1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS ISO 11040-2:2011Prefilled syringesPart 2: Plunger stoppers for dental localanaesthetic cartridgesBS ISO 11040-2:2011 BRITISH STANDARDNational forewordThis British Standard is
2、the UK implementation of ISO 11040-2:2011. It supersedes BS 7652-2:1995, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/212, IVDs.A list of organizations represented on this committee can be obtained on request to its secretary.This publication doe
3、s not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. BSI 2011 ISBN 978 0 580 70605 9 ICS 11.040.10; 11.040.25; 11.060.20 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was publi
4、shed under the authority of the Standards Policy and Strategy Committee on 30 April 2011.Amendments issued since publicationDate T e x t a f f e c t e dBS ISO 11040-2:2011Reference numberISO 11040-2:2011(E)ISO 2011INTERNATIONAL STANDARD ISO11040-2Second edition2011-04-01Prefilled syringes Part 2: Pl
5、unger stoppers for dental local anaesthetic cartridges Seringues prremplies Partie 2: Bouchons-pistons pour cartouches dentaires danesthsie locale BS ISO 11040-2:2011ISO 11040-2:2011(E) COPYRIGHT PROTECTED DOCUMENT ISO 2011 All rights reserved. Unless otherwise specified, no part of this publication
6、 may be reproduced 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 T
7、el. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2011 All rights reservedBS ISO 11040-2:2011ISO 11040-2:2011(E) ISO 2011 All rights reserved iiiForeword ISO (the International Organization for Standardization) is a worldwide federati
8、on of national standards bodies (ISO member bodies). The work of preparing International Standards 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
9、. International organizations, governmental and non-governmental, in liaison with ISO, also take 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 w
10、ith the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to 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 appr
11、oval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility 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 11040-2 was prepared by Technical Comm
12、ittee ISO/TC 76, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use. This second edition cancels and replaces the first edition (ISO 11040-2:1994), which has been technically revised by: aligning this International Standard with the ISO 8871 series
13、; separating requirements on plunger stoppers (this part of ISO 11040) and seals; the latter are now completely covered by ISO 11040-3; revising Table 1 on dimensions of plunger stoppers; revising the requirements on material, hardness, freedom from leakage and sliding characteristics; adding requir
14、ements on resistance to ageing. ISO 11040 consists of the following parts, under the general title Prefilled syringes: Part 1: Glass cylinders for dental local anaesthetic cartridges Part 2: Plunger stoppers for dental local anaesthetic cartridges Part 3: Seals for dental local anaesthetic cartridge
15、s Part 4: Glass barrels for injectables Part 5: Plunger stoppers for injectables Part 6: Plastic barrels for injectables BS ISO 11040-2:2011ISO 11040-2:2011(E) iv ISO 2011 All rights reservedIntroduction Primary packaging components made of elastomeric materials are an integral part of medicinal pro
16、ducts. As such, the principles of current Good Manufacturing Practices (cGMP) are applicable to the manufacturing of these components. Principles of cGMP are described in ISO 15378, and in GMP Guidelines published by the European Community5and the United States of America6. BS ISO 11040-2:2011INTERN
17、ATIONAL STANDARD ISO 11040-2:2011(E) ISO 2011 All rights reserved 1Prefilled syringes Part 2: Plunger stoppers for dental local anaesthetic cartridges 1 Scope This part of ISO 11040 specifies the shape, dimensions, material, performance requirements and labelling of plunger stoppers for dental local
18、 anaesthetic cartridges intended for single use only. NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can be affected significantly by the nature and performance of the primary packaging. 2 Normative references The following referenced documen
19、ts are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 48, Rubber, vulcanized or thermoplastic Determination of hardness (hardness b
20、etween 10 IRHD and 100 IRHD) alternative normative reference to ISO 7619-1 ISO 3302 (all parts), Rubber Tolerances for products ISO 7619-1, Rubber, vulcanized or thermoplastic Determination of indentation hardness Part 1: Durometer method (Shore hardness) alternative normative reference to ISO 48 IS
21、O 8871-1, Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates ISO 8871-4, Elastomeric parts for parenterals and for devices for pharmaceutical use Part 4: Biological requirements and test methods ISO 11040-1, Prefilled syringes Part 1
22、: Glass cylinders for dental local anaesthetic cartridges ISO 11040-3, Prefilled syringes Part 3: Seals for dental local anaesthetic cartridges 3 Classification Plunger stoppers shall be classified as follows: Type A: plunger stoppers without cavities; Type B: plunger stoppers with one cavity; Type
23、C: plunger stoppers with two cavities. BS ISO 11040-2:2011ISO 11040-2:2011(E) 2 ISO 2011 All rights reserved4 Shape and dimensions 4.1 Shape and dimensions of plunger stoppers shall be as shown in Figure 1 and as given in Table 1. a) Type A b) Type B c) Type C Key d1, d2diameters of plunger stoppers
24、 Figure 1 Shape and dimensions of plunger stoppers showing positions of cavities Table 1 Dimensions of plunger stoppers Dimensions in millimetres DiameterNominal inner diameter of the glass cylinderaTypebd1min. d2max. 6,85 0,15 A 7,1 6,65 6,85 0,15 B 7,2 6,65 6,85 0,15 C 7,4 6,65 a In accordance wit
