1、BRITISH STANDARD BS1679-8: 1992 Containers for pharmaceutical dispensing Part 8: Specification for glass and plastics containers for solid dosage forms, semi-solids and powdersBS1679-8:1992 This British Standard, having been prepared under the directionof the Packaging and Freight Containers Standar
2、ds Policy Committee, was published under the authority of the Standards Board and comes intoeffect on 15 December1992 BSI 07-1999 First published as BS1679 October1950 Second edition May 1965 Third edition as separate Part4August 1969 Fourth edition as Part8 December1992 The following BSI references
3、 relate to the work on this standard: Committee reference PKM/27 Draft for comment86/43451 DC ISBN 0 580 21290 4 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 Techn
4、ical Committee PKM/27, upon which the following bodies were represented: Association of British Health-care Industries Association of Clinical Pathologists British Box and Packaging Association British Glass Manufacturers Confederation College of Ophthalmologists Department of Health Guild of Hospit
5、al Pharmacists Metal Packaging Manufacturers Association National Pharmaceutical Association Pharmaceutical Services Negotiating Committee Pira International Public Health Laboratory Service Royal Pharmaceutical Society of Great Britain The following bodies were also represented in the drafting of t
6、he standard, through subcommittees and panels: British Plastics Federation Chemical Industries Association Institute of Packaging Amendments issued since publication Amd. No. Date CommentsBS1679-8:1992 BSI 07-1999 i Contents Page Committees responsible Inside front cover Foreword ii Introduction 1 1
7、 Scope 1 2 References 1 3 Definitions 1 4 Materials 1 5 Construction and design of container bodies 2 6 Closures 2 7 Performance 2 8 Marking 3 9 Information to be provided by the manufacturer or supplier 3 Annex A (informative) Guidance on the selection of materials for containers and closures 4 Ann
8、ex B (normative) Method of test for light transmission of glass 4 Annex C (normative) Method of test for resistance to crushing 4 Annex D (normative) Method of test for resistance to bite forces 5 Annex E (normative) Method of test for water vapour transmission 5 Annex F (informative) Constructional
9、 details of suitable test apparatusforthetest methods for resistance to crushing (Annex C) andresistance to bite forces (Annex D) 6 Figure 1 Suitable apparatus for testing resistance to crushing andbite forces 7 Table 1 Tolerances on nominal capacity for glass containers 2 Table 2 Water vapour trans
10、mission limits 3 Table 3 Closing torques to be applied in the water vapour transmission test 5 List of references Inside back coverBS1679-8:1992 ii BSI 07-1999 Foreword This Part of BS1679has been prepared under the direction of the Packaging and Freight Containers Standards Policy Committee. It wil
11、l supersede Part2 of BS1679:1965and BS1679-4:1969which are to be withdrawn. NOTEIt is intended that following publication of this revision there will be a twelve month period during which Part2 of BS1679:1965and BS1679-4:1969remain in existence to enable manufacturers to put the new requirements int
12、o effect. This revision combines the specification for glass and plastics containers in one British Standard since it is considered that the essential requirements for a satisfactory dispensing container are the same irrespective of the material from which it is constructed. A new requirement and a
13、method of test for resistance to bite forces have been introduced, following reported instances of children having ingested medical products after biting into containers. Requirements for moisture transmission are now related to the capacity of the container. These requirements provide a classificat
14、ion by grades to assist selection of the container which affords the necessary degree of protection for the particular product to be dispensed. The introduction of a range of quantitative values for the moisture barrier properties of containers should facilitate the early establishment of links betw
15、een these values and terms such as “airtight” and “well-closed” which are currently used in pharmacopoeias to describe pharmaceutical containers. Major changes to the pattern of pharmaceutical dispensing are currently in prospect and a consequence of their implementation will be a shift in the onus
16、for providing dispensing containers from the pharmacist to manufacturers of pharmaceutical products. These impending changes have been anticipated in the revised specification which provides performance requirements appropriate to most reclosable dispensing containers. In view of the importance of t
