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1、BRITISH STANDARD BS 795:1983 Incorporating Amendment No. 1 Specification for Ampoules UDC 621.798.124:615.014.83:666.176 Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:26:19 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 795:1983 This British Standard, having
2、 been prepared under the direction of the Packaging and Freight Containers Standards Committee, was published under the authority of the Board of BSI and comes into effect on 30 September 1983 BSI 10-1999 First published June 1938 First revision March 1953 Second revision October 1961 Third revision
3、 September 1983 The following BSI references relate to the work on this standard: Committee reference PKM/563 Draft for comment 80/60604 DC ISBN 0 580 13167 X Cooperating organizations The Packaging and Freight Containers Standards Committee, under whose direction this British Standard was prepared,
4、 consists of representatives from the following: The organizations marked with an asterisk in the above list, together with the following, were directly represented on the Technical Committee entrusted with the preparation of this British Standard: Association of Drum ManufacturersGlass Manufacturer
5、s Federation* British Bag FederationInstitute of Packaging British Fibreboard Packaging AssociationInstitute of Trading Standards Administration* British Food Manufacturing IndustriesInstitution of Production Engineers Research AssociationMetal Packaging Manufacturers Association* British Paper and
6、Board Industry FederationMinistry of Defence (PIF)Oil Companies Materials Association British Stationery and Office ProductsPaintmakers Association of Great Britain Ltd. FederationPira (Research Association for the Paper and Chemical Industries Association*Board, Printing and Packaging Industries)*
7、Collapsible Tube Manufacturers AssociationSoap and Detergent Industry Association Department of Trade Paper, Printing,The Society of Motor Manufacturers and Publishing, Services and DistributionTraders Limited Department of TransportTimber Packaging and Pallet Confederation Food Manufacturers Federa
8、tion Incorporated*Timber Research and Development Association General Council of British Shipping Association of the British PharmaceuticalMilk Marketing Board IndustryNational Association of Cider Makers Brewers SocietyNational Association of Soft Drinks British Pharmacopoeia CommissionManufacturer
9、s British Soft Drinks CouncilPharmaceutical Society of Great Britain Campden Food Preservation ResearchRoyal College of Midwives AssociationScotch Whisky Association Dairy Trade FederationScottish Association of Soft Drinks Department of Health and Social SecurityManufacturers Department of TradeSoc
10、iety of Glass Technology Honey Importers and Packers AssociationWine and Spirit Association of Great Britain Medical Research CouncilCoopted member Amendments issued since publication Amd. No.Date of issueComments 4889July 1985Indicated by a sideline in the margin Licensed Copy: London South Bank Un
11、iversity, London South Bank University, Fri Dec 08 10:26:19 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 795:1983 BSI 10-1999i Contents Page Cooperating organizationsInside front cover Forewordii 1Scope1 2Type references1 3Nomenclature and letter symbols1 4Materials2 5Dimensions and performance req
12、uirements2 6Test methods4 7Gauging code5 8Printing and packaging5 9Marking6 Appendix A Recommended ampoule seal characteristics22 Appendix B Recommended method to open “easy-open” ampoules22 Figure 1 Nomenclature and letter symbols2 Figure 2 Type B ampoule6 Figure 3 Type C ampoule6 Figure 4 Type H a
13、mpoule8 Figure 5 Type J ampoule8 Figure 6 Type K ampoule9 Figure 7 Type L ampoule10 Figure 8 Type M ampoule10 Figure 9 Type N ampoule11 Figure 10 Type P ampoule13 Figure 11 Type Q ampoule14 Figure 12 Type R ampoule15 Figure 13 Type S ampoule16 Figure 14 Type V ampoule17 Figure 15 Type W ampoule18 Fi
14、gure 16 Type X ampoule19 Figure 17 Type Y ampoule20 Figure 18 Torque testing device for break force test21 Table 1 Type references1 Table 2 Dimensions of type B ampoules7 Table 3 Dimensions of type C ampoules7 Table 4 Dimensions of type H ampoules8 Table 5 Dimensions of type J ampoules9 Table 6 Dime
15、nsions of type K ampoules9 Table 7 Dimensions of type L ampoules10 Table 8 Dimensions of type M ampoules11 Table 9 Dimensions of type N ampoules12 Table 10 Dimensions of type P ampoules13 Table 11 Dimensions of type Q ampoules14 Table 12 Dimensions of type R ampoules15 Table 13 Dimensions of type S
16、ampoules16 Table 14 Dimensions of type V ampoules17 Table 15 Dimensions of type W ampoules18 Table 16 Dimensions of type X ampoules19 Table 17 Dimensions of type Y ampoules20 Publications referred toInside back cover Licensed Copy: London South Bank University, London South Bank University, Fri Dec
