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1、BRITISH STANDARD BS ISO 22413:2007 Transfer sets for pharmaceutical preparations Requirements and test methods ICS 11.040.20 ? Licensed Copy: London South Bank University, London South Bank University, Sun Apr 01 14:47:28 GMT+00:00 2007, Uncontrolled Copy, (c) BSI BS ISO 22413:2007 This British Stan
2、dard was published under the authority of the Standards Policy and Strategy Committee on 30 March 2007 BSI 2007 ISBN 978 0 580 50411 2 National foreword This British Standard was published by BSI. It is the UK implementation of ISO 22413:2007. The UK participation in its preparation was entrusted to
3、 Technical Committee CH/212, IVDs. A list of organizations represented on CH/212 can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard
4、 cannot confer immunity from legal obligations. Amendments issued since publication Amd. No. DateComments Licensed Copy: London South Bank University, London South Bank University, Sun Apr 01 14:47:28 GMT+00:00 2007, Uncontrolled Copy, (c) BSI Reference number ISO 22413:2007(E) INTERNATIONAL STANDAR
5、D ISO 22413 First edition 2007-03-01 Transfer sets for pharmaceutical preparations Requirements and test methods Ensemble de transfert pour prparations pharmaceutiques Exigences et mthodes dessai BS ISO 22413:2007 Licensed Copy: London South Bank University, London South Bank University, Sun Apr 01
6、14:47:28 GMT+00:00 2007, Uncontrolled Copy, (c) BSI ii Licensed Copy: London South Bank University, London South Bank University, Sun Apr 01 14:47:28 GMT+00:00 2007, Uncontrolled Copy, (c) BSI iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references. 1 3 Design and designation
7、 . 2 3.1 Design 2 3.2 Designation for a transfer set with housing 4 3.3 Designation . 4 4 Material 4 5 Physical requirements 5 5.1 Particulate contamination 5 5.2 Tensile strength 5 5.3 Tightness. 5 5.4 Free flow 5 5.5 Piercing device 5 5.6 Penetration force 5 5.7 Fragmentation. 6 5.8 Air inlet and
8、air outlet. 6 5.9 Protective caps . 6 5.10 Transfer sets with a housing. 6 6 Chemical requirements 6 7 Biological requirements. 6 8 Testing of physical requirements . 6 8.1 Particulate contamination 6 8.2 Tensile strength 6 8.3 Tightness of transfer set 7 8.4 Free flow 7 8.5 Piercing device 7 8.6 Pe
9、netration force 7 8.7 Testing on fragmentation. 7 8.8 Effectiveness of air inlet and air outlet with air filter 7 8.9 Efficiency of protective caps. 7 9 Testing of chemical requirements 7 10 Testing of biological requirements. 7 11 Packaging 7 12 Storage. 8 13 Labelling 8 13.1 Unit container 8 13.2
10、Shelf or multi-unit container 8 Annex A (normative) Testing of fragmentation of transfer sets with plastic piercing devices . 9 Annex B (normative) Testing of fragmentation of transfer sets with metal piercing devices . 11 Bibliography. 13 BS ISO 22413:2007 Licensed Copy: London South Bank Universit
11、y, London South Bank University, Sun Apr 01 14:47:28 GMT+00:00 2007, Uncontrolled Copy, (c) BSI iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally c
12、arried 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 part in the wor
13、k. 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 to prepare Inter
14、national 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 that some of th
15、e 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 22413 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use. BS ISO 22413:20
16、07 Licensed Copy: London South Bank University, London South Bank University, Sun Apr 01 14:47:28 GMT+00:00 2007, Uncontrolled Copy, (c) BSI v Introduction Transfer sets for pharmaceutical preparations transmit fluids from one container to another by using gravity, vacuum or overpressure. The transf
17、er sets shall mix fluids or dissolve dry substances and are used in combination with infusion and injection containers. The transfer sets consist of at least two piercing devices, which may be connected with each other in different ways. Transfer sets may have a housing. Examples of different design
18、s: a) two piercing devices connected to each other (similar to piercing devices of infusion containers); b) a metal cannula, bevelled on both sides or a combination of a) and b); c) metal cannulae mostly having a hub or a grip plate in the middle to be fixed to the plastic part; d) plastic piercing