17、he closure component of the container in relation to water vapour transmission performance, a further requirement has been introduced for instances where the closure is not supplied together with the container body. This requires the supplier to provide the purchaser with details of closures which e
18、nsure that the container conforms to the relevant requirements. 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 immunity f
19、rom legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pagesi andii, pages1 to8, 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 the amendment
20、 table on the inside front cover.BS1679-8:1992 BSI 07-1999 1 Introduction Containers used for the dispensing of solid dosage forms, such as capsules, lozenges, solution tablets and tablets, are normally rectangular, cylindrical, or oval in shape and are closed with a child-resistant device, a screw
21、cap or other close-fitting closure. Semi-solids, such as applications, creams, gels, ointments and pastes, are normally dispensed in wide-mouth, cylindrical containers, closed with a screw cap or other close-fitting closure. Both the above types of container are normally amber in colour, although op
22、aque and natural plastics containers are also used. Dusting powders, granules, insufflations and bulk powders (for oral ingestion) are normally dispensed in wide-mouth, cylindrical containers, closed with a screw cap or other close-fitting closure. Glass containers may be clear or amber in colour, w
23、hile plastics containers may be natural, opaque or amber in colour. The capacity ranges of containers normally used for pharmaceutical dispensing are as follows. 1 Scope This Part of BS1679specifies requirements for materials, construction, capacity, neck finish and performance for glass and plastic
24、s containers and their closures intended for dispensing solid dosage forms, semi-solids, powders and similar non-liquid pharmaceutical preparations. Methods of test are included for light transmission, mechanical strength, resistance to bite forces and water vapour transmission. No requirements are
25、specified for shape or dimensions of containers for solid dosage forms and powders but the shape and proportions of containers for semi-solids are defined. 2 References 2.1 Normative references This Part of BS1679incorporates, by reference, provisions from specific editions of other publications. Th
26、ese normative references are cited at the appropriate points in the text and the publications are listed on the inside back cover. Subsequent amendments to, or revisions of, any of these publications apply to this Part of BS1679only when incorporated in it by updating or revision. 2.2 Informative re
27、ferences This Part of BS1679refers 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 should be made to the latest editions. 3 Definitions For the purposes of this
28、 Part of BS1679the following definitions apply. 3.1 container the receptacle which encloses and protects the dispensed pharmaceutical products NOTEThe closure is a component of the container. 3.2 closure a device that permits opening and resealing of the container body to maintain its enclosing and
29、protective functions. The seal may be an integral part of the closure or may be achieved by a liner or wad 3.3 liner a compressible gasket which may be faced NOTEThe term “wad” is also used. 3.4 nominal capacity the volume which a container should hold when filled to the appropriate filling point 3.
30、5 point of fill the level to which a glass container is intended to be filled 4 Materials 4.1 Container bodies shall be manufactured from either: a) amber or white flint soda lime silica glass; or b) plastics materials that are natural, coloured or opaque. 4.2 Closures shall be manufactured either f
31、rom metal, which may be lacquered, or from a coloured or opaque plastics material. 4.3 Liners, if fitted, shall be of suitable resilience (see7.4) and may have a facing. NOTEFurther guidance on the selection of materials of construction for containers and closures is given in Annex A. Solid dosage f
32、orms 10ml to125ml with occasional use of capacities up to500ml Semi-solids 15ml to800ml Powders 15ml to1000mlBS1679-8:1992 2 BSI 07-1999 5 Construction and design of container bodies 5.1 Surface All surfaces shall be commercially clean and free from blemishes which preclude use. A smooth, plain surf
33、ace shall be available for labelling. 5.2 Wall thickness The wall thickness shall be such that the closed container meets the requirements of7.1, 7.2, 7.3 and7.4. 5.3 Capacity 5.3.1 Glass containers The capacity of glass container bodies shall be expressed as the nominal capacity (in millilitres) to
34、 the point of fill. The tolerances on nominal capacity shall be as specified in Table 1. Table 1 Tolerances on nominal capacity forglass containers 5.3.2 Plastics containers The brimful capacity shall be not less than the stated nominal capacity (in millilitres) and shall not exceed it by more than1