17、08 10:26:19 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 795:1983 ii BSI 10-1999 Foreword This British Standard, prepared under the direction of the Packaging and Freight Containers Standards Committee, was first published in 1938 and revised in 1953 and 1961. This third revision has been prepared
18、at the request of the Department of Health and Social Security and includes performance requirements, notably for the force required to open the “easy-open” ampoules that are now in general use. Easy-open ampoules are characterized by a ceramic band at the constriction which has a differential coeff
19、icient of thermal expansion, and do not require the filing of a notch at the constriction to facilitate opening. Since the introduction of easy-open ampoules, the use of ampoules that require notching has declined. In recent years ampoule filling technology has become increasingly sophisticated and
20、more stringent regulatory controls have been introduced. The ampoule manufacturer is required to maintain a consistently high standard of quality and dimensional accuracy. It is therefore considered necessary to provide guidance for defect classification, acceptable quality levels, and sampling meth
21、ods, although certain requirements, such as the glass type, are a matter of agreement between the purchaser and the supplier. Four new ampoule designs have been included in this revision which, in recent years, have become widely used. The reference letters V, W, X and Y have been allocated, on an a
22、rbitrary basis, to avoid confusion with the existing reference letters. The dimensions of wider-stem ampoules, types V and W, developed for use with larger diameter needles in order to achieve faster filling speeds, are specified with tightened tolerances. Types X and Y originated in Germany and are
23、 based closely on forms B and D respectively in DIN Standard 58 377-1 (1977). Other ampoule designs are currently used, although many of these are specific to only one manufacturer or user and little benefit could therefore be gained by specifying their dimensions in this standard. The performance r
24、equirements given in this standard, however, would be equally applicable to these ampoules. The original designs have been retained with no dimensional changes, as they continue to be used. Eccentricity and certain additional dimensional requirements have been included for the four new designs as th
25、e necessary data are available, but these dimensions have not been specified for the original designs as the data are not readily available. Although no changes have been made to the dimensions of the original designs, advances in technology have facilitated a tightening of tolerances; for instance,
26、 the tolerance specified on the body diameter is 0.2 mm or 0.3 mm (dependent on capacity), although the nominal body diameter may be varied within the tolerance specified in the tables. Appendix A and Appendix B give guidance on the sealing of ampoules and opening of easy-open ampoules respectively.
27、 This standard supersedes BS 795:1961, which is withdrawn. This British Standard calls for the use of substances and/or procedures that may be injurious to health if adequate precautions are not taken. It refers only to technical suitability and in no way absolves the user from statutory obligations
28、 relating to health and safety at any stage of manufacture or use. In particular, attention is drawn to the break force test (6.6) and the use of monochlorobenzene in the test for light transmission (6.1). Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:26:19
29、 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 795:1983 BSI 10-1999iii 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 imm
30、unity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i to iv pages 1 to 22, 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
31、 amendment table on the inside front cover. Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:26:19 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv blank Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:26:19 GMT+00:00 2006
32、, Uncontrolled Copy, (c) BSI BS 795:1983 BSI 10-19991 1 Scope This British Standard specifies the materials, dimensions and performance requirements for the types of glass ampoule listed in Table 1 and specifies a sampling procedure for ampoules that are normally manufactured and sold in bulk. Pre-s
33、cored ampoules are not covered by this standard because of the inherent risk of perforation at the score and the possibility of cracks propagating from the score line. The following performance requirements are specified in this standard: light transmission of amber ampoules residual stress freedom
34、from internal impurities freedom from cracks eccentricity verticality hydrolytic resistance break force for easy-open ampoules quality of break for easy-open ampoules NOTEThe titles of the publications referred to in this standard are listed on the inside back cover. 2 Type references Ampoules shall
