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1、 Reference number ISO 9187-1:2006(E) ISO 2006 INTERNATIONAL STANDARD ISO 9187-1 Third edition 2006-04-15 Injection equipment for medical use Part 1: Ampoules for injectables Matriel dinjection usage mdical Partie 1: Ampoules pour produits injectables Copyright International Organization for Standard
2、ization Provided by IHS under license with ISO Licensee=Aramco HQ/9980755100 Not for Resale, 04/23/2007 02:16:10 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 9187-1:2006(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensi
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5、taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. ISO 2006 All rights reserved. Unless otherwise specified, no part of this publication may be reprodu
6、ced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749
7、 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2006 All rights reserved Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Aramco HQ/9980755100 Not for Resale, 04/23/2007 02:16:10 MDTNo reprod
8、uction or networking permitted without license from IHS -,-,- ISO 9187-1:2006(E) ISO 2006 All rights reserved iii Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standard
9、s is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take
10、part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is t
11、o prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility
12、that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 9187-1 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use.
13、 This third edition cancels and replaces the second edition (ISO 9187-1:2000), which has undergone a minor revision with the addition of footnote a) in Table 1. ISO 9187 consists of the following parts, under the general title Injection equipment for medical use: Part 1: Ampoules for injectables Par
14、t 2: One-point-cut (OPC) ampoules Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Aramco HQ/9980755100 Not for Resale, 04/23/2007 02:16:10 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 9187-1:2006(E) iv ISO 2006
15、 All rights reserved Introduction Ampoules are suitable packaging materials for storing pharmaceutical products until they are administered to the patient. Owing to the direct contact between injectables and the primary container over extended storage periods, possible interactions are avoided in or
16、der to guarantee patient safety. Adequate means to achieve this objective include proper selection of primary packaging materials, the choice of suitable package design and the availability of specific requirements and methods for testing individual container systems. In the past, four standardized
17、forms of ampoule (forms A, B, C and D) have been in widespread use. However, form A is no longer used in the pharmaceutical industry and consequently has not been included in this part of ISO 9187. To avoid any confusion among manufacturers and users, it was decided to retain the same designation le
18、tters (i.e. B, C and D) for the forms of ampoules in current use, and to disregard the letter A. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Aramco HQ/9980755100 Not for Resale, 04/23/2007 02:16:10 MDTNo reproduction or networking permitte
19、d without license from IHS -,-,- INTERNATIONAL STANDARD ISO 9187-1:2006(E) ISO 2006 All rights reserved 1 Injection equipment for medical use Part 1: Ampoules for injectables 1 Scope This part of ISO 9187 specifies materials, dimensions, capacities, performance and packaging requirements for three f
20、orms of glass ampoule (forms B, C and D) for injectable pharmaceutical products. It is applicable to ampoules with and without a colour break-ring. The provision of ampoules with a colour break-ring, and the choice of colour of the break-ring, is subject to agreement between the manufacturer and use