35、0%. 5.4 Neck finish The neck finish shall be such that the container body fitted with a suitable closure meets the requirements specified in7.4. The sealing surface shall be such that a closure without a liner may be fitted. If the container body is to be fitted with a screw closure, the thread and
36、bore dimensions of glass containers shall conform to the gauging requirements of BS1918-1:1978and the neck finish of plastics containers shall comply with either BS1918-1:1978or BS5789:1979. 5.5 Shape and ratio of dimensions (containersfor semi-solids) Containers for semi-solids shall have a ratio o
37、f height to diameter not greater than3 : 2. NOTEContainers for semi-solids should preferably be cylindrical. 6 Closures 6.1 Closures shall be commercially clean and free from blemishes which preclude use. 6.2 The internal dimensions of the closure shall be suitable for the neck finish (see5.4) and t
38、he closed container shall meet the requirements specified in7.4. 6.3 Closures shall be designed to minimize the possibility of their being labelled or written upon, but instructions for their removal may appear on the upper surface. NOTEChild-resistant closures, tamper-evident closures and closures
39、designed for removal by persons with impaired manual dexterity may be fitted, provided that all the requirements of this standard are met. 7 Performance 7.1 Resistance to light 7.1.1 Amber glass containers When tested by the method described in Annex B, containers of amber glass shall permit the tra
40、nsmission of no more than10% of the incident radiation at any wavelength between290nm and450nm. 7.1.2 Plastics containers When tested in accordance with BS2782-5:Method521A:1992the total light transmitted by the specimen (I 3 ) shall be not more than10% of the incident intensity (I 2 ) at any wavele
41、ngth between290nm and450nm. 7.2 Resistance to crushing When tested by the method given in Annex C, closed containers shall support a force of35N without fracture, without indentation beyond3mm and without displacement of the closure. Nominal capacity Tolerance ml ml Up to and including25 From25 up t
42、o and including50 From50 up to and including75 From75 up to and including100 From100 up to and including125 From125 up to and including150 From150 up to and including175 From175 up to and including200 From200 up to and including250 From250 up to and including300 From300 up to and including350 From35
43、0 up to and including400 From400 up to and including450 From450 up to and including500 From500 up to and including600 From600 up to and including700 From700 up to and including800 From800 up to and including900 From900 up to and including1000 2.0 2.9 3.5 4.1 4.5 5.0 5.3 5.7 6.3 6.9 7.5 8.0 8.6 9.0 9
44、.8 10.7 11.4 12.0 12.6BS1679-8:1992 BSI 07-1999 3 7.3 Resistance to bite forces Containers for solid dosage forms in which the smallest cross-sectional dimension is40mm or less (i.e.capable of being bitten by a child) shall, when tested by the method given in Annex D, support a force of110N without
45、fracture into fragments. 7.4 Water vapour transmission Closed containers shall be classified as grade A, B or C on the basis of their water vapour transmission. For a container, fitted with closure, to be described by one of the above grades it shall conform to the appropriate requirements given in
46、Table 2 when tested and assessed in accordance with the method given in Annex E. Table 2 Water vapour transmission limits 7.5 Hydrolytic resistance Glass container bodies shall be of at least hydrolytic resistance class HC D when tested in accordance with BS3473-4.1:1989. 8 Marking 8.1 Containers Th
47、e base of each container shall be embossed or otherwise marked with: a) the nominal capacity in millilitres; b) the manufacturers name or trademark; c) the mould or cavity number. 8.2 Packages Each transit package shall be clearly marked with: a) description of container, which includes: 1) referenc
48、e mark; 2) material of construction (e.g.glass, polypropylene, polyethylene); 3) nominal capacity (in millilitres); b) description of the closure (if present) which includes: 1) reference mark; 2) type of closure, neck dimension and, if appropriate, thread configuration; c) manufacturers or supplier
49、s name and address. When the closure is included, the transit package shall be marked with the number and date of this British Standard and the grade of the container e.g.BS1679-8:1992:Grade A. 1) 9 Information to be provided by the manufacturer or supplier When closures are not supplied with the container bodies the manufacturer or supplier shall supply details of suitable closures, including child resistant closures where appropriate, which, when fitted according to the manufacturers instructions, ensure that the containers conform to the relevant requireme