19、devices directly connected to a grip plate, or held by a tube at a distance to allow a higher hydrostatic pressure; e) piercing devices with an additional ventilation channel that may end in the other tip or outside; f) piercing devices also with an air filter; g) piercing devices with housings serv
20、ing, among other things, as a guide and a fixation on the connected containers for a secure, injury-free and contactless application. BS ISO 22413:2007 Licensed Copy: London South Bank University, London South Bank University, Sun Apr 01 14:47:28 GMT+00:00 2007, Uncontrolled Copy, (c) BSI blank Lice
21、nsed Copy: London South Bank University, London South Bank University, Sun Apr 01 14:47:28 GMT+00:00 2007, Uncontrolled Copy, (c) BSI 1 Transfer sets for pharmaceutical preparations Requirements and test methods 1 Scope This International Standard applies to sterilized single use transfer sets that
22、are used for pharmaceutical preparations. 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 referenced document (including any amend
23、ments) applies. ISO 7864:1993, Sterile hypodermic needles for single use ISO 8362 (all parts), Injection containers and accessories ISO 8536 (all parts), Infusion equipment for medical use ISO 15223, Medical devices Symbols to be used with medical device labels, labelling and information to be suppl
24、ied ISO 15747, Plastics containers for intravenous injection ISO 15759, Medical infusion equipment Plastics caps with inserted elastomeric liner for containers manufactured by the blow-fill-seal (BFS) process BS ISO 22413:2007 Licensed Copy: London South Bank University, London South Bank University
25、, Sun Apr 01 14:47:28 GMT+00:00 2007, Uncontrolled Copy, (c) BSI 2 3 Design and designation 3.1 Design The designs of the individual components are given in Figures 1, 2 a), 2 b), 3 a) and 3 b). The drawings serve as an illustration of possible transfer sets. Other designs are acceptable. Key for Fi
26、gures 1 to 3 1 piercing device 2 channel 3 channel with air filter for ventilation, optionally lockable 4 protective cap 5 connection of piercing devices by hub, grip plate or tube Figure 1 Transfer set with one channel Figure 2 a) Transfer set with two channels Figure 2 b) Alternative transfer set
27、with two channels BS ISO 22413:2007 Licensed Copy: London South Bank University, London South Bank University, Sun Apr 01 14:47:28 GMT+00:00 2007, Uncontrolled Copy, (c) BSI 3 Figure 3 a) Transfer set with an air inlet/air outlet Figure 3 b) Alternative transfer set with an air inlet/air outlet BS I
28、SO 22413:2007 Licensed Copy: London South Bank University, London South Bank University, Sun Apr 01 14:47:28 GMT+00:00 2007, Uncontrolled Copy, (c) BSI 4 3.2 Designation for a transfer set with housing The designation of a transfer set with housing is given in Figure 4. The drawing serves as an illu
29、stration of a possible transfer set. Other designs are acceptable. Key 1 piercing device 2 channel 3 housing Figure 4 Transfer set with housing 3.3 Designation Example 1: A transfer set without housing (NH) is designated by the term “Transfer set“, the number of this International Standard and the i
30、nitials NH. Transfer set ISO 22413 NH Example 2: A transfer set with housing (WH) is designated by the term “Transfer set“, the number of this International Standard and the initials WH. Transfer set ISO 22413 WH 4 Material The materials for the transfer sets and their individual components shall co
31、mply with the requirements in accordance with Clause 5. If the components come into contact with the liquid to be transferred, the chemical and biological requirements in accordance with ISO 8536-4 shall be met. Piercing devices are manufactured from appropriate materials, e.g. metal and/or plastic.
32、 BS ISO 22413:2007 Licensed Copy: London South Bank University, London South Bank University, Sun Apr 01 14:47:28 GMT+00:00 2007, Uncontrolled Copy, (c) BSI 5 5 Physical requirements 5.1 Particulate contamination Transfer sets shall be manufactured under such conditions that minimize particulate con
33、tamination. All parts shall be smooth and clean. When tested according to 8.1 the evaluation number of the particulate contamination shall not exceed 90. 5.2 Tensile strength 5.2.1 When tested as specified in 8.2 the transfer set shall withstand a static tensile force of not less than 15 N for 15 s.