21、r. Ampoules complying with this part of ISO 9187 are intended for single use only. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the
22、 referenced document (including any amendments) applies. ISO 720, Glass Hydrolytic resistance of glass grains at 121 degrees C Method of test and classification ISO 1101, Geometrical Product Specifications (GPS) Geometrical tolerancing Tolerances of form, orientation, location and run-out ISO 2859-1
23、, Sampling procedures for inspection by attributes Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection ISO 4802-1, Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 1: Determination by titration method and classification ISO 48
24、02-2, Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 2: Determination by flame spectrometry and classification ISO 7500-1, Metallic materials Verification of static uniaxial testing machines Part 1: Tension/compression testing machines Verification and calibration
25、of the force-measuring system Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Aramco HQ/9980755100 Not for Resale, 04/23/2007 02:16:10 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 9187-1:2006(E) 2 ISO 2006 All
26、rights reserved 3 Dimensions and designation 3.1 Dimensions The dimensions of ampoules shall be as shown in Figures 1, 2 and 3 (forms B, C and D respectively) and as given in Table 1. 3.2 Designation Designation of ampoules shall consist of the descriptor word “ampoule“, followed by a reference to t
27、his part of ISO 9187, followed by the ampoule form, the nominal volume, the colour of the glass and, if applicable, mention of a colour break-ring. EXAMPLE 1 Designation of a form B ampoule without colour break-ring with a nominal volume of 10 ml, made of colourless glass (cl) complying with the req
28、uirements of this part of ISO 9187: Ampoule ISO 9187-1 B 10 cl EXAMPLE 2 Designation of a form B ampoule with a colour break-ring (cbr) with a nominal volume of 10 ml, made of colourless glass (cl) complying with the requirements of this part of ISO 9187: Ampoule ISO 9187-1 B 10 cl cbr 4 Material Co
29、lourless (cl) or amber (br) glass of hydrolytic resistance grain class ISO 720 HGA 1 shall be used. A change in the chemical composition of the glass material should be notified by the tube manufacturer to the user at least nine months in advance. 5 Requirements 5.1 Hydrolytic resistance When tested
30、 in accordance with ISO 4802-1 and ISO 4802-2, the hydrolytic resistance of the internal surface of ampoules shall comply with the requirements specified for hydrolytic resistance container class ISO 4802- HC 1. 5.2 Annealing quality Ampoules shall be annealed; the maximum residual stress of uncolou
31、red ampoules after annealing shall not produce an optical retardation exceeding 50 nm per millimetre of glass thickness. 5.3 Breaking force It is presumed that the ampoules to be tested are provided with a predetermined breaking point, such as a ceramic ring, at the constriction. When tested in acco
32、rdance with Clause 6, the breaking force shall be as specified in Table 2. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Aramco HQ/9980755100 Not for Resale, 04/23/2007 02:16:10 MDTNo reproduction or networking permitted without license from
33、 IHS -,-,- ISO 9187-1:2006(E) ISO 2006 All rights reserved 3 Key 1 constriction 2 sealing point 3 stem 4 bulb 5 shoulder 6 base or bottom Key 1 funnel Key 1 dome NOTE For other dimensions, see Figure 1. NOTE For other dimensions, see Figure 1. NOTE For dimensions of parameters, see Table 1. Figure 1
34、 Form B: stem, cut ampoule with constriction Figure 2 Form C: stem, open-funnel ampoule with constriction Figure 3 Form D: stem, sealed ampoule with constriction Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Aramco HQ/9980755100 Not for Resa
