BS 1679-5-1973 Containers for pharmaceutical dispensing - Eye dropper bottles《药剂容器规范 第5部分 眼药水点滴瓶规范》.pdf

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1、BRITISH STANDARD BS 1679-5: 1973 Incorporating Amendment No. 1 Specification for Containers for pharmaceutical dispensing Part 5: Eye dropper bottles UDC 615.014.83:621.798.147:615.457BS1679-5:1973 This British Standard, having been approved by the PackagingStandards Committee,was published underthe

2、 authority ofthe Executive Board on 12November 1973 BSI 10-1999 First published October 1950 First revision May 1965 Part 5, first published as a separate part, November 1973 The following BSI references relate to the work on this standard: Committee reference P/188 Draft for comment 71/61291 ISBN 0

3、 580 07644 X Co-operating organizations The Packaging Standards Committee, under whose supervision this British Standard was prepared, consists of representatives from the following Government departments and scientific and industrial organizations: Association of Steel Drum Manufacturers British Pa

4、per and Board Makers Association British Paper Bag Federation British Paper Box Federation* British Plastics Federation* British Tin Box Manufacturers Association* Chemical Industries Association Collapsible Tube Manufacturers Association Confederation of British Industry Crown Agents for Oversea Go

5、vernments and Administrations Department of the Environment Department of Trade and Industry Envelope Makers and Manufacturing Stationers Association Fibreboard Packing Case Manufacturers Association Food Manufacturers Federation Incorporated Glass Manufacturers Federation* Institute of Packaging In

6、stitute of Trading Standards Administration Ministry of Defence (Procurement Executive) Oil Companies Materials Association Packaging Films Manufacturers Association Paintmakers Association of Great Britain Pira Research Association for the Paper and Board Printing and Packaging Industries* Soap and

7、 Detergent Industry Association Society of Motor Manufacturers and Traders Technical Section of the British Paper and Board Makers Association Timber Packaging and Pallet Confederation The scientific and industrial organizations marked with an asterisk in the above list, together with the following,

8、 were directly represented on the committee entrusted with the preparation of this British Standard. Association of the British Pharmaceutical Industry British Closure Manufacturers Association British Pharmacopocia Commission Department of Health and Social Security Guild of Public Pharmacists Inst

9、itute of Purchasing and Supply National Pharmaceutical Union Pharmaceutical Society of Great Britain Individual experts Amendments issued since publication Amd. No. Date of issue Comments 1423 April 1974 Indicated by a sideline in the marginBS1679-5:1973 BSI 10-1999 i Contents Page Co-operating orga

10、nizations Inside front cover Foreword ii 1 Scope 1 2 Description 1 3 Materials 2 4 Construction 2 5 Capacity 5 6 Performance requirements 5 7 Sampling 6 8 Marking 6 Appendix A Method of test for limit of alkalinity of bottle 7 Appendix B Method of test for limit of alkalinity of dropper tube 7 Appen

11、dix C Pre-treatment of teats for tests for limits of water extractandoffreeacid or alkali 7 Appendix D Method of test for limit of water extract of teat 8 Appendix E Method of test for limit of free acid or alkali of teat 8 Appendix F Method of test for efficiency of closure of assembled bottle 8 Ap

12、pendix G Autoclaving 9 Figure 1 Eye dropper bottle 1 Figure 2 Neck finish 3 Figure 3 Teat 4 Figure 4 Cap 5 Publications referred to 10BS1679-5:1973 ii BSI 10-1999 Foreword This Part of this British Standard is one of a series which has been prepared under the authority of the Packaging Standards Com

13、mittee, following a request from the then Ministry of Health for British Standards for containers suitable for pharmacists to use for National Health Service dispensing. The following specifications have already been issued in this series as Parts of BS1679 “Containers for pharmaceutical dispensing”

14、 Part 1 “Paperboard boxes and cartons and components” Part 2 “Glass Containers” Part 3 “Metal Containers” Part 4 “Plastics Containers” Part 6 “Glass medicine bottles” and Part7 “Ribbed oval glass bottles”. Part 5 of this standard deals with eye dropper bottles and their component parts and was first

15、 published in 1965. The present edition has been modified to allow the use of bottles other than those of hexagonal cross section provided that they are readily distinguishable by touch. The designs of the cap, teat and neck finish of the bottle have been modified to improve the efficiency of closur

16、e of the container, and these items are now more closely specified than in the previous edition. 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 doe

17、s not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, pages1 to 10, an inside back cover and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. Th