34、 5.2.2 When using metal piercing devices the steadiness under tensile or compressible force without breaking shall comply with the values listed in Table 2 of ISO 7864:1993. 5.3 Tightness The transfer set shall be air-tight, no leaks of air or liquid shall occur when tested according to 8.3. Sterili
35、ty shall be maintained. 5.4 Free flow When tested according to 8.4 a free flow of air and/or liquid shall be ensured. 5.5 Piercing device The piercing devices shall be suitable for penetration of the intended closure system for injection and/or infusion containers made of glass or plastic. After pun
36、cture, a free flow shall be ensured. When tested according to 8.5 the surface of the piercing devices shall be smooth and free of burrs. The maximum diameter of the piercing device shall be no greater than 6,5 mm. 5.6 Penetration force When tested according to 8.6 the penetration forces determined i
37、n Table 1 shall not be exceeded. Table 1 Penetration force Type of piercing device Penetration force N max. Counterpart Transfer sets with metal piercing device 10 Injection stoppers ISO 8362-2 20 A (Annex B) Hardness: 40 Shore A to 55 Shore A Transfer sets with plastic piercing device 80 Infusion s
38、toppers ISO 8536-2 32 A (Annex B) Hardness: 40 Shore A to 55 Shore A NOTE Freeze-drying stoppers (FD stoppers) may have tight channels at the bottom that affect the penetration force considerably. BS ISO 22413:2007 Licensed Copy: London South Bank University, London South Bank University, Sun Apr 01
39、 14:47:28 GMT+00:00 2007, Uncontrolled Copy, (c) BSI 6 5.7 Fragmentation 5.7.1 The design of the piercing devices should avoid fragments being emitted during piercing. 5.7.2 If plastic piercing devices are tested according to Annex A, a maximum of two fragments per 10 penetrations may occur. 5.7.3 I
40、f metal piercing devices are tested according to Annex B, a maximum of three fragments per 100 penetrations may occur. 5.8 Air inlet and air outlet For transfer sets containing an air inlet device with air filter, the device shall allow venting and maintain sterility. Testing shall be effected accor
41、ding to 8.8. The air filter should be hydrophobic. 5.9 Protective caps The protective caps at the end of the transfer sets shall maintain the sterility of the closure-piercing device. Protective caps should be secure but easily removable. The protective caps shall be appropriate for the intended ste
42、rilization process. 5.10 Transfer sets with a housing 5.10.1 Transfer sets with a housing shall be designed in order to comply with the series of International Standards ISO 8362 and ISO 8536 as well as to comply with the International Standards ISO 15747 and ISO 15759. 5.10.2 The transfer sets with
43、 a housing should be designed in a manner that injury or contact with cannulae is prohibited by the housing, the protective caps or by suitable packaging. 6 Chemical requirements According to ISO 8536-4. 7 Biological requirements According to ISO 8536-4. 8 Testing of physical requirements 8.1 Partic
44、ulate contamination Testing according to ISO 8536-4. 8.2 Tensile strength Expose the transfer set to be tested to a static tensile force of 15 N applied along the longitudinal axis for 15 s. Inspect whether the transfer set withstands the test force applied. For metal piercing devices the testing of
45、 the hub of the metal cannula shall be done according to Clause 13 of ISO 7864:1993. BS ISO 22413:2007 Licensed Copy: London South Bank University, London South Bank University, Sun Apr 01 14:47:28 GMT+00:00 2007, Uncontrolled Copy, (c) BSI 7 8.3 Tightness of transfer set Seal the transfer set at on
46、e end. Apply an internal overpressure of 50 kPa for 15 s using air at the open end, submerge it in water and determine whether air escapes. Close the air inlet, if available, during testing. 8.4 Free flow Visually inspect if the lumen is free of contractions. 8.5 Piercing device Visually inspect if
47、the surface of the piercing device is smooth and free of burrs. Ensure the diameter complies with 5.5. 8.6 Penetration force 8.6.1 For plastic piercing devices testing shall be done according to ISO 8536-2:2001, Annex B. 8.6.2 For metal piercing devices testing shall be done according to ISO 8362-2:
48、1988, Annex B. 8.7 Testing on fragmentation 8.7.1 For plastic piercing devices testing shall be done according to Annex A. 8.7.2 For metal piercing devices testing shall be done according to Annex B. 8.8 Effectiveness of air inlet and air outlet with air filter According to ISO 8536-4. 8.9 Efficienc
49、y of protective caps Perform an efficiency test in order to determine whether the protective caps can be removed without contact of the protected parts. The protective caps shall not fall down under their own weight. 9 Testing of chemical requirements According to ISO 8536-4. 10 Testing of biological requirements According to ISO 8536-4. 11 Packaging 11.1 The transfer sets shall be packed individually and ready to use. A single pack shall be designed in a way that ensures packaging