. A.3.3 Wash and dry the selected specimen. A.3.4 For measurement in liquid, immerse the specimen in a parallel-sided glass cell filled with a liquid which has a refractive index similar to that of the glass. A.4 Procedure A.4.1 Measurement in air
31、 A.4.1.1 Mount the test specimen in the carrier of the measuring instrument using wax or other suitable material, so that the light beam is normal to the surface of the section and reflection losses are minimal. A.4.1.2 Measure the light transmission between 290 nm and 450 nm, either continuously wi
32、th the appropriate measuring instrument, or at suitable intervals with a manual instrument. A.4.2 Measurement in liquid A.4.2.1 Mount the glass cell containing the test specimen in the measuring instrument. A.4.2.2 Measure the light transmission between 290 nm and 450 nm, either continuously with th
33、e appropriate measuring instrument, or at suitable intervals with a manual instrument. A.4.2.3 Repeat the measuring procedure on a glass cell containing the liquid medium only. A.5 Expression of results A.5.1 Measurement in air A.5.1.1 For equipment measuring directly in percentage transmission, div
34、ide the measured percentage transmission by 0.92 to correct for the loss of transmission caused by the surface reflectance of the specimen. A.5.1.2 For equipment measuring absorbance, calculate the specimen percentage transmission T as follows. a) Add log10 0.92 to the measured absorbance, to correc
35、t for the loss of transmission caused by the surface reflectance of the specimen. Call this corrected value x. b) Convert the corrected absorbance to percentage transmission T using the equation: log10 T = log10 100 x where x is the corrected absorbance calculate in A.5.1.2 a). A.5.2 Measurement in
36、liquid A.5.2.1 For equipment measuring directly in percentage transmission, calculate the specimen percentage transmission T using the equation: T = A.5.2.2 For equipment measuring absorbance, calculate the specimen percentage transmission T as follows. a) Subtract the absorbance of the control cell
37、 from the absorbance off the specimen cell. Call this corrected value x. b) Convert the corrected absorbance to percentage transmission T using the equation: log10 T = log10 100 x where x is the corrected absorbance calculated in A.5.2.2 a). percentage transmission of specimen cell percentage transm
38、ission of control cell - -100 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 24 03:29:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 6 blank Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 24 03:29:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 1679-6:1994 BSI 07-1999 List of references (s
39、ee clause 2) Normative references BSI publications BRITISH STANDARDS INSTITUTION, London BS 1918, Glass container finishes. BS 1918-1:1978, Specification for continuous thread finish. BS 3473, Chemical resistance of glass used in the production of laboratory glassware. BS 3473-4, Methods for determi
40、nation of hydrolytic resistance of the interior surfaces of glass containers. BS 3473-4.1:1989, Determination by titration method and classification. Informative references BSI publications BRITISH STANDARDS INSTITUTION, London BS 4602:1977, Specification for the use of metric units in specification
41、s for glass containers and finishes. BS EN 28317:1993, Child-resistant packaging. Requirements and testing procedures for reclosable packages. Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 24 03:29:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 1679-6: 1994 BSI 389 Chiswick High Road London
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