18、is will be indicated in the amendment table on the inside front cover.BS1679-5:1973 BSI 10-1999 1 1 Scope This Part of this British Standard specifies materials, construction, capacity, performance and sampling requirements for eye dropper bottles for dispensing purposes. Methods of test are given i

19、n the Appendices. NOTEThe title of the British Standard referred to in this standard is given on page 10. 2 Description An eye dropper bottle consists of a bottle fitted with a cap, teat and dropper tube. A typical example is illustrated inFigure 1. Figure 1 Eye dropper bottleBS1679-5:1973 2 BSI 10-

20、1999 3 Materials 3.1 Bottle. The bottle shall be made of either: 1) amber neutral glass, or 2) amber soda glass which has been surface treated during manufacture by a process that reduces the amount of alkali released from the interior surface when in contact with aqueous liquids. A surface-treated

21、soda glass bottle is not intended to be used more than once, since repeated autoclaving may lead to alkali release. If the bottle is to be autoclaved more than once, neutral glass should be used. (See clause8.) 3.2 Dropper tube. The dropper tube shall be made of clear colourless neutral glass and sh

22、all be annealed after manufacture. 3.3 Teat. The teat shall be made of good quality rubber, either natural or synthetic. NOTE 1Some anti-microbial substances used in eye-drops, particularly benzalkonium chloride, may leach out additives from natural and certain synthetic rubber teats. NOTE 2It is in

23、advisable to use the teat more than once. NOTE 3A natural rubber teat can be sterilized by autoclaving at115Cto116 C for thirty minutes; it should not be subjected to dry heat for sterilization. Some synthetic rubbers, e.g. silicone rubber, have good heat resistance, and teats of these materials may

24、 be sterilized by dry heat at 150 C for one hour as an alternative to autoclaving. (See, however, Note2of3.4.) 3.4 Cap. The cap shall be made of tasteless and odourless phenolic plastics material which has been suitably cured to withstand autoclaving at 115 C to116 C for thirty minutes. NOTE 1It is

25、inadvisable to use the cap more than once. NOTE 2The cap may not withstand dry heat at 150 C for one hour. (SeeNote3of3.3.) 4 Construction 4.1 Bottle 4.1.1 Ribbing. The bottle shall be ribbed vertically so that the ribs are always distinguishable by touch. An adequate plain surface shall be availabl

26、e for labelling. 4.1.2 Cleanliness. The bottle shall be clean and free from extraneous matter. 4.1.3 Wall thickness. Wall thickness shall be reasonably uniform and shall be sufficient to ensure a sturdy container that will not fracture in normal use or during autoclaving. 4.1.4 Neck finish. The bott

27、le shall have an external screw thread and shall conform to the dimensions shown inFigure 2. 4.2 Dropper tube 4.2.1 Construction. The dropper tube shall consist of a glass tube with a minimum wall thickness of0.5mm and outside diameter of a range between7.0mm and7.5mm. It shall have a flanged rim at

28、 one end with a ball ended delivery hole at the other. It shall be straight or angled (seeFigure 1c andFigure 1d) and of such a length that when the complete eye dropper bottle is assembled the dropper tube end is approximately5mm from the base of the bottle. 4.2.2 Cleanliness. The dropper tube shal

29、l be clean and free from extraneous matter. 4.3 Teat 4.3.1 General. The teat shall conform to the shape and dimensions shown inFigure 3. No reference letters or figures shall be embossed on the upper or lower flange surfaces. 4.3.2 Cleanliness. The teat shall be clean and free from extraneous matter

30、. 4.4 Cap 4.4.1 General. The cap shall be a screw closure sufficiently strong to prevent distortion or fracture on repeated tightening of the closure assembly on to the bottle. It shall conform to the dimensions shown inFigure 4. There shall be no reference letters or figures on the sealing surface.

31、 The thread shall be suitable for the neck finish of the bottle. 4.4.2 Cleanliness. The cap shall be clean and free from extraneous matter.BS1679-5:1973 BSI 10-1999 3 Figure 2 Neck finishBS1679-5:1973 4 BSI 10-1999 Figure 3 TeatBS1679-5:1973 BSI 10-1999 5 5 Capacity The capacity of the bottle shall

32、be suitable to contain10 ml of solution when the eye dropper bottle is assembled with the dropper tube in the solution. 6 Performance requirements 6.1 Alkalinity of bottle. The test solution in any one of the sample bottles shall not change colour from pink to the full yellow colour of the compariso

33、n solution when tested according toAppendix A. The initial sample shall be taken as described in7.1.1. If the test solution in two or more bottles of the initial sample changes colour from pink to the full yellow colour of the comparison solution when so tested, then the consignment represented by t