35、 be classified according to the type references given in Table 1. 3 Nomenclature and letter symbols The various parts of the ampoule shall be referred to as shown in Figure 1. A type Q ampoule is shown for convenience. The letter symbols used in the Table 2 to Table 17 represent the dimensions shown
36、 in Figure 1. Dimensions that are specific to particular types of ampoule are shown in the appropriate figures. Table 1 Type references Reference letter Description of ampouleFigure/ table no. Designs included in BS 795:1961 BFlat bottom, narrow stem ampoule, with constriction2 CFlat bottom, wide st
37、em ampoule3 HDouble-pointed ampoule4 JFriable (crushable) ampoule5 KFreeze-drying ampoule6 LFreeze-drying ampoule7 MFlat bottom, wide stem ampoule, with constriction8 NFlat bottom, open-funnel, narrow stem ampoule, with constriction9 PFlat bottom, narrow stem, cut ampoule (for tip sealing), with con
38、striction10 QFlat bottom, narrow stem, cut ampoule (for draw-off sealing), with constriction11 RFlat bottom, wide stem, cut ampoule, with constriction12 SFlat bottom, open-funnel, wide stem ampoule, with constriction13 New designs not included in BS 795:1961 VModification of type Q with wider stem a
39、nd increased wall thickness14 WModification of type Q with wider and longer stem and increased wall thickness15 XModification of type Q (DIN form B)16 YDomed closed ampoule (DIN form D)17 Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:26:19 GMT+00:00 2006, U
40、ncontrolled Copy, (c) BSI BS 795:1983 2 BSI 10-1999 4 Materials 4.1 Glass type. Ampoules shall be manufactured from a type of glass appropriate to their end use. NOTEAmpoules for injectable preparations will normally be required to be manufactured from a type of glass specified for that purpose in t
41、he European Pharmacopoeia1), which includes requirements for hydrolytic resistance. 4.2 Colour. Ampoules shall be made from either uncoloured or amber glass. When tested as described in 6.1, the logarithm of the percent transmission of light at wavelengths below 500 nm of the glass from which amber
42、ampoules are made shall satisfy the following formula: NOTEAmber glass can only give a limited measure of protection against light. Preparations that are particularly photosensitive or are likely to be exposed to sunlight for extensive periods should be packaged and stored in such a manner as to aff
43、ord increased protection. 4.3 Annealing. All ampoules shall be annealed. 4.4 Residual strain. The maximum residual strain of uncoloured ampoules after annealing shall not produce an optical retardation exceeding 50 nanometres per millimetre of glass thickness when tested as described in 6.2. NOTEThe
44、 test described in 6.2 cannot be applied quantitatively to amber ampoules, although such ampoules should be assessed qualitatively, under polarized light, for residual strain. 5 Dimensions and performance requirements 5.1 Dimensions. The dimensions of the ampoules shown in Figure 2 to Figure 17 incl
45、usive shall be as specified in the appropriate tables. NOTEFor types B to S inclusive, dimension a in Table 2 to Table 13 is given with a “tolerance” that specifies the permitted range for the nominal body diameter. The nominal body diameter may be any value within this range agreed between the purc
46、haser and the supplier. A tolerance of 0.2 mm (for ampoules of up to and including 10 ml capacity) or 0.3 mm (for ampoules of greater than 10 ml capacity) shall be applied to the nominal body diameter, and the diameter shall not be outside the permitted range, even at the extremes of the tolerances.
47、 For types B and M the top shall be sealed. For types C and J the top shall be open, as shown in Figure 3 and Figure 5 respectively. The top of type C shall be glazed, but the bore of the stem shall not be reduced. For type Y, dimension a shall exceed dimension h. For types B, M, N, P, Q, R and S, t
48、he internal diameter at the constriction shall be not less than the minimum internal diameter of the stem at the gauging point. For types B, N, P and Q, dimension f shall be approximately twice dimension e. 5.2 Sampling. General Inspection Level I of BS 6001:1972 shall be used for assessing visual a
49、nd dimensional defects. Special Inspection Level S-4 shall be used for assessing functional defects (see 5.4), as shown in Tables I and IIA of BS 6001:1972. The expression of non-conformance shall be in terms of percent defective, as defined in 3.2 of BS 6001:1972. ais the body diameter bis the body height cis the height to gauging point dis the overall height eis the stem diameter at gauging point fis the bulb diameter (at widest point) gis the constriction diameter (at narrowest point) including
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