35、le, 04/23/2007 02:16:10 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 9187-1:2006(E) 4 ISO 2006 All rights reserved Table 1 Dimensions of ampoules Dimensions in millimetres Nominal volume ml Dimension 1 2 3 5 10 20 25 30 10,75 10,75 12,75 14,75 17,75 22,5 22,5 22,5 Bo
36、dy d1 a tol. 0,15 0,15 0,15 0,15 0,20 0,25 0,25 0,25 6,5 6,5 6,5 7 7,5 8,5 8,5 8,5 Constriction d2 b tol. 0,5 0,5 0,5 0,5 0,5 0,5 0,5 0,5 8,5 8,5 8,5 9 9,5 12 12 12 Bulb d3 tol. 0,5 0,5 0,5 0,5 0,5 1 1 1 6 6 6 7 7,1 7,8 7,8 7,8 Stem d4 tol. 0,35 0,35 0,35 0,35 0,35 0,5 0,5 0,5 9 9 10,7 12,2 13 14 14
37、 14 Funnel d5 c tol. 0,8 0,8 0,8 1 1 1 1 1 10 10 10,5 12 13,5 13,5 13,5 13,5 Dome d6 c tol. 1 1 1 1 1 1 1 1 8 8 8 9 9,5 11 11 11 External diameter Flared end d7 tol. 1 1 1 1 1 1 1 1 60 72 75 83 102 113 128 143 Form B h1 tol. 1 1 1 1 1 1 1 1 67 79 82 90 109 120 135 150 Form C h2 tol. 1 1 1 1 1 1,5 1,
38、5 1,5 70 83 89 95 112 126 141 156 Overall height Form D h3 tol. 1 1 1 1 1 1 1 1 25,5 37,5 39,5 46,5 62 76 91 106 Height to constriction h4 tol. 0,5 0,5 0,5 0,5 1 1,3 1,3 1,3 47 57 62 68 87 100 115 130 Height to gauging point h5 tol. 2 2 2 2 2 2 2 2 Body height h6 min. 21 33 35 41 55 65 80 95 Height
39、Centre of constriction to bulb h7 max. 4,5 4,5 5 5,5 6 6,5 6,5 6,5 1 1 1,5 1,5 2 2,5 2,5 2,5 Radius r tol. 0,5 0,5 0,5 0,5 0,5 0,5 0,5 0,5 1 1 1 1 1,25 1,5 1,5 1,5 Base Depth of the base e tol. 0,5 0,5 0,5 0,75 1 1 1 1 0,5 0,5 0,5 0,55 0,6 0,7 0,7 0,7 Glass thickness of body w1 tol. 0,03 0,03 0,03 0
40、,03 0,04 0,04 0,04 0,04 0,37 0,37 0,37 0,40 0,47 0,50 0,50 0,50 Glass thickness of stem at gauging w2 tol. 0,05 0,05 0,05 0,05 0,05 0,05 0,05 0,05 Glass thickness at base w3 min. 0,3 0,3 0,3 0,4 0,4 0,5 0,5 0,5 0,7 0,7 0,7 0,7 0,8 1 1 1 Glass thickness of constriction w4 tol. 0,1 0,1 0,1 0,15 0,15 0
41、,2 0,2 0,2 Glass thickness of dome w5 0,1 to 0,25 0,1 to 0,30 Circular run-out tolerance t d 0,6 0,6 0,8 1 1 1,2 1,2 1,2 Wall thickness Volume to centre of constriction V ml 1,5 2,3 3,5 5,5 11,5 23,5 28,5 33,5 a The deviation from the perpendicularity between bottom and length axis at the body outsi
42、de diameter shall not exceed an angle of 2. b If there is a need to reduce the constriction diameter, e.g. due to reducing of particles, it shall be agreed between manufacturer and purchaser. c No point of the funnel and the dome shall be outside of the body diameter. d The run-out tolerance shall b
43、e measured at the sealing point (according to ISO 1101). Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Aramco HQ/9980755100 Not for Resale, 04/23/2007 02:16:10 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 918
44、7-1:2006(E) ISO 2006 All rights reserved 5 Table 2 Breaking force Breaking force Nominal volume Length l (= l1 + l2) mm Fmin. N Fmax. N 1 2 3 5 36 (= 18 + 18) 80 10 90 20 25 30 60 (= 22 + 38) 30 100 6 Test for breaking force 6.1 Principle The test is suitable for determining the force required to se
45、parate the ampoule stem from the body and for assessing whether a clean break is obtained. 6.2 Apparatus 6.2.1 Tensile testing machine The tensile testing machine shall be in accordance with ISO 7500-1 and have the following characteristics: a test speed, v, of 10 mm/min, and a measuring range for f
46、orce of 200 N. NOTE Other test procedures, e.g. with a power increase of 20 N/s, are admissible if equivalent results can be obtained. An example of the test set-up is illustrated in Figure 4. 6.3 Sampling 6.3.1 Number of samples Random sampling in accordance with ISO 2859-1 (inspection level S-4) i
47、s recommended. 6.3.2 Conditioning of samples The temperature of the samples shall be 20 C 5 C. 6.4 Procedure Set the distance between the metal bars, as shown in Figure 4, so that the force is imparted on the middle of the bars at an angle of 90 to the axis of the ampoule. Apply the force using the tensile testing machine to rupture. Record the breaking force. Copyright International Organization for Standardization Provided by IHS under license with