34、hat sample shall be deemed not to comply with the alkalinity requirements of this standard. Nevertheless, if the test solution in only one bottle of the initial sample, taken as described in7.1.1, changes colour from pink to the full yellow colour of the comparison solution, a second sample shall be

35、 taken as described in7.1.2. If the test solution in any bottle of the second sample changes colour from pink to the full yellow colour of the comparison solution, the consignment represented by that sample shall be deemed not to comply with the alkalinity requirements of this standard. 6.2 Light re

36、sistance of bottle. The walls of the bottle shall not allow the transmission of more than10% of the incident radiation of any wavelength between300nm and400nm. 6.3 Alkalinity of dropper tube. The test solution shall not change colour from pink to the full yellow colour of the comparison solution whe

37、n the dropper tubes are tested in accordance withAppendix B. The sample shall be taken as described in7.1.1. 6.4 Water extract of teat. The yield of water extract shall not exceed one milligram per teat when tested in accordance with Appendix D. The sample shall be taken as described in7.2. Figure 4

38、 CapBS1679-5:1973 6 BSI 10-1999 6.5 Free acid or alkali of teat. The volume of0.01N acid or alkali shall not exceed0.6ml per teat when tested in accordance withAppendix E. The sample shall be taken as described in7.2. 6.6 Efficiency of closure of assembled eye dropper bottles. None of the sample eye

39、 dropper bottles shall show a significant change in the volume of its contents, nor contain dye when tested in accordance withAppendix F. The initial sample shall be taken as described in7.1.1. If two or more of the eye dropper bottles show a significant change in the volume of their contents or con

40、tain dye when so tested, then the consignment represented by that sample shall be deemed not to comply with the requirement of this clause. Nevertheless, if only one of the eye dropper bottles of the initial sample taken as described in7.1.1 shows a significant change in the volume of its contents o

41、r contains dye, a second sample shall be taken in accordance with7.1.2. If any of the eye dropper bottles of the second sample shows a significant change in the volume of its contents or contains dye, then the consignment represented by that sample shall be deemed not to comply with the requirement

42、of this clause. In addition, none of the teats or caps from the eye dropper bottles tested shall be significantly changed in shape or size and all of the teats shall remain resilient and free from stickiness. 7 Sampling 7.1 Sampling for alkalinity of bottles and dropper tubes and the efficiency of c

43、losure of assembled eye dropper bottle 7.1.1 Initial sample. The number of bottles, dropper tubes or assembled eye dropper bottles in the initial sample for each of these tests shall be ten, taken by random selection from each consignment. 7.1.2 Second sample. If a second sample is required (see6.1

44、and6.6), the second sample shall be ten bottles or assembled eye dropper bottles, taken by random selection from the part of the consignment remaining after the initial sample was taken. 7.2 Sampling for water extract and free acid or alkali of teats. The number of teats in the sample for these test

45、s shall be not less than twenty, taken by random selection from each consignment. 8 Marking Bottles complying with the requirements of this specification shall be permanently embossed on the base as follows: Bottles made from neutral glass with a cross Bottles made from surface-treated soda glass wi

46、th a circle.BS1679-5:1973 BSI 10-1999 7 Appendix A Method of test for limit of alkalinity of bottle A.1 Reagents Water. Use water complying with the requirements of BS3978. Carbon dioxide-free water. Boil vigorously for a few minutes a quantity of water in a borosilicate-glass flask, and then allow

47、to cool, protecting the water from the atmosphere by attaching a guard tube containing soda lime. Prepare this water freshly as required. Sodium hydroxide,0.05N. Strong methyl red indicator solution. Warm40mg of methyl red with75ml of (95%v/v) ethanol. When solution is effected, add3.75ml, or a suff

48、icient quantity of0.02N sodium hydroxide, and dilute to100ml with carbon dioxide-free water. The solution should satisfy the following test. Titrate10ml of the indicator solution, undiluted, with0.02N sodium hydroxide until the colour matches that of10ml of N potassium dichromate; not less than0.40m

49、l and not more than0.45ml of0.02N sodium hydroxide is required. Acid methyl red solution. Mix750ml of carbon dioxide-free water with8.3ml of0.02N hydrochloric acid, add20ml of strong methyl red indicator solution, and dilute to one litre with carbon dioxide-free water. Prepare this solution freshly as required. A.2 Procedure Immediately before testing, clean the sample bottles by rinsing thoroughly four times with warm water; after each rinsing allow the bottles to drain for thirty seconds, and remove any remaining drops