BS 1679-6-1994 Containers for pharmaceutical dispensing - Specification for glass medicine bottles《药剂容器 玻璃药瓶规范》.pdf

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1、BRITISH STANDARD BS 1679-6: 1994 Containers for pharmaceutical dispensing Part 6: Specification for glass medicine bottles UDC 615.014.8:621.798.147-033.5BS1679-6:1994 This British Standard, having been prepared under the directionof the Packaging and Freight Containers Standards Policy Committee, w

2、as published under the authority of the Standards Board and comes intoeffect on 15 May 1994 BSI 07-1999 First published October 1967 Second edition February 1984 Third edition May 1994 The following BSI references relate to the work on this standard: Committee reference PKM/27 Draft for comment 93/3

3、05994 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 Committee (PKM/-) to Technical Committee PKM/27, upon which the following bodies were represented: Association

4、of British Health-care Industries Association of Clinical Pathologists British Glass Manufacturers Confederation Department of Health Guild of Hospital Pharmacists Metal Packaging Manufacturers Association National Pharmaceutical Association Pharmaceutical Services Negotiating Committee Public Healt

5、h Laboratory Service Pira International Royal College of Ophthalmologists Royal Pharmaceutical Society of Great Britain Amendments issued since publication Amd. No. Date CommentsBS1679-6:1994 BSI 07-1999 i Contents Page Committees responsible Inside front cover Foreword ii 1 Scope 1 2 References 1 3

6、 Nominal capacity and reference number 1 4 Materials 1 5 Design and construction 1 6 Marking 4 7 Performance 4 8 Closures 4 Annex A (normative) Method of test for light transmission 5 Figure 1 Style and dimensions of medicine bottles 2 Table 1 Nominal capacity and reference number 1 Table 2 Brimfull

7、 capacity and dimensions of medicine bottles 3 List of references Inside back coverBS1679-6:1994 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 Society o

8、f 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 It supersedes BS 1679-6:1984, which is withdrawn.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 neck

9、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-resistant

10、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 im

11、munity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, pages1 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 in th

12、e amendment table on the inside front cover.BS1679-6:1994 BSI 07-1999 1 1 Scope This Part of BS 1679 specifies requirements for materials, design and construction for a range of glass bottles for dispensing liquid medicines for oral use. 2 References 2.1 Normative references This Part of BS 1679 inc

13、orporates, 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 listed on the inside back cover. For dated references, only the edition cited applies; any subsequent amendments to,

14、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 cited publication applies, together with any amendments. 2.2 Informative references This Part of BS 1679 refers to

15、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 should be made to the latest editions. 3 Nominal capacity and reference number The nominal capacities and correspon

16、ding reference numbers for the range shall be as given in Table 1. Table 1 Nominal capacity and referencenumber 4 Materials The bottles shall be made from amber or white flint soda-lime-silica glass. 5 Design and construction 5.1 The brimfull capacity, nominal mass and principal dimensions of the bo

17、ttles 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 finish of the bottles shall be as specified in BS 1918-1:1978 for the R3/22 and R3/28 neck finishes. NOTEUnits for

18、 all dimensions (including finishes), capacities, mass and tolerances are expressed as specified in BS 4602. Nominal capacity ml Reference number 50 N 50 100 N 100 150 N 150 200 N 200 300 N 300 500 N 500BS1679-6:1994 2 BSI 07-1999 NOTEAll bottles in this series have profiles similar to that illustra

19、ted, consistent with the dimensions given. Figure 1 Style and dimensions of medicine bottlesBS 1679-6:1994 BSI 07-1999 3 Table 2 Brimfull capacity and dimensions of medicine bottles Reference number Capacity Nominal mass Principal dimensions (See Figure 1) Design dimensions a(See Figure 1) Neck fini

20、sh b Brimfull Tolerance A B C D E F G R H R (nominal capacity in ml) ml ml g max. mm min. mm max. mm max. mm mm mm mm mm mm R3 size N 50 57.1 3.0 53 99.9 97.9 46.4 28.0 12.7 48.6 21.1 37.0 110.0 22 N 100 108.6 4.5 92 120.2 118.2 57.6 34.9 15.9 58.2 21.1 45.0 135.0 22 N 150 160.6 5.5 129 134.6 132.4

21、65.1 39.4 17.4 65.1 21.1 51.0 155.0 22 N 200 213 6.0 171 148.1 145.9 71.3 43.1 19.0 71.4 25.5 56.0 170.0 28 N 300 318 7.5 236 168.6 166.2 81.2 49.1 22.2 81.7 25.5 64.0 195.0 28 N 500 519.5 9.5 360 196.3 193.9 95.4 57.9 25.4 96.4 25.5 75.0 225.0 28 a These dimensions are for mould-making purposes onl

22、y. b For neck finish, see BS 1918-1:1978.BS1679-6:1994 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 light When tested by the method descri

23、bed 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 with BS 3473-4.1:1989. 8 Closures In

24、ternal dimensions of screw closures shall be suitable for the appropriate neck finish given in Table 2.BS1679-6:1994 BSI 07-1999 5 Annex A (normative) Method of test for light transmission A.1 Principle A spectrophotometer or similar instrument is used to measure the transmission of light, at the sp

25、ecified 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 Spectrophotometer or other instrument(s) capable of producing light at wavelengths between290 nm and 450 nm and of measuring the light transmitted

26、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 transmission 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 suitab

27、le 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 corresponds 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 sp

28、ecimen 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 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 norm

29、al to the surface of the section and reflection losses are minimal. A.4.1.2 Measure the light transmission between290nm and 450 nm, either continuously with 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 ce

30、ll containing the test specimen in the measuring instrument. A.4.2.2 Measure the light transmission between290nm and 450 nm, either continuously with the appropriate measuring instrument, or at suitable intervals with a manual instrument. A.4.2.3 Repeat the measuring procedure on a glass cell contai

31、ning 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, divide 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

32、For equipment measuring absorbance, calculate the specimen percentage transmission T as follows. a) Add log 100.92 to the measured absorbance, to correct for the loss of transmission caused by the surface reflectance of the specimen. Call this corrected value x. b) Convert the corrected absorbance t

33、o percentage transmission T using the equation: log 10T = log 10100 x where x is the corrected absorbance calculate inA.5.1.2 a). A.5.2 Measurement in liquid A.5.2.1 For equipment measuring directly in percentage transmission, calculate the specimen percentage transmission T using the equation: T =

34、A.5.2.2 For equipment measuring absorbance, calculate the specimen percentage transmission T as follows. a) Subtract the absorbance of the control cell from the absorbance off the specimen cell. Call this corrected value x. b) Convert the corrected absorbance to percentage transmission T using the e

35、quation: log 10T = log 10100 x where x is the corrected absorbance calculated inA.5.2.2 a).percentage transmission of specimen cellpercentage transmission of control cell -100 6 blankBS1679-6:1994 BSI 07-1999 List of references (see clause 2) Normative references BSI publications BRITISH STANDARDS I

36、NSTITUTION, 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 determination of hydrolytic resistance of the interior surfaces of glass cont

37、ainers. 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 specifications for glass containers and finishes. BS EN 28317:1993, Child-resistant

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