25、h ISO 11040-1. b See Clause 3. 4.2 In order to avoid adhesion of the plunger stoppers to each other, there shall be spacers. The height of the spacers shall not exceed 0,3 mm. The shape of the spacers should be agreed between manufacturer and cartridge assembler. 4.3 If not otherwise specified, gene
26、ral dimensional tolerances shall be in accordance with ISO 3302. BS ISO 11040-2:2011ISO 11040-2:2011(E) ISO 2011 All rights reserved 35 Designation Plunger stoppers can be designated according to their type; see Clause 3 and Figure 1. The designation shall be expressed as the word “plunger”, followe
27、d by a reference to this part of ISO 11040, followed by the letter designating the type. EXAMPLE Designation of a plunger stopper of Type C (i.e. with two cavities): Plunger ISO 11040-2 C 6 Material The elastomeric material used shall meet the requirements specified in Clause 7. Plunger stoppers sha
28、ll be made from the elastomeric formulation originally tested and approved by the end-user. The manufacturer of plunger stoppers shall ensure the conformance of each delivery with the type sample and compliance with previously agreed functional and compendial requirements. The elastomeric material s
29、hall withstand two sterilization cycles when autoclaving in saturated steam at (121 2) C for 30 min without impairment of its function under the conditions of normal use. In case of other sterilization methods, e.g. irradiation, the suitability of the material shall be evaluated. 7 Requirements 7.1
30、General The requirements specified in 7.2 to 7.4 represent minimum requirements which refer to the condition of the elastomeric plunger stoppers on receipt by the user. 7.2 Physical requirements 7.2.1 Hardness The hardness agreed between manufacturer and user shall not differ from the nominal value
31、by more than 5 Shore A when tested in accordance with ISO 7619-1 on a special test specimen. Alternatively, the hardness can be tested on the plunger stoppers in accordance with ISO 48. If tested in accordance with ISO 48, the microhardness shall not differ by more than 5 IRHD from the type sample.
32、The manufacturer should provide suitable test specimens upon request. 7.2.2 Freedom from leakage The cartridges shall be free from leakage at the plunger when tested in accordance with the method given in Annex A. 7.2.3 Sliding characteristics The sliding characteristics are influenced by all compon
33、ents of the container closure systems and process parameters, e.g. siliconization. The testing of complete systems is described in ISO 11499. The results depend on the configuration and the pretreatment (dry, kind of liquid, storage time, etc.). BS ISO 11040-2:2011ISO 11040-2:2011(E) 4 ISO 2011 All
34、rights reserved7.2.4 Resistance to ageing The maximum time between the date of manufacture and the pharmaceutical use should be agreed upon between the manufacturer of the plunger stoppers and the user. The plunger stoppers shall maintain their performance characteristics throughout the entire shelf
35、 life of the medicinal product. The shelf life is determined by the stability test conducted by the user. NOTE Ageing depends upon the storage and handling conditions. A guide to storage of vulcanized rubber is given in ISO 2230. 7.3 Chemical requirements The requirements in ISO 8871-1 apply. 7.4 Bi
36、ological requirements The requirements in ISO 8871-4 apply. 8 Labelling Packed plunger stoppers which meet the requirements of this part of ISO 11040 can be labelled with the designation given in Clause 5. BS ISO 11040-2:2011ISO 11040-2:2011(E) ISO 2011 All rights reserved 5Annex A (normative) Leaka
37、ge test A.1 Principle Water-filled cartridges are prepared using the plunger stoppers to be tested. By means of a suitable device, force is applied to the plunger stopper during a defined time interval. Any observed leakage is recorded. The leakage test of the plunger stoppers and the seals (see ISO
38、 11040-3) can be combined. A.2 Apparatus A.2.1 Cartridge cylinders, in accordance with ISO 11040-1. A.2.2 Plunger stoppers, to be tested. A.2.3 Seals, in accordance with ISO 11040-3. A.2.4 Suitable equipment, to prepare water-filled cartridges. A.2.5 Cartridge holder, for example as specified in ISO
39、 9997 or ISO 11499. A.2.6 Pressurizing device, capable of applying a force of (30 3) N. A.3 Procedure A.3.1 Fill 10 cartridges completely with water, ensuring that they are free of any air, using the plunger stoppers to be tested. The water may be replaced by a coloured solution in order to improve
40、the visibility of the leakage. A.3.2 Place the first cartridge, mounted in the cartridge holder (A.2.5), into the pressurizing device (A.2.6), and apply a force of (30 1) N for 1 min. Check for leakage at the plunger stopper. SAFETY PRECAUTIONS Ensure that adequate safety measures are in place to pr
41、otect the operator. A.3.3 Repeat the operation described in A.3.2 on the remaining cartridges. A.4 Expression of results Report the number of leakages observed at the plunger stopper. Report whether the testing of the plunger stoppers and the seals (see ISO 11040-3) has been combined. BS ISO 11040-2
42、:2011ISO 11040-2:2011(E) 6 ISO 2011 All rights reservedBibliography 1 ISO 2230, Rubber products Guidelines for storage 2 ISO 9997, Dental cartridge syringes 3 ISO 11499, Dentistry Single-use cartridges for local anaesthetics 4 ISO 15378, Primary packaging materials for medicinal products Particular
43、requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) 5 EC Guide to Good Manufacturing Practice for Medicinal Products, III/2244/87, Rev. 3 January 1998 as amended 6 US/FDA Code of Federal Regulations BS ISO 11040-2:2011BS ISO 11040-2:2011ISO 11040-2:
44、2011(E) ICS 11.040.10; 11.040.25; 11.060.20 Price based on 6 pages ISO 2011 All rights reserved This page deliberately left blankBSI is the independent national body responsible for preparing British Standardsand other standards-related publications, information and services. It presents the UK view
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